|ARIAD restructures Merck partnership. SenoRx acquired by C.R. Bard. After the bell, Endo Pharma buys HealthTronics. Lexicon soars on Phase II results|
|By BioMedReports Staff|
|Wednesday, 05 May 2010 21:00|
Below is a list of the companies that made news in the healthcare sector on Wednesday, May 05, 2010.
Endo Pharmaceuticals (Nasdaq:ENDP) after the market closed Wednesday, announced that it has signed an agreement to acquire HealthTronics, Inc. (Nasdaq:HTRN), a leading U.S. provider of urological products and services. The acquisition expands Endo's product offerings to urologists with the addition of lithotripsy, benign prostate hyperplasia (BPH) and prostate cancer therapies, as well as anatomical pathology services for the detection and diagnosis of cancer and other conditions. Under the terms of the merger agreement, Endo will commence an all cash tender offer to acquire 100 percent of the outstanding shares of HealthTronics for approximately $223 million or $4.85 cash per HealthTronics share plus the assumption of approximately $35 million in net debt. HealthTronics shares that are not acquired in the tender offer will be purchased at the same price in a second-step merger. HealthTronics will operate as a wholly-owned subsidiary of Endo. Separately, Endo reported that is has acquired the exclusive right to negotiate the buyout of Medical Enterprises Group, developer of the Synergo system aimed at treating non-muscle invasive bladder cancer.
In the after hours market, shares of HealthTronics jumped $1.21 or 33%.
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), soared after the bell after the biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, presented results from its positive Phase 2 clinical study with LX1031 in patients with non-constipating irritable bowel syndrome (IBS) at Digestive Disease Week (DDW) 2010 in New Orleans, Louisiana. LX1031 is an oral, serotonin synthesis inhibitor that acts locally in the gastrointestinal tract targeting tryptophan hydroxylase (TPH), an enzyme necessary for the production of serotonin. LX1031 is the first TPH inhibitor to be evaluated in human clinical trials for the treatment of IBS. Results from the randomized, placebo-controlled study of 155 patients with non-constipating IBS showed that patients who received LX1031 four times a day for 28 days experienced significant improvement in global assessment of relief of IBS pain and discomfort over the four-week dosing period as compared to placebo. "These findings are especially important in IBS, which has been lacking an objective biochemical marker. The 5-HIAA biomarker correlation with clinical response in this study validates the mechanism of action of LX1031," said Dr. Philip Brown, senior vice president of clinical development at Lexicon. "We intend to integrate measures of 5-HIAA in future clinical development of LX1031, which could reduce variability and improve response rates."
After the bell shares of Lexicon surged 16% or 25 cents to $1.75.
Also after the bell:
Emergent BioSolutions Inc. (NYSE: EBS) after the bell announced its financial results for the first quarter ended March 31, 2010.
For the first quarter 2010, total revenues were $46.8 million as compared to $64.5 million in 2009, and net income was $2.5 million, or $0.08 per share, as compared to $11.1 million, or $0.37 per share, in 2009. The 2010 performance was primarily driven by sales of BioThrax (Anthrax Vaccine Adsorbed) based on scheduled deliveries to the Strategic National Stockpile.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) moved higher after the bell today after the company announced strong financial results for the first quarter ended March 31, 2010 and updated guidance for sales and expenses for 2010.
Total revenues for the quarter ended March 31, 2010 were $35.2 million, compared to $22.1 million for the quarter ended March 31, 2009, representing a 59% increase. XYREM net sales for the first quarter of 2010 were $28.7 million, compared to $17.7 million for the first quarter of 2009, representing a 62% increase. Net sales of once-daily LUVOX CR extended-release capsules were $5.5 million for the first quarter of 2010, compared to $3.6 million for the first quarter of 2009, representing a 54% increase. Total revenues for the first quarter of 2010 also included $0.9 million in royalties and contract revenue compared to $0.8 million for the first quarter of 2009. The increase in XYREM product sales in the first quarter of 2010 compared to the first quarter of 2009 was due primarily to the impact of price increases taken in 2009, and to a lesser extent, a 5% increase in volume."In the first quarter, Jazz Pharmaceuticals continued in its mission to help improve patients' lives by providing therapies to address serious medical conditions. The commercial team delivered another quarter of solid performance in achieving year-over-year growth in sales and prescriptions for both of our products," said Bob Myers, President of Jazz Pharmaceuticals.
