|Charles River acquires WuXi PharmaTech. After the bell, NexMed and Dynavax move higher|
|By BioMedReports.com Staff|
|Monday, 26 April 2010 19:43|
Below is a list of the companies that made news in the healthcare sector on Monday, April 26, 2010.
Charles River Laboratories International, Inc. (NYSE: CRL), a leading global provider of research models and associated services and of preclinical drug development services, and WuXi PharmaTech Inc. (NYSE: WX), a leading drug research and development outsourcing company with expertise in discovery chemistry and with operations in China and the United States, today announced that they have signed a definitive agreement under which Charles River and WuXi will combine in a cash and stock transaction valued at approximately $1.6 billion.
The combined company, which will retain the name Charles River, will offer an expanded portfolio of products and outsourced services to multinational pharmaceutical, biotechnology and medical device companies and academic and government institutions who increasingly seek the flexibility to access high quality, early-stage drug development expertise from chemistry to man from one global company.
Shares of WuXi jumped more than 17%, closing the day at $19.41, up $2.84. Charles River, which also announced lower 1st quarter today, slumped on the news, dropping more than 15%, closing at $33.55, off $6.62.
After the bell Monday:
NexMed, Inc. (NASDAQ: NEXM) surged after the bell today announced that the U.S. Food & Drug Administration has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.
The Company also noted that in IND review communication, the FDA has given NexMed the opportunity to move PrevOnco directly into a Phase 3 trial that would support marketing approval, subject to positive study results. In order to pursue this regulatory path, NexMed would need to expand the proposed Phase 2 study design to use PrevOnco in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR, the currently marketed first-line anticancer treatment for patients with either HCC or advanced renal cell carcinoma (cancer of the kidney).
PrevOnco incorporates lansoprazole, which is the generic anti-ulcer compound approved under the name Prevacid and marketed in the U.S. by Takeda Pharmaceuticals North America, Inc. In vitro and in vivo data generated to date has demonstrated the ability of lansoprazole to inhibit tumor cell growth and enhance survival in mouse models of cancer alone, and in combination with Doxorubicin.
Shares moved up 55% in the after hours market.
Dynavax Technologies Corporation (NASDAQ:DVAX) shot up after the bell today as the company presented preclinical data that confirms the expected immunogenicity and mechanistic effects of its Universal Flu vaccine. In addition to the demonstrated ability of Dynavax's vaccine to generate cytotoxic T-cells and cytotoxic antibodies, the data presented today at the Thirteenth Annual Conference on Vaccine Research in Baltimore, MD, show that the universal components of Dynavax's vaccine enhance the efficacy of a standard flu vaccine by increasing antibody production directed at virus neutralization. These data are key indicators of immunogenicity and the potential for dose-sparing in the event of a pandemic. Dynavax's Universal Flu vaccine is uniquely designed to combine a TLR9 agonist and two conserved antigens, NP and M2e, with a standard trivalent flu vaccine.
"The vaccine candidate presented at the Vaccine Research conference represents the final formulation that we intend to take into the clinic. We have now confirmed the key biological effects of this molecule, and are on-track to begin clinical development imminently," noted Dino Dina, M.D., President and CEO.
After the bell shares jumped nearly 7% on heavy volume.
In other news Monday:
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that Novartis has elected to fully exercise its current right to purchase 55,223 unregistered shares of Alnylam’s common stock in accordance with the terms of the Investor Rights Agreement between Alnylam and Novartis, dated September 6, 2005. The exercise of this right and election to purchase the maximum number of additional shares under the terms of the Agreement allows Novartis to maintain its current ownership level of Alnylam common stock of approximately 13.4%.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has entered into an Option Agreement with an undisclosed large multi-national pharmaceutical company to obtain a non-exclusive worldwide license for the use of BioSante’s 2A/Furin technology in the expression of antibodies. The technology is covered by four issued U.S. patents incorporating BioSante’s 2A/Furin technology into antibody expression in viral vectors in order to rapidly generate stable, high producing antibody cell lines. The subsequent cell lines may greatly reduce the time and lower the cost of antibody production compared to current commercial technologies. Financial terms of the Option Agreement were not disclosed. The option period will last up to six months, at which time the multi-national pharmaceutical company may exercise its option to enter into a non-exclusive license for the use of BioSante’s 2A/Furin technology."The market for antibody products was approximately $31 billion in 2008 and growing," said Stephen M. Simes, president and chief executive officer of BioSante.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) announced today that it has received notice from The NASDAQ Stock Market confirming that the Company has regained compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market.
