Vivus's ED Drug Marketing Approved; Auxilium Pharma Reports XIAFLEX Data from Multicord Print E-mail
By William Kent   
Thursday, 18 September 2014 18:41

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 18, 2014.
Vivus Inc. (NASDAQ: VVUS) shares rose sharply in pre-market activity after its fast-acting erectile dysfunction drug won marketing approval Thursday from federal regulators.

The drug, avanafil, can be effective when taken as early as 15 minutes before sexual activity, the company said. The U.S. Food and Drug Administration cleared the drug for marketing in its first approval of an erectile dysfunction treatment in nearly 10 years.

"Patients are looking for a safe and effective treatment that also works fast," lead investigator Wayne J.G. Hellstrom of Tulane School of Medicine said.

Vivus holds worldwide development and commercial rights to avanafil, excluding Asia, through a license from Mitsubishi Tanabe Pharma Corp.

Avanafil is to be marketed as Stendra by Auxilium Pharmaceuticals Inc. under a Vivus license covering the U.S. and Canada.

Berlin-Chemie AG holds a similar license from Vivus covering much of Europe, Australia and New Zealand, while Sanofi SA sells the drug in the Middle East and Russia.

After opening sharply higher, Vivus traded recently at $4.25 per share, up a 9.5 percent.


Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
, a specialty biopharmaceutical company, announced the first presentation of positive safety and efficacy data from the AUX-CC-867 MULTICORD (MULtiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytrens) Phase 3b study. This study evaluated collagenase clostridium histolyticum (CCH) for the treatment of two Dupuytren's cords concurrently in the same hand. In addition, the study examined expanded flexibility with timing of the finger extension procedure. Additional positive data were presented from the AUX-CC-862 retreatment study that evaluated the retreatment of recurrent contracture in joints that were previously treated with CCH. These data will be presented at the 69th Annual Meeting of the American Society for Surgery of the Hand (ASSH) being held in Boston, September 18-20, 2014. XIAFLEX® (CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord.

DC is a progressive hand disease that can present with multiple collagen "cords" that limit finger movement. It is estimated that 35 to 40 percent of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time1.

"I believe these dual joint results are encouraging as they strongly suggest that XIAFLEX should provide a non-surgical option for treating appropriate DC patients with two affected joints concurrently in one office visit," said Gary M. Pess, M.D., an orthopedic surgeon with Central Jersey Hand Surgery. "Additionally, data supporting the ability to delay the finger manipulation procedure for up to 72 hours show that there should be a benefit to both patients and physician offices' scheduling flexibility."

"In my opinion, the retreatment data support that XIAFLEX can provide expanded treatment options for physicians and appropriate DC patients," said James R. Verheyden, M.D. President of The Center for Orthopedic and Neurosurgical Care & Research. "The study provides data supporting that XIAFLEX retreatment may be an option for recurrent DC patients who were previously treated with XIAFLEX using the non-surgical, in-office injection procedure."

"These data from the MULTICORD study formed the basis of our sBLA filing for a labeling expansion for the treatment of two cords concurrently and delayed finger extension" said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals. "We are looking forward to our PDUFA date in October and if approved, we believe that two concurrent XIAFLEX injections may allow more rapid overall treatment of multiple affected joints, without the need to wait approximately four weeks between treatments as required in the current labeling."

