|Response Genetics gains on license deal with GSK. MAP jumps on Phase III update. After the bell Achillion Pharma surges on positive data|
|By BioMedReports.com Staff|
|Tuesday, 11 May 2010 19:03|
Below is a list of the companies that made news in the healthcare sector on Tuesday, May 11, 2010.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) soared after the bell today as the company reported additional preliminary data from its Phase 1b clinical trial of ACH-1625, which demonstrated that both the third and fourth patient cohorts receiving treatment with ACH-1625 achieved meaningful reductions in HCV RNA after five-day monotherapy, with continued safety and tolerability in patients with hepatitis C (HCV). ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
"We continue to be pleased with the robust results from these additional cohorts of our ACH-1625 Phase 1b trial with HCV-infected patients," said Michael D. Kishbauch, Achillion's President and Chief Executive Officer. "It is impressive that at all dose levels ACH-1625 has shown meaningful viral load reduction and sustained viral suppression post treatment course. Importantly, we believe the results from these last two cohorts demonstrated that ACH-1625 was effective at a lower dosing level and in a once-daily dose, features that distinguish our drug and suggest it could offer improvements over other protease inhibitors currently in development."
Mr. Kishbauch continued, "In summary, these data round out the phase 1b program for ACH-1625 very favorably. If these results are sustained through further development, we believe the combination of potency, safety/tolerability, dosing flexibility and durability of effect will position ACH-1625 as a potential best-in-class protease inhibitor, while strategically enhancing Achillion for a variety of options. We remain very encouraged by these compelling results and look forward to advancing the drug into Phase 2 studies in the coming months."
Shares were up nearly 20% in the after hours session, gaining 45 cents to $2.81.
NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, after the market closed reported results for its first quarter ended March 31, 2010.
During the first quarter of 2010, NeurogesX finalized commercialization plans and completed training of the U.S. launch teams for Qutenza (capsaicin) 8% patch. These include field-based sales representatives, reimbursement specialists and a team of contract clinical educators to assist physicians with education, training, and access to treatment and reimbursement. In addition, a dedicated reimbursement hotline is available to further assist patients and physician offices to facilitate access to coverage.
Pharmasset, Inc. (Nasdaq:VRUS) announced that it has commenced an underwritten public offering, subject to market and other conditions, of 3,200,000 shares of its common stock pursuant to an effective shelf registration statement.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), today after the bell announced financial results for the first quarter ended March 31, 2010. "During the first quarter of 2010, we accomplished two of our key corporate objectives, namely gaining approval of the NDA for Silenor and adding substantial cash to our balance sheet," said Richard W. Pascoe, Somaxon’s president and chief executive officer. "We are now focused on leveraging those assets as we continue our efforts to maximize value for our stockholders, including seeking a U.S. commercial partnership, building a U.S. commercial presence and preparing to launch Silenor, a highly differentiated insomnia treatment, in the second half of the year."
In news from earlier in the day:
Response Genetics, Inc. (Nasdaq:RGDX) soared today after the company, focused on the development and sale of molecular diagnostic tests for cancer, announced it has signed a non-exclusive license agreement with GlaxoSmithKline. Under the terms of the agreement, GSK gains certain rights to Response Genetics’ proprietary PCR analysis technology and diagnostic expertise to assess BRAF gene mutations in human tumor samples. Payments will be made to Response Genetics upon achivement of agreed-to milestones. Further financial details were not disclosed.
The BRAF gene encodes B-Raf proto-oncogene serine/threonine-protein kinase (B-raf), a protein involved in cell signaling and cellular growth and differentiation. Specific genetic mutations have been correlated with the development of certain forms of cancer.
"As a provider of genetic testing services to GSK, we are pleased to continue to support GSK’s clinical trial program," said Kathleen Danenberg, president and CEO of Response Genetics. "Through access to our proprietary technology, Response Genetics provides pharmaceutical companies with unique information and insights. By identifying specific genetic mutations, such as in the BRAF gene, we hope to enable the development of diagnosis tools for disease prognosis that may aid in treatment decisions."
Shares initially jumped as high as $3.25 but pulled back, closing the day at $2.50, up more than 16% on the day.
MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) moved higher today after the company provided an update on its development program for LEVADEX orally inhaled migraine therapy. LEVADEX has completed Phase 3 efficacy development for the acute treatment of migraine.
"We continue to make good progress with our LEVADEX program," said Timothy S. Nelson, President and CEO of MAP Pharmaceuticals. "Recent clinical and CMC discussions with the FDA have provided us with clarity regarding the content to be included in our NDA submission. We plan to submit an NDA for LEVADEX for the acute treatment of migraine in the first half of 2011, bringing us one step closer to our goal of providing the underserved migraine patient population with a new and differentiated treatment option."
Shares of MAP surged more than 10% or $1.59 to close at $17.08.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has closed the previously announced public offering of 10,000,000 shares of its common stock; including 1,500,000 shares sold pursuant to the full exercise of an over-allotment option previously granted to the underwriters. All of the shares were offered by AVANIR Pharmaceuticals, Inc. The net proceeds to AVANIR from the sale of shares in this offering, after deducting underwriting discounts and commissions, were approximately $26.6 million.
Boston Scientific Corporation (NYSE:BSX) today announced U.S. Food and Drug Administration approval for LATITUDE 6.0, a software upgrade to the Company's LATITUDE Patient Management system. The LATITUDE system enables physicians to remotely monitor patients with implantable cardiac devices. The upgrade provides enhanced functionality, including the ability to view an expanded history of a patient's remote follow-up data.
