|Genta soars after FDA fast track designation. Opexa Therapeutics moves higher ahead of Multiple Sclerosis therapy data|
|By BioMedReports.com Staff|
|Tuesday, 06 April 2010 18:54|
Below is a list of the companies that made news in the healthcare sector on Tuesday, April 06, 2010.
Genta Incorporated (OTCBB: GETA.OB) soared higher today after announcing that the U.S. Food and Drug Administration (FDA) has granted the Company’s request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
Based on promising results in a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial of tesetaxel as 2nd-line treatment in patients with advanced gastric cancer who have failed a single 1st-line regimen. As defined, the 1st-line regimen must comprise a platinum-containing compound (cisplatin, carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine, or S-1). The Fast Track designation targets the patient population that is enrolling in the Phase 2b trial.
Genta has formulated a trial design and clinical protocol for a randomized, double-blind, placebo-controlled Phase 3 trial of tesetaxel in this patient population. In developing the trial, the Company completed a dose-ranging and pharmacokinetic study of tesetaxel plus capecitabine (Xeloda®; Hoffmann LaRoche, Inc.). Results from that study showed that full doses of each of these orally administered drugs could be administered together without causing overlapping side-effects.
Genta plans to submit its proposed Phase 3 trial to FDA in the 2nd-quarter in order to secure a Special Protocol Assessment (SPA). The Company looks forward to meeting with the FDA to discuss the trial design. Shares of Genta
soared 76% or 3.5 cents to close the trading session at $.081. Volume of 119 Million shares was nearly 15 times the daily average.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), moved higher today after the company developing a novel T-cell therapy for multiple sclerosis (MS), announced that they have been selected to present key efficacy data at the upcoming American Academy of Neurology (AAN) 62nd Annual Meeting to be held in Toronto, Canada.
Dawn McGuire, M.D., Chair of Opexa’s Clinical Advisory Board and the Company’s acting Chief Medical Officer, will present data from the Phase 2b TERMS clinical trial which demonstrated promising efficacy and safety data in patients treated with Tovaxin®, the Company’s lead therapy for MS.
The data will be presented during a poster session on Wednesday, April 14, 2010 from 6:00 to 7:30 p.m. Shares were up more than 14%, jumping 31 cents to $2.52 on twice the daily average for volume.
Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced the pricing of a public offering of 3,500,000 shares of its common stock. The offering is expected to close on or about April 9, 2010, subject to customary closing conditions. In addition, Ardea Biosciences has granted the underwriters a 30-day option to purchase up to an additional 525,000 shares to cover overallotments, if any.
Baxter International Inc. (NYSE: BAX) and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors. This ready-to-use patch can be applied directly to the bleeding area either dry or wet. In the presence of saline, blood or other bodily fluids, the coagulation factors dissolve to form a fibrin clot, which adheres the TachoSil patch to the bleeding surface and achieves hemostasis.
"Controlling bleeding has always been a challenge in cardiovascular surgery, and we are constantly looking for new ways to achieve hemostasis effectively," said Dr. Yoshiya Toyoda, M.D., Ph.D., Head of Cardiothoracic Transplantation at the Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh Medical Center (UPMC). "As a ready-to-use patch, TachoSil represents a new and different option, which I believe will be a welcomed addition to the armamentarium of adjunctive hemostasis products used in cardiovascular surgery today."
Cerus Corporation (NASDAQ:CERS) announced today that it has secured a $10 million growth capital credit facility from Oxford Finance Corporation. The credit facility provided a $5 million loan to Cerus upon closing, which occurred on March 31, 2010, and allows Cerus to draw an additional $5 million between September 30, 2010 and December 31, 2010. The credit facility is secured by Cerus’ assets other than intellectual property. "We are pleased to be working with Oxford Finance and to have put in place a non-dilutive growth capital facility," said Kevin D. Green, vice president, finance and chief accounting officer of Cerus Corporation. "We believe this financing provides us with the capital necessary to continue growing our European platelet and plasma business and realize our plan of driving that business to profitability."
Emerging World Pharma Inc. (Pinksheets:EWPI), an investor in generic based pharmaceutical companies manufacturing within developing nations, announces that African Global Pharma Ghana Ltd has formed an exclusive marketing and distribution agreement with the Catholic Diocese of Sunyani, Ghana. Emerging World Pharma had earlier provided an investment into African Global Pharma and has an option to increase their investment and percentage of profits by up to 25%..
Exact Sciences Corp. (Nasdaq: EXAS ) today announced that it will present at the Future Leaders in Biotech Industry Conference, which is being held Thursday, April 8, at the Millennium Broadway Hotel in New York. Maneesh K. Arora, Exact’s chief financial officer, will make the company’s presentation at 3:30 p.m. EDT. A live webcast of the presentation will be available through the company’s web site.
Generex Biotechnology Corporation (Nasdaq:GNBT) the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has commenced legal proceedings against TheStreet.com, Inc. and Adam Feuerstein in the Supreme Court of the State of New York seeking $250,000,000 in damages for business defamation, product disparagement, and injurious falsehood. The claims arise out of articles authored by Feuerstein and published on TheStreet.com website on March 19 and March 26, 2010.
Generex contends that the articles disseminate numerous defamatory statements about the Company, its management, and its flagship product, Generex Oral-lyn(TM), and that the articles put forward several ostensible statements of fact that are, in truth, misleading or outright misstatements made with malicious intent or with a reckless disregard for the truth.
"These articles go well beyond the expression of disparaging opinion or fair comment," said Mark Fletcher, Generex's Executive Vice-President & General Counsel. "Feuerstein and TheStreet.com have abused their public forum by spreading categorical falsehoods about Generex and Generex Oral-lyn(TM) when a modicum of due diligence would have revealed the truth, an injury then compounded by unfounded and libelous allegation and innuendo. We are now seeking to hold Feuerstein and TheStreet.com accountable for the damage they have unjustifiably inflicted on Generex and its stockholders."
Merge Healthcare Incorporated (NASDAQ: MRGE) moved higher today after reporting that it intends to offer $200 million aggregate principal amount of senior secured notes due 2015, which will be used to fund a portion of the proposed acquisition of AMICAS, Inc. (NASDAQ: AMCS). Merge previously announced that is acquiring Amicas, a medical imaging software company, for $248 million.
Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, announced today that it intends to offer units consisting of shares of its common stock and warrants to purchase shares of its common stock in a public offering. The Company plans to use the net proceeds from this offering to fund the previously announced expansion of its ongoing Phase II clinical trial of CD-NP in acute heart failure patients, and for general corporate purposes and working capital.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR ) announced that data from the fidaxomicin Phase 3 clinical studies will be presented at the 20th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria. Derrick Crook, M.D. will present Saturday, April 10, 2010 3:30pm–4:30pm Central European Summer Time (6:30am-7:30am PST): "Randomized clinical trial in Clostridium difficile infection confirms equivalent cure rate and lower recurrence rate of fidaxomicin vs. vancomycin" and Mark A. Miller, M.D. will present Saturday, April 10, 2010 3:30pm-4:30pm Central European Summer Time (6:30am-7:30am PST): "Three simple ESCMID severity criteria predict poor cure rate and slower resolution of diarrhea in Clostridium difficile infection".
Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that it (and its subsidiary Par Pharmaceutical and development partner MN Pharmaceuticals of Turkey) has entered into a settlement agreement with sanofi-aventis (sanofi) that resolves patent litigation related to its generic version of sanofi's and Debiopharm's Eloxatin® (oxaliplatin injection) product, a drug used to treat colorectal cancer, in the U.S. District Court for the District of New Jersey.
