Aeterna Zentaris: FDA Grants IND for Phase 2A Trial with AEZS-130; Gilead Receives European Marketing Authorization for Eviplera® Print E-mail
By Staff and Wire Reports   
Monday, 28 November 2011 20:04
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 28, 2011.

Aeterna Zentaris Inc. (NASDAQ: AEZS) announced the U.S. Food and Drug Administration (FDA) has granted Jose M. Garcia, MD, PhD, Assistant Professor, Division of Diabetes Endocrinology and Metabolism, Departments of Medicine and Molecular and Cell Biology, Baylor College of Medicine and Michael I. DeBakey Veterans Administration Medical Center, in Houston Texas, an Investigational New Drug (IND) approval for the initiation of a Phase 2A trial to assess the safety and efficacy of repeated doses of the Company's ghrelin agonist, AEZS-130 (macimorelin), in patients with cancer cachexia. Cachexia, which is characterized by diminished appetite and food intake in cancer patients, is defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months.

This is a double-blind, randomized, placebo-controlled Phase 2A trial to test the effects of different doses of the ghrelin agonist, AEZS-130, in 18 to 26 patients with cancer-cachexia. The study will be conducted under a cooperative research and development agreement (CRADA) with the Michael I. DeBakey Veterans Administration Medical Center which will be funding the study. AEZS-130 will be provided by Aeterna Zentaris. The study will involve 3 sequential groups receiving differing doses of AEZS-130. Each dose group will have 6 patients who will receive AEZS-130 and 2 patients who will receive placebo.

After analysis of safety and efficacy at each dose level vs. placebo, a decision will be taken either to decrease or increase the dose. If there are major safety issues, the study will be stopped. For this study, adequate efficacy will be defined as a ≥0.8 kg of body weight gain or a ≥50 ng/mL increase in plasma IGF-1 levels. The primary objective of the study is to evaluate the safety and efficacy of repeated oral administration of AEZS-130 at different doses daily for 1 week in view of developing a treatment for cachexia.

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Gilead Sciences, Inc. (Nasdaq: GILD) announced the European Commission has granted marketing authorization for Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil), a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL. Todays authorization allows for the commercialization of Eviplera in all 27 countries of the European Union (EU).

Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet.

Eviplera combines Gileads Truvada®, a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine 200 mg and tenofovir disoproxil 245 mg, and Tibotec Pharmaceuticals rilpivirine 25 mg, marketed by Janssen-Cilag International N.V. as Edurant®.

The authorization of Eviplera was supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec that evaluated the safety and efficacy of rilpivirine compared to efavirenz in treatment-naïve HIV-infected adults. Both studies included a background regimen of two nucleosides/nucleotides, which for the majority of patients was Truvada. A bioequivalence study, conducted by Gilead, demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate administered separately. The single-tablet regimen received regulatory authorization from the U.S. Food and Drug Administration under the trade name Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in August 2011.

Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of this single-tablet regimen in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of the product in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Tibotec will be responsible for the commercialization of rilpivirine as a single agent and will hold rights to co-detail the single-tablet regimen in these territories.

The companies also have finalized an agreement for the development and commercialization of this single-tablet regimen for the rest of world, including resource-limited settings. Gilead will be responsible for the registration, distribution and commercialization of the single-tablet regimen in certain European countries, Latin America and the Caribbean. Tibotec will be responsible for all countries outside of the Gilead territories, the most significant of which include Asia Pacific, including Japan, the Middle East, Eastern Europe and all of Africa.



Also Monday:



ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the 2011 Deutsche Bank BioFEST conference in Boston. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s oncology pipeline on Monday, December 5 at 10:45 a.m. (ET).

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Oppenheimer 22nd Annual Healthcare Conference during December 13-14, 2011 at the Waldorf Astoria in New York City.

Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, signed an exclusive agreement with Jeil Medical Corporation for distribution in the U.S. and Canada of Jeil's LeForte System.

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) has been informed by the United States Patent & Trademark Office (USPTO) that it has rejected all claims of US Patent No. 7,824,588 (the '588 Patent) which is currently being asserted against BDSI by MonoSol RX, LLC (MonoSol).

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the manufacturing facility expansion in Novato, CA.

