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BVTI, ABPI, TLON, DCTH, ACTC, XOMA, OREX, potential big winners for 2011

Eric Sebastien — Tue, 04 Jan 2011 19:52:12 +0000

The following companies might be the next big movers and winners of the 2011 year. With significant milestones achieved and unique products, they are leaders in their respective fields and are ready to deliver shareholder value in the coming months.

Biovest International

Following the April 2010 approval of Provenge, we believe a key question in investors’ minds is “who could be next after Provenge in the cancer immunotherapy sector?”. Biovest is the only company that has Phase III data in hand that they will look to file with the FDA in 2011.

In December 2010, Biovest have presented additional data from its Phase III clinical trial at ASH 2010. These data expand and refine the Phase III study findings previously reported at ASCO and further establish BiovaxID’s clinical benefit in the treatment of lymphoma. The data arise from a detailed analysis of Biovest’s manufacturing process in conjunction with the clinical outcomes observed in the Phase III clinical trial. The findings demonstrate that a fundamental protein characteristic of BiovaxID profoundly impacts clinical benefit following vaccination in follicular lymphoma.

Approximately half of the patients (46%) in the Phase III clinical trial had tumor cells bearing the IgM isotype protein (and therefore were provided with BiovaxID manufactured with IgM isotype), and the remainder had tumor cells bearing IgG isotype protein (and therefore were treated with BiovaxID manufactured with IgG isotype). The tumor isotype of the vaccine was previously believed to be unimportant to clinical benefit.

The new analysis revealed that patients receiving BiovaxID manufactured with an IgM isotype experienced a dramatic disease-free survival benefit, while patients receiving BiovaxID manufactured with the IgG isotype did not experience a clinical benefit from vaccination.

The findings presented at ASH 2010 are highly statistically significant and clarify the outcomes presented for the Phase III clinical trial.

The ASH 2010 findings represent a new scientific discovery and a major step for Biovest, these data will bolster the efficacy determination for BiovaxID and support Biovest regulatory strategy.

Biovest intends to seek accelerated/conditional approval regulatory pathway, in part because BiovaxID has received orphan designation in both the U.S. and the EU for the treatment of follicular lymphoma; the use of BiovaxID is supported by a body of evidence from three separate clinical trials; follicular lymphoma is an uncured, fatal disease and BiovaxID represents a new mode of action with robust clinical benefit. Under BiovaxID conditional approval strategy, Biovest would anticipate that additional studies would be required and accordingly, Biovest regulatory strategy includes Phase IV, post-approval trials to be designed with input from the regulatory agencies.

The Clever Bull anticipates that Biovest will file his BLA in the first part of 2011 for a possible approval in Q4 2011 or early 2012. Biovest is also a very good candidate for a buy out, Genentech for example might find interesting to add BiovaxID to his solution Rituxan which is the current standard of care actually.

Accentia

Accentia Biopharmaceuticals recently announced a strategic agreement with Baxter Healthcare Corp. to provide Accentia with the exclusive, worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of designated autoimmune diseases including multiple sclerosis.

The Company noted Cyclophosphamide is the active drug used in Revimmune therapy, Accentia’s proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases.

According to Accentia’s President, Samuel S. Duffey, “We consider our agreement with Baxter to be highly strategic to Accentia’s plans for the development and commercialization of Revimmune. We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to reference Baxter’s data related to cyclophosphamide not only assures that Accentia will have access to the highest quality supply of cyclophosphamide, but also facilitates Accentia’s regulatory strategy and reinforces its market position. With this agreement in place, we are planning a robust clinical and regulatory development strategy to advance our mission to establish Revimmune as a new standard-of-care treatment for patients suffering from autoimmune diseases, including orphan indications with potential accelerated regulatory pathways, as well as major indications such as multiple sclerosis.”

Study Results: Revimmune for Multiple Sclerosis

Researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune.
An article titled “Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis” was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient’s functional status.

Accentia believes these preliminary results to be unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up.

Accentia’s interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc., and Accentia also maintains a royalty interest in Biovest’s biologic products.

Analytica International, Inc. is a wholly-owned subsidiary of Accentia which provides a broad range of consulting services to pharmaceutical and biotechnology companies. Analytica’s team in New York and Germany includes research professionals at the Master’s and Doctoral level in the fields of medicine, epidemiology, biochemistry, statistics, engineering, public health, pharmacy, health economics and business administration.

Accentia Biopharmaceuticals is now in a better position to achieve significant long-term growth. The pipeline targets multi-billion dollar market opportunities and the recent agreement with Baxter is a great development since the Data from Cytoxan will be used in the regulatory process for Revimmune.

Talon Therapeutics

Complete original NDA of Marqibo will be submitted in first half of 2011.

The Company’s lead cancer therapeutic candidate is Marqibo (vincristine sulfate liposome injection), a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine, for the treatment of relapsed/refractory adult acute lymphoblastic leukemia (ALL).

Hana presented results from the registration-enabling Phase II clinical trial (rALLY) of Marqibo for ALL in June 2010 at the ASCO meeting. The data were compelling. Marqibo was administered as third-, fourth-, fifth-, and sixth-line single-agent therapy for ALL patients. The trial achieved 35% overall response rate with a predictable and manageable toxicity profile. The complete response (CR) and CR with incomplete blood count recovery (CRi) were 20%. The median CR/CRi duration was 5.3 months, and median survival in responders was 7.4 months.

Marqibo remains both a near term and long term value for Hana. The drug candidate represents a large opportunity. Marqibo is intended to replace standard vincristine chemotherapy. Vincristine is widely and globally used to treat lymphomas, leukemias, myeloma, solid tumors, and childhood cancers. Vincristine is a major component of highly effective combination chemotherapy regimens such as R-CHOP, R-CVP, CVAD, VAD, and VP. It’s estimated that more than 2.4 million doses of Vincristine were sold in the US and Europe per year. However, although Vincristine is used in a broad range of chemotherapies, it is limited by its pharmacokinetics and toxicity profile. Individual doses (1.4 mg/m2) are limited to 2.0 mg regardless of patient size. Frequent, early onset peripheral neuropathy limits cumulative dosing in lymphoma and leukemia induction to approximately 6-8 total mg and rarely more than 12 mg.

Based on the above encouraging Phase II results, Hana completed the pre-NDA meeting with the FDA in April 2010 and recently also in November 2010. The original NDA filing will be completed by the first half of 2011. Hana has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation from the European Medicines Evaluation Agency in adult ALL. We estimate Marqibo will get the FDA approval in the second half of 2011. Submission of Marqibo for EU approval is planned to happen in 2011.

We think Hana is entering a transition period from a pure development stage company into a commercialization concern. With an appropriate growth strategy in place, the Company is well positioned to deliver shareholder value in the next few months.

Delcath System

On 22 Dec 2010, Delcath Systems Completed the NDA Submission to the FDA for its Chemosaturation Delivery System.

Delcath is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath is developing a proprietary system for Chemosaturation Therapy that is designed to administer high doses of chemotherapeutic agents to a diseased organ or a region of the body while protecting the patient from potential systemic side effects.

The Chemosaturation Therapy system is designed to be a repeatable, minimally invasive procedure that isolates the blood flow of the targeted organ, saturates the isolated organ with therapeutic agent, and then filters out toxic levels of the drug before returning it to the patient.

There is actually no great treatment for any liver cancer. In our opinion DCTH’s system will be the gold standard of care, and will open up numerous opportunities for other big pharmaceutical and biotech companies which could use this system to benefit and test other cancer drugs.

Analysts continue their bullish sentiment on Delcath Systems, following their recent accomplishments with the NDA submission and CE Mark technical filing. We are confident that DCTH should receive approval in 2011.

Advanced Cell Technology

Advanced Cell Technology is a leader in the field of regenerative medicine. They announced recently that the FDA has cleared the Company’s Investigational New Drug application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). Advanced Cell Technology is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world. There are currently no treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

“ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine,” said Gary Rabin, Interim Chairman and CEO of ACT. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible.”

Xoma

XOMA is at the forefront of antibody discovery and development, one of the most powerful and transformative fields of drug innovation today. Building on a pioneering proprietary pipeline, a world-class antibody discovery and development platform, plus multiple revenue streams, XOMA is creating innovative human antibody therapeutics with the potential to transform medicine and reshape people’s lives.

Recently, XOMA and Les Laboratoires Servier, announced the signing of a regional agreement to jointly develop and commercialize XOMA 052, XOMA’s anti-inflammatory drug candidate, in multiple indications. Key elements of this agreement include: XOMA will receive approximately $35 million upfront, up to approximately $470 million in payments and tiered royalties up to a mid-teens percentage rate. XOMA retains development and commercialization rights for Behcet’s uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier receives similar rights in the rest of the world. Servier will fund the first $50 million of XOMA 052 development expenses and 50% of further expenses for the Behcet’s uveitis indication. XOMA 052 is expected to advance into Phase 3 development in Behcet’s uveitis in 2011. Servier will fund development for diabetes and cardiovascular disease indications in exchange for worldwide rights. XOMA retains an option to reacquire the development and commercialization rights to the diabetes and cardiovascular indications in the U.S. and Japan by paying an option fee and partial reimbursement of incurred development expenses. If XOMA reacquires these rights, it has the ability to license them to one or more third parties.