Highlights of the data presented include:
Results were presented from the AUX-CC-867 MULTICORD Phase 3b study that provides data supporting that two concurrent CCH injections can be used in the treatment of hands with multiple affected joints, without the need to wait 30 days between single treatments, as required in the current approved product label for XIAFLEX. In the study, concurrent injections of CCH to treat two Dupuytren's contractures on the same hand reduced fixed flexion contractures (FFCs) and increased range of motion (ROM). These results support those of two previously conducted pivotal studies examining multiple concurrent injections, AUX-CC-861 and AUX-CC-864.
Delayed manipulation data from the MULTICORD study was selected for the ASSH Meeting's Best Paper Session. These data support the ability to vary the time between a CCH injection and the finger extension procedure from 24 hours, per the current product labeling, to 72 hours and may allow for greater flexibility for both physicians and patients.
Data presented from the AUX-CC-862 Retreatment study support retreatment of recurrent contractures in joints that were previously treated with CCH which may allow optionality for CCH patients. The investigator assessment of improvement and patient satisfaction showed that 85 percent of treated joints achieved positive outcomes. Study results also suggest an improvement in FFC and ROM in both metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints.
Following concurrent CCH injections to two affected joints (one injection per treated joint), FFCs reduction and clinical success rates were higher among joints with lower baseline severity compared to those with higher baseline severity. Lacerations were more common among patients with more severe pretreatment contractures.
A post-hoc analysis of the MULTICORD study examined concurrently treating two affected joints (one injection per treated hand) of the same hand using local anesthesia (LA) prior to finger extension, which may result in greater reduction in FFCs. Although the risk of skin laceration may be increased with LA, it was numerically lower when the finger extension was performed at 72 hours as opposed to 24 or 48 hours. All lacerations were treated with wound care or suture placement.

The U.S. Food and Drug Administration is currently reviewing Auxilium's submission of a supplemental Biologics License Application (sBLA) requesting approval of XIAFLEX for the treatment of two Dupuytren's cords concurrently. The PDUFA date for the sBLA is October 20, 2014.

Also Thursday:

Abiomed Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced the appointment of Ingrid Goldberg, as Director of Investor Relations.

Amedica Corporation (Nasdaq:AMDA), a commercial biomaterial company focused on silicon nitride ceramics as a material platform to develop, manufacture and sell novel medical devices, today announced its expected participation in the following investor conference:  Singular Research 9th Annual Best of the Uncovereds Conference, Monday, September 22, 2014, 2:30 p.m. Pacific Time, Luxe Hotel in Los Angeles, CA.

Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced it has recently surpassed fifty percent of the target enrollment for the company's ongoing pivotal Phase III ADAPT trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC).

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that David Jackson, Ph.D., Vice President of Diagnostics & Companion Diagnostics, has been selected as Chair of World CDx Boston 2014, the 5th annual summit of this meeting, being held September 23-25, 2014 in Boston, Mass.

Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of revolutionary bone grafts and coatings for medical applications, today announced that its CEO, Dan Goldberger, will present at the Singular Research 9th Annual Best of the Uncovereds Conference, to be held September 22, 2014 at the Luxe Hotel in Los Angeles, CA.

Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that the Company has engaged Houlihan Lokey as its financial advisor to advise it on potential strategic alternatives for the Company's business.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular oncology diagnostics company specializing in circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) biomarker analysis, today announced that the Company has been granted a patent in China for its microfluidic channel technology used to capture CTCs.

Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, presented an abstract entitled "ALLogeneic Heart STem Cells To Achieve Myocardial Regeneration (ALLSTAR): The Six Month Phase I Safety Results" with an oral presentation by Dr. Raj R. Makker, M.D., of Cedars-Sinai Medical Center, at the Transcatheter Cardiovascular Therapeutics (TCT) conference at the Walter E. Washington Convention Center, Washington, DC on September 16, 2014.

Cerulean Pharma Inc. (Nasdaq:CERU)
, a leader in Dynamic Tumor Targeting™, today announced that Oliver S. Fetzer, Ph.D., President and Chief Executive Officer, will present BioCentury's 2014 Newsmakers in the Biotech Industry Conference on Friday, September 26th at 1:30 p.m. ET in New York.