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) ("Connectyx"), www.connectyx.com, the manufacturer and distributor of the MedFlash®, an innovative Personal Health and Wellness Management System (ePHM) designed for maintaining personal health records (PHR), announced today the launch of the company's international expansion in the marketing and distribution of MedFlash into Israel.

The University of Cambridge and Elan Corporation plc. (NYSE: ELN) today announced the launch of The Cambridge-Elan Centre for Research Innovation and Drug Discovery (Cambridge-Elan Centre), which will be located at the University of Cambridge, England.

Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) for further evaluation of cabozantinib, Exelixis’ lead compound, in a variety of solid tumors.

Fluidigm Corporation (NASDAQ:FLDM)
today announced that President and Chief Executive Officer Gajus Worthington will participate in the 23rd Annual Piper Jaffray Healthcare Conference on Wednesday, November 30, 2011, at the New York Palace Hotel, New York City, beginning at 3:00 p.m. Eastern Time.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Eviplera®(emtricitabine/rilpivirine/tenofovir disoproxil), a complete once-daily single-tablet regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL. Today’s authorization allows for the commercialization of Eviplera in all 27 countries of the European Union (EU).

iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of cancer, will showcase its family of computer-aided detection (CAD) and advanced imaging solutions at the Radiological Society of North America (RSNA) Annual Meeting this week in Chicago, Ill.

Imaging3™, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced the company's participation in the Radiological Society of North America's Scientific Conference held annually in Chicago, IL.

IsoRay, Inc. (Amex: ISR) announced today it has shipped its first GliaSite® radiation therapy system. The Company initiated sales after receiving final approval this week from the State of Washington Department of Health to manufacture its GliaSite® radiation therapy system.

Lightlake Therapeutics Inc. (OTCBB: LLTP)
(the “Company” or “Lightlake”), an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today that it has launched its new corporate website, http://lightlaketherapeutics.com, and will be conducting a conference call followed by a Q & A session on Tuesday, November 29, 2011 at 5:00 PM EST to update shareholders and other interested parties on the Company’s current endeavors.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG)
(the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that the Company will be participating in the Piper Jaffray 23rd Annual Healthcare Conference being held November 29-30, 2011 at the Palace Hotel in New York City.

Mesa Laboratories, Inc., (Nasdaq: MLAB) is pleased to announce that John J. Sullivan, President and CEO, will be presenting at the LD MICRO Growth Conference on Thursday, December 8th at 11:00 Pacific time.

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

MMRGlobal, Inc. (OTCBB: MMRF) (www.mmrvideos.com) today announced that it has just been granted a patent protecting methods of making compositions for B-cell vaccines and will soon also have Notice of Allowance for another U.S. Patent protecting "Methods of treating a patient with a B-cell lymphoma."

Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection, packaged in 250 mg and 500 mg Single-use Vials.

OncoVista Innovative Therapies, Inc. (OTCBB: OVIT), a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies with reduced toxicity and improved patient safety, announced today that it has entered into an agreement with Oncology Therapeutic Development (OTD), a consulting and early Clinical Development focused CRO, to initiate a Phase Ib clinical trial of Cordycepin associated to Pentostatin for the treatment of patients with terminal deoxynucleotidyl transferase (TdT)-positive refractory leukemia.

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR)
will host investors and analysts in New York City on December 5, 2011 for a corporate overview and update with a focus on its commercial strategy and launch of DIFICID.

PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that Eric I. Richman, President and Chief Executive Officer will present at the Piper Jaffray 23rd Annual Healthcare Conference being held November 29-30, 2011.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that results from a joint study by researchers at Rosetta Genomics and the Department of Cardiovascular Medicine, Lady Davis Carmel Medical Center in Haifa, Israel, show that elevated serum levels of specific microRNAs identify systolic heart failure (HF) patients and correlate with important clinical prognostic parameters.

ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that it is scheduled to present at the following investor conferences in December 2011:

Spectrum Pharmaceuticals (NasdaqGS:SPPI) today announced that Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President, has been invited to chair the opening ceremonies and ring the Nasdaq Stock Market opening bell on Tuesday, November 29, 2011.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the 23rd Annual Piper Jaffray Health Care Conference with William Marth, President & CEO, Teva Pharmaceuticals – Americas, presenting on Wednesday, November 30, 2011 in New York.

TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced that it has acquired the website www.BusinessList.com in a cash and debt transaction, no common or preferred shares were issued.



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