|Abbott wins EU Approval for Use of Humira Drug; NeurogesX Provides Update on NGX-1998|
|By Staff and Wire Reports|
|Wednesday, 11 April 2012 19:00|
Humira, the best-selling arthritis drug that forms the cornerstone of Abbott Laboratories' (NYSE:ABT) pharmaceutical business, has been approved in Europe for ulcerative colitis, the U.S. drugmaker said.
The green light from the European Commission follows a positive opinion from the European Medicines Agency in February and marks the seventh indication for Humira in the European Union since its first approval in 2003.
Humira, one of the world's biggest-selling drugs with sales forecast by analysts to be around $9 billion this year, is the first self-injectable biologic therapy for ulcerative colitis, a chronic disease that causes ulcers in the colon.
NeurogesX, Inc. (NASDAQ:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, announced the U.S. FDA has accepted the Company's request for an End-of-Phase 2 meeting to discuss the continued clinical investigation of NGX-1998 as a treatment for certain neuropathic pain conditions including, specifically, the Company's plans for entering NGX-1998 into Phase 3 development. The Company anticipates that the End-of-Phase 2 meeting will occur in the third quarter of 2012.
NGX-1998, NeurogesX' most advanced product candidate, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. The Company believes that the clinical data obtained to date should support moving to a Phase 3 clinical development program, which it believes can be initiated by the end of 2012.
The Phase 2 study that NeurogesX completed at the end of 2011 was a 12-week, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Its protocol-specified objectives were met, including the primary endpoint of a percentage change from baseline as compared to placebo in a patient-reported numeric pain rating scale (NPRS) score during weeks two through eight. A total of 183 patients were treated in the Phase 2 study. Patients were randomized into one of three groups: NGX-1998 capsaicin 10% solution, NGX-1998 capsaicin 20% solution or placebo, according to an unequal allocation scheme of 2:2:1. NGX-1998 exhibited a dose response. Although no topical anesthetic was used during the second stage of the study, the patients were able to tolerate the treatment procedure. No patients discontinued the study due to adverse events, and the incidence of adverse events and serious adverse events in patients treated with NGX-1998 were similar to the placebo-treated group.
Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in RNA therapeutics and obesity, today announced that it has acquired Alvos Therapeutics, Inc. (formerly known as Mercator Therapeutics, Inc.), a privately-held company that licensed a large platform of proprietary human-derived homing peptides from MD Anderson Cancer Center (MDACC) and the method for their discovery.
ArQule, Inc. (NASDAQ: ARQL) today announced the pricing of an underwritten public offering of 7,150,000 shares of its common stock at a price of $7.30 per share.
BSD Medical Corporation (NASDAQ:BSDM) (the “Company” or “BSD”) announced today that the Company’s new Microwave Ablation System (MicroThermX®) products were showcased at the Company’s exhibition booth at the 37th annual scientific meeting of the Society of Interventional Radiology (SIR), which was held March 24 to 29, 2012 in San Francisco.
Cannabis Science, Inc. (OTCBB: CBIS.OB) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is pleased to provide new photographs of the existing treatment for patient three who has a “worst case” of treatment resistant, Squamous Cell Carcinoma. Cannabis Science has received positive feedback from both the patient and his Oncologist.
Dyax Corp. (NASDAQ: DYAX) the manufacturer of KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older, has announced the launch of its HAE genetic counseling program.
InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that CEO Frank Reynolds is scheduled to appear on local TV affiliates in Charlotte, Indianapolis and Greensboro.
Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of naturally sourced supplements based on Real Food Technology® solutions, is pleased to announce that its annual global convention—MannaFest—will be held this week from April 12–14, in Fort Worth, Texas.
Mauna Kea Technologies (NYSE Euronext: MKEA), leader on the endomicroscopy market, today announced that the company's Board of Directors appointed new board member Gilles Brisson to the role of Chairman of the Board.
Medidata Solutions (NASDAQ: MDSO) announced today a major new release of Medidata Balance™, a randomization and trial supply management (RTSM) application which is part of Medidata’s comprehensive clinical cloud platform. Balance now provides the popular block randomization methodology in addition to the powerful and flexible dynamic allocation methodology it previously offered.
McKesson Corporation (NYSE: MCK) announced today that it has been selected by the Department of Veterans Affairs (VA), which runs the nation's largest integrated healthcare system, to continue as the VA's prime pharmaceutical supplier.
MMRGlobal, Inc. (OTCBB: MMRF) and temporarily (OTCBB: MMRFE) (the "Company") today announced that on April 5, 2012, it learned of an inadvertent omission, due to a formatting error, of the Item 9A information required in its Annual Report on Form 10-K for the fiscal year ended December 31, 2011, timely filed with the Securities and Exchange Commission ("SEC") on March 30, 2012 (the "10-K").
Nuvilex, Inc. (OTCQB:NVLX), through its Singapore-based biotech company associate, SG Austria, announced completion of substantial therapeutic antibody patent portfolio talks, culminating in the addition of the Exclusive Worldwide License to the existing SG Austria patent position for encapsulating therapeutic antibody-producing cells.
Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, today announced it will report financial results for the first quarter ended March 31, 2012 on Thursday, May 3 after market close, followed by an investor conference call on the same day at 4:30 p.m. EDT (1:30 p.m. PDT).
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares in the offering are to be sold by Pacira.
PearlBrite™ Concepts, Inc. ("PearlBrite"), a wholly owned subsidiary of Delta Entertainment Group, Inc. ("Delta Entertainment") (OTCQB: DENG) (OTCBB: DENG), will be releasing 1 minute and 2 minute short form infomercials nationally to promote its new at home consumer teeth whitening kit & pen, which whitens teeth 2 to 10 shades, offering a full money back guarantee (www.pearlbrite.net) this month.
Proteonomix, Inc. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced the termination of the Research Agreement and Phase 1 clinical trial with the University of Miami.
PURE Bioscience, Inc. (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today reported the launch of the PURE Complete Cleaning, Sanitizing and Disinfecting System.
St. Louis–based law firm Carey, Danis & Lowe announces a lawsuit against Pfizer Inc. (NYSE: PFE), maker of the antidepressant drug Zoloft, that was originally filed in St. Louis Circuit Court then removed to federal court by the drugmaker, has been ordered back to the state court.
Repligen Corporation (NASDAQ:RGEN) today announced that Mr. Michael A. Griffith has been appointed to serve on the Company’s Board of Directors. Mr. Griffith, 53, has extensive leadership experience in the bioprocessing and biopharmaceutical industries, as well as significant commercial and investment banking expertise.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today sent an open letter to shareholders of Illumina, Inc. (NASDAQ: ILMN) urging them to vote the GOLD proxy card for Roche’s independent director nominees and other proposals at the 2012 Illumina annual meeting to be held on 18 April 2012.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that further testing shows that the newest molecule the Company has designed to inhibit the malaria parasite is nearly three times more potent as an inhibitor of the drug-sensitive 3D7 strain of the malaria parasite than its best previous molecule.