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Bristol-Myers Squibb to Acquire ZymoGenetics
* Builds on Long-standing Commitment to Virology * Gains Full Rights to Promising Phase II Hepatitis C Biologic, Pegylated-Interferon Lambda * Obtains FDA-Approved Specialty Surgical Biologic, RECOTHROM® * Attains Early Clinical and Pre-clinical Programs in Oncology and Immunoscience Bristol-Myers Squibb Company (NYSE:BMY - News) and ZymoGenetics, Inc. (NASDAQ: ZGEN - News) announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash. The transaction, with an aggregate purchase price of approximately $885 million, or approximately $735 million net of cash acquired, has been unanimously approved by the boards of directors of both companies.
Rexahn Pharmaceuticals Submits Serdaxin Phase IIb Protocol to FDA for Major Depressive Disorder (MDD)
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD). The Phase IIb study will assess Serdaxin’s efficacy as a treatment for major depressive disorder in approximately 300 subjects. The planned double blind, randomized, placebo-controlled trial will be conducted at multiple sites in the U.S. and will measure the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary efficacy endpoint.
Oncolytics Biotech(R) Inc. Announces Randomized Phase II Ovarian Cancer Study to be Conducted by the Gynecologic Oncology Group and Sponsored by the National Cancer Institute
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN(R) in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer (GOG186H). The study has been approved and will be sponsored by the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, under its Clinical Trials Agreement with Oncolytics. Oncolytics will provide clinical supplies of REOLYSIN for this study. The Study Chair will be Dr. David E. Cohn of The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.
Rexahn Pharmaceuticals Announces Publication of New Preclinical Research Data for Novel Anticancer Compound RX-8243
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of a research article in Bioorganic & Medicinal Chemistry Letters on the anti-tumor activity of RX-8243 and its analogues. The article offers data demonstrating that RX-8243, an isoquinolineamine analogue, significantly inhibits the growth of human cancer cells, including paclitaxel (Taxol®) resistant HCT-15 human colorectal cancer cells and the growth of tumor in in vivo model of nude mice injected with paclitaxel-resistant HCT-15 human colorectal cancer cells.
Orexigen® Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave® in North America
Orexigen® Therapeutics, Inc. (Nasdaq:OREX ) and Takeda Pharmaceutical Company Limited , today announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen's investigational drug for the treatment of obesity, in the United States, Canada and Mexico. Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.
Ebix to Acquire Atlanta Based, Leading Health Technology Services Company A.D.A.M.
Combined Company will have a Powerful Health Information and Services Exchange for Employers, Benefits Brokers, Hospitals, Healthcare Organizations and Consumers --Ebix Expects the Merger to be Immediately Accretive and Generate 15 cents of Additional Diluted EPS in Year One Ebix, Inc. (NASDAQ: EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance industry, today announced that it has signed a merger agreement with Atlanta based A.D.A.M., Inc. (NASDAQ: ADAM), a leading provider of health information and benefits technology solutions in the United States. Ebix will acquire A.D.A.M. on a debt-free basis for aggregate merger consideration of $66 million.
Alexza's Staccato® Nicotine Licensed to Cypress Bioscience
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has licensed its Staccato nicotine technology to Cypress Bioscience, Inc. (Nasdaq: CYPB). The Staccato nicotine technology is a novel electronic multidose delivery system designed to help people stop smoking. The Staccato nicotine technology is intended to improve on a well-validated smoking cessation approach by delivering nicotine via inhalation, mimicking the nicotine effects of smoking without the harmful side effects associated with cigarettes. "The Staccato system is a broad technology platform and Alexza has more Staccato-based product candidates than we can currently afford to develop on our own. In early July, we outlined our strategy to advance Staccato-based product candidates into development through self-funding and through collaborations," said Thomas B. King, Alexza President and CEO. "Today's announcement of the licensing of our Staccato nicotine technology to Cypress, along with our recently announced plans to advance AZ-007 (Staccato zaleplon) into Phase 2 clinical development, are examples of our execution of this dual-tracked development strategy."
