|Sunesis and Royalty Pharma Announce Agreement; Forest Labs and Almirall Announce Extended Review Period|
|By Staff and Wire Reports|
|Thursday, 29 March 2012 18:59|
Sunesis Pharmaceuticals (Nasdaq:SNSS) and Royalty Pharma announced Royalty Pharma has agreed to pay Sunesis $25 million, under certain circumstances related to the successful development of Sunesis' lead product candidate vosaroxin, to acquire a royalty on future worldwide net sales of vosaroxin.
Sunesis is evaluating vosaroxin in a pivotal Phase 3, randomized, double-blind, placebo-controlled trial, the VALOR trial, in patients with first relapsed or refractory acute myeloid leukemia (AML). The VALOR trial employs an adaptive trial design that permits a one-time increase in sample size at the interim analysis by its Data and Safety Monitoring Board (DSMB). At the interim analysis, expected in the third quarter of 2012, the DSMB will examine pre-specified efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as planned or implement a one-time sample size adjustment of 225 additional evaluable patients.
Under terms of the agreement, Royalty Pharma will invest $25 million immediately following VALOR's interim analysis if: (a) the study stops early for efficacy, in exchange for a 3.6% participation payment on future net sales; or (b) the one-time sample size increase is being implemented, in exchange for a 6.75% participation payment on future net sales as well as two warrants. In the case when VALOR proceeds to its planned 450 patient enrollment, Royalty Pharma has the option to make a $25 million investment upon the unblinding of the study in exchange for a 3.6% participation payment on future net sales. The warrants issued to Royalty Pharma are exercisable if VALOR's sample size is increased and are each to purchase 1,000,000 shares of Sunesis common stock at an exercise price of $3.48 and $4.64 per share, respectively. Sunesis currently holds all worldwide commercial rights to its vosaroxin product.
Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC) announced the U.S. FDA will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). No additional data has been requested by the agency to complete the review. FDA action is now expected by July 2012.
This FDA notification follows the Pulmonary-Allergy Drugs Advisory Committee (PADAC) February 2012 meeting during which the committee endorsed the efficacy and safety of twice-daily aclidinium bromide 400ug with a positive 12 to 2 vote in favor of approval.
The efficacy and safety of aclidinium was studied in a clinical trial program including 2,717 COPD patients in 9 studies. In these trials, aclidinium demonstrated significant improvement in lung function, with a low incidence of side effects, comparable to placebo.
Affymetrix, Inc. (NASDAQ:AFFX) today announced that it has signed a global distribution agreement with Almac Group Ltd., an established company that provides an extensive range of pharmaceutical services.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced data from a Phase 2 study of asfotase alfa in adolescents and adults with hypophosphatasia (HPP), a severe and ultra-rare metabolic disorder.
The team at AirWare Labs (OTCBB: CDYY) has completed the product development for their drug-free, break-through technology-based Product, AIR.
ArQule, Inc. (Nasdaq: ARQL) today announced eight presentations of clinical and pre-clinical data for tivantinib (ARQ 197) at the Annual Meeting of the American Association for Cancer Research (AACR), held from March 31 – April 4 in Chicago, Illinois.
Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, today announced the acceptance of fourteen abstracts for presentation at the American Association for Cancer Research (AACR) 2012 Annual Meeting.
AstraZeneca (NYSE: AZN) today announced that the US District Court for the District of New Jersey has found the formulation patent protecting SEROQUEL XR® (quetiapine fumarate) extended release tablets to be valid.
Bio-Path Holdings, Inc., (OTCBB: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has entered into a services agreement with Los Angeles-based investor relations firm PondelWilkinson to assist the Company in implementing an investor and public relations program geared to the individual retail investment community.
BrainStorm Cell Therapeutics (OTCBB: BCLI), a developer of adult stem cell technologies and CNS therapeutics, has issued a CEO update to shareholders and investors, with a review of recent accomplishments.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported financial and operating results for the three and 12 months ended December 31, 2011.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces the signing of a definitive agreement to acquire MedEfficiency, Inc. (“MedEfficiency”), manufacturer of the TCC-EZ™ Total Contact Cast system, for $14.5 million in cash.
GenMark Diagnostics, Inc. (NASDAQ: GNMK), announced today that it has entered into a license agreement with PerkinElmer, granting GenMark a non-exclusive license under PerkinElmer’s microfluidics patent portfolio.
GenSpera, Inc. (OTCBB:GNSZ) announced the successful completion of the dose-escalation component in the ongoing Phase I trial of its lead chemotherapeutic agent, G-202.
Genzyme, (EURONEXT: SAN and NYSE: SNY), a Sanofi company and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), announced today that new two-year data from a phase 3 long-term extension study of KYNAMROTM (mipomersen sodium) were presented at the XVI International Symposium on Atherosclerosis in Sydney, Australia.
Hercules Technology Growth Capital, Inc. (NASDAQ: HTGC), a leader in customized debt financing for entrepreneurial venture capital and private equity-backed companies in technology-related markets including cleantech and life science, announced today they have appointed Jessica Baron to permanently serve as the Company’s chief financial officer effective immediately.
Idera Pharmaceuticals, (NASDAQ: IDRA) a biotechnology company developing novel therapeutics for autoimmune diseases and cancer, today announced that it will present at the 11th Annual Needham Healthcare Conference on Wednesday, April 4th 2012, at 4:00 pm EST at the New York Palace Hotel in New York City, NY.
Interleukin Genetics, Inc. (OTCQB: ILIU) today issued financial and operational results for its fiscal fourth quarter and full fiscal year ended December 31, 2011.
MMRGlobal, Inc. (OTCBB: MMRF), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, plans on filing its 2011 Annual Report on Form 10-K for the period ended December 31, 2011 with the U.S. Securities and Exchange Commission on Friday, March 30, 2012 after the close of market.
Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) today announced that Dr. Thomas Tulip, Executive Vice President and Chief Business Officer, will participate at the 11th Annual Needham Healthcare Conference on April 3 - 4 at the New York Palace Hotel in New York City.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that Cooper Collins, President and Chief Executive Officer, will present at the 11th Annual Needham Healthcare Conference on Tuesday, April 3, 2012 at 10:40 a.m. EST.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has increased its offer price for all outstanding publicly-held shares of Illumina, Inc. (NASDAQ: ILMN) to US$ 51.00 per share in cash.
Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that management will present at the upcoming 11th Annual Needham Healthcare Conference in New York, NY. The presentation is scheduled for Tuesday, April 3, at 10:00 a.m. Eastern time.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today that it will host a joint symposium on Body Shaping featuring its VelaShape body contouring system and the recently acquired UltraShape focused ultrasound fat lipolysis system at the 2012 Anti-Aging Medicine World Congress & Medispa Conference in Monte Carlo.
Take Care Health Systems, a wholly-owned subsidiary of Walgreens (NYSE: WAG) (NASDAQ: WAG), and Tufts Health Plan today announced the opening of a workplace health center called the BeWell Center, offering wellness and preventive care, symptom care, and laboratory services to Tufts Health Plan employees and contractors.
University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS), a diversified, integrated multi-specialty health delivery system, today announced that its flagship Houston-based University General Hospital has been named a Blue Distinction Center for Bariatric Surgery® by Blue Cross and Blue Shield of Texas for demonstrating better overall quality of care and patient results in bariatric surgery.
VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (PINKSHEETS:VPTDF) is pleased to announce that it has received CE Approval for the Company's new Pulmonary Arterial Hypertension (PAH) application for the VentriPoint Medical System™ (VMS™).