|Targacept stops TC-6987as diabetes treatment candidate; Affymax and Takeda Announce FDA Approval of OMONTYS®|
|By Staff and Wire Reports|
|Tuesday, 27 March 2012 19:35|
Targacept, Inc. (NASDAQ: TRGT) announced top-line results from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in the United States, one in asthma and one in type 2 diabetes.
In the type 2 diabetes study, the primary outcome measure, change in fasting plasma glucose, was not met, and Targacept will not pursue further development of TC-6987 as a treatment for diabetes. TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor (NNR) discovered by Targacept scientists using Pentad™, the company’s proprietary drug discovery platform."
The type 2 diabetes study was a double blind, placebo controlled, parallel group Phase 2 trial conducted at 24 sites in the United States. The study enrolled 112 adult patients, with 87 patients completing.
“The exploratory asthma trial of TC-6987 as an adjunct to a low-dose inhaled corticosteroid showed a drug effect that was seen at the first assessment point, 30 minutes after initial dosing, and was sustained throughout the duration of the study, suggesting that TC-6987 has promise and may also have benefit in a monotherapy setting,” said James F. Donohue, M.D., Professor of Medicine at the University of North Carolina, School of Medicine, Department of Medicine in Chapel Hill.
“With the positive outcome in our TC-6987 asthma study, we have accomplished our goal of detecting in patients a signal of the potential of NNR Therapeutics in the treatment of disorders outside of the CNS, while at the same time further establishing a favorable safety and tolerability profile for this alpha7-selective NNR Therapeutic,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer.
Affymax, Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Company Limited, announced the U.S. FDA approved OMONTYS® (peginesatide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the United States.
The FDAs decision was based on a New Drug Application (NDA), which included results from two randomized, controlled, open-label, Phase 3 studies (EMERALD 1 and 2) that demonstrated the safety and efficacy of OMONTYS dosed once monthly, compared to epoetin dosed between one-to-three times per week (according to product labels), in maintaining hemoglobin (Hb) levels in anemic CKD patients on dialysis. In these studies, the most commonly reported adverse reactions were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication. The EMERALD studies were part of the largest clinical program to support the NDA of an ESA in the treatment of anemia in CKD. Enrolling 2,606 patients, including approximately 1,600 dialysis patients, the OMONTYS Phase 3 program was also the first to prospectively compare, in a head-to-head manner, the cardiovascular safety of different ESAs. Cardiovascular safety was evaluated based on a composite cardiovascular safety endpoint adjudicated by a blinded and independent committee. See below for Important Safety Information about OMONTYS, including Boxed Warnings as well as limitations of use.
In the approval action letter, the FDA outlined post-marketing requirements: an observational study and a randomized controlled trial to be completed with final reports submitted in 2018 and 2019, respectively. The objectives of the studies are to evaluate cardiovascular safety and assess safety of long-term use in adult patients on dialysis, in particular in the incident patient population. In addition, the post-marketing commitment includes the initiation of pediatric studies with target dates for completion between 2016 and 2027. Letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS) to inform them that OMONTYS is not indicated in patients with CKD not on dialysis. In two trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events.
The approval of OMONTYS now provides a therapeutic alternative to treat anemia of CKD in adult patients on dialysis, one of the most common complications affecting this patient population, said John Orwin, chief executive officer, Affymax. For over two decades, doctors have relied primarily on one erythropoietin-based treatment in the dialysis setting. With OMONTYS, doctors and patients will have access to a once-monthly alternative for the treatment of anemia in adult CKD patients on dialysis.
The FDAs approval of OMONTYS signifies an important milestone for the partnership between Takeda and Affymax as we fulfill our goal of providing an important new treatment option for the hundreds of thousands of CKD patients on dialysis who live with anemia, said Azmi Nabulsi, M.D., president, Takeda Global Research & Development Center, Inc. OMONTYS is an example of our commitment to making treatment options available that accommodate the needs of evolving healthcare markets, such as the renal community.
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) approved OMONTYS® (peginesatide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the United States.
Agilent Technologies Inc. (NYSE:A) today released GeneSpring 12.0, a major expansion of its popular bioinformatics software designed to enable a new level of medical science breakthroughs.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at the 11th Annual Needham Healthcare Conference on Wednesday, April 4, 2012 at 10:40 a.m. ET at the New York Palace Hotel.
