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Clinical Data’s Vilazodone Approved!

BioTech InvestmentParadigm.com — Sat, 22 Jan 2011 17:02:41 +0000

Yesterday evening the FDA announced that Vilazodone, a novel combination SSRI/5HT1A receptor agonist antidepressant from Clinical Data (CLDA), received approval for marketing in the U.S. This is certainly cause for celebration among Clinical Data’s shareholders as this was a ‘first pass’ approval, a feat that is becoming rarer and rarer with today’s increasingly risk averse FDA. Furthermore, the approval should be considered a win for the biotech sector as a whole as investor confidence has been waning on the heels of MannKind’s (MNKD) rejection of Afrezza and Depomed’s (DEPO) mysterious conflict with its licensing partner Abbott (ABT). Hopefully the sector’s share price hemorrhage will slow or reverse over the next week on news of the approval.

The approved trade name for Vilazodone will be ViiBryd. While the name ranks highly among ‘worst drug names I’ve ever heard’, it probably won’t unseat this one as the absolute worst.

Clinical Data efforts now turn completely to securing a licensing partner for the drug or an outright buyer of the company as CLDA likely does not have the funds to launch the drug itself. Forest Labs (FRX) would be a likely suitor as it recently reported a failure in its Phase III study of Levomilnacipran, another potential SSRI antidepressant. Securing a partner or buyer will be no easy task as Viibryd’s revenues will already be squeezed by an existing partnership with Merck KGaA (MKGAY). Under the agreement, Clinical Data owes milestone payments and royalty payments “in the lower double-digits” to Merck. Additionally, the absence of sexual side effects must live up to management’s hype in order to gain a share of the crowded and largely genericized antidepressant market.

Congrats to Clinical Data and its shareholders!

Press release below the fold:

FDA NEWS RELEASE

For Immediate Release: Jan. 21, 2011
Media Inquiries: Sandy Walsh, 301-796-4669 ; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Viibryd to treat major depressive disorder

The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person’s lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

For more information:

FDA: Antidepressant Use in Children, Adolescents, and Adults

National Institute of Mental Health: Depression

Clinical Data’s Vilazodone Approved!

BioTech InvestmentParadigm.com — Sat, 22 Jan 2011 17:02:41 +0000

The approved trade name for Vilazodone will be ViiBryd. While the name ranks highly among ‘worst drug names I’ve ever heard’, it probably won’t unseat this one as the absolute worst.

Congrats to Clinical Data and its shareholders!

Press release below the fold:

FDA NEWS RELEASE

For Immediate Release: Jan. 21, 2011
Media Inquiries: Sandy Walsh, 301-796-4669 ; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Viibryd to treat major depressive disorder

The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

For more information:

FDA: Antidepressant Use in Children, Adolescents, and Adults

National Institute of Mental Health: Depression

FDA Requests More Clinical Trials for MannKind’s Afrezza

BioTech InvestmentParadigm.com — Wed, 19 Jan 2011 20:47:26 +0000

After an exciting trading day than involved a suspected ‘bear raid’ and, not one, but two trading stops during the day, MannKind was issued a complete response letter (CRL) for its inhalable insulin therapy Afrezza. There was certainly a lot of hype leading up to the decision as news of the new therapy swept virtually every major news outlet in the previous month. This is the second such CRL for Afrezza, the first coming in March of 2010.

The rejection appears to center primarily around lack of data in MannKind’s second generation inhaler, often referred to as Dreamboat. MannKind must perform two additional clinical trials using the new inhaler and obtain head-to-head information on the two devices. There were also a number of minor issues relating to usage, handling, shipment, storage, safety literature, and training for the next generation device.

This is certainly bad news for MannKind and its investors, as additional trials are likely to be expensive and time consuming. This is especially rough for an already highly leveraged company. However, the path to approval appears to be much more clear. The new device appears to be quite effective and there is a high likelihood of success in the new trials. I feel confident that Afrezza will eventually find its way into patients’ hands, but the road to approval has proven to be long and difficult for MannKind.

Disclosure: No positions.

Full press release:

MannKind Corporation Receives Complete Response Letter from the FDA for AFREZZA(R)

VALENCIA, Calif., Jan 19, 2011 (BUSINESS WIRE) –

MannKind Corporation (Nasdaq: MNKD) today announced that it has received a complete response letter from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for AFREZZA^(R) (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.

A complete response letter is issued by the FDA’s Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.

The principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind’s next-generation inhaler to the phase 3 trials conducted using its MedTone^(R) inhaler. The FDA has requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices. In the complete response letter, the FDA stated that after an adequate titration of study medication there should be at least twelve weeks of relatively stable insulin dosing at the end of the treatment period.

The FDA has also requested additional information concerning the performance characteristics, usage, handling, shipment and storage of the next-generation device, an update of safety information related to AFREZZA as well as information on proposed user training and changes to the proposed labeling of the device, blister pack, foil wrap and cartons.

“As we reported last fall, we have already begun a series of studies of the next-generation device in patients with type 1 (Affinity 1) and type 2 (Affinity 2) diabetes,” said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Consistent with the direction we received in the complete response letter, these trials are designed to focus on careful titration of insulin dose and include at least twelve weeks of stable dosing. We plan to meet with the agency as quickly as possible in order to be confident that these trials, with appropriate modifications to incorporate a comparison to the MedTone device, will suffice in addressing the agency’s questions about patient use and robustness of the next-generation device.”

Mr. Mann continued, “While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program. We remain committed to working with the FDA to make AFREZZA available to people with diabetes.”

MannKind will host a conference call at 4:00 pm (Eastern Time) on January 19, 2011. To participate in the live call by telephone, please dial 888-942-9866 or 415-228-3901 and use the participant passcode: MANNKIND. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at www.mannkindcorp.com. A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing 888-562-4434 . A replay will also be available on MannKind’s website for 14 days.

About AFREZZA^(R)

AFREZZA^(R) is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy- to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of mealtime insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients with both type 1 and type 2 diabetes.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its diabetes pipeline includes AFREZZA^(R) and MKC253. MannKind has submitted a NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MKC253 is currently in phase 1 clinical trials. Other products in MannKind’s pipeline include the cancer immunotherapy platform MKC1106, which is currently in phase 2 clinical trials. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind’s clinical trials, future interactions with the FDA, MannKind’s plans for the development and commercialization of AFREZZA and the regulatory status of MannKind’s product candidates, that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, difficulties or delays in seeking or obtaining regulatory approval, MannKind’s ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2009 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

SOURCE: MannKind Corporation

Investors:
MannKind Corporation
Matthew Pfeffer
Chief Financial Officer
            661-775-5300     �
mpfeffer@mannkindcorp.com
or
Media:
MCS Healthcare Public Relations
Laura de Zutter
            908-234-9900     �
laurad@mcspr.com

Depomed “Puzzled” by Abbott’s Unwillingness to Launch DM-1796

BioTech InvestmentParadigm.com — Tue, 18 Jan 2011 23:05:18 +0000

Today, Depomed’s (DEPO) share price dipped mysteriously mid-day by over 10%. Upon market close, a press release was issued by Depomed potentially explaining the mysterious drop. Abbott is apparently convinced that they are not responsible for launching and commercializing Depomed’s DM-1796, an extended release form of gabapentin for the treatment of post-herpetic nueralgia.

I’ve listened to the conference call and wanted to share my impressions.

First, the argument is over whether or not Abbott is obligated to launch and commercialize DM-1796. There appears to be no argument over the rest of the licensing agreement. Specifically, these alleged obligations are:

(i) to make the first commercial sale of DM-1796 to occur within a specified period of time following FDA approval;
(ii) to perform a minimum number of sales calls annually;
(iii) to make specified minimum promotional expenditures; and
(iv) to use commercially reasonable efforts to commercialize DM-1796 in the United States following approval of the DM-1796 NDA.

Depomed then went on to state that the obligations total between $85 and $135 million.

It’s important to note that Abbott stands by the rest of its obligations. I’m actually puzzled myself as to why Carl Pelzel, Depomed’s CEO, believes this means Abbott has decided that DM-1796 doesn’t fit into its product portfolio. I’m more inclined to believe this is a disagreement over what is actually implied in one specific passage of the licensing agreement, but it’s neither my specialty nor do we have enough information to overrule Mr. Pelzel’s impressions.

Depomed seems absolutely certain that it has the upper hand in the dispute. Mr. Pelzel stated they have hired outside counsel to analyze the licensing agreement and they conclude that Depomed, indeed, is in the right here. Of course, this is largely what you’d expect from a company or else we’d never get to this point. I’m certain that Abbott has a large law department that has addressed the issue thoroughly as well. It will be interesting to see how this plays out.