In 2011, XOMA and Servier expect to hold discussions with multiple regulatory agencies to initiate Phase 3 studies of XOMA 052 in Behcet’s uveitis.

Orexigen Therapeutics

We were among the first to enlighten the potential of Orexigen and we stated in July 2010 that Orexigen might be the best play among the 3 companies with respect to Weight Loss Drugs. While Orexigen received a positive recommendation from the FDA advisory committee for the treatment of obesity, the advisory committee’s decision is a non-binding recommendation to be considered by the FDA in finalizing the review of the Contrave NDA.

On 2 Sep 2010, Orexigen Therapeutics and Takeda Pharmaceutical Company Limited announced that they have entered into an exclusive partnership to develop and commercialize Contrave (naltrexone SR/bupropion SR), Orexigen’s investigational drug for the treatment of obesity, in the United States, Canada and Mexico. Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity/ Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory. Under the terms of the agreement, Orexigen and Takeda will work together on ongoing development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities. The parties will share in the costs of any future development of the product.

Orexigen has a PDUFA date in January 31th 2011.

Full Disclosure:

-Author has Long positions on BVTI, ABPI and TLON.
-The Clever bull has NOT been compensated in any way by any of the above mentioned companies to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

TheCleverBull.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Clever Bull has not been compensated by any of the above mentioned companies. Please read our report and visit our Web site, www.thecleverbull.com, for complete risks and disclosures.

Accentia (PINK:ABPI) is advancing potential blockbuster drug candidates

Eric Sebastien — Thu, 02 Dec 2010 18:56:56 +0000

Accentia is a biopharmaceutical company focused on commercialization of innovative product based on revolutionary discoveries in the field of immunology.

Accentia is advancing a portfolio of potential blockbuster drug candidates which target multi-billion dollar market opportunities. These late-stage products include: BiovaxID®, a novel anti-idiotype cancer vaccine for the treatment of B-cell malignancies including indolent follicular non-Hodgkin’s lymphoma; Revimmune™, a novel ultra-high-dose formulation of a previously approved chemotherapeutic agent expected to show utility in the treatment of up to 80 autoimmune diseases, with an initial focus on multiple sclerosis; and SinuNase™, a novel formulation of a previously approved anti-fungal for the topical, intranasal treatment of chronic sinusitis.

Accentia’s interest in BiovaxID is based on its majority ownership stake in Biovest International, Inc., and Accentia also maintains a royalty interest in Biovest’s biologic products.

Pipeline:

BiovaxID®

BiovaxID is a personalized, patient–specific therapeutic vaccine designed to stimulate the patient’s own immune system to recognize and destroy cancerous B–cells (a specific type of white blood cell or lymphocyte) that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non–Hodgkin’s lymphoma, BiovaxID is designed to kill only cancerous B–cells, with the initial indication of indolent follicular non–Hodgkin’s lymphoma. Additionally, it is anticipated that BiovaxID could potentially be used to treat other types of blood cancers, such as Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia and Multiple Myeloma.

Originally developed by researchers at the National Cancer Institute and Stanford University, BiovaxID holds the potential to be the very first anti–cancer vaccine to achieve U.S. and/or broad global approvals. Of the 130,000 new cases of non–Hodgkin’s lymphoma (NHL) diagnosed every year in the U.S. and Europe, approximately 30% fall into the category of indolent, follicular B–cell NHL, which is the segment that BiovaxID is initially targeting. Although chemotherapy, radiation and certain immunotherapies are routinely used to treat indolent, follicular B–cell NHL, such treatments are by no means considered a cure, are often very difficult to tolerate, with relapse likely if not inevitable. There is an urgent need to improve existing regimens in order to indefinitely sustain remission rates, thus representing an enormous opportunity for BiovaxID.

Completed Phase II Study:

After completing the vaccination protocol (n=20), with a median 9-year following complete response to chemotherapy (PACE):

•    45% of patients remained tumor-free (continuous complete remission) after a median of 8-years.
•    95% of patients were still alive after 9-years.
•    95% had significant T-cell activity and/or 75% B-cell activity against their lymphoma cells

Completed Phase III Study:

Enrollment was for newly diagnosed patients with follicular non-Hodgkin’s lymphoma. Randomization required that patients achieve a complete clinical remission (CR or CRu) following chemotherapy. Both arms of the clinical trial were well-balanced in terms of stage and degree of malignancy and in terms of patient characteristics at enrollment and randomization. The modified intent-to-treat (ITT) analysis from the point of randomization for all patients in the trial who received at least one dose of BiovaxID or control vaccination (n=117; 2:1 ratio of BiovaxID versus control) showed that the median duration of complete remission in the BiovaxID arm of the study was 44.2 months which is clinically and statistically significant compared to the control arm, median duration of cancer-free survival of 30.6 months. BiovaxID prolonged the cancer-free survival by 13.6 months or 44% (p-value = 0.045; HR = 1.6) with a median follow up of 56.6 months (range 12.6 to 89.3 months).

Revimmune™

Accentia holds the worldwide exclusive license to Revimmune for the treatment of autoimmune diseases, such as multiple sclerosis. Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at Johns Hopkins University School of Medicine, Revimmune uses an already-approved active pharmaceutical (cyclophosphamide) in a novel, patent-pending, ultra-high dose, pulsed administration capable of “rebooting” a patient’s immune system. Revimmune therapy is believed to act by completely eliminating mature lymphocytes throughout the body while selectively sparing immune stem cells in the bone marrow. Shortly following a course of Revimmune, a natural “rebooting” process takes place as bone marrow stem cells repopulate the immune system without memory of the autoimmunity.

Investigators at Johns Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to the new immune system over 2 to 3 weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

Revimmune is the world’s first therapy to propose the restoration of neurologic and physical functions and offer the potential for the elimination of autoimmunity.

Recently Accentia Biopharmaceuticals announced a strategic agreement with Baxter Healthcare Corp. to provide Accentia with the exclusive, worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of designated autoimmune diseases including multiple sclerosis.

Cyclophosphamide is the active drug used in Revimmune therapy, Accentia’s proprietary system-of-care being developed for the treatment of a broad range of autoimmune diseases.

The agreement also grants Accentia with the exclusive right for designated indications to reference Baxter’s proprietary, historical data related to cyclophosphamide as part of Accentia’s planned clinical and regulatory development of Revimmune. The agreement designates Baxter as Accentia’s sole source of cyclophosphamide for Revimmune.

Study Results: Revimmune for Multiple Sclerosis

In addition to multiple sclerosis, investigators at Johns Hopkins have successfully treated the following autoimmune diseases in preliminary studies and case experiences: Systemic Lupus; Myasthenia Gravis; Aplastic Anemia; Autoimmune Hemolytic Anemia; Refractory Scleroderma; Acquired Pemphigus; Rheumatoid Arthritis and Crohn’s Disease.

SinuNase™

Accentia holds the worldwide, exclusive commercial rights to SinuNase (topical amphotericin B 0.01% suspension), an intranasal, low-dose antifungal product, as granted by the Mayo Clinic. SinuNase is especially unique because it is the first product to target what is believed to be the true cause of chronic sinusitis: fungal-induced inflammation. SinuNase is self-administered into a patient’s nasal cavity and holds the potential to be the first product approved for treating chronic sinusitis.

Currently, there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMEA) approved treatments for chronic sinusitis, which affects more than 60 million sufferers in the U.S. and Europe. SinuNase is the only intranasal, anti-fungal chronic sinusitis product that has been submitted as an Investigational New Drug (IND) to the FDA, and while SinuNase failed to achieve its primary endpoint in its initial Fast-Track pivotal Phase 3 clinical trial, Accentia found certain encouraging results that warrant further development. Accentia is continuing to analyze these results to determine the optimal course of future clinical development of SinuNase.

More than 60 Million CS Sufferers in U.S. and Europe with Sales Potential > $5B

SinuTest™

Accentia has the exclusive commercial rights in the U.S. to the patented diagnostic, SinuTest™, which is a diagnostic used to measure eMBP (eosinophilic major basic protein) in the nasal mucin of the suspected chronic sinusitis patients. SinuTest is the only confirmatory lab test available for the diagnosis of chronic sinusitis, and it is currently being marketed by Accentia to Ear, Nose and Throat Specialists (ENTs) and Allergy Specialists. SinuTest is expected to provide physicians with a tool to predict those patient candidates best suited to benefit from treatment with SinuNase.

Financial:

On November 17, 2010, Accentia Biopharmaceuticals announced that the Company and its majority-owned subsidiary, Biovest International, have both successfully completed their reorganizations. Pursuant to their respective Plans of Reorganization approved by the bankruptcy court, Accentia and Biovest have now formally exited Chapter 11 as fully restructured organizations.

Conclusion:

Accentia Biopharmaceuticals is now in a better position to achieve significant long-term growth. The pipeline targets multi-billion dollar market opportunities and the recent agreement with Baxter is a great development. Data from Cytoxan will be used in the regulatory process for Revimmune.

