So far, 2012 has been the best year for the Biotechnology and Drugs industry. So many stocks surged in the last three months based on clinical trial results, U.S. Food and Drug Administration (FDA) approval, FDA Advisory Committee's recommendation, European commission approval, recommendation from independent committees, partnership with big pharmaceuticals, acquisitions, and so on. Below is the list of six biotechnology companies that have huge upside - or downside - potential in the month of May.
Biotech stocks are high risk-reward stocks and hence considerable analysis is required before trading. Use this list as a potential starting point for your analysis.
Protalix BioTherapeutics Inc. (PLX)
Drug Name: Taliglucerase alfa - PDUFA; Date: May 1, 2012
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system, ProCellEx. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner in an environment free of mammalian components and viruses. Protalix's lead compound, taliglucerase alfa, an enzyme replacement therapy for the treatment of Gaucher disease, completed phase III development.
Taliglucerase alfa is a plant-derived enzyme replacement therapy for the treatment of Gaucher disease, completed phase III development. The U.S. Food and Drug Administration granted Protalix a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2012 for taliglucerase alfa. Marketing applications for taliglucerase alfa have been filed in the United States, Europe, Israel, Brazil and Australia.
On Feb 9, 2012, Professor Ari Zimran, M.D., Director of the Gaucher Clinic said:
Pivotal and follow-up clinical studies of taliglucerase alfa to date demonstrate that taliglucerase alfa may be an effective treatment for Gaucher disease. "The results of this 24 month extension trial suggest that taliglucerase alfa has the potential to become a treatment alternative for Gaucher disease patients it be approved.
Protalix has a market cap of 567.60 Million and is currently trading around $6.25 with a 52-week range of $4.06 to $7.28.
Alexza Pharmaceuticals, Inc. (ALXA)
Drug Name: ADASUVE- PDUFA; Date: May 4, 2012
Alexza Pharmaceuticals, Inc. (Alexza)lexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.
ADASUVE is an anti-agitation product candidate that combines Alexza's proprietary Staccato system with loxapine, an antipsychotic currently available in the U.S. as an oral formulation for the management of schizophrenia. The ADASUVE NDA was resubmitted in August 2011, completed an advisory committee meeting in December 2011, received a notice of extension of the Prescription Drug User Fee Act (PDUFA) goal date in January 2012, and has a new PDUFA goal date of May 4, 2012.
On January 23, 2012, Thomas B. King, President and Chief Executive Officer of Alexza Pharmaceuticals said:
We continue to believe that we are on a pathway to gain approval of ADASUVE in the United States and We appreciate the efforts of the FDA to complete their review of our NDA and we will continue to support the continued review of the NDA.
Alexza has a market cap of $66.20 Million and is currently trading around 0.57 with a 52 week range of $0.46 to $1.91.
Regeneron Pharmaceuticals Inc (REGN)
Drug Name: ARCALYST - Adcom; Date: May 8, 2012
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets two products, ARCALYST® (rilonacept) Injection For Subcutaneous Use and EYLEA™ (aflibercept) Injection. Regeneron also has completed several Phase 3 studies and is conducting an additional Phase 3 clinical trial for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion.
ARCALYST, is currently indicated in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. The U.S. Food and Drug Administration has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy. On May 8, 2012, FDA panel will review Arcalyst for additional indication in preventing gout flares in patients initiating uric acid-lowering therapy.
Gout is a condition that occurs when the bodily waste product, uric acid, is deposited in the joints and/or soft tissues. In the joints, these uric acid crystals cause inflammation, which leads to pain, swelling, redness, warmth, and stiffness in the joints. Untreated chronic gout can lead to joint and kidney damage.
On November 22, 2012, George D Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories said:
Based on the positive data from our Phase 3 efficacy studies and the more than 1300 patients in our safety study, we believe that ARCALYST has the potential to become an important new therapy for patients with gout who are initiating uric acid-lowering therapies. Gout is a serious and sometimes debilitating disease, characterized by elevated levels of uric acid in the blood, which requires treatment with uric acid-lowering therapy to avoid gout flares and its long-term complications.
Regeneron has a market cap of $10.99 billion and is currently trading around $117.02 with a 52-week range of $42.55 to $124.49.
