| PPD Opens Pharmacovigilance and Medical Communications Center in Sofia, Bulgaria (Business Wire) WILMINGTON, N.C.----PPD, Inc. today announced the opening of a pharmacovigilance and medical communications center in Sofia, Bulgaria, delivering its full range of drug safety, medical information and medical writing services to meet growing client demand. us.rd.yahoo.com |
ERT Industry Poll and Sponsor Endorsement Confirms eC-SSRS is an Effective Method of Suicidality Monitoring in Clinical Trials (PR Newswire) ERT , Â a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces that a recent survey of over 250 respondents reported that all clinicians polled found the Columbia Suicide Severity Rating Scale to be an effective method for prospectively monitoring suicidality. us.rd.yahoo.com |
Life Sciences Deals Go on Summer Break The Burrill Report submits: By Marie DaghlianBritish consumer goods company Reckitt Benckiser (RBGPF.PK) agreed to buy SSL International, the maker of Durex condoms and Scholls footcare products, for $3.8 billion in cash, a 33 percent premium to SSL’s closing price the day before the announcement. It was the only major deal, albeit one on the fringes of life sciences, during a slow week. This is not the first time Reckitt has had its eyes on the complementary products in SSL’s portfolio, having courted the company back in 2003 when its shares were trading at a third of their present value. “The acquisition of SSL will provide a step change to Reckitt Benckiser's global health and personal care business, which has been a key driver of Reckitt Benckiser's net revenue growth and profit progression,” said Bart Becht, CEO of Reckitt Benckiser, in a statement. Investor speculation over the possibility of a counter offer from a big pharmaceutical company, most likely Johnson & Johnson (JNJ) or GlaxoSmithKline (GSK), quickly drove SSL’s shares above the offer price. Pharma companies have been looking at the over-the-counter sector as a growth driver, especially in emerging markets. Sanofi-Aventis (SNY) acquired consumer products company Chattem for $1.9 billion just over a year ago as part of its diversification strategy. Reckitt Benckiser expects the SSL acquisition to enhance its businesses in China and Japan, boosting its health and personal care unit to account for about $4 billion in net revenues per year, about one third of its total net revenues. The company will fund the acquisition with cash on hand and a new $1.9 billion credit facility from HSBC. Shares of Reckitt rose 3.4 percent on news of the deal. Private equity firm Ramius sent a letter to the board of directors of Cypress Bioscience (CYPB) offering to acquire the outstanding shares of the company it does not already own for $4 per share in cash, a 60 percent premium over its closing price just before the offer. Ramius, one of Cypress’ biggest shareholder, owns 9.9 percent of Cypress and expressed disappointment over the management of the company. Cypress’ shares have dropped 82 percent in the past five years at the same time that the Nasdaq Composite Index has gained 6 percent. “The Cypress Board needs to realize that a management team that continues to destroy shareholder value by making increasingly risky investments with shareholder money is not a management team to follow blindly,” says Jeffrey Smith, Ramius partner and managing director, in the letter. “The correct conclusion at this juncture is to stop, hire a reputable banker, and maximize value for all shareholders.” Ramius also stated in the letter that it would be willing to consider an acquisition structure that would allow management to continue the development of BL-1020, recently acquired from BiolineRx if they are able to fund the required financing for the phase 2b trial themselves or from a third party financing source, so that shareholders will have an opportunity to retain future upside potential from its development without funding the risk. Drugmaker Eli Lilly (LLY) completed its acquisition of Alnara Pharmaceuticals, first announced on July 2, and disclosed financial details of the deal. Lilly acquired the private developer of metabolic disease therapeutics for $180 million upfront and up to $200 million in additional payments contingent upon potential future regulatory and commercial milestones. Alnara's lead product liprotamase, a non-porcine pancreatic enzyme replacement therapy, is under review by the U.S. Food and Drug Administration for the treatment of exocrine pancreatic insufficiency caused by