Aradigm Corporation (OTCBB:ARDM) today announced financial results for the fourth quarter and full year ended December 31, 2011.
AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) today announced that previously reported clinical data on tivozanib, AVEO’s lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, and preclinical data on AV-203, AVEO’s ErbB3 inhibitory antibody, will be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2012 being held March 31-April 4, 2012 in Chicago.
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI), today announced that Biovest has formally established its Scientific Advisory Board (SAB) comprised of key opinion leaders from prestigious institutions including the MD Anderson Cancer Center, the Abramson Cancer Center at the University of Pennsylvania, the University of Michigan Medical School and the H. Lee Moffitt Cancer Center.
Codexis, Inc. (Nasdaq:CDXS), a developer of industrial enzymes to enable the production of biofuels, biobased chemicals, and pharmaceutical intermediates, today announced it has been awarded a key patent from the U.S. Patent and Trademark Office covering an important component of the company’s proprietary enzymatic technology that can be used for production of cellulosic biofuels.
CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in the 11th Annual Needham Healthcare Conference on Tuesday, April 3, 2012 at 10:40 AM Eastern Time.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced the upcoming presentation of research demonstrating that INNO-206 in combination with either doxorubicin or a novel albumin-binding methotrexate drug induced complete tumor remissions in animal models of human pancreatic cancer.
Enzo Biochem, Inc. (NYSE:ENZ) announced today that Barry Weiner, President, and David Goldberg, Vice President, Corporate Development, and Interim President Enzo Clinical Labs, will be presenting at the 11th Annual Needham Healthcare Conference on Tuesday Apr 3, 2012 at 8:00 AM at The New York Palace Hotel in New York, N.Y.
Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has cleared the PillCam Patency Capsule for use with PillCam SB and expanded the indications for use of the PillCam SB video capsule for patients with known or suspected small bowel disease, including the visualization and diagnosis of Crohn's disease.
Global Health Voyager, Inc. (OTCBB: GLHV), a publicly-traded, full-service, international medical tourism company, announced a planned launch of 24/7 nursing support service for its users.
Ryan & Maniskas, LLP (www.rmclasslaw.com/cases/ista) is investigating potential claims against the board of directors of ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) concerning possible breaches of fiduciary duty and other violations of law related to the Company’s efforts to sell ISTA to Bausch & Lomb in a transaction valued at approximately $500 million.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, announced today that the Company will deliver a presentation on the identification and characterization of immunogenic epitopes from CD133 and their potential for use to immunologically target cancer stem cells (CSCs) at the Annual Meeting of the American Association for Cancer Research, which will be held from March 31 to April 4, 2012 at McCormick Place in Chicago, Illinois.
Mannatech, Incorporated (NASDAQ: MTEX), the leading innovator and provider of nutritional supplements based on Real Food Technology® solutions, recently announced the publication of a comprehensive literature review reporting the effects of polysaccharides on brain function.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, will hold its first-quarter 2012 sales and earnings conference call with institutional investors and analysts at 8 a.m. EDT on Friday, April 27.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) will present at the 11th Annual Needham Healthcare Conference in New York on Tuesday, April 3, 2012 at 8:40 a.m. ET.
Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) today announced consolidated 2011 financial results, reviewed key 2011 accomplishments and reiterated that it expects to initiate the commercial launch of EXPAREL® (bupivacaine liposome injectable suspension) in the U.S. the week of April 9.
RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) today announced that it has signed a term sheet with Lee’s Pharmaceutical (HK) Limited, headquartered in Hong Kong, for the license of Thymosin Beta 4-based products, including the Company’s RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong and Macau.
Response Genetics Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced its consolidated financial results and business progress for the full year and fourth quarter ended December 31, 2011.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it will present new pre-clinical data on its oncology compound RX-3117 during a poster session at the American Association for Cancer Research (AACR) 103rd Annual Meeting being held in Chicago, Illinois, March 31 - April 4, 2012, at the McCormick Place Convention Center.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the appointment of Dr. George Farmer as Vice President of Corporate Development, leading the communications, competitive intelligence and strategy functions.
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced top-line results from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in the United States, one in asthma and one in type 2 diabetes.