|RxNews Recap for Tuesday 03-09-10. InterMune flys on FDA panel review. Facet BioTech bought out by Abbott.|
|By BioMedReports.com Staff|
|Tuesday, 09 March 2010 19:13|
InterMune, Inc. (Nasdaq:ITMN) rocketed in the after hours market after the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.
IPF is a rare and fatal lung disease that affects approximately 200,000 people in the United States and Europe. If approved by the FDA for commercialization, Esbriet would be the first medication to be made available to IPF patients in the United States.
"We are pleased with the outcome of today's Advisory Committee meeting," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "We look forward to working closely with the FDA as review of the Esbriet NDA continues."
Though the Advisory Committee's recommendations are not binding, they will be considered as the FDA completes its review of the New Drug Application (NDA) for Esbriet. Esbriet received Orphan Drug, Fast Track and Priority Review designations by the FDA. Priority Review designation may be granted by the FDA to an NDA for drugs that have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists. A target date of May 4, 2010 has been set under the Prescription Drug User Fee Act (PDUFA). Shares of InterMune were halted during the regular trading session and did not open until 4:45PM EST this afternoon where they quickly shot up to the mid 30 dollar range and finally settled at $38.31, up a whopping $15.01 or 64.42%.
Abbott (NYSE:ABT) and Facet Biotech Corporation (Nasdaq:FACT) after the market close announced today a definitive agreement for Abbott to acquire Facet, enhancing Abbott's early- and mid-stage pharmaceutical pipeline. Abbott will acquire Facet for $27 per share in cash for a net transaction value of approximately $450 million, which includes a purchase price of approximately $722 million less Facet's projected cash and marketable securities at closing of approximately $272 million.
The acquisition brings access to biologics in two key therapeutic areas, immunology and oncology. The compounds include daclizumab – a Phase II investigational biologic intended to treat multiple sclerosis (MS) that is expected to move into Phase III development in the second quarter 2010 – and oncology compounds in early- to mid-stage development. Daclizumab is being developed in collaboration with Biogen Idec and certain oncology compounds are being developed in collaboration with other parties. Shares of Facet exploded in the after hours market, jumping 67.24% to $27.11 after closing the regular session at $16.21.
Also after the bell:
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, after the market closed today reported its financial results for the fourth quarter and year ended December 31, 2009.
"Together with our partner, Biovail, we are pursuing a broad development strategy designed to leverage the clinical and commercial potential of pimavanserin in three separate indications with large unmet medical needs," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "During 2010 we plan to initiate a new Phase III trial in Parkinson’s disease psychosis, a Phase III trial as adjunctive therapy for schizophrenia, and a Phase II feasibility study for Alzheimer’s disease psychosis. We believe that this multifaceted development program with pimavanserin coupled with our two clinical programs in collaboration with Allergan and our IND-track program in collaboration with Meiji Seika positions ACADIA with multiple attractive product and commercial opportunities and significant growth potential."
Allergan, Inc. (NYSE: AGN) saw its shares jump in the after hours market after The Food and Drug Administration said it approved the companies botulinum-based drug Botox to treat spasms of the elbow, wrist and fingers. Botox is known for it's ability to smooth wrinkles, but the drug has also been used to treat neck spasms, eye muscle disorders and excessive underarm sweating. Under the latest FDA indication, Allergan will be able to market Botox as a treatment for adults with spasticity in the flexor muscles of the elbow, wrist, and fingers. "Muscles affected by spasticity have increased stiffness and tightness, which may lead to pain, difficulties with hygiene and other activities of daily living, and may affect how a patient looks," said Dr. Russell Katz, director of the FDA's division of neurology products. Shares were up $2.14 in the after hours market.
Cardiome Pharma Corp. (NASDAQ:CRME) a product-focused drug development company dedicated to the advancement and commercialization of novel treatments for disorders of the heart and circulatory system, today after the market closed reported financial results for the fourth quarter and year ended December 31, 2009.
Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that Mr. Eli Hurvitz is relinquishing his position as Chairman and member of the Board of Directors of the Company in order to focus on recovering from a recently diagnosed illness. The Company's Board of Directors has unanimously appointed Mr. Zeev Bronfeld, a longstanding member of the Board of Directors, to serve as interim Chairman of the Board, effective immediately.
In news from earlier in the day:
Aastrom Biosciences, Inc. (Nasdaq:ASTMD), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported the final patient treatment in the company's ongoing U.S. Phase 2 surgical clinical trial designated IMPACT-DCM. Treated at Emory University Hospital Midtown in Atlanta, GA, this patient received direct injections of Aastrom's tissue repair cells for the treatment of dilated cardiomyopathy (DCM), a severe form of congestive heart failure in which the heart becomes weakened and enlarged and cannot pump blood efficiently. With the treatment of the final patient in this trial, Aastrom is positioned to report six-month interim data on all enrolled patients later this year.
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced the commencement of the "Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus" trial (SAVOR-TIMI 53), a multicenter, randomized, double-blind, placebo-controlled Phase 4 study, to evaluate treatment with ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult type 2 diabetes patients with cardiovascular risk factors. The five-year study will follow approximately 12,000 patients with type 2 diabetes, who have either a history of previous cardiovascular events or multiple risk factors for vascular disease, and includes patients with renal impairment.
Cardium Therapeutics, Inc. (NYSE Amex: CXM) today announced that it has entered into agreements with certain institutional investors to sell $5.0 million out of its proposed $10 million registered direct offering. The balance of the registered direct offering is expected to be confirmed by additional investors on or around March 12, 2010 resulting in aggregate gross offering proceeds to Cardium of up to approximately $10 million, before deducting placement agent fees and offering expenses. Cardium expects to use the proceeds from the offering for general corporate purposes. Shares dropped nearly 19% on ten times the daily average volume.
CANTEL MEDICAL CORP. (NYSE:CMN) reported a 29% increase in net income to $4,876,000, or $0.29 per diluted share, on a 6.7% increase in sales to $66,587,000 for the second quarter ended January 31, 2010. This compares with net income of $3,774,000, or $0.23 per diluted share, on sales of $62,420,000 for the second quarter ended January 31, 2009. For the six months ended January 31, 2010, the Company reported a 55% increase in net income to $11,044,000, or $0.65 per diluted share, on an 8.5% increase in sales to $137,582,000. This compares with net income of $7,107,000, or $0.43 per diluted share, on sales of $126,826,000 for the six months ended January 31, 2009.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, saw its shares soar today after the company announced that the Japanese Administration has granted marketing approval of its newly designed, high-end Sonolith I-Sys lithotripsy device.
The lithotripsy market in Japan ranks number one worldwide in both total lithotripsy sales volume and installed base. Physicians in Japan have been historically quick to adopt new innovative, high-end devices. As the latest device to enter the Japanese market, the Sonolith I-Sys is an easy to use and effective tool that delivers benefits to both patients and physicians. With unique, integrated and robotized features, Sonolith I-Sys fully addresses the Japanese lithotripsy market demands for new high-end technologies.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Japan is the largest global lithotripsy market and the latest key territory we have received approval for Sonolith I-Sys. This approval is a major milestone and further validates EDAP's position as a major worldwide player in the lithotripsy field, with Sonolith I-Sys approved in all lithotripsy markets in the world. We are very enthusiastic with the Japanese approval of our Sonolith I-sys lithotripter. We are convinced that our innovative, high-end device perfectly suits the Japanese lithotripsy market and will allow us to successfully address the strong demand of major clinical centres and University hospitals. We are all the more excited as the approval coincides with the upcoming annual Japanese Urology Association (JAU) Congress, to be held in Morioka on April 27-30, 2010. At the event, our Sonolith I-sys will be highlighted and introduced as the latest innovative lithotripsy device." Shares closed up nearly 21% or 52 cents to end the day at $3.04 and continued to climb in the after hours session.
Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the fourth quarter and year ended December 31, 2009. Revenues for the fourth quarter ended December 31, 2009 were $44.1 million, compared to $29.6 million for the comparable period in 2008. The increase in revenues was primarily due to increased license revenue from our 2008 collaboration with Bristol-Myers Squibb Company for XL184 and XL281 in addition to our 2009 collaboration with sanofi-aventis for XL147 and XL765. "We are pleased with our accomplishments in 2009, which are clearly reflected in the significantly improved financial performance of the company. Our revenue has increased substantially as a result of our partnering efforts, and our expenses and net loss for 2009 are down compared to the prior year. Furthermore, with over $220 million in cash at the end of 2009, we comfortably met our cash guidance for the year," said George A. Scangos, Ph.D., President and Chief Executive Officer of Exelixis. "We have further focused our resources on XL184, XL147 and XL765. We made substantial progress on these and other programs during 2009, and I look forward to presenting the results at ASCO in June.".
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that David P. Southwell has been named Executive Vice President and Chief Financial Officer. He will report directly to H. Thomas Watkins, President and Chief Executive Officer, and will serve as a member of the Management Committee of the Company. Mr. Southwell has served as a member of the HGS Board of Directors since July 2008, and he is resigning from the Board to accept this new position. His new appointment is effective March 22, 2010.
MedQuist Inc. (Nasdaq:MEDQ), a leading provider of technology-enabled clinical documentation services, today announced that it has been awarded a contract by Detroit Medical Center (DMC), a nationally respected healthcare system, to provide transcription outsourcing services. This award expands MedQuist's existing relationship to include services for Emergency Medicine documentation for six of DMC's major organizations: Children's Hospital, Detroit Receiving Hospital, Harper University Hospital, Huron Valley-Sinai Hospital, DMC Surgery, and Sinai-Grace Hospital..
Oncothyreon Inc. (Nasdaq:ONTY) today announced that Gamehost Income Fund ("Gamehost") has determined that certain proposed changes to the Income Tax Act (Canada) announced on March 4, 2010 by the Canadian Federal Minister of Finance will adversely affect the benefit to Gamehost of the arrangement between it and Oncothyreon, previously announced on February 18, 2010, pursuant to which Oncothyreon was to sell its interests in Oncothyreon Canada Inc., an indirect wholly owned subsidiary, and 0811769 B.C. ULC, an indirect wholly owned subsidiary. As a result, Gamehost has determined that it will no longer be proceeding with the transaction and Gamehost and Oncothyreon have mutually agreed to terminate the arrangement..
Orexigen® Therapeutics, Inc. (Nasdaq:OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.
Sanofi-aventis (EURONEXT: SAN) (NYSE: SNY) and Merck & Co., Inc. (NYSE: MRK) announced today that sanofi-aventis has exercised its option to combine Merial with Intervet/Schering-Plough, Merck’s Animal Health business, to create a global leader in Animal Health.
The new joint venture will be equally-owned by Merck and sanofi-aventis. The formation of this new animal health joint venture is subject to execution of final agreements, antitrust review in the United States, Europe and other countries and other customary closing conditions. The completion of the transaction is expected to occur in approximately the next 12 months.
WebMD Health Corp. (Nasdaq:WBMD) announced today that it intends to commence a tender offer later this week to purchase up to 5,800,000 shares of its common stock at a price per share of $45.80. The number of shares proposed to be purchased in the tender offer represents approximately 11% of WebMD's currently outstanding common shares. The NASDAQ Official Closing Price of WebMD's common stock on March 8, 2010 was $43.78 per share.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at the 22nd Annual ROTH OC Growth Stock Conference on Tuesday, March 16, 2010, at 3:00 p.m. PT (6:00 p.m. ET) at the Ritz-Carlton, Laguna Niguel in California.