Neuralstem Files FDA Application for First Chronic Spinal Cord Injury Stem Cell Trial
Neuralstem, Inc. (NYSE Amex: CUR) announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells. This multicenter Phase I safety trial will enroll a total of 16 long-term, or chronic, spinal cord injury patients, with an American Spinal Injury Association (ASIA) Grade A level of impairment, one-to-two years post-injury. ASIA A refers to a patient with no motor or sensory function in the relevant segments and is considered to be complete paralysis. "We are filing an application with the FDA to test our spinal cord stem cells in a second medical condition with substantial unmet needs," said Neuralstem CEO and President, Richard Garr. "The proposed trial is primarily designed to test the safety of both our cells and delivery method in chronic spinal cord injury patients."
Somaxon Pharmaceuticals Announces Silenor® Co-Promotion Agreement with Procter & Gamble
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that Somaxon and Procter & Gamble (NYSE: PG) have entered into a co-promotion agreement for Silenor® (doxepin), a newly-approved treatment for insomnia characterized by difficulty with sleep maintenance. Under the terms of the agreement, Somaxon and Procter & Gamble will co-promote Silenor with a combined 215 sales representatives in the U.S. market. Procter & Gamble’s professional health care sales force will promote Silenor to targeted primary care and other high-prescribing physicians. Somaxon’s focus will be on specialists and other top-decile physicians who treat insomnia. In addition, Procter & Gamble will promote Silenor to targeted pharmacies and will provide supplemental managed care support services for Silenor. Somaxon has also granted Procter & Gamble a right of first negotiation relating to rights to develop and market Silenor as an over-the-counter medication in the U.S.
Isotechnika Pharma and 3SBio Announce Strategic Partnership to Develop and Commercialize Voclosporin in China
Isotechnika Pharma Inc. ("Isotechnika") (TSX: ISA), a biopharmaceutical company focused on the discovery and development of immune modulating therapeutics, and 3SBio Inc. ("3SBio") (NASDAQ: SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced the signing of a development and commercialization agreement for voclosporin, a next generation calcineurin inhibitor being developed for use in the prevention of organ rejection following transplantation and the treatment of autoimmune diseases. The transaction will provide Isotechnika with proceeds of US$6 million. Isotechnika will receive an upfront non-refundable licensing payment of US$1.5 million with an additional US$4.5 million invested by 3SBio through a convertible debenture.
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.
Additional Phase III clinical trial with Urocidin(TM) expected to commence in 2010
- analysis of data from first Phase III clinical trial nearing completion - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, today provided an update on the clinical development program for its proprietary product for non-muscle-invasive bladder cancer - Urocidin(TM). Bioniche and its development partner, Endo Pharmaceuticals Inc. (NASDAQ: ENDP), are in the process of finalizing a protocol for an additional clinical trial - expected to begin enrolling patients in 2010. Details of this new protocol, when finalized, will be made publicly available via the U.S. National Institutes of Health clinical trial registration service at http://www.clinicaltrials.gov.
Cardica and Intuitive Surgical Enter Into License Agreement
Cardica, Inc. (Nasdaq: CRDC) today announced that Cardica and Intuitive Surgical, Inc. have entered into a license agreement providing Intuitive with a worldwide, exclusive license to Cardica's intellectual property, which relates to tissue cutting, stapling and clip appliers, for use in the robotics field. Pursuant to the license agreement, Cardica and Intuitive may also enter into future product development agreements. Intuitive has paid Cardica $12 million for a royalty-bearing license and equity investment in approximately 1.25 million shares of Cardica's common stock. The license excludes vascular anastomosis applications.
BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System
BSD Medical Corporation (NASDAQ: BSDM) (Company or BSD) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market its MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of BSD’s 510(k) Premarket Notification submission authorizes the commercial sale of the MTX-180 in the United States. The MTX-180 was designed to provide a higher power, optimized system targeted to the growing therapeutic interventional and surgical oncology market. The MTX-180 utilizes innovative synchronous phased array technology that was developed and patented by BSD to deliver targeted microwave energy to ablate (destroy) soft tissue. BSD employed its extensive 32-year background in developing thermal therapy systems in the design of the MTX-180.