NexMed, Inc. (NASDAQ: NEXM), moved higher after the bell as the company announced that the Canadian Patent Office has issued a Notice of Allowance for NexMed’s patent application entitled, "Crystalline Salts of Dodecyl 2-(N,N-Dimethylamino)-Propionate." This patent, when issued, will provide Canadian patent protection to May 2020, and is one in a series of patents and pending applications that NexMed owns on the NexACT technology and NexACT-based products under development.
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today after the market close reported its results for the first quarter 2010. "With over $90 million of new capital and pro forma cash of more than $150 million, we are now fully positioned to deliver multiple value-driving catalysts in 2010 and 2011 as we advance two Phase 3 registration programs, GATTEX in short bowel syndrome and NPSP558 in hypoparathyroidism," said Francois Nader, MD, president and chief executive officer of NPS. "We look forward to reporting top-line results from the Phase 3 STEPS study of GATTEX in late 2010 or early 2011 and reaching our patient enrollment target in the Phase 3 REPLACE study of NPSP558 later this year. Additionally, we are ensuring regulatory-readiness for the timely filing of new drug applications for both compounds and planning for the launch of our first product in 2012."
Osiris Therapeutics, Inc. (NASDAQ:OSIR) moved 4% higher after the bell today as the company announced that it is resuming enrollment in its clinical trial evaluating Prochymal for patients with treatment-resistant Crohn’s disease. The findings of an interim analysis showed that for the primary endpoint of disease remission, Prochymal is approaching statistical significance in the intent to treat (ITT) population, and has reached significance in the per protocol population. Additionally, the analysis showed that Prochymal continued to demonstrate a benign safety profile with no significant differences in any of the pre-defined safety outcomes compared to placebo. The decision to resume enrollment was made following discussions with the Food and Drug Administration (FDA) about the results of the interim analysis.
Savient Pharmaceuticals, Inc. (Nasdaq:SVNT) after the bell today announced that its board of directors, with input from its financial advisors, has determined that a sale of Savient, post-approval of KRYSTEXXA by the U.S. Food and Drug Administration (assuming KRYSTEXXA is approved), would be the best way to realize the full commercial potential of KRYSTEXXA on a global basis and would be the optimal outcome for the Company's shareholders and other stakeholders.
Savient's board of directors made this determination after a careful evaluation of potential strategic alternatives for the Company. The Company does not plan to make any further announcements or engage in any discussions with analysts or stockholders regarding this effort unless and until a definitive agreement providing for the sale of Savient is executed.
Savient also today reported financial results for the three months ended March 31, 2010. For the first quarter of 2010, the Company had a net loss of $8.3 million, or $0.13 per basic and diluted share, on total revenues of $1.1 million compared with a net loss of $21.9 million, or $0.41 per basic and diluted share on total revenues of $1.1 million for the same period in 2009. The Company ended the quarter with $95.0 million in cash and short-term investments, a decrease of $13.2 million since December 31, 2009.
The FDA agreed to file for review the resubmission of the BLA for KRYSTEXXA, deemed the resubmission a Class 2 response, and established September 14, 2010 as the Prescription Drug User Fee Act (PDUFA) action date.
In news from earlier in the day Wednesday:
Inergetics, Inc. (OTCBB:MBTG), as forcasted last month by BioMedReports, announced today that the company received notification from the Financial Industry Regulatory Authority (FINRA) that the Company's symbol change was formally approved today, May 5, 2010. Effective tomorrow, May 6th 2010, the Company's ticker symbol, as quoted on the OTC Bulletin Board, will change from MBTG to NRTI.
The Company's ticker symbol change follows its recent name change from Millennium Biotechnologies, Inc. to Inergetics, Inc., which was announced on March 17, 2010.
Inergetics' more accurately reflects the science behind the Company's unique product formulations and its mission to create and distribute proprietary nutritional supplements that are highly effective in improving overall human health and wellness. The company is in the process of developing its powdered protein/exercise recovery formula, Surgex, into a ready to drink, functional beverage. Shares of Inergetics moved up more than 6% today.
ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that it has restructured its July 2007 collaboration with Merck & Co. Inc. (NYSE:MRK) for the development, manufacture, and commercialization of ridaforolimus – ARIAD’s investigational mTOR inhibitor. Under the terms, ARIAD has granted Merck an exclusive license to develop, manufacture and commercialize ridaforolimus in oncology, and Merck will assume responsibility for all ridaforolimus activities, including clinical trials and regulatory filings. In exchange, Merck will make an upfront cash payment of $50 million to ARIAD and will reimburse ARIAD for its ridaforolimus expenses incurred since January 1, 2010, estimated to be approximately $19 million. Merck will also fund 100 percent of future ridaforolimus development, manufacturing and commercialization costs, effective immediately. In addition, ARIAD will be eligible to receive up to $514 million in regulatory and sales milestones based on the successful development and commercialization of ridaforolimus in multiple indications.
"The restructuring of our ridaforolimus partnership represents the culmination of over a year of negotiations with Merck and speaks to the strong commitment both companies are making to broadly develop and commercialize ridaforolimus as a potential new treatment for patients with cancer," stated Harvey J. Berger, M.D. chairman and chief executive officer of ARIAD.
"With Merck assuming all costs associated with the development, manufacture and commercialization of ridaforolimus and providing ARIAD with near-term cash payments totaling approximately $69 million, we have greatly strengthened our balance sheet," he added. "We are retaining critically important commercial value through substantial global royalties, regulatory and sales milestones and a co-promotion option and eliminating the need for us to fund fifty percent of the ridaforolimus costs. This will allow us to focus our resources on commencing the pivotal trial for our next promising product candidate – AP24534 – our investigational pan BCR-ABL inhibitor and on advancing development of AP26113 – our investigational ALK inhibitor."
On heavy volume, shares of ARIAD moved up nearly 6%, closing the day at $4.03. Shares continued higher in the after hours session, trading at $4.17.
SenoRx, Inc. (Nasdaq:SENO) today announced it has entered into a definitive agreement to be acquired by C. R. Bard (NYSE:BCR) at a price of $11 per share, or approximately $213 million. "Our agreement with Bard represents an attractive valuation for SenoRx shareholders, and as an all cash offer, provides liquidity for shareholders," said John Buhler, SenoRx President and Chief Executive Officer. "We believe the merger represents a great opportunity for the combined companies to create product leadership by offering a broader range of high-quality breast care products to our customers."
SenoRx, located in Irvine, California, markets the EnCor stereotactic-guided and MRI-guided breast biopsy systems, the Gel Mark line of breast tissue markers and the Contura balloon catheter for the treatment of breast cancer. The company reported 2009 revenues of $55.6 million. Upon completion of the merger, SenoRx will become part of Bard’s Peripheral Vascular division.
Shares of SenoRx jumped $1.28 or 13% to close the day at $10.96.
In other news Wednesday:
Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) announced today that it has executed a $15 million working capital loan agreement with Hercules Technology Growth Capital. The funds available under the loan will be used for capital equipment and working capital purposes. In connection with the loan, Alexza issued Hercules warrants to purchase 376,394 shares of common stock at an exercise price of $2.69 per share, which was the 50-day average daily weighted average trading price at the time the term sheet for the loan was issued by Hercules.
Aradigm Corporation (OTCBB:ARDM) today announced it received clearance from the U.S. Food and Drug Administration (FDA) for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application.
"We are very pleased to have an opportunity to investigate the utility of ARD-3100 in young CF patients and potentially provide another therapeutic option for the pediatric population," said Dr. Igor Gonda, president and CEO of the Company. "The IND approval follows Aradigm’s previously reported encouraging results in adult patients with cystic fibrosis, and in patients with non-cystic fibrosis bronchiectasis."
"A once-a-day inhaled antibiotic, such as ARD-3100, would reduce the treatment burden for people with cystic fibrosis and be a welcome advance that could improve the lives of those with this disease," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation.
BioTime, Inc. (NYSE Amex: BTIM) today reported financial results for the first quarter ended March 31, 2010 and provided an update on recent corporate developments.
