Biopharma Drug Approval Watch List

by: StockMatusow

Columbia Labs (CBRX)

Drug: CRINONE (progesterone gel)

CRINONE 8% is a vaginal progesterone gel utilizing our sustained-release bio-adhesive technology indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology treatment for infertile women with a progesterone deficiency.

On January 23, an FDA advisory committee recommended that CRINONE not be approved for the indication in which it was created. The final FDA decision is expected this week, and the prospects do not look good for approval here.

The company also has a class action suit filed against it for share holders who have lost a ton of money in the stock. The stock was as high as $4.32 before plummeting all the way down to around $0.60.

My verdict: Stay away for now as CRINONE will not be approved, notwithstanding several potential legal issues the company is currently facing.

Discovery Labs (DSCO)

Drug: Surfaxin

Surfaxin is a liquid instillate formulation targeting Respiratory Distress Syndrome. In April 2009, Discovery Labs received from the FDA a Complete Response Letter (CRL) which contained the requirements that must be addressed to gain U.S. marketing approval for the drug. This marks the 4th time since 2004 the company has received a CRL from The FDA in regards to Surfaxin.

On September 2, 2011, Discovery Labs submitted its Complete Response to the 2009 CRL. Is the 4th time a charm?

Sufaxin has an upcoming PDUFA data of March 6, 2012.

My verdict: The company received its last CRL on Sufaxin that raised questions about certain aspects of a quality control stability and release test. In my opinion, this is the last minor hurdle that I am confident the company has finally cleared, therefore I believe the 4th time will be the charm for Sufaxin.

Astex Pharma (NASDAQ:ASTX)

Drug: Dacogen

Dacogen (decitabine) is a DNA Injectable hypomethylating agent currently FDA approved for the treatment of myelodysplastic syndromes (MDS).

However, in early February of this year, The Oncologic Drugs Advisory Committee voted 10-to-3 against recommending Dacogen as a treatment for acute myeloid leukemia (AML) for patients over the age of 65. It is not likely The FDA will approve the drug for AML, but being already approved for MDS, and with several other drugs in their pipeline and strong partnerships, Astex may still be a decent swing trade at its current price of $1.96.

My verdict: Dacogen will not gain approval for AML treatment in The United States this time around. I would hold off buying the shares until after the final FDA decision date of March 6th, 2012. Dacogen has an upcoming decision for approval in the second quarter 2012 in the EU, with EU partner Johnson & Johnson (NYSE:JNJ). An EU approval of Dacogen means 10 years of European exclusivity for JNJ, which is estimated to earn $230 million with the drug by 2016.


Drug: Peginesatide

Peginesatide is designed to treat anemia associated with chronic renal failure. Hematide is a synthetic peptide-based erythropoiesis stimulating agent designed to stimulate production of red blood cells

On December 8th, 2011, The Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that Peginesatide demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD). The scheduled PDUFA date for Peginesatide is March 27, 2012.

My verdict: Peginesatide will be approved by The FDA for the treatment the drug is indicated for. The stock has more than doubled in price since The advisory panel gave a favorable recommendation for Peginesatide in December of 2011. The stock seems to be set up for a sell-off on the news of approval, since it is likely the drug will be approved. My opinion is that investors should wait until after the March 27th approval date before making an investment here. Whatever decision you make with Affymax, please proceed with caution and take into consideration the huge run-up the stock has already seen recently.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Disclaimer: This article is intended for informational and entertainment use only and should not be construed as professional investment advice. Always do you own complete due diligence before buying and selling any stock.