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.

From a short-term perspective, as a daily trader it is easy to notice why Vivus has a lot of upside possibilities. A textbook Cup and Handle pattern is on the verge of forming (Dec.6.2010 – daily chart), where a breakout above $7.10 could lead to an easy pop towards $7.25.

The bollinger bands was also tested at the top, which resulted in the stock pulling back slightly, and now it seems ready to make another move higher.

Relative Strength Index (RSI) also looks extremely bullish, having reached the bottom as it touched the 30 mark, and is now beginning to trend up as it moves towards a bullish cross.

Technical divergences can persist for weeks before fulfilling their downside potential. That would give enough time for a sharp, quick wave v which would then be followed by a reversal.

The other news of the day is a better than 1% drop in the EuroDollar. Other components of the Dollar Index are fairly flat. The drop in the Euro may have something to do with persistent news on Greek and Irish debt. There may be a “European Debt Crisis” shakeout soon.

The selling in Euro in conjunction with a European debt scare should shake out metals, commodities and stocks and create a buying opp just in time for the ECB to pull off some kind of QE3 of their own to bail out the situation. At which point asset prices will surge again.

This is pure speculation, of course. But the action in the Euro is curious and has been wonky for a couple of weeks now. It’s one of the things that have made me question some of the inflationist assumptions that are ingrained in the markets now. In my opinion should the above scenario come to pass we should not panic out of longer term positions but should be ready to buy FAST as soon as we see an abc correction to support.

There is some chance of a short term top in asset prices and a short term bottom in the dollar.

Tonight there is general weakness in Asia and in commodities while the dollar has strengthened. There is no real “reason” for it, though I suspect that some kind of European sovereign debt jitters are brewing. The Euro has broken down out of the rising wedge indicated in the last update:

If this is an early warning of a debt crisis shakeout then I say “great”! The bears will think it’s “The Top”, the “D” word will once again be spoken in fear, the ECB will print tons of cash, bailout whatever needs to be bailed out and then things will rocket back up to new highs. That is likely to be the pattern over and over again…crisis, fear, mini panic, bailout, rally, new highs.

We have seen many markets break to the upside of rising wedges and channels, an unusual technical occurrence, very bullish IF IT STICKS. If these markets fail back through their patterns and fail badly then that is very bearish. My guess is we see some support retested and then new highs.

Indeed we have seen Euro weakness and dollar strength as sovereign debt concerns regarding Ireland and Portugal have grown. There was no real news to spark today’s selling, which is a little more bearish in that the selling was organic and not news driven. I think that there are indications in the technicals which may point to an intermediate term top and a pullback. I can’t advocate putting any new money to work nor can I say that we should be shorting. The best we can do is continue to ride existing long positions and wait for the correction.

The move off of the QE2 announcement started out like a wave 3 move but has since stalled and the technicals have not really shown the kind of internal strength that would be associated with a wave 3. I’m looking at the recent highs as probably a wave 5 off the August bottom. In that context I am looking for an intermediate term pullback to start anytime now.

The Euro has indeed broken down out of an abcde rising wedge (possible leading diagonal) pattern. I think it’s got more downside to at least the 38.2% Fib retracement of the recent rally.

General asset price direction is tied to the fate of the EuroDollar at this time, with markets tethered to the dollar inflation trade and subject to a bout of fear as questions surrounding Portugal and Ireland mount.

Tonight Cisco announced earnings and the market did not like the results or the guidance. CSCO fell by 12%. Nasdaq 100 futures appear to have broken key support.

The uptrend from the August bottom is gone and we have an upside wedge breakout that has failed back through the formation, a particularly bearish occurrence. If this move holds and we sell down on Thursday then we probably have the beginnings of an intermediate term decline.

In early October, Stocks Above the 50 Day EMA topped out at levels frequently associated with a market high. Recently, the indicator has apparently made a lower high even as the market has moved up creating a divergence.

The McClellan Oscillator is showing a divergence similar to those shown at the January and April tops.

The white boxes show an area of lengthy consolidation in the vicinity of the 0 line after which the indicator breaks down with the market.

Traders should be taking some money off the table here and gearing up to buy after an abc decline. It could last about 1-2 weeks, maybe less. The spark could be any bit of news from Europe. I would not recommend shorting because the decline could be very short lived or it may not even materialize at all. Again, the setup is for a pullback within the context of a wave 3 bull move, not a major top.

The report issued on Wednesday (November 10) seems to have been borne out by market action. The current situation is pregnant with precarious possibilities including a renewed European debt crisis, a US mortgage debt crisis and a US Municipal bond crisis. Any of these could cause a deeper retrenchment in risk assets followed by the customary money printing and bailout leading to a reflation of asset prices.

So far we have a decline to the 20 EMA on SPX, which has contained pullbacks throughout the recent rise. RSI appears to have rolled over and other indicators lead me to believe that we will see SPX test the 50 EMA as a minimum target on this decline.