Cadence Pharmaceuticals, Inc. (Nasdaq:CADX) announced today that on May 4th it resubmitted its New Drug Application to the U.S. Food and Drug Administration for its investigational product candidate, OFIRMEV (acetaminophen) injection, for the treatment of pain and fever in adults and children. Cadence received a Complete Response letter from the FDA in February 2010 which indicated that the OFIRMEV NDA could not be approved only due to deficiencies observed during the FDA's facility inspection of Cadence's third party manufacturer. The Complete Response letter did not cite any safety or efficacy issues or require that any additional studies be conducted prior to approval.
CEL-SCI Corporation (NYSE AMEX: CVM) today provided an update on its planned Phase III clinical trial of its cancer immunotherapy drug candidate Multikine. The Company, together with its development partners Teva Pharmaceutical Industries and Orient Europharma, has already selected 40 of the planned 50 global medical centers where the Multikine Phase III study will be conducted. In addition, all major vendors for the study have now been chosen. CEL-SCI expects to enroll the first patient in the study during the third quarter of 2010.
The trial is expected to be the largest head and neck cancer clinical study ever conducted, with more than 800 patients expected to be enrolled worldwide. It will also be the first Phase III study in the world in which cancer immunotherapy is given to treatment naïve patients - before surgery, radiation and/or chemotherapy. This is believed to be the best time to stimulate an anti-tumor immune response as the immune system is still competent.
"We are eager to commence the pivotal study to validate Multikine as the standard of care for newly diagnosed head and neck cancer patients," said Geert Kersten, CEL-SCI’s Chief Executive Officer. "We look forward to confirming the promising results that Multikine has already demonstrated in earlier clinical trials. We have taken every step to both minimize risk and maximize our chances for success."
Mr. Kersten continued, "If the huge success of Dendreon’s Provenge has defined the first generation of cancer immunotherapy, we expect our Multikine to define the second generation. Multikine is an off the shelf product making large commercial production possible, it contains both passive and active immunity and is given before any other cancer therapy, a time when cancer immunotherapy should be most successful."
Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that new data regarding Surfaxin LS (its novel, lyophilized KL4 surfactant dosage form) were presented at the 2010 Pediatric Academic Societies (PAS) Annual Meeting. The two studies presented demonstrate that Surfaxin LS improves lung function and oxygenation while attenuating lung inflammation in the preterm lamb model of respiratory distress syndrome (RDS). The preterm lamb model is recognized by the neonatal scientific community as an acceptable and well-established animal model of RDS in human preterm infants. The PAS Annual Meeting is internationally recognized as the largest, most relevant medical meeting dedicated to pediatric research. Dr. Robert Segal, Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "Surfaxin, our lead product for RDS, has demonstrated a very favorable clinical profile and could potentially be approved by the FDA in 2011 for the prevention of RDS in premature infants.
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today reported its financial results for the first quarter 2010. "With our joint venture with Angelini, we are well positioned for the U.S. launch of OLEPTRO(TM) in the third quarter of this year," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "Following the launch of OLEPTRO(TM), we will have two products commercialized and generating revenue, supported by a pipeline of additional product opportunities. In particular, our INTELLITAB(TM) misuse and abuse-deterrent technology platform, which has the ability to deliver two active ingredients in a single tablet, shows considerable promise and we look forward to advancing multiple products with this platform."
Micromet, Inc. (Nasdaq:MITI) and Boehringer Ingelheim announced today that they have entered into a collaboration agreement for the research, development and commercialization of a new BiTE antibody for the treatment of multiple myeloma. Under the terms of the agreement Boehringer Ingelheim will pay Micromet an upfront cash payment of 5 million euro (approximately $6.6 million). Micromet is eligible to receive development and regulatory milestone payments of up to 50 million euro (approximately $66 million) and tiered low double-digit royalties on product sales outside the U.S. In the U.S. Micromet and Boehringer Ingelheim will jointly co-promote the BiTE antibody with commercial terms commensurate with a profit split. In a separate release today the company announced its financial results for the first quarter ended March 31, 2010.