Accentia Biopharmaceuticals was trading at $1.50 before the reorganization plan was announced, since then the share price went down to $0.77 and has now stabilized at $0.90. We believe that some debtors sold their shares just after the company has formally exited Chapter 11. We think this is now oversold, the company has many catalysts that should drive the price well over the $1 range again.

It is also actually undervalued by the market based on its majority ownership stake in Biovest International.

Full Disclosure:

-Long position on ABPI, the author owns 30.000 shares at an average price of $1.02
-The Clever bull has NOT been compensated in any way by Accentia to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

Biovest International (OTC:BVTI),The Next potential winner in Cancer Immunotherapy Vaccine after Dendreon (NASDAQ:DNDN)

Eric Sebastien — Wed, 01 Dec 2010 16:02:45 +0000

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies. In collaboration with the National Cancer Institute, Biovest has developed a patient-specific, cancer vaccine, BiovaxID®, with three clinical trials completed, including a Phase III study, demonstrating evidence of safety and efficacy for the treatment of indolent follicular non-Hodgkin’s lymphoma and mantle cell lymphoma. It is also developing an automated cell culture instrument. The company also sells hollow fiber bioreactors, cultureware, tubing sets, and other disposable products and supplies.

Here is a recent video presentation of Biovest International. This corporate presentation was recorded during “Cancer Immunotherapy: A Long Awaited Reality”, a conference hosted by BioBusiness.TV and MD Becker Partners on October 21st, 2010, at the New York Academy of Medicine:

http://www.biobusiness.tv/report-on-location/biovest-international-presentation-at-cancer-immunotherapy-conference-1600/

Technically, Biovest International is a majority owned subsidiary company of Accentia Biopharmaceuticals, Inc. (OTC:ABPI).

A new Phase III Data Analysis for BiovaxID®, Personalized Lymphoma Vaccine, will be featured in an oral presentation at the American Society of Hematology (ASH) Annual Meeting on Monday, December 6th in Orlando, Florida.

Cancer immunotherapy represents a new revolutionary treatment modality; we expect growing interest in the investment community for the coming years.

Recently the approval of Provenge, the first active immunotherapeutic agent by Dendreon, has cleared uncertainty of clinical and regulatory paths for the whole class of such drugs. The company has nothing to do with Dendreon Corp. (NASDAQ:DNDN) in the business, but the targets of the potential products use the body’s own immune system to fight tumors strike a similar interest.

With an appropriate growth strategy in place, a very talented management team and amazing Phase III datas, Biovest International is now well positioned to deliver shareholder value in the coming months.

BiovaxID:

BiovaxID is individually manufactured from a tissue biopsy obtained from each patient’s tumor. The vaccine targets a protein unique to each patient, called an idiotype, expressed by cancerous B cells in follicular lymphoma, while sparing normal, healthy B cells that do not express the tumor protein. Additional studies will need to be conducted to determine the efficacy of BiovaxID in patients who have had rituximab therapy (a common lymphoma treatment that was not part of the treatment received by patients in this study), and to determine if the vaccine may also be useful in the treatment of other B-cell lymphomas.

BiovaxID Personalized Vaccine Prolongs Disease-Free Survival for Follicular Lymphoma.
An eight-year, randomized phase III clinical trial reported that BiovaxID, a patient-specific therapeutic vaccine, prolonged disease-free survival in previously untreated patients with follicular non-Hodgkin lymphoma. Patients who received BiovaxID experienced disease-free survival of 44.2 months, compared with 30.6 months for those who received a control vaccine—an increase of 47%.

Development:

Biovest’s BiovaxID, which is in late-stage development for B-cell lymphoma. This cancer immunotherapy stems from work begun in 1986 during the development of a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine primes the immune system to recognize and eliminate cancerous lymphoma cells, while sparing normal B cells. In the vaccine’s cancer target, B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen of the cancer cells that is not present in noncancerous tissue. By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces an immune response against the cancerous cells. There are about 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the United States with a comparable number in Europe.

On Tuesday, 22 Jun, Biovest International, Inc. announced that the Company is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication for its personalized cancer vaccine, BiovaxID. The Company reviewed positive data from an open label Phase II mantle cell lymphoma clinical trial and reported plans to meet with the FDA later this year to discuss a pathway to seek regulatory approval for this hematological indication for which there is no current consensus standard-of-care. Biovest is also currently preparing to seek approvals for BiovaxID for the treatment of follicular non-Hodgkin`s lymphoma. Biovest recently filed an application with the FDA seeking Orphan Drug status for BiovaxID for the mantle cell lymphoma indication. This aggressive form of lymphoma constitutes about 6% of all non-Hodgkin`s lymphoma cases or approximately 7,800 cases per year in the U.S. and Europe combined.

On Monday, 26 July, the FDA has granted Orphan Drug Designation to BiovaxID, Biovest’s personalized cancer vaccine, for a second lymphoma indication mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company’s regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin’s lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.

Financial:

Biovest has been in a difficult position over the last couple of years, having both positive Phase III data in hand while at the same time having financial troubles leading to Chapter 11. Biovest is now reemerging. The financial woes have prevented the company from fully capitalizing on the strength of the clinical data acquired to date. In fact, the Phase III data for BiovaxID was accepted for oral presentation at the ASCO 2009 Plenary Session. It is important to point out that out at this key session highlighting important data, only 4 presentations were accepted and Biovest was one of them. BiovaxID has the potential to be the next up to the FDA for review as a cancer immunotherapy and is designed to treat lymphoma.

On Wednesday, 17 Nov 2010, Biovest International, Inc. announced that the Company has successfully completed its reorganization, and pursuant to Biovest’s Plan of Reorganization approved by the bankruptcy court, the Company has now formally exited Chapter 11 as a fully restructured organization. As now deemed effective, the Plan of Reorganization restructured Biovest’s balance sheet by reducing outstanding debt, rescheduling debt payment obligations and reducing operating expenses. Under the Plan, stockholders retained their common shares. An important part of the confirmed restructuring was a previously announced $7 million financing for which ROTH Capital Partners, LLC acted as the exclusive placement agent. Structural changes to certain agreements are now in effect including the reduction of the outstanding royalty on BiovaxID sales from 35% to 6.30%, thus expected to enhance Biovest’s commercial and partnering opportunities.

Biovest International also received notice from the U.S. Internal Revenue Service (IRS) that it was approved to receive a Federal grant in the amount of approximately $245,000.00 under the Qualifying Therapeutic Discovery Project. The funds were awarded to support the advancement of BiovaxID®, Biovest’s late-stage, personalized cancer vaccine for the treatment of non-Hodgkin’s lymphoma.

Conclusion:

We view Biovest International as ready to capitalize on years of research and clinical experience and view BiovaxID as a revolutionary technology, which could transform cancer therapy. We believe that we are in a timeframe where investors are taking the time to finally educate themselves on the cancer immunotherapy space and would look to place their bets on the next potential Provenge.

Biovest is actually the only cancer immunotherapy product company that has Phase III data in hand that they will look to file with the FDA in 2011.
Biovest International was trading over $2 before the reorganization plan was announced, since then the share price went down to $1.30 and has now stabilized at $1.20. We believe that some debtors sold their shares just after the company has formally exited Chapter 11. We think this is now oversold, the company has many catalysts that should drive the price well over the $2 range again. Not to mention the long potential with a BLA submission and a potential fast approval of BiovaxID, we may have the same move as DNDN did ($3 to $40) in the coming months.

Full Disclosure:

-Long position on BVTI, the author owns 30.000 shares at an average price of $1.39.
-The Clever bull has NOT been compensated in any way by Biovest International to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

INVO Bioscience (OTC:IVOB) next catalysts to come

Eric Sebastien — Thu, 18 Nov 2010 04:12:43 +0000

Recently, Invo Bioscience released amazing result at the 66th Annual Meeting of the American Society of Reproductive Medicine (ASRM) in Denver.

The presentation revealed that CECOLFES produced clinical pregnancy rates of 43% per INVOcell cycle and a 48% clinical pregnancy rate when an embryo has been transferred in the cycle. This outstanding effectiveness was achieved in cycles completed in women from ages 21 to 45. The clinical pregnancy rate for patients aged 40 and younger was 46%. According to the U.S. Center for Disease Control (CDC) current infertility treatments are in the same range of efficacy. The CECOLFES results also indicated that multiple pregnancies occurred in 10% of the patients in the study compared to 30% multiple pregnancies that occur in more traditional fertility treatment regimes. Multiple pregnancies can cause very serious and expensive complications.

Invo Bioscience is progressing very well, latest clinical study for INVOcell has validated the usefulness and efficacy of this amazing device to treat infertility problem.

Now what might be the next catalysts for this Biotech Company?

INVO Bioscience is still searching for a financial partner to start the required clinical study in the US in order to get their device approved by the FDA. Meanwhile INVO Bioscience is actively working on extending its distribution network; recently they have completed and signed distribution contracts in Ukraine and Canada.

Next coming catalyst event for INVO Bioscience might come from Asia, with the expected Class II medical device classification for the INVOcell in China.