Digirad Corporation (NASDAQ:DRAD), surged higher today after the company announced that it has received 510(k) clearance from the U.S. Food and Drug Administration, enabling the Company to market and distribute Ergo, its large field-of-view, general-purpose portable imaging system. Digirad CEO Todd P. Clyde stated, "The ergo system is an important milestone in our strategy to expand our business in the hospital sector by introducing a series of advanced solid-state cameras that are distinguished by their ability to deliver higher clinical value and return on investment than conventional photomultiplier-based camera technologies generally in use today. The ergo provides institutions with the means to dramatically reduce costs for many procedures, improve patient satisfaction, raise productivity and flexibility, and the capability to generate revenues from new procedures -- all critical considerations for hospitals today." Shares closed up 33 cents to $2.39.
Dr. Reddy’s Laboratories (NYSE:RDY) announced today that it launched amlodipine benazepril capsules (2.5mg/10mg, 5mg/10mg, 5mg/20mg, 10mg/20mg), a bioequivalent generic version of Lotrel Capsules, in the US market on April 23, 2010. In September 2009, Dr. Reddy’s had entered into a patent settlement with Novartis on amlodipine benazepril stipulating the dismissal of the lawsuits in the United States. The United States Food & Drug Administration (USFDA) granted an approval of Dr. Reddy’s ANDA for amlodipine benazepril on April 15, 2010.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced today that Bruce Cozadd, the company's Chairman and Chief Executive Officer, will present at Deutsche Bank's 35th Annual Health Care Conference on Monday, May 3, 2010.
Kinetic Concepts, Inc. (NYSE: KCI) today announced the introduction of V.A.C.Via Therapy System, a next-generation negative pressure wound therapy solution that offers clinicians and patients a mobile healing technology with the proven benefits and outcomes of V.A.C. Therapy. V.A.C.Via’s design and engineering brings to the marketplace a combination of the lightest, most mobile and most intuitive technology in this space, to date. The U.S. Food and Drug Administration cleared V.A.C.Via in March. The company is planning its global launch in the third quarter.
Life Technologies Corporation (NASDAQ:LIFE) today debuted the life science industry’s first benchtop sample preparation system designed to increase productivity while eliminating manual and contamination-related challenges traditionally associated with protein and epigenetic protocols. The Invitrogen MAGic™ Sample Processor enables researchers to cut protocol time in half, dramatically reduce experimental errors, and perform technically challenging experiments in protein purification and epigenetics.
Medtronic (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) 510(K) clearance and U.S. launch of the PoleStar® N30 Surgical MRI system, the latest in neuro oncology surgical solutions.
Providing real-time imaging in the operating room (OR), the PoleStar Surgical MRI provides surgeons with targeting and navigational accuracy despite the anatomy movement that may occur during a surgical procedure. With intra-operative imaging information, neurosurgeons gain more confidence to achieve maximum tumor resection, while avoiding critical areas of the brain. Use of the PoleStar system may also reduce the need for revision surgeries and the length of stay at the hospital for the patient.
Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market Methamphetamine Hydrochloride Tablets USP, 5 mg, based on an agreement with licensing partner Coastal Pharmaceuticals. This product, used for the treatment of attention deficit hyperactivity disorder or obesity, is the first generic version of Lundbeck's Desoxyn to be approved by the U.S. Food and Drug Administration (FDA).
Methamphetamine Hydrochloride Tablets had U.S. sales of approximately $9.3 million for the 12 months ending Dec. 31, 2009, according to IMS Health. Mylan's version is available for immediate shipment.
Neurocrine Biosciences, Inc. (Nasdaq:NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Deutsche Bank 35th Annual Health Care Conference in Boston which takes place Monday, May 3, 2010.