Based on Mr. Pelzel’s tone and rhetoric, the licensing partnership has soured considerably. Often during the conference call it seemed as if Mr. Pelzel was laying down an ultimatum to its licensing partner. Clearly, its in both parties’ best interest to commercialize the drug as strongly as possible, but I can’t say that this sort of acrimony bodes well for continuing partnership. It seems like Depomed would be perfectly happy with rights being returned to it, assuming Abbott helps financially with the product launch.

Mr. Pelzel outlined three scenarios in which the dispute could play out:

1 – Abbott complies.
2 – Abbott retains rights but does not launch, this would lead to arbitration and a potential damage award for Depomed.
3 – Licensing rights are returned to Depomed. Mr Pelzel said they would only consider this if Abbott provides cash for commercial launch of DM-1796 with no dilution to shareholders.

Finally, Depomed said repeatedly that nothing has changed in terms of overall market size for the drug.

As a summary, there are two issues which must be analyzed by DEPO shareholders – the facts and what is implied by those facts. Factually, it would appear that Abbott has an issue with one section of the contractual licensing agreement; and that is a few specific commercialization and launching responsibilities. What was implied by Mr. Pelzel by those facts was that Abbott doesn’t want the drug and market sizing may be the primary concern.

I personally find the ‘market size is lacking’ implication to be suspect and perhaps premature, but Mr. Pelzel seems to believe that is the case. I will certainly not pretend I know more about the issue than the CEO himself, so I am inclined to believe there are real questions about the market size for DM-1796. If there are legitimate market concerns, it is logical that the share price should take a bath – though I suspect that there is a reasonable chance this turns out mostly in Depomed’s favor due to the apparent legal due diligence performed by Depomed on the issue.

Disclosure: Long DEPO.

FDA Catalyst Updates

BioTech InvestmentParadigm.com — Wed, 12 Jan 2011 14:39:01 +0000

A few updates you should be aware of, as it’s been a relatively eventful morning thus far.

KV Pharmaceuticals (KV.A)

Today KV Pharmaceuticals today announced that its PDUFA date for Gestiva, previously scheduled for January 13, has been pushed back to April 13. The delay was triggered by the submission of additional data at the FDA’s request. Press release here.

I have hesitated to cover KV for a number of reasons, but it’s largely based on my inferences on the management. Information is hard to come by on Gestiva and press releases aren’t giving shareholders the information they need (or at least in any sort of convenient form). This is enough of a red flag for me to stay away from it. Additionally, Gestiva appears to be a product with a relatively tiny market size to go along with their other products of relatively tiny market size. Furthermore, the company is highly leveraged and operating at a loss, and I doubt Gestiva will change that. Bad management, bad fundamentals, bad product = I’d rather not mess around with it. All in my opinion, of course.

Fibrocell Science, Inc. (FCSC)

The FDA has accepted Fibrocell’s complete response submission for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act (PDUFA) date is June 22, 2011. Press release here.

We generally do not provide coverage for companies at small as Fibrocell (current market cap $13MM), nor do we like to mess with OTC stocks, as we wish to remain above suspicion of trying to influence stock prices. If the market cap increases significantly we’ll be glad to provide some coverage, but expect this to be the last mention of Fibrocell.

Both events can be seen on our calendar.

Disclosure: No positions.

New Year New Money Making Link RoundUp

Michael Vlaicu — Sat, 01 Jan 2011 17:34:39 +0000

New Year New Money Making Link RoundUp

Here at Buy Like Buffett, the goal is to help you build wealth and make money investing the Warren Buffett Way. It’s a New Year which means it time for a new link roundup. These are the best articles online that will help show you different ways to make money.

One Money Design says Shred Your Credit Card In 2011.

Maximizing Money gives you the Best Deals For Your Money.

Investor Junkie explains Why Dollar Cost Averaging Works.

Mark Riddix (my other site) on how to Make Money Using The Internet For Affiliate Marketing.

Smart Passive Income on how You Can Make Money From Shoppers Right Now.

The Dividend Guy Blog on 3 Reasons Why I Go Dividend Investing In 2011.

Smart On Money talks about Starting A Side Business.

As you can see via the links above, you can make money investing, starting a business, or by looking for areas to trim the fat out of your finances.

Read last week’s roundup here.

My Blog Posts From Around The World Wide Web

Michael Vlaicu — Tue, 28 Dec 2010 17:38:08 +0000

My Blog Posts From Around The World Wide Web

Every now and again I do an update of my posts from around the world wide web. Here are a few of the posts that I have had published over the past week.