Cardima, Inc. (OTCBB: CADMD), a medical device company focused on the treatment of atrial fibrillation and manufacturer of the Cardima Surgical Ablation System, announced today that its common stock will commence trading under the new ticker symbol, "CADMD" following the implementation of a reverse stock split in a 1-for-10 ratio. The reverse stock split was approved by the Company’s shareholders at a special meeting held on March 17, 2010 and by its Board of Directors. The Company’s ticker symbol will revert to CADM in approximately 20 business days.
Compugen Ltd. (NASDAQ:CGEN) announced today the discovery and initial experimental validation of CGEN-928 as a drug target for the treatment of multiple myeloma. In recently completed studies, CGEN-928, a membrane protein which previously had no known function or potential clinical utility, demonstrated broad expression in human multiple myeloma tumor cells, including drug resistant and aggressive primary tumor cell lines. In addition, the protein’s expression profile indicates its possible use as both a diagnostic and prognostic marker for multiple myeloma. The potential of CGEN-928 to address these important unmet medical needs was initially predicted through the use of Compugen’s Monoclonal Antibody Targets Discovery Platform.
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) and Phebra Pty Ltd. today announced that Acetadote Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.
DENTSPLY International Inc. (Nasdaq:XRAY) today announced that its Board of Directors declared a quarterly cash dividend of $0.05 per share of common stock, an indicated annual rate of $0.20 per share. The dividend is payable on July 8, 2010 to holders of record on June 25, 2010.
DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the first quarter ended March 31, 2010.
EntreMed, Inc. (Nasdaq:ENMD), today announced the addition of Dana Farber/Harvard Cancer Center (DF/HCC) to the Phase 2 multi-center study entitled "A Phase 2 Study of Oral ENMD-2076 Administered to Patients with Platinum Resistant Ovarian Cancer."
Gilead Sciences, Inc. (Nasdaq:GILD) moved higher today after the company announced that it's Board of Directors has authorized the repurchase of up to $5 billion of the company’s common stock through May 2013.
"Gilead’s Board of Directors and senior management team believe that the stock repurchase program announced today represents an appropriate and strategic use of the company’s cash, while allowing sufficient flexibility for other expenditures going forward, including investments in research and development and licensing or partnership opportunities," commented John C. Martin, PhD, Chairman and Chief Executive Officer.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update today on the Company's Phase 3 program for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The most recent Safety Monitoring Committee meeting of April 30, 2010 for the Phase 3 U.S. pivotal trials of NX-1207 indicated no significant safety concerns for the trials to date. Patient recruitment and trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are proceeding at over 60 well-known urology investigative sites throughout the US.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin, a personalized T-cell therapy for multiple sclerosis (MS), announced today that two of its key patents have been issued by the U.S. Patent and Trademark Office, with a third patent expected to issue later this month based on a received Notice of Allowance.
Viking Systems, Inc. (OTCBB:VKNG) today announced that a prototype version of its Next Generation 3DHD Vision System will be demonstrated with Sony's prototype 3DHD Medical Display in Sony's booth at Hospital Build Asia 2010 which will run May 11 -13 in Singapore.
Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing, and repair, based on hyaluronic acid ("HA") technology, today reported financial results for the quarter ended March 31, 2010.
Chem Rx Corporation (Pink Sheets: CHRX), the third largest long term care pharmacy in the United States, along with certain operating subsidiaries today announced that it has filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code.
Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced that they are presenting data from several studies of two investigational inhaled respiratory compounds at the annual American Thoracic Society International Conference taking place in New Orleans May 14-19, 2010.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its business activities for the first quarter of 2010.
Luna Innovations Incorporated (NASDAQ: LUNA), a company focusing on sensing, instrumentation and nanotechnology, today announced its financial results for the first quarter ended March 31, 2010.
NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today 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.
Pall Corporation (NYSE: PLL), a global leader in filtration, separation and purification, announced today a strategic alliance with Applied Science, Inc. where Pall will act as the exclusive North American distributor of the HemoFlow™ 400 Blood Donation Monitor and Mixer; adding to Pall’s industry-leading family of blood collection and filtration products.
Pro-Pharmaceuticals, Inc. (OTCBB: PRWP) today announced that it has closed the $570,000 final tranche to complete a $6 million private placement with 10X Fund, L.P., which is purchasing unregistered Series B convertible preferred stock and warrants.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that the Company's President and Chief Executive Officer, Noah D. Beerman, will present a corporate overview at the 6th Annual Rodman & Renshaw Global Healthcare Conference, on Tuesday, May 18, 2010 at 9:00 am BST (4:00am EDT) at the Grosvenor House Hotel, London, UK.
SuperGen, Inc. (Nasdaq: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that James S.J. Manuto, Ph.D., President and Chief Executive Officer, will present at the Rodman & Renshaw 6th Annual Global Healthcare Conference on Tuesday, May 18th in London.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) will host a live audio webcast at the Bank of America Merrill Lynch Health Care Conference with Shlomo Yanai, President & Chief Executive Officer, Teva Pharmaceutical Industries Ltd., presenting on Thursday, May 13, 2010 in New York.
Merck & Co., Inc. (NYSE: MRK) today hosted its first R&D and Business Briefing since completion of the Merck and Schering-Plough merger and outlined the company's strategy to drive global business growth.
Response Genetics, Inc. (Nasdaq: RGDX) will announce financial results for the first quarter of 2010 on May 13, 2010, after close of market.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.