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that it has completed enrollment in the RADIANT study, a Phase III clinical trial testing Tarceva as an adjuvant therapy in patients with Stage IB-IIIA non-small cell lung cancer (NSCLC) who have undergone surgery and have EGFR-positive tumors. RADIANT is an international, randomized, double-blinded, placebo-controlled Phase III study that has reached its enrollment goal of 945 patients. The primary objective of the study is to determine whether the targeted therapy Tarceva prolongs disease-free survival when given as an adjuvant therapy. This is defined as a cancer treatment that is given after the primary treatment, which is typically surgery or surgery and chemotherapy in this group of NSCLC patients, to lower the risk of the cancer coming back.
SuperGen, Inc. (NASDAQ: SUPG) today reported financial results for the first quarter ended March 31, 2010.
"SuperGen made significant progress on all critical fronts during the first quarter of 2010, including strengthening our financial position, augmenting our team with new talent, and advancing our portfolio of discovery and development programs and our existing epigenetics partnership with GlaxoSmithKline (GSK). Eisai and Johnson & Johnson continue to expand the worldwide market for Dacogen for Injection, as demonstrated by an 11% growth in current quarter royalty revenue compared to the same prior year period," said James S.J. Manuso, Ph.D., President and Chief Executive Officer. "We were profitable in 2009 and for the 2010 first quarter, our financial position remains strong, and we have sufficient operating cash to fund our anticipated development initiatives during 2010 and beyond."
ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of innovative products for processing and storing adult stem cells, announced today that it has signed two new distribution agreements that will further extend its global reach into Asia and Central and South America for its offerings in the bone marrow stem cell regenerative medicine market. The Company has now completed four new distribution agreements in the past 90 days, significantly enhancing its ability to market and sell its products throughout the world.
Thoratec Corporation (Nasdaq:THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that it has signed a definitive agreement to sell its International Technidyne Corporation (ITC) division to Danaher Corporation (NYSE:DHR). The terms of the transaction call for an initial payment to Thoratec of $110 million in cash upon closing. In addition, the agreement includes an earn-out based on annual gross profit levels achieved by the division's Alternate Site business.
Urigen Pharmaceuticals, Inc. (OTCBB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that the secured debt held by Platinum-Montaur Life Sciences, LLC has been converted into a newly created Series C Preferred Stock of the Company. As a result of the conversion, the lien on the Company’s assets, including its intellectual property will be extinguished.
Amgen (Nasdaq: AMGN) today announced that the Board of Directors has appointed Robert A. Bradway president and chief operating officer (COO), effective May 11.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the Company's previously announced 1-for-25 reverse stock split is now effective, and the Company's common stock will begin trading on a split adjusted basis on the NYSE Amex when the market opens today.
Covidien (NYSE: COV), a leading global provider of healthcare products, today introduced EXALGO (hydromorphone HCI) Extended-Release Tablets, (CII), the only extended-release hydromorphone treatment available in the United States.
ChromaDex Corporation (OTC Bulletin Board: CDXC), a natural products chemistry company which provides novel and innovative ingredients to the dietary supplement, food, beverage and cosmetic markets, announced today the launch of pTeroPure™ pterostilbene(tero-STILL-bean).
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it will conduct the second of its series of four conference calls focused on the drugs in Isis' development pipeline.
Metropolitan Health Networks, Inc. (NYSE AMEX: MDF), a leading provider of healthcare services in Florida, today announced the appointment of six new independent directors to the company's board and the re-appointment of Michael Earley, as the company's Chairman and Chief Executive Officer.
NanoViricides, Inc. (OTC BB: NNVC.OB), announced today that the mark nanoviricides has now become a registered trademark under the US Patents and Trademarks Office (USPTO). The mark was entered into the principal register of trademarks at the USPTO on April 20, 2010.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Deutsche Bank 35th Annual Health Care Conference in Boston.
PositiveID Corporation (NASDAQ: PSID), in conjunction with its development partner RECEPTORS LLC, ("Receptors") announced today that the companies have achieved a milestone in the development of their in vivo glucose-sensing RFID microchip to detect glucose levels in the body.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report first quarter 2010 financial results following the close of the U.S. financial markets on Monday, May 10, 2010.
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