In 2012, biotechnology and drug companies have been all over the news. Many stocks surged in the last eight 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 nine biotechnology companies that have huge upside - or downside - potential in the month of September.
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.
1. Novartis AG (NVS): AdCom Date - September 5
Novartis is a multinational group of companies engaged in the research, development, manufacture, and marketing of healthcare products worldwide. The company has five segments: Pharmaceuticals, Alcon, Sandoz, vaccines and diagnostics and consumer health.
On September 5, 2012, the U.S. FDA Anti-Infective Drugs Advisory Committee will discuss Novartis' new drug application (NDA) 201688, tobramycin inhalation powder for the management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.
Novartis had another FDA AdCom (Cardiovascular and Renal Drugs Advisory Committee) meeting scheduled on September 14, 2012, to discuss new drug application (NDA) 203446, imatinib mesylate for the treatment of pulmonary arterial hypertension (PAH). However, FDA responded to Novartis requesting more data and thus cancelled the Advisory Committee meeting.
In July 2012, U.S. Food and Drug Administration (FDA) and European Commission approved Novartis' drug Afinitor (everolimus) tablets to treat patients with the most common form of advanced breast cancer. Each year, more than 200,000 women are diagnosed with HR+ advanced breast cancer globally.
On August, 6, 2012, Novartis and the University of Pennsylvania (PENN) announced that they entered into a multi-year collaboration to research, develop and commercialize chimeric antigen receptor (CAR) technology for the treatment of cancers. Under the terms of the agreement, Penn grants Novartis an exclusive worldwide license to CARs developed through the collaboration for all indications and CART-19 (a novel investigational CAR therapy).
Novartis has a market cap of $162.59 billion and is currently trading around $60.08 with a 52-week range of $51.20 to $60.62. The stock has gained 5.09% year to date.
Salix Pharmaceuticals acquires, develops, and markets prescription drugs and medical devices used in the treatment of various gastrointestinal diseases in the United States. The company's products include XIFAXAN, MOVIPREP, RELISTOR, OSMOPREP, VISICOL, APRISO, SOLESTA, DEFLUX, METOZOLV ODT, AZASAN, ANUSOL-HC, PROCTOCORT Cream, PEPCID, Oral Suspension DIURIL and COLAZAL.
Progenics Pharmaceuticals (Progenics) is a biopharmaceutical company focusing on the development and commercialization of therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases.
On February 7, 2012, U.S. FDA issued a PDUFA (Prescription Drug User Fee Act) goal date of June 5, 2012, and granted Priority Review designation for Crofelemer 125 mg tablets for the treatment of diarrhea in patients with HIV/AIDS on anti-retroviral therapy. On April 20, 2012, FDA announced that it requires additional time for the review of Crofelemer and extended PDUFA action date by three months to September 5, 2012. Approximately 50% of the 1 million people in the United States living with HIV/AIDS are currently taking an anti-retroviral therapy (ART), and approximately 30% of HIV/AIDS patients on ART (approximately 150,000 patients) experience episodic or chronic diarrhea.
On August 30, 2011, Salix Pharmaceuticals and Progenics Pharmaceuticals submitted the Supplemental New Drug Application to FDA for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. On April 25, 2012, FDA extended the PDUFA goal date from April 27, 2012, to July 27, 2012. On July 27, 2012, US FDA issued a Complete Response Letter (CRL) for RELISTOR requesting additional clinical data.
On August 8, 2012, Salix Pharmaceuticals and Alfa Wassermann S.p.A. announced that they have entered into an exclusive agreement by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin for gastrointestinal and respiratory indications, including Crohn's disease. According to the Crohn's and Colitis Foundation of America (CCFA), more than 700,000 Americans are affected by Crohn's disease.
Salix Pharmaceuticals has a market cap of $2.71 billion and is currently trading around $46.19 with a 52-week range of $25.64 to $55.99. The stock has fallen 3.47% year to date.
Progenics has a market cap of $141.28 million and is currently trading around $4.17 with a 52-week range of $4.13 to $11.34. The stock has fallen 51.17% year to date.
Ironwood Pharmaceuticals is an entrepreneurial pharmaceutical company, which discovers, develops, and commercializes human medicines.
Forest Laboratories develops, manufactures, and sells branded forms of ethical drug products primarily in the United States and Europe.
On April 23, 2012, the U.S. FDA extended the PDUFA action date by three months to complete its review of linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). FDA has not requested any new data to complete the review. As many as 34 million Americans suffer from symptoms associated with CC and 8.5 million patients have sought treatment.
On July 23, 2012, Forest Laboratories and Almirall, S.A. announced that the U.S. FDA has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Ironwood Pharmaceuticals has a market cap of $1.30 billion and is currently trading around $12.11 with a 52-week range of $9.97 to $15.92. The stock has gained 1.17% year to date.
Forest Laboratories has a market cap of $9.10 billion and is currently trading around $34.25 with a 52-week range of $28.47 to $36.44. The stock has gained 13.19% year to date.
6. Navidea Biopharmaceuticals Inc (NAVB & NEOP):
PDUFA Date - September 10
Navidea Biopharmaceuticals is a biopharmaceutical company, which engages in the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is actively developing three radiopharmaceutical agent platforms: Lymphoseek, AZD4694 and RIGScan. These platforms help to identify the presence and status of undetected disease and enable better diagnostic accuracy, clinical decision-making and ultimately patient care.