PURE Bioscience (NASDAQ:PURE), surged today after the creator of the patented silver dihydrogen citrate (SDC) antimicrobial, announced that it has received U.S. Environmental Protection Agency (EPA) registration for its SDC-based disinfectant and food contact surface sanitizer. The product will be marketed as IV-7 Ultimate Germ Defense for Food Contact Surfaces™ (IV-7) by PURE’s sales and marketing representative, Richmont Sciences, LLC. An EPA Category IV disinfectant/sanitizer, IV-7 provides an advantageous combination of high efficacy, low toxicity and efficiency by rapidly eliminating dangerous pathogens, yet no rinse is required. IV-7 Ultimate Germ Defense for Food Contact Surfaces™ harnesses the broad-spectrum power of SDC for use on surfaces and equipment in dozens of settings including food processing plants, farms, food storage areas, restaurants, fast food operations, cafeterias, supermarkets, break rooms, schools, hospitals and other institutions, as well as in homes. IV-7 helps prevent cross-contamination in food contact environments and eliminates odors. In addition, the odorless IV-7 formula does not create irritating fumes, which is a particular benefit for restaurants. Shares moved up more than 24% or 40 cents, closing the day at $2.03.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), and TransDerm, Inc., a biopharmaceutical company developing nucleic acid skin delivery technologies and therapeutics for skin disorders, announced today that they will collaborate on studying the potential utility of RXi’s proprietary compounds in dermatology models. Under the collaboration, the parties will explore the use of both existing and proprietary delivery approaches for dermatological applications. Each party will contribute technology and resources to the collaboration to evaluate and develop novel transdermal RNAi delivery. Financial terms of the collaboration were not disclosed.
Sinovac Biotech Ltd. (Nasdaq:SVA), a leading China-based vaccine manufacturer, announced today its unaudited financial results for the three-month and preliminary twelve-month periods ended December 31, 2009. Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Sinovac had a very productive year executing on its core strategy to support continued growth by simultaneously expanding its pipeline of novel products and increasing capacity to meet rising demand for our world class vaccines. We believe that Sinovac has established itself as a company that can strategically deliver steady and robust growth. Going into 2009 with a net revenue CAGR of 74.0% between 2006 and 2008, we demonstrated this past year that we can exceed this growth and maintain our strategy even as we lead in development to address a global crisis."
Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF) announced that the U.S. Patent and Trademark Office has issued United States Patent No. 7,683,071 covering T2007. The patent, entitled "Composition and method for improved bioavailability and enhanced brain delivery of 5,5-diphenyl barbituric acid," is for one of a class of non-sedating barbiturate compounds currently in development by the Company.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical company, announced today that Health Canada has approved SEASONIQUE. SEASONIQUE is a next generation extended-cycle oral contraceptive for the prevention of pregnancy. SEASONIQUE is manufactured by Duramed Pharmaceuticals, a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd..
Valeant Pharmaceuticals International (NYSE:VRX) moved higher after it announced today its plans to offer, subject to market and other conditions, $350 million principal amount of senior unsecured notes. The offering is expected to commence on or about April 6, 2010. The Company intends to use the net proceeds from this offering to repurchase 3.0% Convertible Subordinated Notes due 2010 of the Company and other securities of the Company, to finance the acquisition of a private branded generics and over-the-counter company located in Brazil for which the Company has signed a binding agreement and for other general corporate purposes.
Virtual Radiologic Corporation (NASDAQ:VRAD), a national radiology practice and a leader in the development of radiologist workflow technology, received notice of allowance of a patent by the United States Patent and Trademark Office for several applications within its technology portfolio. The pending patent, titled "Multiple Resource Planning System," recognizes the rules-based technology vRad uses to receive orders over the internet and automatically assign them to radiologists based on a set of business and clinical rules, including subspecialty training, licensing, credentialing, workload, hospital preferences and other customized parameters.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), moved higher today after the company announced the appointment of George B. Abercrombie to its Board of Directors. Mr. Abercrombie will serve as a member of the Board’s Compensation Committee as well as the Nominating and Corporate Governance Committee. Additionally, Dr. Murray Brennan was elected Chairman of the Board.
Alcon, Inc. (NYSE: ACL) will report on its first quarter financial results for the period ended March 31, 2010 after the market close on Monday, April 26, 2010.