FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.

The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).

Bull or Bear? Vote in Our Poll

The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.

This Week's Watchlist Oct 25 2010 With the FDA

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A, B and Z DNA Structures, the building blocks of Proteins and Amino Acids

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 On tap for this week we have three FDA decisions:

ARNA - Arena received an expected CRL on Saturday for its weightloss drug Lorcaserin. (Subscribers to BioRunUp were immediately notified via SMS and email alerts) The CRL was as expected with no real surprises. It will be interesting to see how the market reacts to the FDA's requests on Monday morning. ARNA closed at $1.63 on Friday after surging nearly 22% at one point during the day. These prices are much below its run-up high of $8 in late July.  Arena Receives CRL

BIOD - Biodel is up for an FDA decision on 10/30/10, and trader consensus is clearly leaning towards a CRL from the FDA. Traders became even more jittery last week as the FDA delivered some heavy handed CRLs to AMLN/ALKS, on a drug that was widely expected to receive approval. The market seemed to react as if saying 'If AMLN/ALKS was 'in the bag' and the FDA required more trials, there is NO way that the FDA will approve Linjeta with that botch India data.' Trading at under a 100M market cap, BIOD has incredible potential on approval. However FDA uncertainty seems to have limited the run-up.

AVNR - Out of this week's watchlist stocks, AVNR seems to have the best odds of approval. Despite this, AVNR still took a hit from the AMLN/ALKS CRL. This was because that CRL was based largely because the FDA was concerned about prolongation of QT interval, a concern that was also expressed by the FDA in Avanir’s first CRL for AVP-923. Will this continue to haunt AVNR? We will soon find out.

EXAS - Its catalyst time for one of our best picks of the year. We recommended EXAS in the high $3 range and were thrilled to watch it climb to over $9. Study results are going to be presented this Friday, 10/29 at the AACR conference.  
 
BioPharma Investor's Decisions:
 
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The Street's FDA Drug Approval Contest: October's FDA Calendar

Image via CrunchBase Here is Ocotber's FDA Calendar. Along with the Calendar I have put my recommendation for each stock. Some you should really be buying, like Alkermes, others you should be shorting, like Arena, Vivus, and Jazz Pharma.

The poll has 3 results:
1. Full Approval
2. Complete Response Letter (aka delayed approval or no approval)
3. No Decision (more time, the FDA has a lot of approvals in such a given short period)

Oct. 1: Hospira's(HSP) Dyloject for acute moderate to severe pain in adults. (CRL)---Big Company so no big deal, still a buy

Oct. 4: Human Genome Sciences'(HGSI) Zalbin for hepatitis C. (CRL--Lupus drug approval set for December so still a buy)

Oct. 11: Alexza Pharmaceuticals'(ALXA) AZ-004 for agitation in patients with schizophrenia or bipolar disorder. (I'm going with No Decision, short this stock, as this is their first FDA decision for the Staccato technology) Slightly leaning toward CRL but I will say No Decision as my final answer.

Oct. 11: Jazz Pharmaceuticals'(JAZZ) JZP-6 for fibromyalgia. (CRL--FDA panel killed this drug, it works but the FDA isn't approving a GHB type drug right now. Short this stock)

Oct. 12: Alkermes'(ALKS) Vivitrol for opioid addiction. (Full Approval--Jim Cramer would say Buy, Buy Buy)

Oct. 16: ISTA Pharmaceutical (ISTA) XiDay is simply aonce daily version of twice daily solution, and avoid generic competition (FDA Approval)

Oct 22: Arena Pharmaceuticals'(ARNA) lorcaserin for obesity. (No way in he##, CRL) I would recommend shorting this stock.

Oct 22: Amylin Pharmaceuticals(AMLN) (Partnered with Alkermes and Eli Lilly) Once weekly Diabetes Shot exenatide or Bydureon---This is a delay from CRL in March so I expect Full Approval this time around.

Oct 28: Vivus'(VVUS) Qnexa for obesity. (Give me a break, CRL) I don't care what data they have come up with, I would recommend Shorting this stock.

Oct 29: Avanir Pharmaceuticals'(AVNR) Zenvia for pseudobulbar affect. (I'm going to go with Full Approval although it's a toss-up)

Forest Labs(FRX) ceftaroline for Community Acquired Pneumonia. I can't find this on the FDA calendar---But I will say Full Approval even though I can't find it.

Oct 30: Biodel's(BIOD) Linjeta for diabetes. (No Decision, short this stock) Again on the fence, possible CRL.

Stock Mailbag, Generex, Sequenom, MELA Sciences, Cardium Therapeutics, Biodel

Image via CrunchBase Another great article from The Street's Adam Feuerstein in his Biotech Stock Mailbag. Mostly on stocks NOT to invest in, or stocks to short, and biopharma stocks for Put Options. Adam's a downer to most parties but he speaks the truth. Whether you like it or not. Sometimes I haven't liked it but if you are looking for long term growth Biotech Stocks you might want to take some of his advice. Plus, you can enter his FDA Drug Approval Contest for October. See what people think about the FDA Drug Approvals Contest.

Biotech Stock Mailbag: Generex