|Angiotech surges on trial results, Novartis ends deal with Alnylam. After the bell: Seattle Genetics to release anticipated data Monday|
|By BioMedReports.com Staff|
|Friday, 24 September 2010 18:56|
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 23, 2010.
Seattle Genetics, Inc. (Nasdaq: SGEN) today after the market closed announced that it will host a conference call and webcast on Monday, September 27, 2010, at 5:30 a.m. Pacific Time (PT) / 8:30 a.m. Eastern Time (ET) regarding top-line results from its brentuximab vedotin (SGN-35) pivotal clinical trial in Hodgkin lymphoma.
The company is developing brentuximab in partnership with Japan's Takeda Pharmaceutical.
In extended trading shares of Seattle Genetics were off 36 cents or nearly 3%.
Allergan, Inc. (NYSE: AGN) after the bell today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX(dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye. Uveitis is characterized by inflammation of the eye’s uvea, which is the middle vascular layer consisting of the iris (anterior), ciliary body (intermediate) and choroid (posterior). Uveitis of the anterior (front) of the uvea is more common and typically does not lead to vision impairment; while posterior uveitis (back of the eye) is associated with more severe outcomes that can include blindness, cataracts, secondary glaucoma and macular abnormalities. Posterior uveitis is the cause of 10 to 15 percent of cases of blindness in the United States. OZURDEX is a biodegradable implant that delivers an extended release of the corticosteroid dexamethasone via intravitreal injection with Allergan’s proprietary and innovative NOVADUR solid polymer delivery system.
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that a summary of the final clinical trial results for the randomized study of Cook Medical's Zilver(R) PTX(R) Drug-Eluting Peripheral Stent for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) was presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D.C. The study - from the largest clinical trial to ever evaluate the performance of a drug-eluting stent (DES) in the treatment of peripheral vascular disease - met its 12-month primary endpoint goals showing non-inferior event-free survival (EFS) and superior patency for the Zilver PTX as compared to balloon angioplasty. Cook Medical, a license holder of Angiotech's paclitaxel technology, has developed Zilver PTX: a self-expanding, highly durable nitinol stent that uses a proprietary technology to deliver a locally therapeutic dose of paclitaxel, a proven anti-restenotic drug, to the target lesion. The data from this clinical trial supports Cook's PMA application submitted to the FDA earlier this year.
"These results establish paclitaxel as the only anti-restenosis drug to ever demonstrate efficacy in the treatment of PAD in a large, randomized, clinical trial," said Dr. William Hunter, President and CEO of Angiotech. "We are optimistic that this study will support Cook's application with the FDA to become the first drug eluting peripheral stent available for the management of patients suffering from PAD in the United States."
On heavy volume, shares of Angiotech surged more than 14% on the news, moving up 8 cents to $0.62.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that Novartis has notified Alnylam that they have formally selected their full and final list of 31 targets, for which they have exclusive rights to discover, develop, and commercialize RNAi therapeutics using Alnylam intellectual property and technology. In return, for any RNAi therapeutic products Novartis develops against these targets, Alnylam is entitled to receive significant milestone payments upon achievement of certain specified development and annual net sales events. In addition, Novartis has notified Alnylam that they have declined their option to execute an Adoption License per the terms of the original 2005 agreement. Novartis has informed Alnylam that they remain fully committed to advance their RNAi therapeutic programs based on their rights to Alnylam intellectual property and technology.
Alnylam also announced today that they will effect a corporate restructuring with an approximately 25% to 30% reduction in overall workforce, as a result of completing the fifth and final planned year of the Novartis alliance. Finally, Alnylam is reaffirming its financial guidance of ending 2010 with greater than $325 million in cash.
Shares of Alnylam fell 95 cents or nearly 7% to $13.27.
Oncothyreon Inc. (Nasdaq:ONTY), announced it has entered into a securities purchase agreement in connection with a private placement. Upon the closing of the private placement, Oncothyreon will receive gross proceeds of approximately $14.9 million resulting from the sale of approximately 4.24 million units at a purchase price of $3.50 per unit. The purchase price per unit represents approximately a 7.2% discount to the 30-day trailing volume-weighted average price of Oncothyreon's common stock through September 23, 2010. Each unit consists of one share of Oncothyreon's common stock and a warrant to purchase 0.75 of a share of common stock.
Shares fell more than 21% on the news, dropping 90 cents to $3.30.
Warner Chilcott plc (Nasdaq:WCRX) today announced that it has agreed to terminate its existing co-promotion agreement with Novartis and signed a definitive agreement to purchase the U.S. rights to Enablex® from Novartis for $400 million in cash. Enablex (darifenacin) is a product indicated to treat adults with symptoms of overactive bladder, which had U.S. sales of approximately $190 million for the year ended December 31, 2009. The transaction remains subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, and is expected to close by the end of October 2010.
"This is an important step in expanding our presence in one of our key therapeutic segments," said Roger Boissonneault, Warner Chilcott's president and chief executive officer. "The acquisition of the U.S. rights to Enablex bolsters our franchise in the urology segment, provides us with greater control in promoting the product and demonstrates our ability to successfully add complementary assets to an already strong product portfolio."