In August 10th, INVO Bioscience along with his distribution partner The Progressive Group, one of the larger med device and equipment distributors in this area, have started the registration process with Chinese FDA authorities.

http://pgbeijing.com/index.php

The Company’s exclusive distribution partner in China, the Progressive Group, has determined after meetings with the SFDA that the regulatory agency may confer a Class II medical device classification on INVOCell, thereby exempting INVO Bioscience from conducting clinical trials to complete the approval process.

Upon approval and addressing appropriate manufacturing requirements, the Progressive Group will be able to distribute INVOCell to Mainland China, Hong Kong and Taiwan.

Dr. Claude Ranoux, founder, president and chief scientist at INVO Bioscience, said, “We are pleased to commence the regulatory approval process in the Peoples Republic of China. INVO Bioscience has leading-edge technology that can provide great benefits to couples looking to address infertility issues in a manner that is cost effective and minimizes the potential for multiple births. We look to our future in China with great anticipation.”

Chinese Market:

Couples in China, the world’s most populous nation, are having difficulty conceiving. Infertility in the country has risen from 12.5 to 15 percent but that number could climb quickly to about 20, according to a report released recently at a forum in Beijing.

However the price tags are prohibitive for most people – worth several or many times their annual salary – but an increasing number of Chinese families are now able to afford the treatment.
“Actually more than 10 million Chinese families need artificial fertilization”, according to Xinhua news agency.

Professor Lu Bodong, vice president of the Second Hospital of Zhenjiang Chinese Medical University in Hangzhou, east China’s Zhejiang Province, attributes rising infertility rates to stressful and unhealthy lifestyles that include excessive drinking and smoking, over-indulgence, and also environmental problems, all of which are side effects of China’s dramatic social and economic changes.

“Now, more and more people are becoming open to fertility treatment. There are more than 200 reproduction centers in China, but this is not enough to meet the demand.”
“The industry is believed to be huge in China.” says Zhao Lixin, deputy director of the reproduction center in east China’s Shandong Province Hospital.

Conclusion:

Invo Bioscience remains a very good investment at this level, a unique product and a distribution network that keep expanding. Next huge development to come should be the Chinese SFDA approval.

Progress made by Invo Biosciences is very promising and we believe that the market is under-valuing this amazing Biotech company, we believe $0.25 per share, a market cap of around $15M, would more fairly represents the company. Its unique product addressing a huge market potential and the large distribution network of partners all over the world should be taken into consideration for calculating the market cap.

INVOCell is CE Mark approved in Europe and Canada and conforms with all consumer health and safety requirements. INVOCell is currently marketed and sold in , Austria, , Canada, Cameroon, Columbia, Dominican Republic, Guatemala, Nicaragua, Pakistan, Panama, Peru, Spain, Togo, Turkey, and Venezuela.

Full Disclosure:
-The Clever bull has been compensated by Invo Biosciences to write articles.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

The Clever bull has been compensated 100 000 shares by Invo Biosciences to write articles.

TheCleverBull.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Clever Bull has been compensated 100 000 shares to write articles for Invo Biosciences. Please read our report and visit our Web site, www.thecleverbull.com , for complete risks and disclosures.

Pullback Opportunity, exclusive interview with Hana Biosciences (OTC:HNAB)

Eric Sebastien — Sun, 14 Nov 2010 03:46:20 +0000

Hana Biosciences provided a business update about the progress made during the third quarter.

link to Nov. 12th CC:

ir.hanabiosciences.com/eventdetail.cfm

Complete original NDA will be submitted in first half of 2011. This change in process is not expected to effect the timing of submission completion, review or potential approval.

“During the third quarter of 2010, our focus was on preparation of the 5 modules that make up the NDA submission for Marqibo(R)” stated Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. “An analysis of data from the Menadione Topical Lotion Phase 1 program showed that it was generally safe and well tolerated. In addition, the dose limiting toxicity and apparent maximum tolerated lotion strength were identified. Our strategy is to seek a partner to enhance and accelerate the continued development of Menadione Topical Lotion.

While this should have been considered as good news, some impatient investors have taken their profit off the table after the recent rise of the share price, +50% in one month (While HNAB was down 28% after the CC, it is good to note that the volume was very low). We think the potential is still here and this might represent a good buy opportunity since the submission of the NDA is just few months away and it will be submitted as a complete original NDA with all the modules.

During the CC Dr. Deitcher was very confident that the NDA will be submitted in the first half of 2011. He stated “We are well on the way to accomplishing that goal…”

Hana Biosciences was working on preparing the 5 modules during the third quarter and this will carry on through the end of the year, almost all of the modules will be completed before the end of 2010, we believe a change for a full submission rather than module by module might be a good strategy and Dr. Deitcher mentioned during the CC that it was suggested and recommended by the FDA, it is most convenient for them.

As of September 30, 2010, the Company had cash, cash equivalents and available-for-sale securities of $27.7 million. With the recent $40M financing round, that brings the market cap of Hana Biosciences to around $50M, which we consider to be still very low regarding the pipeline, and the long term potential for Marqibo in other indications.

The Clever Bull has conducted an exclusive interview with Hana Biosciences to highlight more specific points such as the NDA application, the potential for Marqibo in other indications, Menadione, Warburg financing deal. Here is the interview between The Clever Bull and Craig Carlson, CFO of Hana Biosciences:

1- You are about to fill the rolling NDA for Marqibo, are you confident to get an accelerated approval review? You said the NDA will be filled before end of 2010, are you still on track with this time frame?

Response: On November 8, 2010 we held a pre-NDA follow-up meeting with the FDA. At that meeting we and the FDA agreed that Hana would submit all of the NDA modules simultaneously instead of following a rolling submission process. This change in process is not expected to effect the timing of submission completion, review or potential approval. We anticipate submitting the completed NDA in the first half of 2011. We are pursuing an accelerated approval of Marqibo and the program already has Fast-Track and Orphan Drug designations from the FDA.

2- Can you confirm that other applications with Marqibo such as Front-line NHL and Front-line Ph-ALL which represent a total market of around 5B will both only require Phase III studies? Are they already started or when do you plan to start them?

Response: We expect that studies such as the ones you indicated will only require Phase III studies. However, until a Phase III trial protocol is approved by the FDA there is not 100% certainty. No Phase III clinical trials of Marqibo have commenced. The logical strategy is to receive the FDA’s approval decision on Marqibo’s current indication before committing funds to a large, expensive, label expansion trial.

3- Are those other applications with Marqibo already founded or do you plan to partner with the classic method of upfront payment and royalties system?

Response: For large, expensive, multi-national, Phase III clinical trials, it is common for small companies to seek to share costs with another entity. We are keeping all our options open.

4- Marqibo has been granted EMA Orphan Drug designation in Europe and you said you are exploring the potential for an authorization under exceptional circumstances. Can you tell us more about this process and does it mean Marqibo may be approved in Europe in 1H11?

Response: Hana will seek formal Scientific Advice from EMA in 2011. Approval in Europe will require a full regulatory submission. The approval decision in Europe is anticipated to follow the approval decision in the US.

5- There is actually one clinical trial that is ongoing with the NCI with respect to pediatric cancers ALL, when will we have some data about this promising indication?

Response: The pediatric oncology branch of the NCI will be conducting a Phase 1 pharmacokinetic and dose finding study. The study could take up to 2 years to fully enroll.

6- Now, with respect to Menadione, we are waiting for Top-line data and the start of the Phase II before end of this year. The focus is on Marqibo for now and investors have yet to discover the potential of this topical cream. Since it has the potential to prevent the rash in chemotherapy treated patients and it is also effective to treat psoriasis, can you tell enlighten us about the market potential in term of numbers?

Response: First, we have no clinical data demonstrating the efficacy of Menadione Topical Lotion for treating psoriasis. We recently completed the Phase 1 program. The Phase 1 program has successfully demonstrated that MTL is generally safe and well-tolerated. The dose limiting toxicity, skin irritation and redness, was only observed at the 0.2% lotion strength. The apparent maximum tolerated lotion strength is 0.1%. MTL applied twice daily at all strengths, including the highest lotion strength tested (0.2%) resulted in no appreciable systemic exposure.

Due to the fact that there are no comparable lotions indicated for the treatment of EGFR rash, there is no empirical data establishing the size of the opportunity. It is estimated that there are approximately 45,000 to 50,000 people undergoing EGFR therapy annually in the U.S and Europe.

7- Since Menadione is a topical cream, does it need to go through a classic FDA review process with a NDA filing? You said you plan to find a partner for Menadione, you mentioned discussions with partners are ongoing, can you tell us more about this?

Response: Menadione Topical Lotion requires the completion of the standard FDA clinical trial process. We are unable to comment on discussions with potential partners.

8- You recently signed a financing deal with Warburg Pincus for up to $100M. While many investors fear dilution to come, can you explain the Warburg’s strategy with your company? Do you feel it’s a long term partner that will push Hana Bioscience to a bigger company?

Response: Warburg Pincus has a track record as a long-term investor seeking to generate significant value but we are unable to predict how things will progress with Hana at this time.

