|Arena/VIVUS Race to the Lucrative Anti-Obesity Drug Market; Genzyme sends MS drug Lemtrada to FDA|
|By Staff and Wire Reports|
|Tuesday, 12 June 2012 18:56|
Despite growing global economic concerns, the Biotech Industry has shown investors striking gains in 2012. The SPDR S&P Biotech ETF (XBI) is up over 23 percent year-to-date, nearly 10 times the 2.75 percent gain from Dow Jones over the same period. The anti-obesity drug market has been a hot topic recently as companies race to bring the first weight loss pill to market in nearly 13 years. Five Star Equities examines the outlook for companies in Biotech Industry and provides equity research on Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and VIVUS, Inc. (NASDAQ: VVUS).
Obesity in the U.S. has become a major problem. According to the National Institute of Health in 2009-2010 35.7 percent of adults in the U.S. were obese. On average it is estimated that an obese person spends $1,429 more normal-weight individuals. In 2003, it was estimated that as much as $75 billion of the nation's public health cost was associated with obesity. If something is not done to slow down U.S. obesity rates it is predicted that obesity related spending will rise to $343 billion in 2018 according to numbers from the National Institute of Health.
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Arena's Lorcaserin, an investigational drug candidate intended for weight management, 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. Arena has patents that cover Lorcaserin in the United States, Europe and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain. The Food and Drug Administration is set to make a decision on Lorcaserin by June 27.
Vivus' Qnexa is an investigational drug candidate being developed to address weight loss, type-2 diabetes and obstructive sleep apnea. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. The Food and Drug Administration is set to make a decision on Qnexa by July 17.
Genzyme Corp. has sent its potential therapy for multiple sclerosis (MS), which would be marketed as Lemtrada, to both the U.S. FDA and to European regulators. The drug candidate was a key bargaining chip in the Cambridge, Mass.-based company’s acquisition negotiations with its new parent, French drug maker Sanofi (NYSE: SNY), leading up to the deal announcement in February 2011.
The potential MS therapy is already approved to treat leukemia under the name Campath, and Genzyme executives called results from a second Phase 3 trial for Lemtrada, released earlier this year, “unprecedented.”
The data showed that in a study with over 600 patients who had previously been treated with other drugs, there was a 49 percent reduction in the annualized relapse rate, versus Rebif, made by Rockland, Mass.-based EMD Serono.
“There remains a large unmet treatment need for patients living with active disease and we believe that Lemtrada, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS,” Genzyme CEO David Meeker said in a statement.
Approximately 95 percent of the patients stayed in the trial until the end. Three patients died, but two of those were in motor vehicle accidents, and the other Genzyme attributed to disability associated with a relapse from before the patient joined the trial.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in a proof-of-concept study exploring the use of AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg in treating patients who have post-stroke deficits.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Jane Wasman, Chief, Strategic Development and General Counsel, will present at the Wells Fargo 2012 Healthcare Conference on Tuesday, June 19, 2012 at 2:30 pm ET at the Intercontinental Hotel in Boston, MA.
Alkermes plc (NASDAQ: ALKS) today announced that Janssen Research & Development, LLC has initiated a phase 3 clinical research program for a three-month formulation of INVEGA® SUSTENNA® (paliperidone palmitate), an injectable medicine for the treatment of schizophrenia.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced the publication of new pre-clinical results in the journal Blood (doi: 10.1182/blood-2012-04-423715) that describe targeting the egg-laying nine homolog (EglN) pathway for the treatment of anemia using RNAi therapeutics.
Axia Group (PINKSHEETS:AGIJ) http://www.axiacorporation.com/ is pleased to update its shareholders on business developments.
Biogen Idec (NASDAQ: BIIB) today will be hosting an Analyst Day to provide an update for the investment community on the company’s commercial strategy, select late and early-stage clinical development programs, as well as the revitalization of its research organization.
EncounterCare Solutions, Inc.(PINKSHEETS: ECSL) announced today that it earned $3,091,000 ($.06 per share) through the end of its third quarter (March 31, 2012).
Galena Biopharma (Nasdaq: GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, announced today that their June 7th RetailInvestorConferences.com presentation is now available for on-demand viewing.
GenMark Diagnostics, Inc. (Nasdaq:GNMK) today provided revised revenue estimates for the second quarter ending June 30, 2012 and for the calendar year ending December 31, 2012.
ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209) , a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that Vice Chairman, Mr. Peter Gray, has decided to retire at the company’s Annual General Meeting on the 19th July, 2012.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the closing of its acquisition of EUSA Pharma, a privately-held, specialty pharmaceutical company with a commercial presence in the U.S. and EU and a global distribution network.
Life Technologies Corporation (NASDAQ: LIFE) today announced a partnership with Cellular Dynamics International(CDI), the world's largest producer of human cells derived from induced pluripotent stem (iPS) cells, to commercialize a set of three new products optimized to consistently develop and grow human iPS cells for both research and bioproduction.
Mauna Kea Technologies (NYSE: MKEA), leader in the endomicroscopy market, announced that ANVISA, the National Health Surveillance Agency in Brazil, has cleared the company to sell its Cellvizio® 100 Series endomicroscopic imaging system throughout the country, which represents South America's largest medical device market.
Psychemedics Corporation (NASDAQ: PMD), hair testing pioneer and global leader for twenty-five years, announced that after a rigorous and thorough review, the Food and Drug Administration (FDA) granted the company 510(k) clearances for five new, additional assays to test for the detection of cocaine, opiates, PCP, methamphetamine and marijuana using enzyme immunoassay (EIA) analysis of head and body hair.
PuraMed BioScience®, Inc., (OTCBB: PMBS) announced today that they will be attending NACDS's tradeshow, Marketplace 2012, being held in Denver, Colorado between June 23- 26, 2012.
Regenicin, Inc. (OTC Bulletin Board: RGIN) a biotechnology company specializing in the development of and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, announced today that the Food and Drug Administration (FDA) has granted Orphan Status approval for the PermaDerm® product, the only tissue-engineered skin prepared from autologous (patient's own) skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients.
Veramark Technologies, Inc. (OTCQB: VERA) (PINKSHEETS: VERA), a leading provider of Telecom Expense Management (TEM) solutions, today announced that its VeraSMART® premise-deployed solutions comply with the Final HIPAA Security Rule, confirming compliance with relevant Federal Regulations and reducing risk for companies in the health care industry.