So far, 2012 has been the best year for the biotechnology and drugs industry. So many stocks surged in the last four 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 six biotechnology companies that have huge upside -- or downside -- potential in the month of June.
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. Ariad Pharmaceuticals (ARIA) -- Key Date: June 5, 2012
Ariad Pharmaceuticals, an oncology company, focuses on the discovery, development, and commercialization of medicines for cancer patients. Ariad's approach to structure-based drug design has led to three internally discovered, molecularly targeted product candidates for drug-resistant and difficult-to-treat cancers, including certain forms of chronic myeloid leukemia, soft tissue and bone sarcomas, and non-small cell lung cancer. Ariad's pipeline contains three product candidates: ponatinib, AP26113, and ridaforolimus.
The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 5, 2012. Ariad's partner Merck (MRK) submitted a new drug application (NDA) for ridaforolimus in the U.S. and marketing authorization applications (MAA) in Europe and other geographies. As part of an exclusive license agreement with Ariad, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology.
The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of the investigational agent ridaforolimus (TALTORVIC) as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy. The FDA is not bound by the committee's guidance, but takes its advice into account.
Sarcomas are a group of cancers of connective tissue of the body. Sarcomas can arise anywhere in the body and are divided into two main groups; bone tumors and soft-tissue sarcomas. Ridaforolimus is a novel small-molecule inhibitor of the protein mTOR that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival in cancer cells.
On March 20, 2012, the VP of Clinical Research Oncology for Merck, Dr. Eric Rubin, said:
Merck remains confident in the potential of the investigational agent ridaforolimus for an indication where patients have limited options. We remain committed to bringing forward this promising therapy for patients with metastatic sarcoma, and look forward to further discussions with the FDA regarding this application.
Ariad Pharmaceuticals has a market cap of $2.62 billion and is currently trading around $16.56, with a 52-week range of $7.55 to $16.96.
2. XenoPort (XNPT) -- Key Date: June 9, 2012
XenoPort is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Horizant (gabapentin enacarbil) Extended-Release Tablets is XenoPort's first FDA-approved product. Regnite (gabapentin enacarbil) is approved in Japan for the treatment of moderate to severe primary restless legs syndrome. XenoPort's pipeline of product candidates includes potential treatments for patients with postherpetic neuralgia, spasticity, and Parkinson's disease.
The FDA has accepted for review the supplemental new drug application (SNDA) filed by GlaxoSmithKline (GSK) requesting approval of Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of postherpetic neuralgia in adults. The FDA has set a PDUFA date of June 9, 2012, as a goal for the completion of their review of the SNDA.
On April 4, 2012, XenoPort announced that it was awarded U.S. Patent 8,148,414 for "Prodrugs of Methyl Hydrogen Fumarate, Pharmaceutical Compositions Thereof, and Methods of Use." The term of the patent extends until 2029, subject to potential Hatch-Waxman patent term extensions.
XenoPort has a market cap of $162.82 million and it is currently trading around $4.57 with a 52-week range of $3.46 to $8.44.
3. Onyx Pharmaceuticals (ONXX) -- Key Date: June 20, 2012
Onyx Pharmaceuticals, a global biopharmaceutical company, engages in the development and commercialization of innovative therapies that target the molecular mechanisms that cause cancer in the U.S. and internationally. The company, through its collaboration agreement with Bayer, develops and markets the Nexavar (sorafenib) tablet, a multiple kinase inhibitor for the treatment of liver cancer and advanced kidney cancer.
The FDA's ODAC will review Onyx's NDA for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. ODAC will review carfilzomib at its meeting on June 20, 2012. The PDUFA date for completion of review by the FDA is July 27, 2012.
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the U.S., more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.
On April 26, 2012, Dr. Ted W. Love, executive vice president of Research and Development and Technical Operations at Onyx Pharmaceuticals, said:
Multiple myeloma is a deadly disease for which there are no cures, and we are committed to bringing carfilzomib to patients as quickly as possible. Our team looks forward to discussing the potential efficacy benefit and safety profile of carfilzomib with the advisory committee and will continue to work closely with the FDA during its review.