9- There has been some misunderstanding with the convert prices post R/S. Can you confirm that convert prices did increase 4X also with the R/S and are now at $0.72 and $1.10? We have seen that Warburg is a long term partner with companies they invest on, do you think they will convert and sell their shares on the market or rather they will wait to get the full potential in the coming years before selling any?

Response: The new conversion prices are $0.736 for the Series A-1 Preferred Stock and $1.104 for the Series A-2 Preferred Stock. Based on the Investment Agreement, the preferred shareholders have options for how they may choose to create liquidity for their preferred shares, including converting to common shares or, if there is an acquisition, preferred shareholders may opt to receive proceeds in cash without converting into common shares. We are unable to predict if or when preferred shareholders may choose to convert their preferred shares to common shares.

10- We know that Warburg has a large portfolio of biotech companies that are almost all traded on the NASDAQ with a market cap of over $500M, do you think we might see HNAB back to the NASDAQ in early 2011?

Response: There are certain requirements to be listed on exchanges such as Nasdaq and Amex. Among the requirements are share price, stock holder equity, and market cap, as well as others. We are unable to predict when Hana may meet the necessary requirements, if at all.
Forward-Looking Statement
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “expects,” “plans,” “believes,” “intends,” and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana’s planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; statements regarding the timing and progress of proposed clinical trials; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding our ability to secure a development partner for Menadione Topical Lotion; and statements regarding the Menadione Topical Lotion regulatory approval process. Such statements involve risks and uncertainties that could cause Hana’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana’s clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana’s claims or beliefs concerning Marqibo’s safety and effectiveness; and that Hana will be able to secure a development partner for Menadione Topical Lotion. Additional risks that may affect such forward-looking statements include Hana’s need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana’s reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company’s Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company’s Form 10-Q for the period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.

Full Disclosure:

-Long position on HNAB
-The Clever bull has NOT been compensated in any way by Hana Biosciences or Warburg Pincus to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

INVO Bioscience (OTC:IVOB) released Amazing Clinical Study result for INVOcell

Eric Sebastien — Mon, 01 Nov 2010 01:44:09 +0000

Invo Bioscience released amazing result at the 66th Annual Meeting of the American Society of Reproductive Medicine (ASRM) in Denver.

The presentation revealed that CECOLFES produced clinical pregnancy rates of 43% per INVOcell cycle and a 48% clinical pregnancy rate when an embryo has been transferred in the cycle. This outstanding effectiveness was achieved in cycles completed in women from ages 21 to 45. The clinical pregnancy rate for patients aged 40 and younger was 46%. According to the U.S. Center for Disease Control (CDC) current infertility treatments are in the same range of efficacy. The CECOLFES results also indicated that multiple pregnancies occurred in 10% of the patients in the study compared to 30% multiple pregnancies that occur in more traditional fertility treatment regimes. Multiple pregnancies can cause very serious and expensive complications.

Invo Bioscience is progressing very well, latest clinical studies for INVOcell have validated the usefulness and efficacy of this amazing device to treat infertility problem.

Invo Bioscience keeps signing distribution contracts, recently they have signed an exclusive distribution agreement with the Ukraine-based Biodar Plus Co. to distribute the Invocell product throughout Ukraine and to provide the Invo Bioscience infertility treatments in its in-house infertility center.

According to Invo, Biodar Plus is licensed by the Ukrainian Ministry of Health to provide a range of medical services, including gynecological and infertility treatments, and to distribute certain medical devices.

Ukraine, as a country, suffers the demographic problem of a shrinking population. The Ukrainian government provides a series of cash incentives for couples to encourage an increase in the rate of national childbirth. The Ukrainian Government is also planning the implementation of a monthly subsidy payment for each child less than 18 years old.

Invo Bioscience is expanding his distribution network all over the world, they are already at the next level, being out of R&D with a very good product being marketed in many countries. While financing still remains a challenge for this company, they are still progressing amazingly, there is no doubt that Invo Bioscience will be a leader in the infertility treatment area, their device has already proven a huge efficacy. We may expect more press articles and coverages in the near term after the amazing results published last week, spreading the word among infertility couple all over the world.

Invo Bioscience is still waiting news about federal grants, we shall hear about that pretty soon.

Conclusion:

Invo Bioscience remains a very good investment at this level, a unique product and a distribution network that keep expanding. Next huge development to come should be the Chinese SFDA approval for InvoCell and hopefully grand funding from the Federal.

Progress made by Invo Biosciences is very promissing and we believe that the market is under-valuing this amazing Biotech company, we believe $0.25 per share, a market cap of around $15M, would more fairly represents the company.

Full Disclosure:
-The Clever bull has been compensated by Invo Biosciences to write articles.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

The Clever bull has been compensated 100 000 shares by Invo Biosciences to write articles.

Understanding Warburg Pincus strategy: (OTC:HNAB), (NASDAQ:ISPH), (NASDAQ:ALTH), (NASDAQ:ZGEN), (NASDAQ:EURX), (NASDAQ:ITMN), (NYSE:WX)

Eric Sebastien — Thu, 14 Oct 2010 15:46:27 +0000

That might be a good time to look again at Hana Biosciences, as they have many catalysts and news to release before the end of 2010 that should drive shareholder value:

- Rolling NDA filling for Marqibo in Adult ALL (that means a PDUFA date and the classic run-up period)

- Top-line Menadione Topical Lotion proof-of-concept data

- Initiate Phase 2 Menadione Topical Lotion trial

- Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma with an estimated primary completion date of December 2010 (Final data collection date for primary outcome measure)

2011 might also be a very good year for Hana Biosciences, with the potential approval of Marqibo in Adult ALL and the start of Phase III studies for other indications with Marqibo ($5B market).

For a reminder and due diligence on Hana Bioscience you may take a look at their corporate presentation:

http://files.shareholder.com/downloads/HNAB/1031314646x0x234717/40046CB8-6148-43F6-87AC-D3194C86932C/HNAB_081408.pdf

Recently Hana Biosciences has signed a deal with Warburg Pincus for up to $100M financing. Many investors have had a problem to digest this deal although it is a fantastic step for the development of Hana Biosciences. As soon as the dilution word comes out, investors are scared, but we are talking here about a financing from Warburg, investors must see them as a partner for the long term, let me explain who is Warburg Pincus and what they do.

Warburg Pincus takes a different approach to investing. Private equity at Warburg Pincus means investing at all stages of a company’s life-cycle: From founding start-ups and fostering growth in developing companies to leading complex recapitalizations or large-scale buy-outs of more mature businesses.

Years of private equity experience, deep industry knowledge, and unparalleled networks of resources and contacts help their investment professionals identify opportunities, attract leading entrepreneurs and management teams, and ultimately grow businesses in today’s rapidly changing environment.

They definitely know how to move a company from something small to something much larger.

The firm’s unique, globally-integrated partnership ensures that all of their resources are committed to the success of each portfolio company. Regardless of an investment’s stage of development, industry focus or geography — the right people, with the right experience, are available to every entrepreneur and management team.

So why Hana Biosciences is so undervalued now?

Rather than understanding the long potential, many investors have seen this financial agreement for something bad in the short term. How many small biotechs today would have loved this $100M of available funding? The answer,a lot!

The recent R/S has scared Hana’s investors but that was something necessary. If you look at the Warburg Pincus portfolio they have many public companies that actually trade on the Nasdaq. With some good news to come before the end of this year you can bet that Hana will trade back to the Nasdaq soon.

Warburg is now deeply implicated with Hana Biosciences, they own the majority and you can bet that they have an exit strategy that will benefit to everybody because their business is to make money and to unlock the potential of companies.

Many investors are now afraid to invest in Hana Biosciences because of the potential dilution, but you can be sure that Warburg is not here to dump shares after the first higher trend, if you look at their portfolio they are invested in companies for many years, for some as early as 2000. Their goal is to stay long and maximize their profit. Warburg manages over $30 billion in assets, they don’t need to sell Hana’s shares as soon as the convet price is reached, they will rather take Hana to the next level and maximize their investment. They may also keep their shares until a potential buy out.

Let me remind you that with the reverse split, the convert prices for the Warburg’s shares did increase as well and are now $0.74 for the first preferred serie A1 shares and $1.10 for the serie A2.

We believe Warburg will follow Hana Biosciences for 3 to 5 years or even more, go through the approval of Marqibo in adult Ph-ALL, go through the Phase III study for the Front-line Agressive NHL (market potential of around $5B) at this point we might see Hana with a $500M to $800M market cap which is the average market cap of the companies that Warburg is invested in!

“We are very pleased to be able to provide the financing necessary to advance Hana’s promising product pipeline,” said Jonathan Leff, a Managing Director of Warburg Pincus. “We look forward to working closely with the company’s board and management team to address important unmet needs in oncology.”

Healthcare Portfolio of Warburg Pincus (public companies only):

http://www.warburgpincus.com/portfolio/PortfolioByIndustry.aspx

Headquartered in South San Francisco, California, Hana Biosciences, Inc. (OTCBB: HNAB) is a publicly traded biopharmaceutical company focused on developing and commercializing novel treatments in oncology. Its lead drug, Marqibo, is a novel formulation of the widely used cancer drug Vincristine. Hana has completed a pivotal clinical trial with Marqibo in adults with Acute Lymphoblastic Leukemia (“ALL”), and the Company plans to file for Food and Drug Administration (“FDA”) approval in this indication. One of Hana’s other key development programs, Menadione, is completing Phase I studies for treatment of the serious skin toxicity caused by a major class of approved cancer drugs.