"With the proceeds from our recent financing, we are well-positioned to conduct the planned European pivotal study of blinatumomab in patients with acute lymphoblastic leukemia and other studies intended to support its use as a key component of the standard of care in this indication," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "Our new collaboration with Boehringer Ingelheim is an important step toward our goal to develop a hemato-oncology franchise, with now three BiTE antibodies in research and development that have the potential to address the majority of hematological cancers."
NxStage Medical, Inc. (Nasdaq:NXTM), a leading manufacturer of innovative dialysis products, today reported financial results for the first quarter of 2010 ended March 31, 2010, with total revenue above the top end of its guidance range.
Net revenue for first quarter of 2010 increased to $40.4 million compared with revenue of $33.7 million for the first quarter of 2009, representing a 20% increase. The increase was driven by strong performance of the Company's Home and Critical Care markets, which experienced growth of 33 percent and 36 percent, respectively, when compared with the first quarter of 2009.
Perrigo (Nasdaq: PRGO; TASE) today announced that it has acquired the exclusive U.S. store brand rights to sell and distribute Dextromehtorphan Polistirex Extended Release Suspension Cough Suppressant, the generic version of Reckitt Benckiser's Delsym from Tris Pharma. Tris believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Tris and Reckitt Benckiser are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Tris ANDA filing. Under the agreement Perrigo and Tris will share profits, and Perrigo will pay Tris certain milestone payments.
Delsym is indicated for 12-hour cough relief. It is estimated that it has annual sales of approximately $125 million dollars, according to data provided by Information Resources, Inc.
Radient Pharmaceuticals Corporation (AMEX:RPC) through its US-based subsidiary AMDL Diagnostics Inc., announced today it has signed a collaboration agreement with diagnostics development and commercialization firm Provista Life Sciences LLC (PLS).
Under the terms of the agreement, PLS will provide CLIA (Clinical Laboratory Improvement Amendment certified) laboratory support services to RPC. This includes support for the on-going product development of RPC's Onko-Sure in vitro diagnostic (IVD) cancer test and securing insurance reimbursement and CPT code assignments for clinical laboratories using Onko-Sure in commercial laboratory efforts. This announcement follows RPC's most recent news that PLS has independently validated Onko-Sure as a potential screening tool for breast cancer detection.
Sinovac Biotech Ltd. (Nasdaq:SVA), a leading China-based vaccine manufacturer, announced today that its 30%-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration (SFDA) to commence human clinical trials for its mumps vaccine. Currently, the R&D process for the rubella vaccine is progressing on schedule and the development plan for measles vaccine is underway. Post-approval of a mumps vaccine, the Company plans to commercialize a combination measles, mumps and rubella (MMR) vaccine that will be eligible for the government purchasing program.
Vical Incorporated (Nasdaq:VICL) today announced the enrollment of the first subject in its Phase 1 trial of the company's Vaxfectin-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The trial will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC).
VIVUS, Inc. (Nasdaq:VVUS) today announced that new data on Qnexa, an investigational drug candidate, will be presented on May 6th 2010 at EuroPRevent, the annual congress of the European Association for Cardiovascular Prevention and Rehabilitation, organized by the European Society of Cardiology, in Prague, Czech Republic.
Watson Pharmaceuticals, Inc. (NYSE:WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its 1000 mg/20 mg form of niacin extended-release/simvastatin tablets. Watson's 1000 mg/20 mg niacin extended-release/simvastatin tablets are generic versions of Abbott's 1000 mg/20 mg form of SIMCOR which is indicated for people who have unhealthy cholesterol levels when treatment with simvastatin alone or niacin extended-release alone is not enough, and when a diet low in saturated fat and cholesterol and other non-drug measures alone have not been successful. Abbott Laboratories and Abbott Respiratory, LLC filed suit against Watson on May 4, 2010 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patents. In a separate release later in the day Watson reported that Watson Laboratories, Inc. filed an ANDA with the FDA seeking approval to market a raloxifene hydrochloride tablet. Watson's raloxifene hydrochloride tablet is a generic version of Eli Lilly's EVISTA which is indicated for the treatment and prevention of osteoporosis in postmenopausal women, for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. Eli Lilly and Company filed suit against Watson on May 3, 2010 in the United States District Court for the Southern District of Indiana seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patents.
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