cystic fibrosis, chronic pancreatitis, pancreatectomy and other conditions. Pharmaceutical Merck (MRK) agreed to buy bankrupt Hawaii Biotech’s dengue fever vaccine research unit, expanding its growing lineup of vaccines that includes ones for hepatitis A and hepatitis B; measles, mumps and rubella; human papillomavirus; and influenza. Hawaii Biotech’s dengue fever vaccine is about to enter early stage human clinical trials. Emeryville, California-based cardiometabolic diagnostics company Tethys Bioscience (TETHF.PK) has raised $33 million, comprising $23 million of venture financing and a $10 million working capital loan. New investors Greenspring Associates and Paul Capital Investments, as well as current investors, participated in the financing while the working capital loan was provided by Oxford Finance Corporation and Silicon Valley Bank. The additional $23 million brings the total raised in the company’s series D round to $48 million. The money will support expanded commercialization of the Tethys PreDx Diabetes Risk Score, a multimarker blood test that enables accurate identification of patients who have a high risk of developing type 2 diabetes within five years. Tethys’ test was first sold in 2009 and more than 15,000 PreDx tests have been ordered since then by doctors for patients suspected to be at risk for the disease. Of the more than 57 million Americans who are categorized as being at high risk for diabetes based on conventional testing, most will never develop diabetes. PreDx DRS facilitates identification of the 10-20 percent of individuals at the highest, near-term risk, for whom intervention may be most beneficial. The Tethys PreDx platform includes products in development to determine risk for first-time heart attack, osteoporotic fracture and other cardiometabolic diseases with the goal of improving health outcomes and reducing the devastating economic impact that debilitating, preventable diseases have on individuals and society. Cambridge, Massachusetts-based Euthymics Bioscience, a clinical-stage company developing next-generation antidepressants, completed a $24 million series A financing commitment led by Novartis Venture Funds and Venture Investors, with participation by Hambrecht & Quist Capital Management, GBS Venture Partners, and the State of Wisconsin Investment Board. The financing will be available in milestone-conditioned tranches. The initial tranche was used to complete the acquisition of DOV Pharmaceutical and allow for the continued development of EB-1010 acquired from DOV, an antidepressant for the estimated two thirds of patients who do not respond adequately to selective serotonin reuptake inhibitors. Finally, two companies are planning to go public, listing on the Nasdaq at the end of July and beginning of August. Biotech Trius Therapeutics put itself back on the IPO calendar after postponing its initial offering in March to adjust the late-stage trial protocol for its lead antibiotic. After reaching an agreement with the U.S. Food and Drug Administration on the design and endpoints of the planned trial, it hopes to raise $78 million during the week of July 26 by offering 6 million shares at a price range of $12 to $14. Citi has replaced Credit Suisse as the lead underwriter. Pharmaceutical company NuPathe plans to price during the week of August 2, hoping to raise $75 million by offering 5 million shares at a price range of $14 to $16. The company hopes to launch its lead drug Zelrix, a migraine treatment that has completed late stage trials, in 2012. Leerink Swann and Lazard Capital Markets are the lead underwriters. Complete Story » seekingalpha.com |
Genzyme Sees End to Drug's Rationing Genzyme expects to stop rationing its rare-disease treatment Fabrazyme during the first half of next year, ending a shortage that began in 2009. online.wsj.com |
CellDex Therapeutics Is Back on the Radar VFC submits: CellDex Therapeutics (CLDX) couldn't be held down for too long after losing a Pfizer (PFE) partnership about a month ago, not when Tuesday produced a 25% gain for shareholders. The surge occurred after the company announced that patients who received CDX-110 for the treatment of Glioblastoma brain cancer lived twice as long as those who only received chemo and radiation. CellDex will regain worldwide rights to the treatment on November 1st, and any doubts that may have lingered about the Phase II trial after Pfizer backed might have been nullified by this positive announcement. Complete Story » seekingalpha.com |