|VIVUS rejected by FDA but shares soar. Strong earnings boost Questcor. After the bell: AVANIR finally gets FDA nod, shares double|
|By BioMedReports.com Staff|
|Friday, 29 October 2010 18:22|
After the bell Friday AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) announced that it had recived FDA approval for AVP-923 (Neudexta). In 2006 Avanir received a complete response letter (CRL) for the drug which is intended for the treatment of psuedobulbar affect (PBA) in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). AVP-923 is a combination of dextromethorphan and quininide, both of which have already been approved and marketed for other uses.
In Friday trading shares of Avanir went on a wild ride, trading as low as $1.31 after breaching an intra-day high of $3.05. The stock finally settled the day at $2.42, down 39 cents or 13.88%.
In after hours trading shares were up 15.29% or 37 cents before being halted at $2.79 per share. After the halt, shares shot up to $5.90 per share before pulling back and closing at $5.02, up $2.60, more than 107%.
Forest Laboratories, Inc. (NYSE:FRX) announced after the market close today that Teflaro (ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). The efficacy and safety of Teflaro was established in pivotal trials including 1219 patients treated with the drug.
Teflaro is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. Forest expects Teflaro to be available to wholesalers by January 2011.
"Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications," said Dirk Thye, President of Cerexa, a wholly-owned subsidiary of Forest Laboratories, Inc. "We eagerly anticipate the commercial launch of Teflaro and remain committed to bringing additional new treatments to market that target infectious diseases."
Shares of VIVUS, Inc. (Nasdaq:VVUS) rallied more than 26% in heavy trading Friday. Late Thursday the company reported that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding its New Drug Application for the investigational new drug QNEXA Controlled-Release Capsules. Despite the CRL, the company feels that the FDA has outlined clear guidlines for the drug to evntually be approved. Said Leland Wilson, chief executive officer of VIVUS: "We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity. We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks."
Shares of VIVUS shot up to as high as $8.39 in early trading before pulling back and ultimately closing the day at $7.75, up $1.62.
Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) saw its stock run up more than 12% Friday after the company reported earnings after the bell Thursday. The company reported record sales of $31 million with net income of $11.5 million or $0.18 per shares. The company said that the financial performance was driven primarily by an increase in net sales for Acthar in the treatment of acute exacerbations of multiple sclerosis (MS). Acthar net sales for the treatment of infantile spasms (IS) continued to be within its historic range.
"The third quarter of 2010 results reflect the continued execution of our straightforward growth strategy for Acthar," said Don M. Bailey, President and CEO of Questcor. "We continue to have success in educating neurologists about the benefits of Acthar for patients afflicted with acute exacerbations of MS who have medical issues with steroids, the first-line treatment for this condition.
"With the recent approval from the FDA to market Acthar for the treatment of infantile spasms, we have initiated our commercial efforts in this therapeutic area," continued Mr. Bailey.
On heavy volume, shares of Questcor rose 12.35% or $1.35 to close the day at $12.28. Earlier in the session shares hit a 52 week high of $12.59.
Amicus Therapeutics (Nasdaq:FOLD) and GlaxoSmithKline PLC (NYSE:GSK) today announced a definitive agreement to develop and commercialize Amigal (migalastat HCl), currently in Phase 3 for the treatment of Fabry disease, a rare inherited disorder. Under the terms of the agreement, GSK will receive an exclusive worldwide license to develop, manufacture and commercialize migalastat HCl. Additionally, as part of the agreement GSK and Amicus also intend to advance clinical studies exploring the co-administration of migalastat HCl with enzyme replacement therapy (ERT) for the treatment of Fabry disease.
Under the terms of the Agreement, Amicus will receive an upfront, license payment of $30M from GSK and is eligible to receive further payments of approximately $170M upon the successful achievement of development and commercialization milestones, as well as tiered double-digit royalties on global sales of migalastat HCl. GSK and Amicus will jointly fund development costs in accordance with an agreed upon development plan. Additionally, as part of the collaboration, GSK is purchasing 6.9 million shares of Amicus common stock at a price of $4.56 per share. The total value of this equity investment to Amicus is $31 million and represents a 19.9% ownership position for GSK in the Company. The total cash up-front to Amicus from GSK for the upfront license payment and equity investment is approximately $60 million.
NeoPharm, Inc. (Other OTC:NEOL.PK.pk), a biopharmaceutical company dedicated to the research, development and commercialization of new and innovative therapeutic applications of drugs for cancer and other diseases, today announced it has entered into a merger agreement with Insys Therapeutics, a Phoenix-based drug development company focused on pain and oncology.
Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX.to) announced today that its subsidiary, Biovail Laboratories International SRL (BLS), has agreed to acquire several privately–owned pharmacy skin care brands in Australia. The leading brands, including well-established local brands such as Hamilton's Suncare and Hamilton's Skin Therapy, are ranked #2 in suncare in the Australian pharmacy market. Total annualized sales of the acquired products are approximately AU$10 million. The acquisition is expected to be accretive in 2010.
Varian Medical Systems, Inc. (NYSE:VAR) today announced that CURE Foundation has placed an order for five Varian TrueBeam systems for stereotactic radiosurgery and radiation therapy.CURE Foundation, which placed the order in September, plans to install the TrueBeam systems in existing and new clinics on the U.S. East Coast during 2011.
Echo Therapeutics, Inc. (OTC Bulletin Board:ECTE), a company developing its needle-free Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude™ SkinPrep System for transdermal drug delivery, today announced that Patrick T. Mooney, M.D., CEO, President and Chairman of the Board of Echo Therapeutics will present at the LifeTech Capital 1st Annual Miami Medical Investors Conference being held November 12, 2010 at the JW Marriott Marquis in Miami, Fl.