|Poniard to resume regulatory efforts for cancer drug. Encorium soars on contract awards.|
|By BioMedReports.com Staff|
|Monday, 10 May 2010 17:44|
Below is a list of the companies that made news in the healthcare sector on Monday, May 10, 2010.
News from after the bell Monday:
AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems, today announced that it has received conditional approval from the FDA to evaluate the safety and efficacy of a dual epicardial/ endocardial procedure (DEEP), or hybrid procedure, to treat patients with persistent and long-standing persistent atrial fibrillation (AF). The trial will be conducted at five prominent U.S. medical centers and provides for the enrollment of thirty patients. Initial enrollment is expected to begin during the second half of 2010.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its financial results as of and for the three months ended March 31, 2010. For the three months ended March 31, 2010, the Company reported a net loss of $8.5 million, or $0.39 per diluted share, compared to a net loss of $8.0 million, or $0.43 per diluted share, for the same period in 2009. The Company ended the quarter with $67.1 million of cash and cash equivalents and investments.
Intuit Inc. (Nasdaq:INTU) after the bell Monday announced that it will acquire privately held Medfusion, a Cary, N.C. based leader in patient-to-provider communications. Medfusion offers enhanced online solutions that enable healthcare providers to offer superior service to their patients while improving office efficiency and generating revenue. The cash transaction is valued at approximately $91 million.The acquisition will accelerate Intuit’s healthcare strategy by combining the company’s proven track record in creating innovative, easy-to-use consumer and small business solutions with Medfusion’s industry-leading patient-to-provider communication solutions.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced after the bell today that it is offering to sell 7 million shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), today announced its results for the first quarter ended March 31, 2010.At March 31, 2010, the Company had cash, cash equivalents, interest receivable, and investment securities of $32.1 million, as compared to $35.9 million at December 31, 2009. Ron Bentsur, the Company's Chief Executive Officer, said, "With two compounds currently in three Phase 3 programs, all under SPA's, and sufficient capital to reach our clinical milestones, we believe that we are well positioned to continue to execute on our business plan and unlock the value inherent in our programs."
Micro Identification Technologies, Inc. (OTC.BB:MMTC) announced today that it has obtained an equity financing commitment of up to $5,000,000 from a private equity firm, Dutchess Capital, through its Dutchess Opportunity Fund, LP. During the 36-month term of this equity commitment, Micro Identification Technologies may sell shares of its common stock to Dutchess Capital up to the total committed amount.
NexMed, Inc. (NASDAQ:NEXM) announced data from a pre-clinical study examining the subcutaneous delivery of rituximab, the first FDA-approved therapeutic antibody for the treatment of cancer in the United States. The study results showed that animals receiving subcutaneous injections of rituximab, incorporated with NexACT, demonstrated a 46% enhancement in bioavailability over rituximab, alone.
Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) Sucampo Pharmaceuticals, Inc. today announced the presentation of results from a phase 3 clinical trial investigating the use of lubiprostone in non-cancer pain patients with Opioid-induced Bowel Dysfunction (OBD). These results were the subject of an oral presentation at the Digestive Disease Week (DDW) 2010 conference in New Orleans, Louisiana, on May 5, 2010.
Byron Cryer, M.D., the John C. Vanatta III Professor of Medicine at the University of Texas, Southwestern, in Dallas, Texas, who was an investigator in the trial and presented the data at DDW, said, "Opioid-induced Bowel Dysfunction in patients with chronic non-cancer pain is a serious problem. In the Phase 3 results of this study presented here, some patients received relief from constipation without a reduction in their pain medication."
In news from earlier in the day:
Encorium Group, Inc. (Nasdaq:ENCO), soared today after the full service multinational clinical research organization (CRO) conducting studies in over 30 countries for many of the world's leading pharmaceutical and biotechnology companies, today announced that it has recently been awarded $6.8 million of new business awards, primarily consisting of two Phase III studies for a major Asian technology company that is diversifying its operations into the pharmaceutical industry.