On April 3, 2012, Navidea Biopharmaceuticals announced that the U.S. FDA extended the PDUFA action date for 99m-Tc-Tilmanocept (Lymphoseek®) to September 10, 2012, a 90-day extension from the initial PDUFA date of June 10, 2012. Lymphoseek is an investigational, proprietary radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.
On August 7, 2012, Dr.Mark Pykett, Navidea President and Chief Executive Officer said:
We remain focused on supporting our expected U.S. Lymphoseek approval and commercial launch as well as the planned advancement of its global registration process this year.
Navidea Biopharmaceuticals has a market cap of $417.11 million and is currently trading around $4.03 with a 52-week range of $2.05 to $4.77.
7. Cornerstone Therapeutics, Inc (CRTX): AdCom Date - September 13
Cornerstone Therapeutics is a specialty pharmaceutical company, which engages in the acquisition, development, and commercialization of prescription pharmaceutical drugs for the hospital, niche respiratory, and related specialty markets. Cornerstone acquired lixivaptan through its 2011 acquisition of Cardiokine Biopharma. In March 2012, Cornerstone acquired the North American product rights for FACTIVE (Gemifloxacin Mesylate) tablets. In June 2012, the company acquired EKR Therapeutics, Inc.
On September 13, 2012, the U.S. FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) will review the New Drug Application (NDA) for lixivaptan (CRTX 080) for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The PDUFA action date is scheduled on October 29, 2012. Hyponatremia is a metabolic condition that occurs when there is insufficient sodium (salt) in the blood. Hyponatremia affects up to 6 million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually.
On July 2, 2012, U.S. FDA approved Cornerstone's Abbreviated New Drug Application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product.
Cornerstone Therapeutics has a market cap of $190.13 million and is currently trading around $7.21 with a 52-week range of $4.45 to $8.20. The stock has gained 28.75% year to date.
8. Gilead Sciences, Inc (GILD): PDUFA Date - September 14
Gilead Sciences is a biopharmaceutical company, which discovers, develops, and commercializes human therapeutics for the treatment of life threatening diseases worldwide.
Gilead submitted a New Drug Application (NDA) to the U.S. FDA for the approval of Truvada (to reduce risk of HIV infection) on February 13, 2012, elvitegravir (an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults) on June 27, 2012, and cobicistat (a pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors) on June 28, 2012. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and the U.S. FDA Antiviral Drugs Advisory Committee already provided positive vote for the approval of once-daily oral Truvada on May 10, 2012. If Truvada is approved, then it would be the first drug indicated for uninfected individuals to lower the risk of acquiring HIV.
The U.S. Antiviral Drugs Advisory Committee also voted 13 to one in support of approval of Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.
On August 2, 2012, Gilead, Mylan Laboratories (MYL), Ranbaxy Laboratories Limited (RANBAXY) and Strides Arcolab (STAR) announced that they have entered into agreements to collaborate on promoting access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine (FTC) in developing countries. Under the new agreements, Gilead will provide a technology transfer for the manufacture of emtricitabine, together with funding to assist with investment in process improvements to reduce overall manufacturing costs.
Gilead Sciences has a market cap of $42.74 billion and is currently trading around $56.49 with a 52-week range of $34.45 to $58.84. The stock has gained 38.02% year to date.
9. Regeneron Pharmaceuticals Inc (REGN): PDUFA Date - September 23
Regeneron Pharmaceuticals is a biopharmaceutical company, which discovers, develops, and commercializes medicines for the treatment of serious medical conditions in the United States. Regeneron markets two products, ARCALYST (rilonacept) Injection for subcutaneous use and EYLEA (aflibercept) Injection.
On August 3, 2012, Sanofi (SNY) and Regeneron announced that the U.S. FDA approved ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion, for patients with metastatic colorectal cancer (mCRC). Marketing authorization applications for ZALTRAP are also under review by the European Medicines Agency (EMA) and other regulatory agencies worldwide.
On July 30, 2012, the U.S. FDA issued a Complete Response Letter for the supplemental biologics license application (sBLA) for ARCALYST (rilonacept) Injection for the prevention of gout flares in patients initiating uric acid-lowering therapy and the agency has requested additional clinical data, as well as additional Chemistry, Manufacturing, and Controls (CMC) information related to a proposed new dosage form.
On May 8, 2012, Regeneron and Bayer HealthCare announced that Bayer's Japanese subsidiary, Bayer Yakuhin, Ltd, and Santen Pharmaceutical Co Ltd. ("Santen") entered into a co-promotion agreement for EYLEA (aflibercept) Injection in Japan.
On March 8, 2012, Regeneron and Bayer HealthCare announced that Bayer HealthCare has received approval from the Australian Therapeutic Goods Administration (TGA) for EYLEA (aflibercept) Injection.
The U.S. FDA set the PDUFA action date of September 23, 2012, for EYLEA for the treatment of central retinal vein occlusion (CRVO).
Regeneron Pharmaceuticals has a market cap of $13.10 billion and is currently trading around $136.43 with a 52-week range of $49.58 to $145.04. The stock has gained 146.13% year to date.
Source: Some of the data is sourced from Google Finance, Yahoo Finance, Fidelity and investors site.
Additional Disclosure: I change my positions very frequently and may initiate either long or short positions in the above mentioned stocks at any time.
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.