Arena Pharmaceuticals, Inc (ARNA)
Drug Name: Lorcaserin - Adcom; Date: May 10, 2012
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
On March 26, 2012, Arena Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted the filing of a Marketing Authorization Application (MAA) for lorcaserin, an investigational drug candidate intended for weight control, including weight loss and maintenance of weight loss, in patients who are obese (BMI > 30) or patients who are overweight (BMI > 27) and have at least one weight-related co-morbid condition. The acceptance of the MAA filing begins the EMA's review process.
Jack Lief, Arena's President and Chief Executive Officer said:
Substantial evidence shows that being overweight or obese can have dire human health consequences coupled with tremendous economic burden. With applications under review for approval in both the United States and European Union, lorcaserin has the potential to provide a new treatment for physicians to help patients lose weight and improve their overall cardiometabolic health.
Craig M. Audet, Arena's Vice President of Global Regulatory Affairs said:
We are working diligently with Eisai Inc. to prepare for the FDA advisory committee meeting in May. We look forward to lorcaserin's PDUFA date in June as well as reporting on developments related to the MAA throughout the year.
ARNA has a market cap of $517.81 million and is currently trading around $2.87 with a 52-week range of $1.21 to $3.47.
Gilead Sciences, Inc. (GILD)
1) Drug Name: Truvada (SNDA) - Adcom; Date: May 10, 2012
2) Drug Name: Quad (NDA) - Adcom; Date: May 11, 2012
Gilead Sciences is a biopharmaceutical company that 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 primary areas of focus include human immunodeficiency virus (HIV)/AIDS, liver diseases, such as hepatitis B and C and cardiovascular/metabolic and respiratory conditions.
Gilead Sciences has two drugs, Truvada and Quad with FDA panel Advisory Committee to review these on May 10, 2012 and May 11, 2012 respectively. The Quad contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir; cobicistat, a "boosting" agent that enables elvitegravir once-daily dosing; and Truvada, which is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead's agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
On March 8, 2012, Gilead Sciences announced that the second pivotal Phase 3 clinical trial (Study 103) found that the Quad was non-inferior to a protease-based regimen of ritonavir-boosted atazanavir (ATV/r) plus Truvada® (emtricitabine/tenofovir disoproxil fumarate) at 48 weeks of therapy among HIV-1 infected treatment-naïve adults.
Edwin DeJesus, MD, Medical Director of the Orlando Immunology Center, Orlando, Florida, and principal investigator of Study 103 mentioned that:
The 90 percent response rate demonstrated by the Quad in this study is one of the highest we have seen in any large, randomized HIV clinical trial of an antiretroviral regimen conducted to date. This result is a strong indication of the potential benefit that an integrase-based single tablet regimen could offer patients starting HIV treatment.
Gilead Sciences has a market cap of $34.66 and is currently trading around $45.77 with a 52-week range of $34.45 to $56.50.
Talon Therapeutics, Inc. (TLON.OB)
Drug Name: Marqibo - PDUFA; Date: May 13, 2012
Talon Therapeutics, Inc., formerly Hana Biosciences, Inc. is a biopharmaceutical company. It 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. Talon's NDA seeking accelerated approval of Marqibo (vincristine sulfate liposomes injection) has been accepted for filing by the FDA. Marqibo will be reviewed by the FDA under Subpart H - Accelerated Approval of New Drugs for Serious or Life Threatening Illnesses, for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The PDUFA date is May 13, 2012.
On March 21, 2012, Talon Therapeutics, Inc., announced that the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit/risk assessment for use of Marqibo (vincristine sulfate liposomes injection) seeking the indication for the treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy.
On March 21, 2012, Steven R. Deitcher, M.D., President, Chief Executive Officer and Board Member of Talon Therapeutics said:
We are very pleased the majority of the ODAC members agree that Marqibo offers a meaningful benefit/risk ratio for a very rare patient population that has a grave prognosis and no current standard of treatment. Based on prior FDA discussions, we have received Special Protocol Assessment (SPA) agreement for a large, randomized Phase 3 trial in front-line adult elderly ALL with sites currently open for enrollment.
Talon Therapeutics has a market cap of $14.66 million and is currently trading around $0.67 with a 52-week range of $0.40 to $1.65.
Among these drugs, I believe the ones by Protalix BioTherapeutics , Regeneron Pharmaceuticals and Talon Therapeutics sound more promising than the other three drugs. However, the other three drugs also have huge potential and the shares of the respective companies are likely to surge in the upcoming months - based on positive news.
Disclaimer: Some data is sourced from Google Finance and investors site. 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 the investor to make the correct decision after necessary research.