Kai Lindevall, Chief Executive Officer, of the Company stated, "This is the most significant break-through to date in our business development efforts in the Asian market. We are very pleased to have been awarded these landmark studies for this major high-tech company. To be selected as a preferred provider is the best benchmark we could imagine with which to measure our success in Asia. In addition, we have recently seen a significant increase in the number of requests for proposals and are seeing signs that the market appears to be regaining some of its pre-recession vibrancy, particularly in the case of small to medium sized biopharmaceutical companies, which are a key market for the Company."
Encorium surged $1.38 or 57% to $3.78.
Poniard Pharmaceuticals, Inc. (Nasdaq:PARD) jumped 22% today after the company reported that it will resume its efforts in seeking regulatory for experimental cancer drug candidate, picoplatin. Ronald A. Martell, chief executive officer of Poniard said: "The data generated to date underscore picoplatin's potential efficacy and safety in a variety of solid tumors, and we are currently developing registration strategies for picoplatin in lung, colorectal, prostate and ovarian cancers. Concurrent with this effort, we are continuing to explore strategic alternatives to support and optimize the value of the picoplatin program for our shareholders."
In a separate release today the company announced that data from the Phase 3 SPEAR trial evaluating the efficacy and safety of picoplatin as a second-line treatment in small cell lung cancer (SCLC) has been accepted for an oral presentation during the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting.
"We believe the SPEAR trial, one of the largest second-line SCLC trials conducted in the world, provides valuable clinical insights that can be used to further the study of treatments for small cell lung cancer," said Ronald A. Martell, chief executive officer of Poniard Pharmaceuticals. "The SPEAR data adds to the growing body of clinical evidence that we believe supports the value proposition of picoplatin as an attractive, late-stage, highly versatile anticancer compound that has demonstrated efficacy and safety in a variety of solid tumor types."
Shares of Poniard jumped 23 cents to close the day at $1.27.
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced the approval of a New Drug Submission (NDS) by Health Canada, the regulatory authority in Canada, for ONSOLIS (fentanyl buccal soluble film) in the management of breakthrough pain in opioid-tolerant adult patients with cancer. ONSOLIS is the first product approved in Canada for this indication.
ONSOLIS will be marketed in Canada by Meda Valeant Pharma Canada Inc., a joint venture between BDSI’s commercial partner, Meda AB, and Valeant Canada Limited, a wholly owned subsidiary of Valeant Pharmaceuticals International (NYSE:VRX). ONSOLIS will be launched in the third quarter of this year.
"The regulatory approval of ONSOLIS in Canada represents the culmination of a great collaborative effort between BDSI, Meda, and Valeant," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "ONSOLIS provides an important new option to manage the potentially debilitating effects of breakthrough pain in opioid-tolerant individuals with cancer. As the first oral transmucosal fentanyl product in Canada, our commercial partners have the opportunity to establish and build an important new market for ONSOLIS."
Bio-Rad Laboratories, Inc. (NYSE:BIO) and (NYSE:BIO.B) and the American Red Cross, today announced that the U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, has notified Bio-Rad that it may proceed with its Investigational New Drug (IND) study for the Bio-Rad Dengue NS1 Ag microplate assay. The Red Cross will use the immunoassay to screen approximately 80,000 blood donations from Puerto Rico, where dengue currently is endemic.
Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that dosing of healthy volunteers was completed in the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).
CBLB502 is being developed by Cleveland BioLabs under the U.S. Food and Drug Administration's Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident.
Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI) announced that the Company has just executed an option with Stand-By Systems, owner of the FDA approved SBS 1615 catalytic oxygen generator and other FDA approved breakthrough emergency portable oxygen systems and devices. The SBS 1615 catalytic oxygen generator provides medical grade USP oxygen at the push of a button from self-contained inert dry compounds. Stand-By Systems intends to make this portable personal life-saving device (smaller than the size of a soft drink can) become as common in everyday life as first-aid kits, household fire extinguishers and smoke detectors. The option agreement allows EHSI management to perform due diligence prior to finalizing a definitive agreement. "This gives Emerging Healthcare Solutions a great opportunity to be a part of something tremendous," stated Cindy Morrissey, President of EHSI. "The potential market for these new FDA approved products is immense."
