Biotechnology And Drug Stocks Up For FDA Approval In August

by: StockPandit

In 2012, biotechnology and drug companies have been all over the news. So many stocks surged in the last six months based on clinical trial results, FDA approval, FDA advisory committee recommendation, European commission approval, recommendation from independent committees, partnerships with big pharmaceuticals, acquisitions, and so on. Below is a list of five biotechnology companies that have huge upside - or downside - potential in the month of August.

Biotech stocks are high risk/reward stocks, and therefore, considerable analysis is required before trading. Use this list as a potential starting point for your analysis.

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (NYSE:SNY)

Dug Name: ZALTRAP; PDUFA Date: August 4, 2012

Regeneron Pharmaceuticals discovers, develops, and commercializes medicines for the treatment of serious medical conditions in the United States.

Sanofi, together with its subsidiaries, researches, develops, manufactures, and markets healthcare products worldwide. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Through the acquisition of Genzyme, Sanofi has strongly reinforced its footprint in rare diseases. Sanofi is listed in Paris [SAN] and in New York as SNY.

Regeneron and Sanofi submitted the regulatory applications for marketing approval of ZALTRAP in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen to the European Medicines Agency in the fourth quarter of 2011 and the U.S. Food and Drug Administration [FDA] in February 2012. The U.S. BLA was granted Priority Review status with a PDUFA date of August 4, 2012.

A Priority Review designation is given to drugs if preliminary estimates indicate that the drug product, if approved, has the potential to provide a treatment where no adequate therapy exists or there is a significant improvement compared to marketed products. The filing was based on the Phase III VELOUR study in patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

On April 5, 2012, Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology said:

Sanofi and Regeneron are committed to the continued development of ZALTRAP and we are very pleased that the FDA has chosen to grant Priority Review to ZALTRAP in metastatic colorectal cancer. We look forward to working closely with the FDA to potentially bring an important new option to patients with this difficult disease.

Regeneron has two more drugs with pending US FDA approval during third quarter 2012; ARCALYST (rilonacept) with PDUFA date of July 30, 2012 and EYLEA (aflibercept) Injection with PDUFA date of September 23, 2012. Regeneron has a market cap of $10.82 billion, and is currently trading around $113.70, with a 52-week range of $42.83 to $145.04.

Sanofi has a market cap of $95.55 billion, and is currently trading around $36.09, with a 52-week range of $30.98 to $40.58.

Talon Therapeutics, Inc 9 (OTC:TLON)

Drug Name: Marqibo; PDUFA Date: August 12, 2012

Talon Therapeutics (formerly Hana Biosciences) is engaged in developing and commercializing cancer therapies designed to enable current standards of care. Its two lead product candidates target large markets.

The company is developing Marqibo for the treatment of acute lymphoblastic leukemia and other blood cancers, including lymphoma. Marqibo is a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine.

In March 2012, Talon received a positive vote of 7-4 (and 2 abstain) from the Oncologic Drugs Advisory Committee [ODAC] to support the approval of Marqibo for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia [ALL].

In May 2012, U.S. Food and Drug Administration [FDA] extended PDUFA data for its review of Marqibo from May 13, 2012 to August 12, 2012. Marqibo has already received orphan drug from US FDA and European Medicines Evaluation Agency.

On June 1, 2012, Steven R. Deitcher M.D.,President, Chief Executive Officer and Board Member of Talon Therapeutics said:

We believe Marqibo as part of a multi-drug treatment regimen has the potential to improve the outcomes for patients with newly diagnosed Ph- ALL and we are pleased the HALLMARQ Study which is being conducted under an SPA has commenced enrollment.

Talon is thinking ahead of FDA approval for the commercialization of Marqibo, and the company secured financing of $11 million from Warburg Pincus and Deerfield Management in January, 2012. However, there is a significant insider selling of 629,473 shares during the last three months, and there are no insider purchases during the same period. Talon Therapeutics has a market cap of $21.89 million, and is currently trading around $1.00 with a 52-week range of $0.40 to $1.28.

Gilead Sciences Inc (NASDAQ:GILD)

Drug Name: Quad; PDUFA Date: August 27, 2012

Gilead Sciences discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation.

Gilead Sciences submitted the NDA for the Quad approval on October 27, 2011 and FDA has set a target action date under the Prescription Drug User Fee Act [PDUFA] of August 27, 2012. Marketing approval of the Quad are also pending in Australia, Canada and the European Union. Quad is a complete once-daily, single tablet with a combination of four drugs - elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

Gilead Sciences also submitted a New Drug Application [NDA] to the US FDA for the approval of Truvada (to reduce risk of HIV infection), elvitegravir and cobicistat. Both elvitegravir and cobicistat are the components of the once-daily Quad single tablet regimen. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and FDA AdComm already provided positive vote for the approval of Truvada. If Truvada is approved, then it would be the first drug indicated for uninfected individuals to lower the risk of acquiring HIV.

On June 18, 2012, Gilead Sciences announced that European Medicines Agency [EMA] has validated Marketing Authorization Application [MAA] of elvitegravir, and the review of the MAA will be conducted under the centralized licensing procedure.

Considering the fact that the US FDA Antiviral Drugs Advisory Committee [ADAC] has voted 13-1 to support Quad, FDA approval is more likely. Moreover, Quad demonstrated highest response rate of 90 percent from the study 103. Gilead Sciences has more upside potential in the upcoming months based on pending FDA approval on Quad, elvitegravir, cobicistat, Truvada and pending EMA approval on Quad.

Gilead Sciences has a market cap of $38.81 and is currently trading around $51.25 with a 52-week range of $34.45 to $56.50.

Delcath Systems, Inc (NASDAQ:DCTH)

Drug Name: CHEMOSAT; NDA Filing Date: mid-August 2012

Delcath Systems is a development-stage specialty pharmaceutical and medical device company focused on oncology, initially cancers in the liver. Delcath focuses on the development and clinical study of the Delcath chemosaturation system.

On May 8, 2012, Mr. Eamonn P. Hobbs, President and CEO of Delcath said:

We are in the final stages of completing our New Drug Application (NDA) submission for filing with the FDA for CHEMOSAT. Safety data collection and database migration is complete, the clinical sites have been notified that we will lock the databases on May 25th, and we are confident of submitting our NDA in mid-August.

Following the anticipated NDA submission in mid-August, Delcath expects monthly cash expenses to decrease to $3 million to $4 million for the remainder of 2012. The Company expects revenue from CHEMOSAT sales in the second half of the year will partially offset cash expenditures.

Delcath Systems has a market cap of $76.74, and is currently trading around $1.53, with a 52-week range of $1.40 to $6.64.

(For a look at six biotech names we thought had huge potential in July, click here.)

Some of the data is sourced from Google Finance, Yahoo Finance, Fidelity and investors site.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in (REGN), (DCTH), (GILD), (SNY) over the next 72 hours.

Disclaimer: I am not a registered investment advisor and do not provide specific investment advice. The information contained herein is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. It is up to investors to make the correct decision after necessary research.

I change my positions very frequently and may initiate either long or short positions in the above mentioned stocks at any time.

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