|Tolero and Agrees to Develop and Commercialize Novel BTK; Ampio Announces Extended Analysis of Ampion™|
|By Staff and Wire Reports|
|Monday, 30 April 2012 18:26|
Tolero Pharmaceuticals, a biopharmaceutical company focused on the discovery and development of novel therapeutics to treat cancer and other serious human diseases, and MannKind Corporation (NASDAQ:MNKD), focused on discovering, developing and commercializing therapeutic products for diabetes and cancer, announced a license agreement granting Tolero exclusive worldwide rights to develop and commercialize compounds from MannKinds novel BTK (Brutons tyrosine kinase) program, which are currently being developed for the treatment of hematological malignancies and inflammatory diseases.
Under the terms of the agreement, Tolero will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, for total potential upfront and milestone payments of approximately $130 million. MannKind will also receive tiered royalties on sales of products and a percentage of sublicensing revenue. In addition, MannKind has an option to re-acquire the rights to the program at pre-specified terms until 60 days after the conclusion of the first Phase 1 study. If MannKind exercises this option, then MannKind would assume responsibility for developing and commercializing products and Tolero would become entitled to receive the milestone payments, royalties and sublicensing revenues specified in the agreement.
We are really excited about this opportunity and pleased to be working with an experienced drug development team at MannKind that is passionate about moving this program forward. BTK currently represents one of the most exciting therapeutic targets in oncology, and we feel that our collaborative approach to targeting BTK may uncover some novel utilities not yet fully realized, said Dallin Anderson, Chairman and President of Tolero.
Dr. David Bearss, Founder of Tolero, added, BTK has already been demonstrated to be a validated clinical target in multiple disease settings. We believe that MannKind has developed a series of novel compounds with unique mechanisms of action that may lead to important treatments for cancer and autoimmune diseases, such as rheumatoid arthritis. We are excited to be a strategic partner with MannKind.
Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion™, Optina™ and Zertane™), licensing distribution of those drugs and engaged in further drug development, announced the completion of the planned analysis of the day 84 data of the Ampion™ in the Knee (AIK) study conducted in Australia. With the previously reported positive results 30 days after a single injection to the knees of patients suffering from osteoarthritis, the analysis was extended to also review pain outcomes at day 84 after the injection.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained: "There are a number of ways to analyze the pain score data to determine efficacy. One method is to determine if any change from baseline is significant (each patient serves as their own control). The change from baseline for the Ampion treated patients was statistically significant at both 30 and 84 days after injection (p < 0.05 for day 30 and day 84) and the change from baseline for the placebo treated patients was not statistically significant (p =0.08 day 30, p= 0.34 at day 84).
"The difference in pain relief between Ampion™ and placebo at day 84 after a single injection into the knee was statistically significant (p=0.04, n=32) despite the small number of patients included in each group (saline and Ampion™ groups).
"Another relevant way to assess pain relief is the "responders vs. non- responders" to treatments at day 84. A "responder" was defined as someone who experienced a two or more points shift improvement in pain relief as measured by the numerical pain scale (scale of 1-10). Non-responders experienced an improvement of at most 1 point or an actual worsening of pain relief. Percentage of "responders" in the group who received Ampion™ was more than twice the percentage of those who received saline (53% vs. 24%) and this approached statistical significance (p=0.06)."
"This study in Australia was designed to explore safety and efficacy in a proof of principle study," commented Dr. David Bar-Or, Chief Scientific Officer. "Despite the small number of patients included, we observed prolonged and sustained pain relief in the Ampion™ treated group even after 84 days from a single injection into the knee and the safety profile was good. These are very gratifying results as our in-vitro studies indicate that Ampion™ has multiple mechanisms of action many of which would be consistent with long term efficacy from a single injection. There were no significant adverse events and no minor adverse events that were more common in the Ampion™ group compared to the placebo group indicating the treatment is well tolerated. These results will inform our discussions with the FDA at our scheduled meeting in May 2012 and our design of a pivotal trial in the United States."
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the Company has again been recognized as one of the Best Companies to Work for in New York based on an independent survey identifying the best places of employment in the state. Acorda was ranked 7th among large companies, defined as employing more than 250 people.
Affymax, Inc. (Nasdaq: AFFY) today announced that it will host a teleconference and webcast with management to provide a general business overview, as well as to discuss its first quarter 2012 financial results on Monday, May 7, 2012, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Vikas Sinha, Chief Financial Officer of Alexion Pharmaceuticals, will present at the Deutsche Bank Securities 37th Annual Health Care Conference in Boston at 11:20 a.m. Eastern time on Monday, May 7th, 2012.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) will be presenting at the Deutsche Bank 37th Annual Health Care Conference on Monday, May 7, 2012 at 2:10 p.m. ET / 11:10 a.m. PT in Boston.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will webcast its presentation at the Deutsche Bank 37th Annual Health Care Conference in Boston. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s business on Monday, May 7, 2012 at 4:10 p.m. (ET).
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Bristol-Myers Squibb Company (NYSE: BMY) will present at Deutsche Bank’s 37th Annual Health Care Conference on Monday, May 7, 2012 in Boston. Francis Cuss, senior vice president, Research, will make a formal presentation about the company at 10:40 a.m.
Cannabis Science, Inc. (OTCBB: CBIS.OB) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, was honored to be the Sponsor and an Exhibitor at the 7th national Patients Out of Time, medical cannabis conference in Tucson, Arizona.
Codexis, Inc. (NASDAQ:CDXS), a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced it will host a conference call and webcast on Thursday, May 10, 2012 at 4:30 p.m. Eastern Time to discuss its first quarter 2012 financial results for the period ended March 31, 2012.
Flamel Technologies (NASDAQ: FLML) expects to release its financial results for the first quarter of 2012, on Monday, May 7th, before the market open.
McKesson Corporation (NYSE: MCK) today reported that revenues for the fourth quarter ended March 31, 2012 were $31.7 billion, up 10% compared to $28.9 billion a year ago.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that on Friday, April 27, 2012, the Company filed a Preliminary Proxy Statement in advance of the Company's Annual Meeting of Stockholders scheduled on June 20, 2012.
Repligen Corporation (NASDAQ:RGEN) announced today that Dr. Walter C. Herlihy, President and Chief Executive Officer of Repligen, will host a conference call and webcast on Thursday, May 3, 2012 at 8:30 a.m. EDT.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it has completed patient enrollment in its PRIME clinical study, which is designed to investigate the reduction in the need for erythropoietin stimulating agents (ESA) in hemodialysis patients receiving Soluble Ferric Pyrophosphate (SFP) via dialysate.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency’s Priority Review of the New Drug Application (NDA) for Crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).
Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced it has completed enrollment with 292 patients enrolled in the SYNERGY trial, a Phase 2b clinical trial designed to evaluate the safety and efficacy of Synavive®, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA).