|Amarin Announces FDA DMEP Does Not Plan to Re-instate ANCHOR SPA Agreement; VIVUS, Auxilium Announce FDA Acceptance of Prescribing Information for STENDRA|
|By Staff and Wire Reports|
|Tuesday, 21 January 2014 19:32|
Amarin Corporation plc (Nasdaq: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement."
In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa® (icosapent ethyl) 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease.
Prior to being able to appeal DMEP's October 2013 decision to rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP first be given a formal opportunity for reconsideration. With that step now completed, Amarin plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II (ODE-II), the next level under FDA dispute resolution guidance. Based on information available to Amarin, Amarin does not expect a determination on the pending ANCHOR supplemental new drug application (sNDA) while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
As previously stated, Amarin recognizes the significant challenge it faces in its efforts to reinstate the ANCHOR SPA agreement and obtain approval of the ANCHOR sNDA. There can be no assurance that Amarin will be successful in its effort to reinstate the ANCHOR SPA agreement or obtain a label expansion reflecting the ANCHOR clinical trial. There also can be no assurance that the FDA will not communicate the results of its review of the ANCHOR sNDA prior to the timing expected.
Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
VIVUS, Inc. (Nasdaq: VVUS) and Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) announced the U.S. FDA has accepted a supplemental application that proposes to revise the STENDRA™ (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." The PDUFA date for the supplemental filing is September 20, 2014.
VIVUS had previously announced positive results from this multicenter, placebo-controlled study designed to assess the efficacy of two dosage strengths of STENDRA approximately 15 minutes after dosing.
In the 440-patient study conducted at 30 sites in the U.S., STENDRA patients achieved statistically significant improvement versus placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose following administration. The currently approved prescribing information recommends administration approximately 30 minutes before sexual activity.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to neurodegeneration and apoptosis, and Brewer Sports International (BSI), a multi-faceted global sports advisory firm, are pleased to provide an update surrounding the Amarantus #C4CT Summit hosted by Brewer Sports International, powered by MDM Worldwide, to be held on Wednesday, January 29th in the Trusteeship Council at the United Nations in New York City, NY during Super Bowl Week.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that it has enrolled the first patient in a Phase I dose escalation study evaluating onapristone in post-menopausal women with progesterone receptor (PR) positive tumors, including breast, endometrial and other solid tumors.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced that Medical Professional Services, Inc. (MPS) will use athenahealth's cloud-based Population Health Management offering to improve care quality and coordination across MPS' growing network of providers and patients, in both fee-for-service and risk-based payment scenarios.
BioLife Solutions, Inc. (OTCQB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues, today announced that pursuant to the authorization previously granted by the Company's stockholders, the Company's Board of Directors (the "Board") has fixed 1-for-14 as the ratio for its previously announced reverse stock split.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has entered into an agreement to purchase Repligen Corporation's histone deacetylase inhibitor (HDACi) library and related intellectual property.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced that it has been awarded approximately $1.8 million, net of transaction costs, in non-dilutive financing via the State of New Jersey's Technology Business Tax certificate Transfer program.
CollabRx, Inc. (Nasdaq:CLRX), a data analytics company focused on informing clinical decision making in molecular medicine, announces that Gavin J. Gordon, MBA, PhD, Vice President of Business Development & Strategic Alliances, will present in Track 2 (Big Data: Storage and Management) at the Personalized Medicine World Conference (PMWC) at 2 PM (PST) on January 28, 2014.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the first patient was treated in the EVAS FORWARD-IDE clinical trial, the Company's pivotal clinical trial to evaluate the safety and effectiveness of the Nellix® EndoVascular Aneurysm Sealing System ("Nellix EVAS System") for the endovascular repair of infrarenal abdominal aortic aneurysms.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that data from a preclinical study show its leading galectin-inhibiting drug GR-MD-02 demonstrates an effect on a blood biomarker in an animal model of nonalcoholic steatohepatitis (NASH, or fatty liver disease) with fibrosis.
