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 July.
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. VIVUS Inc (NASDAQ:VVUS) - Key Date: July 17, 2012
VIVUS, Inc., a biopharmaceutical company, is developing therapies to address obesity, sleep apnea, diabetes and male sexual health. Its lead investigational product, Qnexa, has completed Phase 3 clinical trials for the treatment of obesity.
On February 22, 2012, at the meeting of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee, the Advisory Committee voted 20-2 to recommend that Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The FDA is not bound by the recommendations of the Advisory Committee, but will consider the guidance during the review of the Qnexa NDA.
On April 4, 2012, at the FDA's request, VIVUS submitted a comprehensive Risk Evaluation and Mitigation Strategy (REMS) for Qnexa. The Prescription Drug User Fee Act (PDUFA) target date for Qnexa was April 17, 2012. As the submission of the comprehensive REMS was within three months of the PDUFA target date, FDA extended the PDUFA target date by three months, to July 17, 2012, in order to fully review the submission. The three-month extension is a standard extension period.
VIVUS also submitted the 180-day response to the Committee for Medicinal Products for Human Use (CHMP) to the list of outstanding issues for the Qnexa Marketing Authorization Application (MAA) for the European Union (EU) and VIVUS anticipates a response from the CHMP in the second quarter of 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea.
On April 9, 2012, Leland F. Wilson, chief executive officer of VIVUS said:
The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February. We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans.
On April 27, 2012, VIVUS announced that the FDA had approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.
VIVUS has a market cap of $2.48 billion and is currently trading around $24.89 with a 52-week range of $6.13 to $26.75.
2. Amarin Corporation (AMRN) - Key Date: July 26, 2012
Amarin Corporation, a late-stage biopharmaceutical company, focuses on developing the treatment for cardiovascular disease in the field of lipid science. The company's product candidate is AMR101, an ultra-pure omega-3 fatty acid. It is developing AMR101 for the treatment of patients with high triglyceride levels, or hypertriglyceridemia.
Amarin has filed a New Drug Application (NDA) with the FDA for the use of its lead product candidate, AMR101, in the treatment of patients with very high triglyceride levels (≥500 mg/dL), the patient population studied in Amarin's MARINE Phase 3 trial, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012.
AMR101 (icosapent ethyl) is an ultra pure omega-3 fatty acid, comprising not less than 96% EPA (icosapent ethyl), that Amarin is developing as a treatment for patients with very high triglyceride levels (≥500 mg/dL), and for patients with high triglyceride levels (≥200 and < 500mg/dL) who are also on statin therapy for elevated low-density lipoprotein cholesterol, or LDL-C, levels (which we refer to as mixed dyslipidemia).
Amarin currently plans to file a supplemental NDA (SNDA) for the use of AMR101 in the treatment of patients with high triglyceride levels (≥200 and < 500mg/dL) who are also on statin therapy for elevated LDL-C levels, the population studied in the ANCHOR trial, if the FDA approves the MARINE indication and after the REDUCE-IT cardiovascular outcomes trial is substantially underway.
The MARINE, ANCHOR and REDUCE-IT studies are each conducted under a Special Protocol Assessment (SPA) agreement with the FDA. An SPA represents agreement between the FDA and a company on the design and analysis of a clinical trial before it begins.
On May 29, 2012, Amarin announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent covering the pharmaceutical composition of Amarin's AMR101 based on U.S. Patent Application Serial No. 12/052,598, also known as the EPA with no DHA in a capsule application.
On May 8, 2012, Joseph Zakrzewski, Amarin's Chairman and Chief Executive Officer said:
With the MARINE indication PDUFA date in July 2012, we are advancing our business plan to maximize the value of AMR101 which we believe is differentiated in its class with the potential to redefine lipid management therapy.
Amarin has a market cap of $1.69 billion and is currently trading around $12.27 with a 52-week range of $5.99 to $19.87.
3. Horizon Pharma (NASDAQ:HZNP) - Key Date: July 26, 2012
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the Food and Drug Administration approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill.
Horizon has completed the Phase 3 CAPRA-2 study for RAYOS in the United States, Europe and Canada for the treatment of the signs and symptoms of rheumatoid arthritis (RA) and in November 2011, the FDA accepted for filing and review Horizon's New Drug Application for RAYOS. The PDUFA action date is July 26, 2012 based on a standard 10 month review.
Outside the United States, LODOTRA is approved for the treatment of moderate to severe active rheumatoid arthritis when accompanied by morning stiffness in 16 European countries and Israel and is marketed in Europe through Horizon's distribution partner Mundipharma International Corporation Limited, which also has commercial rights in certain Asian and Latin American countries.
On May 29, 2012, Horizon Pharma announced that the U.S. Patent and Trademark Office has issued patent number 8,168,218 titled "Delayed Release Tablet with Defined Core Geometry" that covers RAYOS (5 mg Delayed-Release Prednisone). Horizon is the licensee of the SkyePharma group of companies in respect of the patent and SkyePharma's related proprietary Geoclock technology.
On March 28, 2012, Horizon has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Par Pharmaceutical, Inc. ("Par") and related to an Abbreviated New Drug Application ("ANDA") that Par filed with the U.S. Food and Drug Administration ("FDA") to market a generic version of DUEXIS tablets.