Market cap: $10M (with 20M shares)

Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) based in Raleigh, NC, is a biopharmaceutical company focused on developing and commercializing new treatments for diseases in the ophthalmic and respiratory areas. Founded in 1993 and publicly traded since 2000, Inspire currently markets three ophthalmology products and has two drugs in late-stage clinical development: Denufosol in Phase III for the treatment of Cystic Fibrosis and AzaSite for blepharitis.

Warburg Pincus led a private placement in Inspire in July 2007, and subsequently participated in a follow-on public offering in 2009. Since Warburg Pincus’ original investment, Inspire has successfully completed one Phase III trial of Denufosol for the treatment of Cystic Fibrosis, launched AzaSite for the treatment of bacterial conjunctivitis, and announced positive Phase II trial results of AzaSite for the treatment of blepharitis. Additionally, in 2009, Warburg Pincus and the board recruited a new CEO in Adrian Adams, former President & CEO of Sepracor which he sold to Dainippon Sumitomo for $2.6 billion and former President & CEO of Kos which he sold to Abbott for $3.7 billion.

Market cap: $520M

Allos Therapeutics, Inc. (NASDAQ:ALTH) based in Westminster, Colorado, is a pharmaceutical company focused on developing and commercializing small molecule drugs for the treatment of cancer. The Company’s lead drug, Folotyn, was approved in September 2009 as the first FDA-approved drug for the treatment of relapsed or refractory peripheral T-cell lymphoma, a rare cancer whose sufferers have a very poor prognosis. Allos continues to advance several additional clinical studies of Folotyn in a wide range of other cancer types.

Warburg Pincus led a private placement in Allos in 2005 and subsequently participated in a follow-on public offering in 2008. In 2006, Warburg Pincus and the board recruited a new CEO in Paul Berns, former CEO of Bone Care International which he sold to Genzyme for $600 million. Under Paul’s leadership, Allos has successfully developed and launched Folotyn.

Market cap: $450M

ZymoGenetics, Inc. (NASDAQ:ZGEN) based in Seattle, WA, is a biopharmaceutical company focused on the development and commercialization of protein therapeutics. The Company launched its first drug on the US market in 2008, and has a strong pipeline of additional product candidates in development with meaningful commercial potential.

Warburg Pincus has been a significant investor in ZymoGenetics since 2000, when the firm led the spinout of Zymo from Novo Nordisk A/S, a major pharmaceutical company based in Denmark.

Market cap: $840M

Eurand (NASDAQ:EURX) headquartered in Milan, Italy, is a leading specialty pharmaceutical company that develops, manufactures and commercializes pharmaceutical and biopharmaceutical products. The Company operates from integrated research, development and production facilities in Italy, France and North America, and utilizes proprietary pharmaceutical technologies to develop novel products that have advantages over existing products or address unmet medical needs. Through collaboration arrangements with leading pharmaceutical companies, the Company has successfully applied its portfolio of existing and new technologies to drug products in a diverse range of therapeutic areas, including cardiovascular, gastrointestinal, pain, nutrition and respiratory. Eurand is currently developing and commercializing its own portfolio of therapeutic products to address conditions associated with cystic fibrosis and gastrointestinal disorders.

In partnership with management, Warburg Pincus acquired Eurand from American Home Products, Inc., now part of Pfizer, in 1999. Warburg Pincus subsequently invested additional funds into the Company, primarily to fund a number of acquisitions. Eurand completed its initial public offering on Nasdaq in May 2007 raising gross proceeds of $112 million.

Market cap: $520M

InterMune, Inc. (NASDAQ:ITMN) based in Brisbane, CA, is an independent biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology. The Company was founded in 1999 with a strategy of acquiring clinical-stage products that could benefit from increased development and commercial focus within targeted therapeutic areas. The Company’s pulmonology pipeline includes pirfenidone for idiopathic pulmonary fibrosis (IPF), a progressive disease characterized by inflammation and scarring of the lungs. In hepatology, InterMune, together with its partner Roche, is developing a protease inhibitor, danoprevir (also known as RG7227 and ITMN-191), for the treatment of hepatitis C. InterMune also sells Actimmune, an interferon-gamma approved for the treatment of two rare congenital disorders.

Warburg Pincus led InterMune’s second round of private financing in 2000 to help fund product acquisitions and the execution of clinical trials for and commercialization of new product indications.

Market cap: $820M

WuXi (NYSE:WX) headquartered in Shanghai, China, is a premier contract research organization (CRO) with operations in China and the US. The Company was founded in 2000 as a provider of outsourced research chemistry lab services to the pharmaceutical industry, and has grown rapidly to become the global leader in this field. WuXi has expanded this core lab service business to include biology services, and has developed emerging capabilities in the related areas of clinical and commercial manufacturing and toxicology.

Warburg Pincus became a significant shareholder of WuXi beginning in 2008. Since Warburg Pincus’ investment, WuXi has strengthened its management team, demonstrated strong operational performance despite macro-economic headwinds, and continued to expand its product offering into higher value-added services. In April 2010, WuXi announced a $1.6 billion merger with Charles River Labs to create the first global CRO offering fully integrated early-stage drug development services to clients worldwide.

Market cap: $1.17B

ev3 (NASDAQ: EVVV) headquartered in Plymouth, MN, is a leading global endovascular device company focused on the treatment of peripheral vascular and neurovascular disease. The company’s product portfolio includes a broad spectrum of over 100 products, including stents, embolic protection, PTA balloons and atherectomy devices for the peripheral vascular market, as well as embolic coils, liquid embolics, flow diversion, and access products for the neurovascular market.

Warburg Pincus founded ev3 in 2000, and has fostered the Company’s product development strategy by funding internal development programs and strategic acquisitions. Warburg Pincus also helped recruit a roster of highly talented managers with extensive experience in all aspects of the interventional devices business. ev3 completed an initial public offering in June 2005 and a follow-on public offering in April 2007. In October 2007, ev3 acquired FoxHollow Technologies, a developer of atherectomy devices for the treatment of peripheral vascular disease. In June 2009, ev3 acquired Chestnut Medical Technologies, a privately held company focused on developing neurovascular devices, including the Pipeline Embolization Device for aneurysms.

Market cap: June 1, 2010 – Covidien plc (NYSE: COV) and ev3 Inc. (NASDAQ: EVVV) announced that they have signed a definitive merger agreement under which Covidien will acquire all of the outstanding shares of ev3 Inc. for $22.50 per share in cash, for a total of $2.6 billion, net of cash acquired.

Full Disclosure:

-Long position on HNAB
-The Clever bull has NOT been compensated in any way by Hana Biosciences or Warburg Pincus to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

INVO Bioscience, Inc. (OTC: IVOB), one more step in North America!

Eric Sebastien — Mon, 13 Sep 2010 23:51:12 +0000

INVO Bioscience, Inc. (OTC: IVOB), is engaged in the development of technology for the treatment of infertility. Its device, the INVOcell, and the INVO procedure are designed to provide an alternative infertility treatment for the patient and the clinician. INVO also allows conception and embryo development to take place inside the woman’s body.

The INVOcell is a small capsule that is used in infertility treatment, for the incubation of eggs and sperm for embryo development. Unlike conventional infertility treatments such as in vitro fertilization (IVF), where the eggs and sperm develop into embryos in a laboratory, the INVOcell utilizes the women’s vagina as a natural incubator to support embryo development. This novel INVOcell technology offers patients a more personal approach to achieving pregnancy, decreases the risk of multiple births and reduces the chance for creating unused embryos.

INVOCell is CE Mark approved in Europe and Canada and conforms with all consumer health and safety requirements. INVOCell is currently marketed and sold in , Austria, , Canada, Cameroon, Columbia, Dominican Republic, Guatemala, Nicaragua, Pakistan, Panama, Peru, Spain, Togo, Turkey, and Venezuela.

China partner and development update:

Recently INVO Bioscience announced that it has commenced the registration process for its INVOCell fertility device with the State Food and Drug Administration (SFDA) of the Peoples Republic of China (PRC). The Company’s exclusive distribution partner in the PRC, the Progressive Group, has determined after meetings with the SFDA that the regulatory agency may confer a Class II medical device classification on INVOCell, thereby exempting INVO Bioscience from conducting clinical trials to complete the approval process.

Document submission to the SFDA has begun and needed translations are being performed. Upon approval and addressing appropriate manufacturing requirements, the Progressive Group will be able to distribute INVOCell to Mainland China, Hong Kong and Taiwan.

This was a big news and investors underestimated it in our opinion, China is a huge market as infertile couples rate is one of the highest in the world. Exempting INVO Bioscience from conducting clinical trials to complete the approval process in China is a major milestone in the company development.

