|FDA Grants Hemispherx Extension in Its Pending NDA; Arena Announces Multi-Million Dollar Financing|
|By Staff and Wire Reports|
|Wednesday, 11 January 2012 19:22|
Hemispherx Biopharma, Inc. (NYSE:HEB) announced the FDA granted an extension for the Company to modify its New Drug Application ("NDA") in response to a Complete Response Letter ("CRL") received November 25, 2009 for the Chronic Fatigue Syndrome ("CFS") therapeutic indication. The extension will remain open while Hemispherx submits an amended NDA.
In year 2011, a team of researchers at the Centers for Disease Control ("CDC") and Harvard University reported new data on the magnitude of medical and economic impact of untreated CFS (Cost Effectiveness and Resource Allocation, vol. 9, 2011). According to the study, "CFS patients, their families, employers and society bear significant costs associated with the illness. The symptoms characterizing CFS are common to many illnesses, hence diagnosis is complex& and requiring extensive diagnostic testing and clinical assessment."
In the request for extension, the Company advised the FDA of the findings presented at the IACFS/ME Biennial Scientific Conference held September 22-25, 2011 in Ottawa, Ontario, Canada of a new potential companion diagnostic tests for CFS. The proof of principle study presented in Ottawa compared sequences from massively parallel sequenced serum DNA (Deoxyribonucleic Acid) extracted from either well vetted Hemispherx CFS sera or matching controls. Signature DNA sequences were identified that showed statistically significant separation of CFS serum from matching control serum. "We continue to move forward and are working diligently to pursue approval for Ampligen® as the first treatment for Chronic Fatigue Syndrome in the U.S. and other countries," stated Dr. David Strayer, Medical Director for Hemispherx.
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) announced it has agreed to sell 9,953,250 shares of its common stock, at a price of $1.65775 per share, and approximately 9,953 shares of its Series D Convertible Preferred Stock, at a price of $1,657.75 per share, in a registered direct public offering to entities affiliated with Deerfield Management, a healthcare investment organization. The preferred stock is convertible into an aggregate of 9,953,250 shares of Arena common stock. Arena expects to receive gross proceeds of approximately $33 million. The closing of the offering is expected to take place on or about January 13, 2012.
Arena will use $5 million of the proceeds from this offering to prepay a portion of the loan principal that otherwise would have been required to be repaid in June 2013 under the existing Facility Agreement between Arena and Deerfield.
AdCare Health Systems, Inc. (NYSE Amex: ADK), a nursing home and assisted living company, has been invited to present at the Noble Financial Capital Markets' 8th Annual Equity Conference.
eHealthInsurance (NASDAQ: EHTH), the leading online source of health insurance for individuals, families and small businesses, released answers to questions commonly asked by consumers facing increases in their monthly health insurance premiums.
MELA Sciences, Inc. (NASDAQ: MELA) today announced that it has entered into an expanded three-year manufacturing agreement with its long-term supplier, Askion GmbH, for the production of the MelaFind handheld device.
World Health Energy Holdings, Inc. (OTCQB: WHEN) (PINKSHEETS: WHEN), a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today the signing of a Letter of Intent to acquire the rights to the Middle East from GNE Inc.