The short term chart shows the trend channel break on Friday with a weak intraday retest of the break. The chart shows a potential trajectory for the ABC correction.

I have reduced my long exposure to 25% because I think there is too much risk to the downside at the moment. We do need to keep in mind that we probably are somewhere in a Wave 3 up and we don’t want to be caught out of position when the market turns back up because it will probably happen fast and hard.

My current view is that we have seen the first wave down of an intermediate term correction in risk assets. I am using the June 2009 correction as a sort of template. No two corrections are the same but it helps to have a point of reference. B wave up is apparently in progress as overnight we are seeing substantial strength in Asian trade and US futures with commodities recovering and the dollar selling off.

So far there are no signs from the Treasuries-EuroDollar spread (TED) that anything substantial is happening in Europe. No doubt the Euro Fiat Helicopters are being loaded with cash tonight and will commence a bombing run on the green fields of Ireland very soon.

The short term chart of SPX shows a completed A wave down. B wave up should begin now.

NYSE and Dow Jones indices touched their 50 Day EMAs today. B waves frequently start from there.

Traders should be gathering their capital and preparing for one of the best buying opportunities we are likely to get for a long time. While there is (technically) still some chance for a bearish resolution, overall the signs do not point in that direction at this time. I’ll be keeping one eye on it, of course. More likely, as Wave 3 of (3) unfolds the ingrained, long term bearishness of 10 years will be unwound and it will be very, very, very difficult to get on board as the buying panic proceeds. People get ready!

The action sure has been quite choppy and random of late, which is typical of a triangle correction. Here’s a view of what a triangle might look like:

I don’t think that this is a wave 4 off the July SPX 1010 bottom, but rather a correction of a lesser degree within a larger wave 3 up (ii of 3). If the correction ends up being a flat (looking less likely today) then we would have alternation between the August correction and the present one and that would suggest a wave 4. We’ll also have to look at the indicators to see if they give clues as to the degree of the correction. For now I’m seeing it as a correction of the move off the September bottom and looking for a iii of 3 of (3) setup at the bottom.

Overnight markets are bouncing smartly without any news catalysts. Investors appear to be buying the fear dip. Based on chart, technicals, tape action and resilience of the markets I am tending away from looking for a sharp C wave down and tending now to look for either a triangle correction or an expanded flat correction.

The triangle would probably mean that the price bottom is already in and it’s just a matter of time for the formation to complete. It would probably take about another week, maybe less. Here’s a potential view of how it might develop:

I’m very close to shifting to a general BUY signal. There are growing indications that the wave ii correction of SPX wave i of 3 of (3) up is complete. Here’s a chart of NYSE to give you a sense of where we may be in the market:

Potentially we are at a point where wave 3 impulsive characteristics will assert themselves on multiple time frames simultaneously. It could be a very powerful recipe. It may have begun today.

The short term chart shows an exceptionally choppy decline with an even more choppy wave i and wave ii off the bottom. My tape reading suggests that buyers were taking advantage of any dip at all to load up on stocks.

Late last night stocks and commodities were bouncing sharply and the dollar was selling off. Then S&P announced that they were cutting Ireland’s credit rating (gee thanks S&P, but I’m pretty sure bondholders wanted to know that BEFORE the Irish sovereign debt market tanked). Markets gave up all their gains and went into the red within minutes. Then the dip buyers came in and markets rallied all through the night and into the NY close. Fear dip buying is bullish tape action.

Many sectors have already taken out or matched their recent November highs and April highs. Semiconductors in particular are on a tear. Many economically sensitive sectors are outperforming the broad market (SPX). This list is by no means exhaustive.

The bounce off the low has been a bit of an uneven, “stealth” bounce so it may not feel like a firm bottom is in place yet. But this is probably a minor ii correction within the context of a much larger wave. I am buying here but I would not suggest throwing all your available capital into a single leveraged position in one shot. In other words, don’t bet the farm. There is still risk and anything can happen over the weekend. I do think some nibbling on any dips with a small portion of available capital is prudent at this time.

The EU has bailed out Ireland (as they promised to do last weekend). The markets initially rallied on the news, then sold off and have now bounced back smartly. The US Dollar is essentially flat. The tape action continues to be more suggestive of a bottoming process rather than a breakdown. The end of the correction may be in progress and today’s trade may very well mark the bottom.

The NYSE may have completed an ABC correction with a shallow C wave.

The chart of the SPX futures contract shows an apparent complete abcde corrective triangle with a partial e wave. A break above the trendline could come as soon as Monday, confirming the formation and the bottom.

Many sectors of the market have already matched or exceeded their recent highs and April highs. This shows some underlying strength in the face of the recent correction and the fears of a debt collapse.

If this European debt thing is such a big deal then why is the stock market of the continent’s biggest economy trading at its highs and apparently set to break out?

World Dow Index has apparently completed a five wave triangle correction with a successful test of the 50 EMA.