Onyx Pharmaceuticals has a market cap of $2.86 billion and is currently trading around $44.61, with a 52-week range of $27.17 to $47.80.
4. Repligen Corp. (RGEN) -- Key Date: June 21, 2012
Repligen is a biopharmaceutical company focused on the development and commercialization of therapies that harness biological pathways and deliver value to patients and clinicians in the fields of neurology and gastroenterology. Repligen is a leading supplier of critical biologic products used to manufacture biologic drugs. Repligen was conducting a number of drug development programs for diseases, such as pancreatitis, Friedreich's ataxia, and spinal muscular atrophy.
SecreFlo is a synthetic version of the human hormone secretin. When used in combination with magnetic resonance imaging (MRI), SecreFlo offers a safe, reliable and lower-cost alternative to the diagnostic use of endoscopic retrograde cholangio-pancreatography in examining and evaluating patients with pancreatitis.
The SecreFlo NDA was submitted on Dec. 21, 2011, and was granted priority review by the FDA with a PDUFA goal date of June 21, 2012. The Phase III study's co-primary endpoints were achievement of a statistically significant improvement in sensitivity with minimal loss in specificity. The study met its primary endpoints, demonstrating that the addition of SecreFlo to MRI resulted in a highly statistically significant improvement (p < 0.0001) in sensitivity of detection of 10 pre-specified abnormalities of the pancreatic ducts, with minimal loss in specificity (< 7.5%).
On April 26, 2012, the FDA notified Repligen that the previously scheduled advisory committee meeting for May 31, 2012, has been cancelled by the FDA. The company expects to receive a complete response letter (CRL) on the previously announced June 21 PDUFA date requesting additional clinical trial data to support the NDA. After this news, Repligen stock price went down by 45% in a single day.
On April 26, 2012, Walter C. Herlihy, president and CEO of Repligen, said:
While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need. We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068.
Repligen has a market cap of $138.79 million and it is currently trading around $4.50, with a 52-week range of $2.90 to $7.29.
5. Arena Pharmaceuticals (ARNA) -- Key Date: June 27, 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.
Lorcaserin is an investigational drug candidate intended for weight management, 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 comorbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism.
The FDA has assigned a new PDUFA target date of June 27, 2012. Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a CRL in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011.
On March 26, 2012, Arena Pharmaceuticals announced that the European Medicines Agency (EMA) has accepted the filing of a marketing authorization application 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 comorbid condition. The acceptance of the MAA filing begins the EMA's review process.
Jack Lief, Arena's president and CEO, 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.
Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the U.S. subject to FDA approval of the lorcaserin NDA.
Arena Pharmaceuticals has a market cap of $472.71 million and is currently trading around $2.62, with a 52-week range of $1.23 to $3.47.
6. Bristol Myers Squibb (BMY) -- Key Date: June 28, 2012
Bristol-Myers Squibb is a global biopharmaceutical company. The company is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis. Its products are sold worldwide to wholesalers, retail pharmacies, hospitals, government entities and the medical profession.
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the U.S. Eliquis is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. In 2007, Pfizer (PFE) and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize Eliquis, an investigational oral anticoagulant discovered by Bristol-Myers Squibb.
The FDA has assigned a new PDUFA target date of June 28, 2012, to review Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. At this stage there are no plans for an FDA advisory committee meeting to review the NDA for Eliquis. The FDA has initially set the PDUFUA date as March 28, 2012, and in February, the FDA extended the action date by three months. In March, the company and its partner presented data at the American College of Cardiology annual meeting in Chicago.
Bristol Myers Squibb has a market cap of $56.23 billion and is currently trading around $33.32, with a 52-week range of $25.69 to $35.44.
(For a look at six biotech names we thought had huge potential in May, click here.)
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.