Warner Chilcott will make an upfront $400 million cash payment to Novartis and may be required to make future milestone payments aggregating up to $20 million. Novartis retains the rights to Enablex for all countries outside the U.S. At the closing of the transaction, Warner Chilcott will assume full control of sales and marketing of Enablex for the U.S. market, and expects to assume manufacturing control for the U.S. within three years.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, issued a statement to shareholders Friday, September 24, 2010.
Amgen (Nasdaq:AMGN) announced today that certain lots of EPOGEN® and PROCRIT® (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution.
ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Parallax® Contour® Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement.
Biodel Inc. (Nasdaq:BIOD) announced today that it will be presenting at the following upcoming conferences: Fifth Annual JMP Securities Healthcare Conference, September 28, 2010 at 12:00 pm Eastern time at the New York Palace in New York, NY.
Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, will host a conference call on Wednesday, September 29, 2010, at 11:00 a.m. Eastern to discuss its fiscal year-end June 30, 2010 financial results.
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone.
Capital Group Holdings, Inc. (PINKSHEETS: OOLN), formerly Oasis Online Technologies Corp., announced today that it has acquired Main Street Family Pharmacy LLC in Newbern, TN.
Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, today announces the availability of the fee-based initiation report by Murphy Analytics on Bohai's corporate website.
Celgene Corporation (NASDAQ: CELG) today announced its presentation at the JMP Securities Fifth Annual Healthcare Conference on Tuesday, September 28, 2010 at 1:30 p.m. ET will be webcast live and will be available in the investor relations section of the company's Web site at www.celgene.com.
Clinical Data, Inc. (NASDAQ: CLDA), today presented data from Phase I studies of Stedivaze (apadenoson), which demonstrated overall safety and tolerability in patients with asthma and chronic obstructive pulmonary disease (COPD).
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today announced that Caldolor® (ibuprofen) Injection is gaining momentum and being approved for use in a growing number of medical facilities across the country.
Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, announced today that Gearóid Faherty, Chairman and Chief Executive Officer, is scheduled to present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference.
Gamma Pharmaceuticals Inc. (PINKSHEETS: GMPM) Gamma Pharmaceuticals Inc. announced today the shipment of products pursuant to the purchase order announced August 16, 2010.
GeckoSystems Intl. Corp. (PINKSHEETS:GCKO) announced today that the International Federation of Robotics' (IFR) Statistical Department has recently forecasted $17 billion in annual sales for the global service robot market by end of 2013 in their report published in Frankfurt, Germany September 14.
GeneLink BioSciences, Inc. (OTC Bulletin Board: GNLK) today announced the launch of HelixLife, a private label distribution partnership serving the healthcare and wellness industries.
Genta Incorporated (OTCBB: GETA.OB) today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer.
Kraig Biocraft Laboratories, Inc. (OTCBB:KBLB) is very pleased to announce that the University of Notre Dame and Kraig Biocraft Laboratories will hold a joint press conference Wednesday, September 29, 2010 on the Notre Dame campus to describe a new research breakthrough and its possible biomedical and commercial applications.
MMRGlobal, Inc. (OTCBB: MMRF) (MMR) announced today that it has successfully opposed a Summary Judgment Motion brought by the Lymphoma Research Foundation (LRF) as part of its efforts to protect a portion of the Company's intellectual property, which it previously disclosed on May 3, 2010.
Omnicare, Inc. (NYSE:OCR), a leading provider of pharmaceutical care for the elderly, today announced Erin E. Ascher has been appointed Vice President – Human Resources, and Timothy J. Hopkins has been appointed Vice President – Trade Relations.
Oncothyreon Inc. (Nasdaq:ONTY), announced it has entered into a securities purchase agreement in connection with a private placement.
Ore Pharmaceutical Holdings Inc. (OTCQB:ORXE), announced today the filing of a Form 15 with the Securities and Exchange Commission. Ore filed the Form 15 with the SEC in order to effect a termination of the registration of its common stock under the Securities Exchange Act of 1934.
Pacific Biomarkers, Inc. (OTCBB: PBMC), which provides specialty laboratory services to support pharmaceutical, biotechnology and laboratory diagnostic companies in the conduct of human clinical research, for use in their drug and diagnostic product development efforts, today released its financial results for FY2010.
Palatin Technologies, Inc. (NYSE Amex:PTN) today announced the realignment of its workforce and operations to reflect a strategic reassessment of its research and development activities and corporate objectives.
Perrigo Company (Nasdaq:PRGO; TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC™, and that it provided prior notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner.
Pharmasset, Inc. (Nasdaq:VRUS) announces that management will present at the JMP Healthcare Conference to be held September 27-28, 2010 at the New York Palace Hotel, New York, NY.
Sun Healthcare Group, Inc. (NASDAQ:SUNH) announced today that it intends to refinance its existing senior secured credit facilities with borrowings under a new senior secured credit facility to be entered into by SHG Services, Inc., a subsidiary of Sun.
Tarsa Therapeutics, Inc. and Unigene Laboratories, Inc. (OTC Bulletin Board:UGNE) today reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the underwriter for its offering of 3.35% convertible senior subordinated notes due 2015 has exercised in full its option to purchase an additional $25 million aggregate principal amount of notes.
Warner Chilcott plc (Nasdaq:WCRX) today announced that its subsidiaries, Warner Chilcott Company, LLC and Warner Chilcott Finance LLC, plan to issue an aggregate principal amount of $500 million of 7-3/4% senior notes due 2018 in a private placement.