Generex Biotechnology Corporation (Nasdaq:GNBT) today announced that it has achieved enrolled of over 400 subjects in its pivotal global Phase III study of its flagship product, Generex Oral-lyn(TM), a proprietary buccal insulin spray product designed to replace prandial injections of insulin.
Harbor Biosciences (Nasdaq:HRBR) today released an update to its development program for Triolex to treat obesity-induced insulin resistance and type-2 diabetes mellitus (T2DM). Jerrold M. Olefsky, M.D., Dean for Scientific Affairs and Professor of Medicine at the University of California San Diego School Of Medicine, commented: "Chronic tissue inflammation is emerging as a substantial cause of insulin resistance in obese patients with type 2 diabetes, so it is important to fully explore the potential of anti-inflammatory therapeutic approaches to this disease. Triolex produced excellent anti-inflammatory, insulin sensitizing effects in preclinical studies. The early clinical results in the more obese patients with elevated signs of inflammation show some promise and should be further explored."
Health Discovery Corporation (OTCBB: HDVY) announced today the appointment of Maher Albitar, M.D., a world renowned cancer scientist and inventor, to the position of Chief Medical Officer. Until recently, Dr. Albitar was the Medical Director of Hematology and Oncology and Chief of Research and Development at Quest Diagnostics Nichols Institute (NYSE: DGX).
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX) today updated its drug development progress and reported financial results for the three months ended March 31, 2010. "Achieving the remarkable results from our Phase 2a trial of LX4211 in patients with type 2 diabetes was the defining event of the first quarter," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. "This is the second of our four mid-stage drug development programs to deliver positive proof-of-concept Phase 2a results. In addition, the completion of our recent stock offering has placed us in a strong financial position to execute on our clinical development and business strategies."
Medtronic, Inc. (NYSE: MDT) announced today that it now offers the new Medtronic M-Link cellular accessory, which provides cardiac device patients with an option to securely send information stored in their implanted devices to their clinics via the CareLink Network using cellular signals, rather than a telephone landline. This simplified connection to the CareLink Network enables clinicians to remotely monitor more patients who are implanted with cardiac devices.
Oncothyreon Inc. (NASDAQ:ONTY) today announced that it received written confirmation on May 7, 2010 from the Nasdaq Listing Qualifications Staff that the company has demonstrated compliance with Nasdaq Marketplace Rule 5250(c)(1) for continued listing of the company's securities on The Nasdaq Stock Market. The compliance notification from Nasdaq follows the filing of the company's Annual Report on Form 10-K for the fiscal year ended December 30, 2009 with the Securities and Exchange Commission on May 6, 2010.
PositiveID Corporation (NASDAQ: PSID) announced that it has reported financial results for the quarter ended March 31, 2010, its first full quarter of operations since its acquisition of Steel Vault Corporation in November 2009 and the resulting name change to PositiveID. The Company reported revenues of $673,000 for the first quarter of 2010, compared to revenues of $8,000 for the first quarter of 2009.
As of May 10, 2010 the Company has cash of $5.9 million, inclusive of the first tranche (gross proceeds of $2.3 million) of the recently announced $4.2 million non-convertible preferred stock purchase agreement with Socius Technology Capital Group. PositiveID has no debt. Scott R. Silverman, Chairman and CEO of PositiveID, said, "As we continue to move ahead with the development of our HealthID product portfolio, we believe our strategic direction is well defined and the time has come to initiate quarterly results press releases. We have a strong balance sheet and expect to continue to build our HealthID business, focusing on rapid and unique medical testing devices for both humans and animals."
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today the appointment of Dr. Afsaneh Motamed-Khorasani as Director of Oncology. Dr. Motamed-Khorasani will be responsible for medical affairs for RPC's Onko-Sure in vitro diagnostic (IVD) cancer test, including product research and development, collaboration with Mayo Clinic to advance development of RPC's next-generation Onko-Sure IVD cancer test, on-going clinical trial work, authorship and publication of scientific white papers, articles, abstracts and peer-reviewed papers related to Onko-Sure and future developed products and representation for RPC at various oncology, medical and financial conferences, tradeshows and events.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, announced today the receipt of a new notice of allowance from the United States Patent and Trademark Office for U.S. patent application 11/418,870, including claims related to Sanger hsa-miR-451. miR-451 is used in the Company’s miRview mets test, which accurately identifies the primary tumor site in patients with metastatic cancer and Cancer of Unknown Primary (CUP).
