Ironwood Pharma reports positive Phase III results. Hansen Medical surges after the bell Print E-mail
By BioMedReports.com Staff   
Monday, 01 November 2010 18:53

Below is a look at some of the headlines for companies that made news in the healthcare sector on November 1, 2010.


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.

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced receipt of the final $2.0 million payment from Kaketsuken under the $8.0 million collaboration announced in November 2009. The agreement involves multiple proprietary XOMA antibody research and development technologies, including a new XOMA phage display library, and a suite of integrated information and data management systems. XOMA will be entitled to milestone payments and royalties on sales from products arising from this collaboration. The $8.0 million fee paid by Kaketsuken was recorded by XOMA as revenue in the 2009 fourth quarter. Separately the company announced that it has been awarded grants totaling $977,917 under the Patient Protection and Affordable Care Act of 2010.

Also Monday:

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.

Adherex Technologies Inc. (TSX:AHX) (PINK SHEETS:ADHXF), a biopharmaceutical company dedicated to providing innovative therapies that improve the life of cancer patients, announces the restatement of its interim unaudited condensed consolidated financial statements for the period ending June 30, 2010 and Interim MD&A to accurately reflect (1) the stock-based compensation for 67,692,821 stock options with service inception in June 2010 vesting immediately upon option grant; (2) the classification of the Company's 240,066,664 warrants as derivative financial instruments and recorded at their fair value as a long term liability on the Company's balance sheet; and (3) an accrual for professional services to be rendered to the Company.

Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) announced today that it will report results for its fiscal quarter ended September 30, 2010, on Tuesday, November 9, 2010 following the close of the U.S. financial markets.  

AVANIR Pharmaceuticals, Inc. (Nasdaq:AVNR) today announced a management conference call to discuss the approval of NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) by the U.S. Food and Drug Administration (FDA).

BioSpecifics Technologies Corp. (Nasdaq:BSTC), a biopharmaceutical company developing first in class collagenase-based products, announced today that it will host a conference call and live audio webcast at 8:30am ET on November 8, 2010 to report its third quarter 2010 financial results and corporate highlights.

Cytori Therapeutics (NASDAQ: CYTX) will host a webcast to discuss their third quarter financial results on Thursday, November 4, 2010 at 5:00 PM Eastern Time.

D. Medical Industries Ltd. (NASDAQ:DMED) (TASE:DMDC) a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, reported today on a proposed transaction by its publicly held subsidiary, NextGen Biomed Ltd..

Depomed, Inc. (NASDAQ: DEPO) today reported financial results for the third quarter ended September 30, 2010.

Electronic Control Security Inc. (OTCBB:EKCS) (ECSI), a leading provider of integrated entry control and perimeter security system technologies to the government and private sectors, announced its results of operations for the three months ended September 30, 2010.

GenVec, Inc. (Nasdaq:GNVC) announced today that it has concluded its review of internal and external strategic alternatives initiated by its board of directors on June 15, 2010 without receiving proposals to acquire the Company.

Imaging3™, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced that at 2:30pm PDT, (5:30pm EDT) today the company's CEO, Mr. Dean Janes, will be hosting a conference call.

International Merchant Advisors, Inc. (PINKSHEETS: IMAI) today announced the appointment of James Kragh to the position of Executive Vice President.Kragh, former CEO of Good Health Network, will play a first hand, key role in International Merchant Advisors' plans to expand its current health care operations by aggressively pursuing qualified health care acquisition targets.

Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company has appointed Dr. Tali Skoczylas as Chair of the company's medical advisory board.

MMRGlobal, Inc. (OTCBB:MMRF) (MMR) today announced that subscribers to its MyMedicalRecords Personal Health Record (PHR) or MyESafeDepositBox electronic vault can use the service to make unlimited domestic telephone calls to anyone including family members, friends and armed forces personnel by using the Lifeline telephone/fax number provided by the Company at no additional charge with each account.

Oncothyreon Inc. (Nasdaq:ONTY) will conduct a conference call to discuss its third quarter 2010 financial results and provide a review of its pipeline of products in development on Monday, November 8, 2010 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) today announced that an abstract covering preclinical research with reovirus (REOLYSIN®) is available on the European CanCer Organisation (ECCO) website.

Sanofi-aventis (EURONEXT: SAN; NYSE:SNY) and BMP Sunstone Corporation (Nasdaq:BJGP) announced today that they have signed a definitive agreement under which Sanofi-aventis is to acquire all outstanding shares of BMP Sunstone for USD10 per share, for a total purchase price of USD520.6 million on a fully diluted basis.

Sinovac Biotech Ltd. (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, announced today that it will release its unaudited financial results for the third quarter ended September 30, 2010 before the open of the market on Monday, November 15, 2010.

Summer Infant, Inc. (NASDAQ: SUMR) today announced financial results for the third quarter ended September 30, 2010.




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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