Mark Riddix on How To Break Your Blog Out Of A Traffic Funk.

Blonde and Balanced hosts The 289th Edition of the Carnival of Personal Finance.

The Daily Crux has my article on 5 Steps to Feeling Richer in 2011.

Noozhawk used my post on bonds as a reference for her article on Why She Hates Bonds.

My Personal Finance Journey hosted The Carnival of Wealth.

MoneyedUp post on Investing in Last Year’s Losers.

***I started a new Facebook Page. Like this page by clicking here. ******

Analyzing Mechanics Behind the Stock Market's Heart

Michael Vlaicu — Mon, 21 Jul 2008 04:24:38 +0000

Have you ever wondered what make the stock market rise and fall? If you watch the news at all, you will have seen the stock market prices tumble into a deep red sea one day, while rising through the clouds the very next day. Why stock market prices behave in such a way is a complex question with an even more complicated and intricate answer.

There are many factors that affect the price of stocks: Included is inflation, interest rates, domestic political unrest, war or terrorism, crime, fraud and oil or energy prices to name but a few.

All of these factors will drive the price of the stock market up or down. However regardless of these factors, the price of stocks is liquid and it is determined by how much buyers are prepared to spend and how much sellers will take for their stock.

Simply Demand and Supply — that which breathes life to the Stock Market. Understanding this concept can be a strenuous task, as it takes years of hard work to truly champion the seemingly endless abyss of market analysis.

Usually, to tame the rate of inflation, the federal government hikes interest rates. While this slows the inflation rate, it also raises the interest in small lending institution stocks (these are guaranteed by the government, thus VERY attractive here). This in turn moves investors away from equity stocks in lieu of the guarantee available with the small lenders. Risk here is lower, obviously.

This affects stock prices in several areas of the market. What happens is this: say a stock was selling at $20 per share before the interest rate went up from 5% to 6%. So the stock price is figured like this: 1/. 05= $20. After the hike, the price is now down to $16.67 per share or 1/. 06. This represents an almost 17% drop. Taken right across the market, this can adversely affect many other stocks as well and drive the market down temporarily.

A spike in oil prices can and will affect auto prices, food prices, gas prices and many others, thus effectively pushing inflation upwards. This presses the government to raise interest rates and we have the example above all over again.

War abroad can affect the market, too. A recent example is the war in Iraq, which has driven oil prices up to unprecedented levels. We have all seen the exorbitant gasoline prices that have been the result, but now we are seeing hikes in home lending, grocery prices and transportation costs also.

So as you can see, there are many scenarios that can unfold and affect how the stock market prices rise and fall. All these factors play out together in the rise and fall of the stock market. If you watch it closely, you can pick out the trends and accurately predict price hikes, interest rate increases or when inflation will occur again.

Another factor in how the stock market rises and falls is foreign currency rates. As a particular currency fluctuates, stock prices in companies based in that country will react accordingly. When the Japanese yen falls, so does interest in Japanese technology stocks. Conversely, if the US dollar falls to dangerous levels, our government simply prints some more paper money and places it in circulation. This, in my personal opinion, creates a false sense of security in the economy.

US Fed Printing Money to Avoid Immediate Banking Collapse = Higher Long-term Rates

However you look at it, stock prices affect how we live each coming day. All aspects of our daily routines are affected: Grocery prices, gas prices and the cost of living just to name a few. So watch the stock market closely. It affects you whether you know it or not.

Remember, what makes or breaks a Winner is passion for the simplicity, not the lust for the rewards. Years of endless dedication to analyzing price highs and lows, tireless hours spent searching site after site for the latest news headlines — searching for that one instant mouse click that could skyrocket your portfolio. Your heartbeat raises, your palms become sweaty, you look at your computer screen and you smile. Why? Because you realize you have now become what you were meant to be: An Investment Mogul.

Investing is not just a way of making money for me — Investing is my passion, my desire, my love in life.

What does investing mean to you?

Two essential stock market analysis tools [VIDEO]

Michael Vlaicu — Wed, 16 Jul 2008 19:23:37 +0000

Hey guys — I’ve been really busy with an examination this past week, so the time spent on updating the site was greatly reduced, however I am back! In this video I hope to unearth your interest in two really informative web sites which are essential in your “must have” book of stock market knowledge.

http://www.google.com/ig

http://www.smartmoney.com/map-of-the-market

Feel free to leave any additional comments on the resources you use for your investment needs in the section below!