Medtronic Signs Agreement to Acquire Osteotech
Medtronic Inc., (NYSE: MDT) and Osteotech, Inc., (Nasdaq: OSTE) today announced that the companies have signed a definitive agreement under which Medtronic will acquire Osteotech for $6.50 per share in cash for each share of Osteotech common stock. The total value of the transaction is expected to be approximately $123 million. Osteotech is a leader in the growing field of biologic products for regenerative healing, and has pioneered several innovative technology platforms including Grafton® demineralized bone matrix, a family of products which has a large and growing body of evidence supporting its best-in-class bone generating capabilities. Osteotech's differentiated portfolio of biologics also includes MagniFuse(TM) Bone Grafts and Plexur® Biocomposites, which are utilized in a broad range of musculoskeletal surgical procedures. In addition, Osteotech is in the midst of seeking U.S. Food & Drug Administration clearance for the first product based upon its first-in-class HCT(TM) (Human Collagen Technology) platform, an engineered human collagen biomaterial.
Prospect Medical Holdings, Inc. to Be Acquired by Leonard Green & Partners, L.P. and Management for $8.50 Per Share
Prospect Medical Holdings, Inc. (Nasdaq: PZZ) (“Prospect” or the “Company”) announced today that it has entered into a definitive merger agreement to be acquired for $8.50 per share in cash by an entity sponsored by Leonard Green & Partners, L.P. in which certain stockholders of Prospect will also participate. The total transaction value is approximately $363 million, including the assumption of approximately $158 million in Prospect’s net debt. The merger price represents a 38.9% premium over the closing sale price of Prospect shares on August 13, 2010, and a 29.4% premium to the volume weighted-average closing sale price of approximately $6.57 during the 30 trading days prior to that date. The merger is subject to approval by Prospect stockholders holding a majority of Prospect’s outstanding shares, the expiration or termination of the applicable antitrust waiting period, and other customary closing conditions. The merger is not subject to a financing condition.
Trubion Pharmaceuticals Announces Agreement to be Acquired by Emergent BioSolutions
Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN) today announced the signing of a definitive merger agreement with Emergent BioSolutions Inc. (NYSE:EBS ), in which Emergent has agreed to acquire Trubion. Under the terms of the agreement, each share of Trubion common stock will be converted into the right to receive an upfront payment of $1.365 per share in cash and 0.1641 shares of Emergent BioSolutions common stock. The upfront payment represents a value of $4.55 per share, or approximately $96.8 million, based on Trubion's total common shares outstanding, the net value of dilutive stock options, and the trading average of Emergent BioSolutions common stock for the five days prior to the signing of the definitive agreement. Trubion Pharmaceuticals stockholders will also receive one Contingent Value Right (CVR) per share, which will entitle the holder to receive cash payments based upon achievement of the following predefined milestones:
Dendreon Reports Second Quarter 2010 Financial Results
-- PROVENGE Launched and Expansion On Track -- Dendreon Corporation (Nasdaq:DNDN) today reported results for the quarter ended June 30, 2010. Revenue for the quarter ended June 30, 2010 was $2.8 million compared to $25,000 for the quarter ended June 30, 2009. Revenue for the six months ended June 30, 2010 was $2.8 million compared to $55,000 for the six months ended June 30, 2009. Over the first three months of launch, the company has seen revenue from sales of PROVENGE® (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC) grow from $340 thousand in May to $2.45 million in June and $5.2 million in July.
Study Published in the Journal Endocrinology Further Confirms Therapeutic Potential of PROLOR's Long-Acting Human Growth Hormone
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology. PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens.
EnteroMedics Achieves Major Milestones in Global Regulatory and Commercialization Strategy for the Maestro System
Company Receives Conditional Approval of Investigational Device Exemption; Announces Plans to Commercialize the Maestro RC System in Australia EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that the Company has received conditional approval for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). The IDE outlines plans for conducting a pivotal trial, the ReCharge Trial, evaluating the safety and efficacy of VBLOC® vagal blocking therapy delivered via the Company's second-generation Maestro® RC System in the treatment of obesity. The Maestro System is the first obesity treatment to use neuroblocking technology and represents a less invasive alternative to existing surgical weight loss procedures, which alter digestive system anatomy, lifestyle and food choices and may present significant risks. |
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