|FDA approves Arena's anti-obesity pill Belviq; Anthera Updates Phase 3 Plans|
|By Staff and Wire Reports|
|Wednesday, 27 June 2012 18:40|
The Food and Drug Administration has approved Arena Pharmaceutical's (NASDAQ:ARNA) anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.
In a rare move, the FDA explicitly stated in a press release that Belviq "does not appear to activate" a chemical pathway that was linked to the heart problems seen with fen-phen.
The FDA says the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.
Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.
Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. But the FDA has delayed a decision on that pill until July.
Arena's studies showed that patients taking Belviq, known generically as lorcaserin, had modest weight loss. On average patients lost just 3 to 3.7 percent of their starting body weight over a year. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness. By comparison, average weight loss with Qnexa is 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more.
In May a panel of expert advisers to the FDA voted 18-4 to recommend approval of Arena's drug, concluding that its benefits "outweigh the potential risks when used long term" in overweight and obese people.
Experts say the challenge of weight loss drug development lies in safely turning off one of the body's fundamental directives: to eat enough food to maintain its current weight.
While several drugs are available for short-term weight loss, until Wednesday there was only one FDA-approved prescription drug for long-term weight loss: Xenical from Roche, which is seldom prescribed because unpleasant digestive side effects and modest weight loss.
Other safety failures for diet pills have continued to pile up in recent years.
Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke.
Side effects with the drug include depression, migraine and memory lapses.
Shares of San Diego-based Arena Pharmaceuticals Inc. jumped $3.03, or 34 percent, to $11.88 in trading Wednesday afternoon.
Anthera Pharmaceuticals (NASDAQ: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.
The purpose of the PEARL-SC study was to identify an effective and safe dose for future phase 3 clinical studies and explore key inclusion criteria and clinical endpoints in an effort to maximize differentiation of blisibimod from currently available therapies. The 200mg weekly subcutaneous dose of blisibimod demonstrated a strong trend in improved clinical response as early as week 16 (p= 0.14), at the primary endpoint (p=0.15) and throughout week 44 including a statistically significant improvement at week 20 versus placebo (p=0.02).
In a predefined phase 3 target population of severely ill, seropositive lupus patients, defined as SELENA-SLEDAI ≥10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group demonstrating a 13.8% treatment difference compared to placebo at 24 weeks. In this subgroup, planned for phase 3 studies, separation of clinical response occurred as early as week 8 and was also sustained through week 44.
Accelr8 Technology Corporation (NYSE MKT: AXK) announced today that it has received shareholder approval, met all closing conditions, and has consummated a transaction that will result in an investment of up to $35 million in Accelr8’s common stock.
Aethlon Medical, Inc. (OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has expanded and developed its management team with new appointments and promotions.
Accelr8 Technology Corporation (NYSE MKT: AXK) today announced the appointment of Lawrence Mehren as President and Chief Executive Officer and a member of the Board of Directors.
Baxter International Inc. (NYSE: BAX) today issued its 2011 Sustainability Report, marking the 13th consecutive year the company has released a report about its social, environmental and economic performance.
BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, announced that it is, together with C.R. Bard, a 2012 winner of Microsoft Corporation’s prestigious Life Sciences Innovation Award.
Compugen Ltd. (NASDAQ: CGEN) announced today results demonstrating the therapeutic potential of CGEN-15022, a Compugen-discovered B7/CD28-like membrane protein, as an immune checkpoint target for treatment of multiple cancers.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that full results from its successful Phase 2 clinical trial with the investigational drug DSC127 in patients with diabetic foot ulcers will be published on July 5th in the July 2012 issue of Wound Repair and Regeneration.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the first patient has been dosed in the Company's U.S. phase 2 clinical studyof ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease entitled TARGET-NTM (Treatment with ARIKACE to Realize Greater Efficacy Trial).
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer of Ligand, will present at the JMP Securities 7th Annual Healthcare Conference on Thursday, July 12, 2012 at 9:30 a.m. Eastern (6:30 a.m. Pacific Time).
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Merck and AstraZeneca have amended the option agreement related to their partnership known as AstraZeneca LP (AZLP).
MYOS Corporation (OTCBB: MYOS), a company focused on the discovery, development and commercialization of muscle health and performance therapeutic products, today announced that it has appointed Sol J. Barer, Ph.D., to Chair its Scientific Advisory Board.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch in the U.S. and Canada of the cobas p 312 pre-analytical system, a front-end automation solution that offers comprehensive, vendor-neutral sample management for labs with limited floor space.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has received notice from the Canadian Intellectual Property Office that it has obtained patent issuance for its proprietary drug, Soluble Ferric Pyrophosphate (SFP), the Company's late-stage investigational drug that provides iron replacement to hemodialysis patients with CKD.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced the appointment of Carolyn Beaver to Vice President and Chief Accounting Officer.
Sirona Biochem Corp. (TSX VENTURE:SBM) (PINKSHEETS:SRBCF) (FRANKFURT:ZSB) announced today it has retained Bloom Burton and Co., Canada's largest and most active healthcare-specialized investment banking group.
Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that it has entered into a collaboration with the Infectious Disease Research Institute (IDRI) of Seattle, WA to develop select biodefense vaccines using IDRI's potent and safe synthetic adjuvants in conjunction with Soligenix's proprietary subunit proteins and thermostability platform (known as ThermoVax™).
Sunridge International (PINKSHEETS: SNDZ) announced today that it has received a $1,000,000 payment from Westhouse Medical of the United Kingdom, as partial payment towards the purchase of assets from Sunridge International.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), which specializes in non-addictive treatments for chronic pain syndrome disorders, announces that Chief Executive Officer, Seth Lederman, M.D., will present a corporate overview at the LHA Life Sciences & Medical Technologies Virtual Conference on Thursday, June 28, 2012.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”) including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), announces that the Company will initiate a comparative study on a novel treatment for FM that targets sleep problems associated with chronic pain syndromes. TONIX’s new approach is opiate-free and non-addictive.
Uni Core Holdings Corporation (OTC Bulletin Board), a Hong Kong based holding company, announced today that the Autumn corn-base fertilizer selling project work of five direct sales stores (the Zu'An, Lao Dian, Da Wang, Jiang Cun and Zhong Nan stores in the Hu and Zhouzhi Counties of Shaanxi Province) of Prosperous Agriculture Company Limited ("Prosperous Agriculture"), one of UCHC's subsidiaries, has been successfully completed up to the middle of June, achieving a total sales volume of 965 tons and around RMB3 million of sales turnover this quarter.
United Therapeutics Corporation (NASDAQ: UTHR) today announced that its Board of Directors authorized the repurchase of up to an additional $100 million of the company's common stock.