The board of directors of The Clorox Company (NYSE: CLX) today announced, effective Nov. 20, 2014, Donald R. Knauss will continue serving as chairman and a member of the board, in a newly created executive chairman role, and Benno Dorer will be promoted to chief executive officer and nominated to be elected to the company's board of directors.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), today announced the presentation of preclinical data demonstrating the therapeutic potential of CYC065, Cyclacel's second-generation cyclin dependent kinase (CDK) inhibitor, to treat acute leukemias, and in particular those with rearrangements in the mixed lineage leukemia (MLL) gene.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced new findings from a feasibility study conducted by Kessler Foundation, which reported that eight stroke patients who were prescribed gait training during inpatient rehabilitation training, safely increased their cadence (steps per minute) after six weeks of rehabilitation with the assistance of the Ekso™ GT robotic exoskeleton.
Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, announced today that it has initiated dosing in its Phase 2 trial of Viagenpumatucel-L (HS-110) in patients with non-small cell lung cancer ("NSCLC").

Innovus Pharmaceuticals, Inc., (OTCQB:INNV)
announced today that it has entered into an exclusive marketing and distribution agreement with Tramorgan Limited, a British company ("Tramorgan") under which Innovus Pharma has granted to Tramorgan an exclusive marketing sales and distribution right to market and sell Innovus Pharma's topical  consumer care product to increase penile sensitivity, Sensum+™ in the United Kingdom ("UK").

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospital medicine and post-acute physician group practice company, announced today that it is further expanding its presence in post-acute care in southwest Ohio with the acquisition of Clyo Internal Medicine in Dayton.

Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the full commercial release of the Integra® Freedom Wrist Arthroplasty System in the United States.

Intuitive Surgical (Nasdaq:ISRG)
today announced that it has received FDA clearance for use of the da Vinci S® and da Vinci Si® Surgical Systems in benign, base of tongue resection procedures.

K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced the launch of EVEREST® Minimally Invasive Spinal System at the Society for Minimally Invasive Spinal Surgery (SMISS) Global Forum 2014 in Miami, Fla.

Mitel® (Nasdaq:MITL) (TSX:MNW)
, a global leader in business communications, will deliver a cloud-based communications solution to the University Hospital of the Reunion Island that is enabling faster diagnosis and treatment, and the provision of new patient services, while simplifying and reducing the cost of the day-to-day delivery of voice and data services.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell and gene therapy solutions for the treatment of diseases, today provides its shareholders with an update on recent activities of Nuvilex and outlines future plans for the development of treatments in the areas of cancer and diabetes.

Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that Steven P. James has been appointed to the Company's Board of Directors.

Plumas Bank, a subsidiary of Plumas Bancorp (Nasdaq:PLBC), has partnered with Alexandre Kids, LLC, owned by Blake and Stephanie Alexandre along with their five children, Joseph, Christian, Vanessa, Dalton and Savanna.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today announced that John Orwin, Chief Executive Officer, will present a corporate overview at the Newsmakers in the Biotech Industry Conference on September 26, 2014 at 9:30 a.m. ET.

Relmada Therapeutics, Inc., (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, announced today that it has appointed Mr. Christopher W. James to the position of  Senior Director of Clinical Development.

TriVascular Technologies, Inc. (Nasdaq:TRIV), today announces it will initiate a voluntary field safety corrective action related to certain of its 29 mm Ovation Prime aortic stent grafts, one of five aortic body sizes offered by the company.

VeriTeQ Corporation (OTC Markets:VTEQ)
, a provider of implantable medical device identification and radiation dose measurement technologies, announced today that it has unveiled two new readers used to identify VeriTeQ's Q Inside Safety Technology™ within implantable medical devices: the Q Inside Reader + and the Q Inside Reader XR +.

Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced that Frances K. Heller will rejoin Zafgen's Board of Directors and will also be a member of the Audit Committee.

Zogenix, Inc. (Nasdaq:ZGNX)
, a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today presented data from a one year open label study that demonstrated chronic pain patients who achieved substantial levels of pain reduction with Zohydro® ER, (hydrocodone bitartrate) Extended-Release Capsules, CII experienced a statistically significant (p≤0.001) improvement in functional outcomes from baseline to end of study.

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