Ongoing clinical study in South America:

In June 2010 INVO Bioscience announced the Initial Results of the Clinical Trial Performed at Nacer (Peru), the clinical pregnancy rates of 57 INVO cycles performed in the study in Peru has an average clinical pregnancy rate of 28% per cycle and a multiple pregnancy rate under 12%. These initial results demonstrate the efficacy and reproducibility of the INVO procedure for the treatment of infertile couples. Dr. Diaz stated that is current results are significantly stronger but his overall results are lower because of his initial learning curve.

INVO Bioscience is awaiting the final result of another Clinical Trial Performed at CECOLFES (Columbia), INVO Bioscience has performed 90 INVO cycles and numbers will be out very soon around October. We have been told by the management that it will be a very high rate number, something to be considered has a huge news. The general consensus being that the results are highly positive for the InvoCell device around the world.

Strengthen the position in Canada, moving forward to fund the US Clinical Trial:

INVO Bioscience is now moving to strengthen its position in North America. In Canada, INVO Bioscience has signed a distribution agreement with Invaron Pharmaceuticals. Canada is also a big market for infertility treatment, recently the government in Quebec announced it will help cover the cost of in vitro fertilization (IVF) treatments for infertile couples, the first offer of government subsidization for the costly infertility procedure in North America.

Quebec couples who cannot conceive naturally will be eligible for three free rounds of IVF treatments, which can cost up to CA$15,000 (US$14,531) for a single treatment.

In Canada, 10 to 15% of couples, or more than 300 000 couples are affected by a reduced fertility rate.

The InvoCell device has the CE Mark so there is no need to conduct clinical studies in Canada, however the device needs to be introduced and presented to IVF clinics across the country, the process has already started and major IVF centres have been approached already to use the InvoCell device. We have heard that articles about the InvoCell should be released in different major Canadian newspapers, getting some credibility and publicity for InvoCell among infertile couples throughout the country.

INVO Bioscience is also focusing on starting the US clinical trial, management is in discussions with potential development and commercialization partners in the U.S. and Canada. The potential exists that something gets done to provide additional funding for expansion of the marketing and promotional effort behind Invocell in 2011.

Financing position:

Regarding the financing, INVO Bioscience is now focusing on finding a partner by in-licensing. We are hearing some very loud and credible chatter that an in-licensing deal might happen with a big pharma in Canada or USA.

Additionally, INVO Bioscience qualified for a U.S. federal research grant between $500k and $1 million to start to fund the U.S. regulatory FDA trial for INVOcell. Management has already applied for these funds and expects to hear back by the end of September.

Following the ongoing successful clinical studies in South America, INVO Bioscience is continuing to work to further strengthen their device position around the world. Fundamentally, INVO Bioscience is stronger than at any time in their corporate history, and management is extremely excited about InvoCell’s future. They have commercialized their first product, which is generating revenue in a growing Worlwide market. While revenue and income are still low for now, market cap and Wall-Street valuation does not reflect at all the potential of this little Boston Biotech company.

The company is also looking to tap its reserve equity financing (REF) agreement with AGS Capital Group LLC.
INVO Bioscience and AGS entered into the REF in October 2009, which allows the company to issue common stock for cash consideration of up to $10 million.

Conclusion:

The actual market cap of $2M is ridiculous considering that INVO Bioscience is becoming a strong and recognized company in the infertility field. With a unique device product already CE mark and an international distribution network in place, it would worth already at the very least 10 times the actual market cap! The Zack’s analyst has an outperform recommendation with a target price of $0.25.

We believe that major news are going to be released, we are awaiting for the clinical trial result in Columbia and have been told that it might be surprising and big, also a positive answer from the Federal R&D Tax Credit would be a very big news for the company and investors.

The work already accomplished by the company is amazing and while it is taking more time than anticipated to increase revenue and resulting income, 2011 should improve dramatically for INVO Bioscience.

With an estimated 150 million infertile couples worldwide, at the current market value of only $2M, we believe that this is dramatically underappreciated by Wall Street, recent developments and coming news should easily push up the price above the $0.20 range again.

Full Disclosure:

-No positions on IVOB

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

US Wireless Online (UWRL) Due Diligence

Edward Stevenson — Fri, 04 Jun 2010 04:51:58 +0000

In this piece I will analyze three essential components and share my thoughts with you as to why they are crucial in this context and to US Wireless Online (PINK:UWRL) investors.

Recent News Release

U.S. Wireless Online, Inc. (UWRL) Comments on Recent Stock Price Volatility (Source: http://yhoo.it/9rbRlT)

HENDERSON, NV, U.S. Wireless Online, Inc. (UWRL.PK) today commented on its recent stock price activity in the Pink Sheets market. “We have noted the trading in our stock in the last few weeks,” said Michael York, UWRL President “We feel that the activity is out of line with the Company’s potential are therefore going to investigate the trading activity in the Pink Sheets.”

Bold Statement. Management is aware that a declining share price will not fetch well with investors, or attract traders, for that matter. The intonation implies that UWRL principals will work to resolve the issue. Resolving the issue equates to boosting the share price which equates to the return on investment (ROI) traders & investors seek.

UWRL also asks that shareholders or other having any information that might be relevant to send it to the Company through its investor relations firm at www.minamargroup.net/helpdesk. On Tuesday, UWRL introduced a potential merger with Canadian company Welcome Place (http://www.welcomeplace.ca/ ). Welcome Place provides customers with software and training to teach individuals how to become successful day traders in the futures market. Negotiations are currently underway between US Wireless Online Inc. and Welcome Place, and due diligence on the company is being conducted. UWRL is optimistic about future success of Welcome Place.

“We also wish to emphasize that our development is proceeding as planned and that we intend that there will be no dilution in the equity of the Company. We are also meeting on Monday with our advisors to address this unwarranted and substantial share price decline.

This statement implies that not only is management aware of the share price situation, but that they also intend on helping the situation or resolving it as soon as possible, which is in the best interest of shareholders.

The company confirms that it is not engaged in any sort of dilution and encourages its shareholders to report any unusual trading activity or cross trading or anything irregular to the US regulators. UWRL is monitoring the situation.” A source close to UWRL noted.

The company reminds its shareholders and followers that UWRL was a company in duress obtained through a Nevada court custodianship. UWRL’ “in peril” days are long gone and well behind it. UWRL is a great robust and up and coming company. We remind our followers that Go Green Electronic Recycling; USA based company (current subsidiary) and the Canada based Welcome Place (targeted merger candidate) will be the two secondary operating subsidiaries. They show great future appreciation and potential. The “Main” China based subsidiary remains still to be announced. The mandate for our M&A consultants are to locate an operating company with revenues in the 5 to 10 million dollar range with assets of the same.

Punchline. The ‘good’ stuff. Notice the company understands that in order to market to investors it must give the market what it wants. This news release did just that. Let’s recap: (1)the company reassured shareholders that they are aware of the situation, (2)stated that management will take action to resolve the issue and increase share price to accurately (subjective) reflect the value of US Wireless Online,(3)gathered the interest of new and prospective investors by hinting on significant shareholder value with an up and coming merger, one which has yet to be announced.

Several such candidates have been identified with UWRL agent still in China reviewing and conducting due diligence on the targeted merger companies. In view of the recent price fluctuations this main China merger may be announced any time by the UWRL management to assist the oversold traders cover their positions.

And the company ends off by saying, “don’t turn your back on US Wireless Online, because once the gears are in motion, you’ll regret having done so in the first place”.

Technical Aspect

Technical investigations into the trading patterns of OTC-listed stocks are often arbitrary. The purpose of technical analysis in this context is to grasp the ‘big picture’. The key supporting level appears to be $0.0015; pivotal resistance lies at $0.003.

Most importantly, how would you describe the price/volume relationship in this market? Does volume favor movement to the upside, to the downside, or is volume at a standstill? Following Thursday’s session (June 3rd, 2010), US wireless jumped 33% on the largest one-day volume in its history.

This, itself, suggests that interest towards US wireless Online has increased significantly, amongst investing & trading communities.

Valuation

How much is US Wireless Online worth? If we know how much this company is valued at, we can propose a realistic valuation and translate that to a fair market valuation (pps). At this point our knowledge of this holding company’s assets is limited. However, Us Wireless Online stated in their release that “The mandate for our M&A consultants are to locate an operating company with revenues in the 5 to 10 million dollar range with assets of the same“.

The company previously announced the acquisition of “Go Green Electronic Recycling”, and are in negotiations to acquire “Welcome Place”.

Assume, collectively, these three acquisitions (once finalized) will account for $10M in sales; $10M in shareholders’ equity. With a modest 1X sales multiple or at book value, US Wireless Online would require a capitalization of $10M.

Therefore, we derive a low-end valuation, with an assumption based on the statements that the company has issued:

$10M/2B O/S (assume there are 2B shares outstanding, otherwise the ‘authorized’ count: http://bit.ly/8ZBETL) =$0.005/share

On the high-end, implement any sales or book value multiple that you believe justifies the potential value of this holdings company. That could translate to a price per share of $0.01+

Another useful study is benchmarking. Pull up any chart on a Mina Mar counterpart, for instance, GoIP Global, Inc. (GOIG) and you will find a stock with a similar share structure to UWRL, but one that has already rallied over 6000% (in a matter on a few months). Who is anyone to say that US Wireless Online will follow in suit? While uncertainty exists in every market, we do the best we can with the information available to us, and the trends that envelop the markets. I am of the opinion that US Wireless Online is yet to see a significant upside.