In addition to DUEXIS (Ibuprofen and Famotidine) Tablets and LODOTRA, Horizon has a pipeline of clinically enabled product candidates for the treatment of pain-related diseases and chronic inflammation. Horizon is currently evaluating the development pathway for TruNoc and HZN-602.
Horizon Pharma has a market cap of $135.15 million and is currently trading around $4.01 with a 52-week range of $3.05 to $9.34.
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. Kyprolis is the proposed trade name for carfilzomib. Regorafenib is a compound under development by Bayer. Onyx will receive a royalty on potential future global net sales in human oncology and will co-promote with Bayer in the U.S.
Ligand Pharmaceuticals (Ligand) is a biotechnology company that operates with a business model focused on developing or acquiring assets. The company's technology portfolio CAPTISOL is a formulation technology that has enabled five Food and Drug Administration approved products, including Pfizer's VFEND IV and Baxter International's Nexterone and is being used in a number of clinical-stage partner programs.
Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline (NYSE:GSK), Merck (NYSE:MRK), Pfizer (NYSE:PFE), Eli Lilly & Company (NYSE:LLY), Baxter International (NYSE:BAX), Bristol-Myers Squibb (NYSE:BMY), Celgene (NASDAQ:CELG), Onyx Pharmaceuticals, Lundbeck, The Medicines Company, Curis Inc (NASDAQ:CRIS) and Rib-X Pharmaceuticals (RIBX).
The FDA's Oncologic Drugs Advisory Committee 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 $3.01 billion and is currently trading around $46.73, with a 52-week range of $27.17 to $47.80.
Ligand Pharmaceuticals has a market cap of $249.19 million and is currently trading around $12.66, with a 52-week range of $9.76 to $18.74.
Progenics Pharmaceuticals, Inc. (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. The company is also engaged in research to identify multiplex phosphoinositide 3-kinase (PI3K) inhibitors for blocking signaling pathways in the growth of aggressive cancers. In gastroenterology, its first commercial product is RELISTOR (methylnaltrexone bromide) subcutaneous injection, a first-in-class therapy for opioid-induced constipation approved for sale in over 50 countries worldwide, including the US, the European Union, Canada and Australia. Marketing applications are pending elsewhere worldwide.
Salix Pharmaceuticals, Ltd. is a specialty pharmaceutical company engaged in acquiring, developing and commercializing prescription drugs and medical devices used in the treatment of a variety of gastrointestinal diseases, which are those affecting the digestive tract. The company's products included XIFAXAN, MOVIPREP, RELISTOR, OSMOPREP, VISICOL, APRISO, SOLESTA, DEFLUX, METOZOLV ODT, AZASAN, ANUSOL-HC, PROCTOCORT Cream, PEPCID, Oral Suspension DIURIL and COLAZAL. As of December 31, 2011, its primary product candidates under development included Rifaximin, Crofelemer, Balsalazide disodium tablet, Budesonide foam, Methylnaltrexone bromide and Methylnaltrexone bromide oral.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Salix Pharmaceuticals for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation.
On April 25, 2012, Salix and Progenics announced that the FDA has extended the PDUFA goal date for the agency's review of the Supplemental New Drug Application for RELISTOR (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The FDA has notified Salix that it requires additional time for a full review of the submission and has extended the April 27, 2012, goal date by the standard extension period of three months. The extended user fee goal date is July 27, 2012. The extension requested no additional studies.
RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
Progenics Pharmaceuticals has a market cap of $304.77 million and is currently trading around $9.00, with a 52-week range of $4.50 to $11.34.
Salix Pharmaceuticals has a market cap of $3.03 billion and is currently trading around $52.15, with a 52-week range of $25.64 to $53.99.
6. Regeneron Pharmaceuticals (NASDAQ:REGN) - Key Date: July 30, 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. Regeneron has three regulatory applications pending before the FDA and 10 drug candidates in clinical development.
On May 8, 2012, the Arthritis Advisory Committee of the FDA voted against approval of ARCALYST (rilonacept) injection for subcutaneous use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy. The committee's recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) for ARCALYST, but the committee's recommendation is not binding on the FDA.
The FDA granted a PDUFA date of July 30, 2012 for the sBLA for ARCALYST.
ARCALYST is currently indicated in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (NASDAQ:CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. Rilonacept is also approved, but not marketed, in the EU for the same patient population.
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.
Regeneron and Sanofi (NYSE:SNY) 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 FDA in February 2012. The US BLA was granted Priority Review status with a PDUFA date of August 4, 2012.
Regeneron has filed an sBLA for EYLEA in central retinal vein occlusion (CRVO) in the United States, and has been granted a Prescription Drug User Fee Act (PDUFA) date of September 23, 2012.
Regeneron Pharmaceuticals has a market cap of $12.94 billion and is currently trading around $136.00, with a 52-week range of $42.83 to $145.04.
(For a look at six biotech names we thought had huge potential in June, click here.)
Some of the data is sourced from Google Finance, Yahoo Finance, Fidelity and investors site.
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.
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in AMRN, BAX, BMY, CELG, CRIS, GSK, HZNP, LGND, LLY, MRK, ONXX, PFE, PGNX, RIBX, SLXP, SNY, VVUS, ARNA, OREX over the next 72 hours.