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the U.S. launch of its Wireless USB Adaptor for the [email protected] transmitter, a system that allows important patient data from an implantable cardiac device to be wirelessly downloaded and securely transmitted via telephone for review by a physician. The new Wireless USB Adaptor enables patients using a [email protected] transmitter to transmit data to their physician over cellular networks, allowing for more convenient care than existing landline services provide.
Advanced Cell Technology, Inc. (OTCBB: ACTC) announced today that the company’s Chief Scientific Officer, Robert Lanza, MD, has been recognized by BioWorld, a widely-read publication covering the biotechnology industry, as one of 28 leaders predicted to be the "movers and shakers" of the biotechnology industry over the next twenty years. The story is included in the publication’s 20th anniversary issue.
Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing, and repair, based on hyaluronic acid technology, today reported financial results for the quarter ended March 31, 2010.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the Bank of America Merrill Lynch Health Care Conference on Wednesday, May 12, 2010, in New York City. Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb will make a formal presentation about the company at 10:40 a.m. EDT.
Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at the Bank of America Merrill Lynch 2010 Health Care Conference in New York on Wednesday, May 12th, at 9:20 a.m. ET and the Baird 2010 Growth Stock Conference in Chicago on Wednesday, May 19th, at 11:15 a.m. CT (12:15 p.m. ET).
China Pharmaceuticals, Inc. (OTC Bulletin Board: CFMI) one of China’s leading manufacturers and distributors of prescription and over-the-counter pharmaceuticals, is pleased to announce the launch of its new website: www.chinapharmaceuticalsinc.com.
Dyadic International, Inc. (Pink Sheets: DYAI) a leading-edge early-stage biotechnology company, announced today that its President and Chief Executive Officer, Mark Emalfarb, is scheduled to present at the Rodman & Renshaw 6th Annual Global Healthcare Conference in London, England on Monday, May 17, 2010 at 11:05 a.m. local time (6:05 a.m. EDT).
Dyax Corp. (NASDAQ:DYAX), a developer of novel biotherapeutics for unmet medical needs, announced today that Gustav A. Christensen, President and Chief Executive Officer of Dyax, will present at the Rodman & Renshaw 6th Annual Global Investment Conference, being held May 16-18th at the Grosvenor House Hotel in London, UK.
Forest Laboratories, Inc. (NYSE: FRX) and Nycomed today announced that they will present data from six roflumilast posters during the American Thoracic Society (ATS) International Conference being held in New Orleans, LA, May 14 through May 19, 2010.
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer of novel acute care pain products, today reported its unaudited financial results for the first quarter ended March 31, 2010.
Millipore Corporation (NYSE:MIL), a leading provider of technologies, tools and services for the global life science industry, today released its second annual Sustainability Report, which discloses the company's environmental and social responsibility accomplishments and reaffirms its commitment to delivering on its ambitious sustainability goals.
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today the successful outcome of a Phase 1 trial for MoxDuo CR, a controlled-release (CR) Dual-Opioid(TM) designed to provide 12 hours of pain relief in patients suffering from moderate to severe chronic pain (including cancer, lower back, osteoarthritis and neuropathic).
Repros Therapeutics (NasdaqCM: RPRX) today announced financial results for the first quarter ended March 31, 2010.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in hematology and oncology, today reported financial results for the first quarter ended March 31, 2010.
Unigene Laboratories, Inc. (OTCBB: UGNE) has reported its financial results for the quarter ended March 31, 2010.
Walgreens (NYSE: WAG)(NASDAQ: WAG) executive vice president and chief financial officer Wade Miquelon will present during the Bank of America Merrill Lynch 2010 Health Care Conference in New York City tomorrow, Tuesday, May 11, 2010, at approximately 11:20 a.m. Eastern time.
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