|Perrigo Confirms Filing ANDA with FDA For Generic Acanya; Omeros Announces FDA Accepts Omidria as Brand Name for OMS302|
|By Staff and Wire Reports|
|Wednesday, 20 November 2013 20:59|
Perrigo Company (NYSE: PRGO;TASE) announced that it has filed with the U.S. FDA an Abbreviated New Drug Application (ANDA) for Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% and has notified Dow Pharmasciences, the owner of the New Drug Application (NDA) of its filing.
On November 15, 2013, Dow Pharmasciences and Valeant Pharmaceuticals filed suit against Perrigo in the United States District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act.
Acanya® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Annual sales were approximately $122 million annually, as measured by Symphony Health Solutions.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in extended topical product development. As always, Perrigo is committed to making quality healthcare more affordable for our customers."
Omeros Corporation (NASDAQ: OMER) reported that the U.S. FDA accepted the proposed brand name Omidria™ for OMS302, the Company's proprietary product in development for use in intraoperative lens replacement (ILR) surgery. FDA's acceptance of the proprietary brand name is subject to the Agency's final determination prior to any approval of the product's New Drug Application (NDA) and market launch, expected in 2014. Omeros earlier received allowance of the trademark application for Omidria from the U.S. Patent and Trademark Office.
The FDA reviews proposed proprietary names, taking into account potential for confusion between the proposed name and the names of marketed drugs and pending products for which marketing applications are currently under review. The brand name Omidria was also submitted to the European Medicines Agency (EMA), with a decision anticipated later this year. Omeros recently registered Omidria as a European Community Trade Mark.
"Throughout branding analyses conducted with ophthalmic surgeons and nurses using both regulatory and marketing criteria, Omidria scored very high globally – across the US, Canada, Europe and Asia as well as in Mexico and South America," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With FDA's acceptance, we can now accelerate the development of the Omidria brand in preparation for the product's anticipated market launch in 2014."
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced a broad strengthening of its biologics business strategy.
Amicus Therapeutics (Nasdaq:FOLD) and GlaxoSmithKline (GSK) today announced that Amicus has obtained global rights to develop and commercialize the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.
Aratana Therapeutics, Inc. (NASDAQ: PETX), a biopharmaceutical company focused on the licensing, development and commercialization of innovative medications for pets, today announced positive results from its dose-ranging study of AT-001, the company's innovative drug for treating pain in dogs with osteoarthritis.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, is scheduled to participate in a Q&A session at the 25th Annual Piper Jaffray Healthcare Conference at The New York Palace Hotel in Manhattan. AngioDynamics' Q&A session will be at 11 a.m. Eastern Time, Tuesday, December 3, 2013.
Caliber Imaging & Diagnostics (OTCQB:LCDX), formerly Lucid, Inc., has appointed Steven M. Ridge as Midwestern Regional Sales Manager and Ben J. Alexander as Western Regional Sales Manager, both newly created positions.
CollabRx, Inc. (Nasdaq:CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, announces that Thomas R. Mika, Chief Executive Officer, will present at the LD MICRO Sixth Annual Conference at 11 a.m. (PST), Track 1, on December 3, 2013.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, MD, PhD, President and Chief Executive Officer of Five Prime, will present at the 25th Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2013 at the New York Palace Hotel in New York City at 11:30 a.m. (Eastern Time).
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospitalist physician group practice company, announced today that it has acquired two acute care hospitalist practices on Florida's west coast: Naples-based Neapolitan Inpatient Care, LLC , and Venetian Hospitalist Services, LLC, headquartered in Venice.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will be webcasting its participation at the 25th Annual Piper Jaffray Healthcare Conference in New York, NY.
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that Christophe Lavigne, the Company's President and Chief Executive Officer, and Bob McNamara, the Company's Executive Vice President and Chief Financial Officer, will be presenting at the Piper Jaffray 25th Annual Healthcare Conference to be held on December 3-4 at the New York Palace Hotel in New York, NY.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today announced that, at the unanimous recommendation of its Board of Directors, it has terminated for cause its relationship with Jason Domingo and Ovation Marketing Group, Inc., one of the Company's lead distributors.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced a research collaboration with BioMarin that will use Myriad's novel HRD (Homologous Recombination Deficiency) test to identify tumor types that may be sensitive to BioMarin's investigational product candidate, BMN-673. Specific terms of the deal were not disclosed.
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced a clinical and regulatory update related to its synthetic oral retinoid program, as well as the initiation of a review of strategic alternatives. For the review, the Board of Directors has engaged Credit Suisse to act as financial advisor.
RCM Technologies, Inc. (Nasdaq:RCMT), a premier provider of business and technology solutions designed to enhance and maximize the operational performance of its customers through the adaptation and deployment of advanced information technology, engineering and specialty healthcare services, today announced that it has mailed a letter to stockholders discussing why it does not believe that the Legion Group's nominee Bradley Vizi is a credible "champion" of corporate governance and detailing why stockholders should question his qualifications to portray himself as any kind of "authority" on corporate governance.
Relypsa, Inc. (Nasdaq:RLYP), a clinical-stage biopharmaceutical company, today announced the closing of its initial public offering of 7,877,500 shares of its common stock at an initial public offering price of $11.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,027,500 additional shares of common stock. Relypsa's common stock is listed on The NASDAQ Global Select Market under the trading symbol "RLYP."
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that seven abstracts have been accepted for presentation at the 55th annual meeting of the American Society of Hematology (ASH), which will be held December 7-10, 2013, in New Orleans, LA.
As a reminder to certain stockholders and warrant holders of Stereotaxis, Inc. (Nasdaq:STXS), as well as holders of separately purchased subscription rights, the current rights offering is scheduled to terminate this Thursday, November 21, 2013, at 5:00 pm New York City time.
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that David Mowry, the Company's President and Chief Executive Officer, and Shawn McCormick, the Company's Chief Financial Officer, will present at the Piper Jaffray 25th Annual Healthcare Conference.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that the United States Patent and Trademark Office has awarded it U.S. patent no. 8,584,349, entitled "Flexible Manufacturing System."