Hemispherx Biopharma (NYSE MKT:HEB), today announced that Dr. William M. Mitchell of Vanderbilt University will present a research paper on January 21, 2014 at the Keystone Symposia Conference on Pathogenesis of Respiratory Viruses entitled "Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus (H5N1) by Low Dose Natural Human IFN-α Administered to the Buccal Mucosa."
iCo Therapeutics Inc. (TSXV: ICO) (OTCQX: ICOTF) announced today that it has undertaken an overnight marketed public offering (the "Offering") of units (the "Units"), comprised of common shares of the Company and common share purchase warrants (a "Warrant").
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the appointment of Patrick Ryan as the Company's Chief Operating Officer. Mr. Ryan, a global supply chain expert and seasoned medical device executive, most recently served as Chief Operating Officer and President, International, of Alphatec Spine, where he was responsible for Manufacturing & Supply Chain, Research & Development, Clinical, Regulatory & Quality and International Sales & Operations.
Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that it has been notified of an unsolicited "mini-tender offer" made by TRC Capital Corporation to the stockholders of the Company to purchase up to 250,000 shares of the Company's common stock, or approximately 0.65% of the Company's outstanding common stock. TRC Capital's offer price of $405.00 per share is approximately 3.54 percent below the Company's closing price of $419.88 on January 14, 2014, the day before commencement of the offer.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced the appointment of Daniel W. Olmstead to the newly created position of Vice President, Payer Access.
Life Technologies Corporation (NASDAQ: LIFE) today announced the availability of the only USDA-licensed, real-time PCR test to detect Tritrichomonas foetus (T. foetus) –a sexually transmitted disease in cattle that leads to early embryonic losses and infertility, resulting in significant economic impact to the cattle industry due to open (non-pregnant) and late-calving cows.
M Line Holdings, Inc. (OTC:MLHC), a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled ("CNC") Equipment, today announced Company revenues of $5,806,080 for the six months ended December 31, 2013 as compared to $4,421,473 for the six months ended December 31, 2012, representing a 31% increase.
Nektar Therapeutics (Nasdaq: NKTR) today announced that it has commenced an underwritten public offering of 8,500,000 shares of its common stock. In connection with this offering, Nektar will also grant to the underwriters a 30-day option to purchase up to an additional 1,275,000 shares of common stock. J.P. Morgan and Jefferies are acting as joint book-running managers in the offering.
Repligen Corporation (Nasdaq:RGEN) announced today that it has entered into an asset purchase agreement with BioMarin Pharmaceutical Inc. ("BioMarin") to advance Repligen's histone deacetylase inhibitor (HDACi) portfolio.
Tauriga Sciences, Inc. (OTCQB:TAUG), a diversified company focused on generating profitable revenues through license agreements and the development of a proprietary technology platform in the nano-robotics space, and its strategic partner Bacterial Robotics LLC ("Bacterial Robotics"), today announced the completion of a confidential whitepaper to engineer and construct a Polychlorinated Biphenyl ("PCB") remediating bacterial robot ("BactoBot™") for the nuclear industry ("NuclearBot™").
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, confirmed today that it has received US$14.5 million of the net US$16.5 million in near term payments as outlined in the terms of an option agreement signed with Monsanto, which supports the application of Tekmira's proprietary delivery technology and related intellectual property (IP) for use in agriculture.
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that it has entered into a research collaboration with the Walter and Eliza Hall Institute of Medical Research to examine TetraLogic's SMAC-Mimetic birinapant in viral infections.
ThermoGenesis Corp. (Nasdaq:KOOL) a cellular therapy medical device company and TotipotentRX Corporation, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular and orthopedic disease announce their co-sponsored Phase Ib clinical trial safety and efficacy results treating no-option patients suffering from critical limb ischemia with Totipotent's CLIRST (Critical Limb Ischemia Rapid Stem cell Therapy) treatment.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced the U.S. market launch of ThrombiDisc topical hemostat, a thrombin-based pad used as an adjunct to manual compression to control surface bleeding from vascular access sites and percutaneous catheters or tubes.