The likelihood is that an intermediate term bottom in stocks is in place and new highs will be seen soon. If so then we will have confirmation that we are in a Wave 3 move. In this move we want to establish and hold our positions tenaciously (like Old Turkey) since entry points will be difficult and scarce. If we were at a bearish C wave high and about to begin a Wave 3 down, as many believe, then this would be the time for it. The market has refused to comply and the technicals show little sign that it will. Tape action is resiliently bullish showing that bulls are anxious to buy this and any dip.

Chances are pretty good that we have seen a bottom to the correction here. I am long SPX from 1183. If the market closes today near its lows then I will stop this position out. If it closes below 1172 tomorrow then I will need to assume a deeper c wave is in progress and would close the position at a small loss.

Picture perfect textbook triangle correction pattern now complete. All that remains is a breakout above the upper rail of the formation.

Big move in futures worldwide. SPX short term downtrend broken.

It appears that I have once again nailed a major turn in the market. As long as the market closes above 1190 we can buy or add to our long position.

Of course it’s not how they open but how they close that matters and anything can happen before the end of the day. But the setup and the technicals tend to indicate that this is the start of a big move.

Huge breakout to initiate Wave 3 move.

12/01/10 BULLBEAR TRADING UPDATE 3:

So far indications are that the rally that began two days ago with a retest of the 1173 low is the bottom for the correction. There is some chance that we are beginning a B wave up and there will be a final C wave down to complete the correction. But the triangle formation and the fact that it took two weeks of basing activity to complete tends to suggest strongly that we have a completed correction of the move off the September bottom. Unfortunately we do not have a lot of corroboration from the technical indicators yet. We did see SPX test the 50 EMA three times and each time it held quite well. We also have a major breakout on the daily and monthly charts of the SPX/30 Year Treasury ratio which STRONGLY suggests an important bullish event is underway.

This move, particularly on the monthly chart, is enormously significant and really suggests we are in an important Wave 3 phase.

Please note that the assembled excerpts contain only a fraction of the charts and analysis delivered during that time period. As I analyze I am developing the thread of a primary scenario while simultaneously proposing alternative Bull and Bear scenarios.

Key Highlights:

• Case-Shiller 20-city Index dropped to 0.59% from a forecast of 1.0% and 1.67% prior
• Chicago PMI came in at 62.5 when it was expected to be 58, though most question the validity
• Consumer Confidence hit 54.1 from a forecast of 52, experts believe this was simply due to the typical Christmas rally
• MBA Mortgage Applications at -16.5%, this shows a drastic increase
• ISM Index came in at a dismal 56.6 while it was fore-casted to be 57.2, yet the markets ignored it
• Construction spending is up, though many speculate it is due to bailout money
• Crude Inventories rose dramatically to 1.07M barrels, not surprisingly, as it expected to hit $100 soon, thus tumbling the economy futher downwards
• Initial Claims up to 436K from forecast of 415K
• Continuing Claims 4270K from a forecast of 4200K
• Unemployment rate rose to 9.8% from a forecast of 9.7% and a prior 9.6% rate
• Factory Orders down 0.9% while market expected 2%

The negative cycle continues to send the markets’ fundamentals downward, yet the equity prices continue inflating due to the constant US Dollar and Euro manipulation. Seems like the only safe play nowadays is Gold.

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.

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.

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.

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.

Other Potential Autoimmune Indications:

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.

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.

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.

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.

This shouldn’t come as such a surprise to experienced traders, who know very well, when the whole world is sure about one thing, the exact opposite tends to happen. Retailer and mutual fund players have grown increasingly perma-bullish towards risk-on behaviour, as even the worst of news seems to flow in one ear and out the next.

(click image to enlarge)

From a technical perspective, the murky water becomes more clear, and we are able to see why the recent $600B government monetized debt has been unable to lift the markets. The US Dollar, at one point, was shorted at an unbelievable rate of 97%, something rarely seen, thus leaving it prime for an epic squeeze.

The chart clearly shows that the RSI (Relative Strength Index) bottomed out near the 30, becoming very oversold, and is now finally starting to bounce back, similar to January 2010. MACD divergence also seems to be moving in a positive direction, and is inching closer to a bullish cross. Slow stochastics have already made a bullish cross and are beginning to gain momentum as investors buy into the currency as a safe play away from risk.

The target for the Head and Shoulders pattern would be an immediate attempt at breaking the neckline located at the $90 level, which was seen back in late 2008, early 2009, and mid 2010. This is one of the strongest chart patterns, thus once it comes into fruition, expect equity markets around the world to begin a sell-off.

Currently we lie just below the 50% retracement, which should pose some resistance, along with the 50 and 200-days moving averages, though wouldn’t expect these to put up much of a fight.

Many speculators and consipracy theoriests believe that global news and events follows the markets lead, will this principle hold true this time?

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.

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.

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.

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.

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.