Aquagold International Looks To Expand Production (PINK:AQUI)

Michael Vlaicu — Fri, 16 Apr 2010 01:38:00 +0000

AQUAGOLD INTERNATIONAL INC. (PINK: AQUI) is a global distributor of premier Canadian spring water products. Since the company’s inception, the South-Pacific region has been the focus of its operations. The area’s extremely fast growing demands and the creation of Aquagold Asia, a Chinese corporation, have allowed Aquagold International to establish a prominent position in the Chinese market.

Great things have occurred last year for AQUAGOLD Canada and at the production facilities located in Canada. The growing market for AQUAGOLD bottled water means that the Company needs to ensure that distribution is running smoothly. Canadian operations are responsible for production and logistics for all of AQUAGOLD International.

In 2009, the Company secured $197M in contracts and the Company is actively searching for international shipping companies that are aligned with the Company’s vision and can deliver what the Company anticipates to be continuous and substantial growth. AQUAGOLD began delivery of its flagship product to Shanghai in June as well as the acceptance of the letter of credit by the opening bank in China. A portion from this first order went to the Dashang Group, the largest retailer in Northeast China and the fifth largest retailer of any kind in China. Management believes the successful delivery of product is the result of the strong leadership team of the Company.

In China, AQUAGOLD has seen significant momentum in all of its sales and marketing endeavours as the Company continues to successfully increase brand awareness in the Asia Market. The hit television show AQUAGOLD Superface continued to be very popular in China, and was seen by over Thirty million viewers each week. In September, the televised finale took place in Beijing and was followed by a dinner reception where the Beijing area winner was crowned. Chairman Long, from the China International Culture and Communication Center, was the guest of honor and accepted a donation from AQUAGOLD to the Chinese government’s charity fund as well as the company’s pledge to contribute a donation from every sale of AQUAGOLD bottled water at the Expo in China

AquaGold Superface Show on TV

AQUAGOLD Superface also participated in the historical annual festival in Jinan, where the Company continued its brand exposure with the models donning the AQUAGOLD uniform and promoting the bottled water. The AQUAGOLD Superface television show has created several important synergistic associations including with the Editor-in-Chief of “Model Magazine,” Steve Zhong, who is also the Superface Executive Producer. The viewership as well as the prominent Chinese individuals who attended the dinner and festival showed that AQUAGOLD Superface continues to garner attention for the company and its products

CEO, Mark Oliver Hassoun interviewed by Steve Zhong

On the North American continent, AQUAGOLD sponsored one of the largest events ever held celebrating China-United States Relations. “Celebrating the Full Moon Together – A Series of Events Celebrating the 30th Anniversary of the Establishment of Diplomatic Relations between China and the United States,” took place in New York City in October. This event was highlighted by Dr. Henry Kissinger, former US Secretary of State and Chai Zemin, General Advisor of the United States and China Foundation, each being awarded the “Sino-US Friendship Lifetime Achievement Award.” Many notable Chinese and Americans attended and AQUAGOLD was honored to sponsor this event. As a part of the Company’s sponsorship of the event, AQUAGOLD bottled water was available to the guests in attendance

The biggest news in September 2009 was the signing of a contract with the DEVNET agency of the United Nations allowing AQUAGOLD products to be featured in the DEVNET section of the United Nations Pavilion at the Shanghai World Expo in 2010. York Tang, COO of Asia Operations, Mark-Oliver Hassoun, Vice President of Asia Market Sales and attended a signature dinner and ceremony to celebrate this new partnership relationship.

Ceremony dinner at the DEVNET pavilion in Shanghai

The Shanghai Expo, to be held from May to September 2010, is expected to draw over 200 nations and approximately 70 million visitors. AQUAGOLD has an incredible opportunity to introduce the Company’s bottled water product to the world. In addition this contract allows the Company to participate in the pre-opening of the Expo. With these groups putting their stamp of approval on the product, Management believes AQUAGOLD has an unprecedented international sales and marketing platform.

The success of the sales and marketing activity has led AQUAGOLD to formulate plans to increase its sales force. The Company anticipates the sales team increasing to approximately 50 people, as well as hiring 4 Sales Managers with experience in the bottled water industry and key relationships in the market. AQUAGOLD anticipates introducing the product in concentrated areas that include Shanghai, Beijing and the surrounding coastal areas before eventually moving on to second tier markets in China. The On and Off Trade markets, the retail market and the institutional market will be specific market focus areas for the Sales Managers.

AQUAGOLD bottled water has been given prestigious shelf space and is currently on the shelves, ready for sale, at LianHua Supermarket stores. AQUAGOLD representatives will be promoting the Company’s bottled water, distributing information about the product, and available for questions at the retail locations where the product is being sold. By the end of 2006, LianHua had a total of 3716 shopping centers, supermarkets and convenience stores. The Company will also be introducing the concept of onsite water tasting at other various points of sale including hotels, restaurants and karaoke clubs.

AquaGold bottles in Chinese Supermarket

As a result, over the next five years, Aquagold International is poised to respond to the world’s fastest growing market in the bottled water industry. In order to fulfill the growing demand, recent nominations of highly qualified professionals to Aquagold International’s Board of Directors and marketing team have occurred in both Canada and China.

“The quality and purity of our water has been very well-received,” stated Mark-Oliver Hassoun, Vice President of Asian Market Sales. “The reality television show, ‘AQUAGOLD Superface,’ has been a huge success, exposing our company and product to an estimated thirty million viewers per week. We continue to see increasing demand for this luxury brand item, and we look forward to creating further original and innovative ways to introduce our product to Chinese consumers.”

China Water problem situation:

With less than one percent of the earth’s total water mass available for consumption and only nine countries in the world holding upwards of 60% of this essential resource, Aquagold International is passionate about pursuing its mission to become the pre-eminent provider of premier Canadian spring water. Aquagold International believes in the careful management of this crucial life resource to ensure sustainable long-term supply. To this end, the Company has recently signed a co-packaging agreement with Les Eaux Saint-Leger Waters Inc, located in Montreal and known for its consistency in quality and production of bottled water products at standards that exceed government requirements.

You may have heard that China has some of the worse water pollution problems in the world. This week the Chinese government reported that things are even worse than they thought. China has just finished its first comprehensive review of pollution sources. The study found that by at least one key measure, water pollution is twice as bad as they had reported just two years ago. The best snapshot is China’s water quality is horrible, really bad. They have massive industrial contamination; they have massive contamination of human wastes because their waste water systems are not up to any sort of decent standards. We’ve known for many, many years that China’s water quality is bad and it’s beginning to constrain the things that they can do with their water.

China has many water problems of course. They have a very serious quantity problem as well. They’re water short in the northern part of China, sort of like the United States is water short in the western part of the United States. But part of their water quantity problems is the fact that they’ve so badly contaminated so much of their water that even when they have it, they often can’t use it, it’s too contaminated for human use, and it’s even often too contaminated for additional irrigation use.

An official and an old man sit on a dried-up reservoir in Jiulong town in China

Some parts of China are suffering their worst drought in over 50 years. In the cities, demand for water is also increasing as China’s economic boom continues. Environmentalists warn current levels of water consumption may not be sustainable. Pollution is so severe the government estimates 40% of water in the country’s major rivers is fit only for industrial or agricultural use. More than a decade of near double-digit economic growth has put serious strain on water demand in China, which has only 7% of the world’s total water resources, compared with more than 20% of the global population. In the area where Beijing and Tianjin are located there are some cities which in five to seven years will run out of water.

Due to contaminated water being widespread in China, urban families started buying mineral water for water drinking and the market is very promising for pure and clean water especially for foreign water source such as Canadian natural water. Chinese people are very well aware that Canada is a very green and natural country.

Conclusion:

The water is now called the Blue Gold and it will be the most valuable resource in the coming years. AquaGold and his natural Canadian water source is very well positioned in China to profit from this huge boom coming as water becomes a very big problem for not only country side people but also citizen from big cities in China.

The Chinese market is very special and hard to penetrate but once you are very well implanted and your network is fully operational then you can see your sales shoot up to the roof. AquaGold is now very well positioned and has created his network of retailers and local politicians which may now unlock the full potential of the operational sales team to move forward.

A recently signed contract for the 2010 International Shanghai Exposition is huge news. AquaGold will be able to present their product to around 200 different nations present at the expo; this is a real opportunity to introduce AquaGold to many countries.

On the financial side, AquaGold recently announced their move from “Pink Sheets Limited Information” to “Pink Sheets Current Information” in OTC electronic markets.

With China being now the third largest consumer market for bottled water in the world, AquaGold is very well positioned to be a major actor with his very high quality water and very high identity brand.

AquaGold is definitely a winner, with a strong and natural product on constant and increasing demand which is poised to growth exponentially for the coming years.

Disclosure: No Positions

TheMarketFinancial is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.