|Ironwood Pharma reports positive Phase III results. Hansen Medical surges after the bell|
|By BioMedReports.com Staff|
|Monday, 01 November 2010 18:53|
After the market close Monday, Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) and Almirall, S.A. (ALM:MC) today announced positive top-line results from a 26-week pivotal Phase 3 clinical trial assessing the efficacy and safety of once-daily dosing of linaclotide 266 mcg in patients with irritable bowel syndrome with constipation (IBS-C).
"These very positive results represent a significant milestone in the Phase 3 clinical trial program for linaclotide which has been developed specifically to provide long term relief from the symptoms of irritable bowel syndrome with constipation, an area in which a very high unmet need exists," said Per Olof Andersson, Chief Scientific Officer, Almirall.
"We continue to see that linaclotide significantly improves abdominal pain and constipation symptoms. The results of these Phase 3 data show that patients with IBS-C experienced sustained improvement of their symptoms over 26 weeks," said Mark Currie, Ph.D, Chief Scientific Officer, Ironwood. "We are looking forward to the opportunity to bring this treatment to the millions of patients suffering from IBS-C globally."
This trial, MCP-103-302, conducted in North America jointly by Ironwood and its U.S. partner Forest Laboratories, Inc., was designed to support regulatory submission for linaclotide in both Europe and the U.S. In a separate press release issued today, Ironwood and Forest announced positive top-line results from this trial for the U.S. endpoints.
In extended trading shares of Ironwood were up $1.33 or 12.58% to $11.90.
Shares of Hansen Medical, Inc. (NASDAQ:HNSN),a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, surged today after the bell after the company announced that it has received unconditional Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) authorizing a clinical trial to investigate the use of the Sensei® X Robotic Catheter System and the Artisan Control Catheter for treatment of Atrial Fibrillation (AF), the most common cardiac arrhythmia. The trial was conditionally approved earlier this year as announced in a Hansen Medical press release on May 12, 2010.
"This comparative study is an important milestone toward our goal of expanding the universe of patients that benefit from robot assisted AF procedures," said Hansen Medical President and CEO Bruce Barclay. "We are encouraged and gratified by the prestigious medical centers and physicians that are or have expressed interest in participating in the trial, and we believe that the study results will provide an important comparative assessment of the use of robotic technology for this application."
On heavy volume, shares of Hansen were up 22 cents or 13% to $1.89 in the after hours market.
Depomed, Inc. (NASDAQ:DEPO) today announced after the bell that it has received a $2.5 million milestone payment from Merck under its agreement to license certain patents directed to metformin extended release technology for the development of fixed dose combinations of sitagliptin and extended release metformin.
ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP.ob), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has been awarded $1.5 million in government grants.
Biomoda, Inc. (OTC BB:BMOD.ob) announced receipt of $244,479 in federal grant funding for its CyPath® diagnostic assay for the detection of early-stage lung cancer.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced positive results from a series of CPP-115 preclinical safety and efficacy evaluations. CPP-115 was found to have a significantly improved retinal safety profile compared to vigabatrin. Additionally, the compound was found to be orally absorbed, not metabolized, and generally safe as determined in a battery of critical initial safety evaluations. Finally, CPP-115 induced significant responses in accepted animal models supporting potential efficacy as a treatment of both epilepsy and stimulant addiction.
CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has received a $733,437 grant under The Patient Protection and Affordable Care Act of 2010 (PPACA). The grant was related to three of the Company’s projects, including the Phase III trial of Multikine.
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has received a $733,438 grant under The Patient Protection and Affordable Care Act of 2010 (PPACA).
Marina Biotech, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, announced today that it was awarded cash grants totaling approximately $733,000 under the U.S. Government's Qualifying Therapeutic Discovery Project ("QTDP") program.
NeoStem, Inc. (NYSE Amex: NBS) an international biopharmaceutical company with operations in the U.S. and China, today announced that Dr. Ian Zhang, President and Managing Director of NeoStem (China), Inc., the Company's wholly-owned subsidiary, will present "Building a Stem Cell Business in China" at the Cell Therapy Industry Summit 2010 hosted by Life Technologies Corporation (Nasdaq:LIFE) at the Sheraton Carlsbad Resort & Spa on November 3-5, 2010.
RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) announced today that it has been awarded $733,438 under HR: 3590 – Patient Protection and Affordable Care Act in immediately available funds. Under the Act, $1 billion was made available to stimulate promising therapeutic research for serious and life-threatening diseases by small biotechnology companies. Applicants were required to submit detailed information demonstrating that their research conformed to the parameters of the Act, along with a summary of qualifying expenditures that formed the basis for the award. RegeneRx submitted three applications, one for each of its drug candidates under active development. All three applications received an award.
Tongjitang Chinese Medicines Company (NYSE:TCM) a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it has entered into a definitive agreement and plan of merger with Hanmax Investment Limited, Fosun Industrial Co., Limited and Tonsun International Company Limited. Mr. Xiaochun Wang, Chairman of the Company's board of directors, Chief Executive Officer of the Company and the beneficial owner of approximately 51% of the Company's outstanding ordinary shares, controls Hanmax. Fosun beneficially owns approximately 32% of the Company's outstanding ordinary shares.
Under the terms of the merger agreement, each ordinary share of the Company (including shares represented by American Depositary Shares, each of which represents four ordinary shares) issued and outstanding immediately prior to the effective time of the merger, other than the ordinary shares and ordinary shares represented by American Depositary Shares owned by Hanmax, Tonsun and Fosun, will be cancelled in exchange for the right to receive $1.125 (or $4.50 per American Depositary Share).
Shares of TCM rose 41cents or 10.38% to $4.36.
AdCare Health Systems, Inc. (NYSE Amex:ADK), a recognized innovator in senior living and health care facility management, issued and sold an additional $750,000 in unsecured subordinated convertible notes to certain accredited investors.