Alkermes Gains FDA Approval For Vivitrol, Anticipating Oct 22 Approval with Amylin Pharmaceuticals

Image via CrunchBase

Again another winning prediction from my FDA calendar for October.  Expect large gains for Alkermes tomorrow.  I wouldn't sell the stock as they have another approval up on Oct. 22nd in conjunction with Amylin and Eli Lilly for Bydureon, a weekly injectible diabetes medication.  I expect a FDA approval for that one too.  But you never know with the FDA.  Amylin already has approvals for daily injections but has modified the technology for weekly injections, so again I anticipate its approval as well.  Good news for Alkermes.

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Wikinvest---Alkermes (ALKS)
Wikinvest--Amylin Pharmaceuticals (AMLN)

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 Alkermes addiction drug wins wider U.S. approval

Tue Oct 12, 2010 7:26pm EDT

* Vivitrol already used in U.S. for alcoholics
* Approval may help turn around money-losing drug
* Shares up nearly 69 percent in 2010
* Shares up another 4.2 percent after hours

Big Pharma Earnings Preview: US Drug Makers May Report Lower 3Q Profits

Stocks Mentioned in this article: 
Johnson and Johnson (JNJ)
Eli Lilly and Co.  (LLY)
Merck  (MRK)
Pfizer  (PFE)


EARNINGS PREVIEW: US Drug Makers May Report Lower 3Q Profit

By Nathan Becker, Of DOW JONES NEWSWIRES

TAKING THE PULSE: Analysts expect most major U.S. drug makers to post third- quarter earnings slightly lower than those a year earlier, as sales of several big-name drugs have declined recently after some consumers cut back on health- care costs. Health-care reform and European national health programs imposing price cuts on drugs also offer added pressure for companies. Results in recent quarters have been skewed by big acquisitions, either boosting companies' revenue or sagging their bottom lines because of charges. Several of the industry bigwigs have also been subject to downbeat credit-ratings news because of recent problems with supply and pipeline issues, as well as upcoming patent expiry.

COMPANIES TO WATCH:

Big Gains For Pain Therapy Stocks Today: KG, PTIE, WPI, ENDP

So Pfizer is increasing their portfolio with King Pharmaceuticals, a maker of veterinary meds and pain therapies.  In addition to this news, another company came into the spotlight for pain management therapies.  This company is Pain Therapeutics (PTIE).  Pain Therapeutics is in clinical trials now in collaboration with King Pharmaceuticals so look for Pfizer to kick in some clinical trial expertise with Pain Therapeutics (PTIE).  Additional companies involved in pain therapies is Endo Pharmaceuticals.  I highly suggest buying Endo as a buy right now.  Since June 2010 Endo's stock has risen form 20.22 to its current trading at 34.99.  I suggest a limit order to buy at some discount.  Another Pain therapies stock is Watson Pharmaceuticals, a generic drug maker. 

My opinion on this is that Pain Therapeutics could be slightly overvalued on the hyped news, and although it may seem attractive to buy right now, I suggest waiting for the pullback as it will be years before these clinical trials are actually approved by the FDA.  Also, I am a little cautious placing a buy on Pfizer right now as they will be losing patents on Lipitor next year and other brand name drugs will become available as generics.  I might actually place Pfizer's stock right now on hold or sell, as earnings could be lower than expected.  Just because everyone is doing it does not make it a buy in my opinion. I actually do not necessarily see King Pharmaceuticals as such a hot buy with only 4.85% profit margin and 18M in profits on 380M in revenue.  But given that layoff will presume who knows. 

Stick to your guns and remain a cautious investor and good things will come.  I apply Warren Buffett's principles to the BioPharma Stock World and like purchasing stocks at a discount.  You should be searching for the next Pfizer and not chasing after something that is overly hyped.  Just my opinion.

Stocks mentioned in this article

Pfizer--(PFE)
King Pharmaceuticals --(KG)
Endo Pharmaceuticals --(ENDP)
Pain Therapeutics --(PTIE)  Up 18.56% today on the news
Watson Pharmaceuticals--(WPI)

Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

Roche Touts Drug For ESMO

Roche Drug T-DM1 Outdoes Herceptin With Chemotherapy

By Rob Waters - Oct 8, 2010 3:02 PM ET Tweet (1)LinkedIn Share

Roche Holding AG said its two-drug treatment combining an anticancer agent with Herceptin, the company’s $5.27-billion breast cancer drug, was about as effective as, and caused fewer side effects than, Herceptin with chemotherapy.

The results, presented at the European Society for Medical Oncology meeting in Milan, were the first to measure the effectiveness of Roche’s experimental drug called trastuzumab- DM1 as an initial therapy in patients with a particular subtype of breast cancer. T-DM1 is a member of a new class of experimental drugs called antibody-drug conjugates that combine antibodies and anticancer drugs.