Deals & Data
Amgen reports that a recent study showed its osteoporosis drug candidate, Denosumab, beat a rival drug in reducing and delaying the rate of fractures in men with prostate cancer. The drug, also called Prolia, is viewed by Wall Street as Amgen's next blockbuster product and a way to revive the company's revenue. It is under review by the FDA for several uses, including postmenopausal osteoporosis and as a treatment for bone loss in breast and prostate cancer patients undergoing therapy.
Suneva Medical said its cosmetic wrinkle filler Artefill showed positive results in an 18-month interim analysis of an ongoing study.
Shares of Orexigen rose after a Jefferies & Co. analyst recommended buying the stock, citing the potential for the company's obesity drug candidate Contrave.
Sequenom has obtained rights to develop and commercialize a diagnostic test from New Haven, CT-based Optherion to predict a patient’s genetic predisposition to late-stage, age-related macular degeneration, a progressive eye disorder that can lead to a loss of central vision.
San Diego-based Tragara Pharmaceuticals, which has focused its current drug development on two compounds for treating tumors, has raised $5 million of a targeted $10 million venture round, according to a recent regulatory filing.
The Dana-Farber Cancer Institute and the Sanford-Burnham Medical Research Institute have agreed to sell the rights to antibodies designed to be used to protect against and fight influenza. Roche and its wholly owned subsidiary, Genentech, will acquire for an undisclosed sum the rights to manufacture, develop and market the antibodies for flu viruses. Dana-Farber and Sanford-Burnham will receive license fees and milestone payments as well as royalties if treatments or diagnostics result from the antibodies.
Vertex Pharmaceuticals said two doses of oral VX-809 once daily met the secondary efficacy endpoint of significantly reducing mean sweat chloride levels vs. placebo in a Phase 2a trial to treat cystic fibrosis.
Xoma raised $21 million through the sale of 42 million units at $0.50 in a follow-on underwritten by Lazard. Xoma's XOMA 052 is in Phase II testing to treat Type I and Type II diabetes and cardiovascular disease.
Biogen Idec Inc. received notice that Carl Icahn plans to nominate three directors to the company's board at this year's annual meeting. The planned nominees are Thomas Deuel, Eric Rowinsky and Richard Young. Icahn also proposed to amend Biogen Idec's bylaws to fix the board at 12 members. Last year, Icahn proposed four nominees, including Deuel, but succeeded in placing only two on the board: Alexander Denner and Richard Mulligan. Four seats are up for election this year. 
Sequenom Inc. launched its SensiGene Fetal RHD Genotyping test to detect fetal Rhesus D (RhD) incompatibility in RhD-negative pregnant women. The test, which detects circulating cell-free fetal (ccff) DNA in maternal blood, runs on Sequenom's MassARRAY platform and will be performed at the company's CLIA-certified lab. Sequenom said this is the first commercial test using its SEQureDx technology.
Optimer Pharmaceuticals has nailed the second big trial designed to prove it has a new antibiotic for a deadly infection people can get in hospitals. Optimer’s experimental antibiotic, fidaxomicin, was roughly equivalent to the gold standard vancomycin drug when attempting to cure patients infected with “C.difficile” bacteria. The Optimer drug was about twice as good as vancomycin at preventing dangerous recurrences. Optimer was also recently featured on Channel 10 News.
Xoma started enrolling a 325-patient, Phase 2b trial of its potential once-a-month treatment of type 2 diabetes. Xoma said the trial will be conducted at up to 70 sites in the United States over six months. It expects to report initial results of the study in first-quarter 2011.
Life Technologies will team with the Ignite Institute on creating the largest next-generation genomic sequencing facility in North America, part of which includes Ignite purchasing 100 of the firm's new SOLiD 4 Sequencing System. The newest system generates up to 100 gigabases of mappable sequence data per run at a cost of $6,000 per genome.
The Bill and Melinda Gates Foundation will donate $10 billion over the next decade to research vaccines and make them available to the world's poorest countries, the Microsoft co-founder and his wife said Friday.
A federal court in New York will hear a crucial legal challenge against the patent office and a Utah company, Myriad Genetics. A group of medical researchers, doctors associations, patient advocacy groups, and the American Civil Liberties Union are challenging the validity of Myriad’s patents for two gene sequences responsible for most hereditary cases of breast and ovarian cancer. These patents give the company a monopoly on tests that show women whether they are likely to get cancer based on mutations in those sequences—and on research that could help develop better tests and less toxic treatments for cancer.
The California stem cell agency has responded to recommendations from a key state panel for more openness, accountability and transparency on the part of CIRM, indicating disagreement with many of the suggestions, including the identification of all applicants for public money. CIRM also challenged the CFAOC's authority to conduct performance audits and said it is engaged in a review of its “core scientific programs” by outside scientists, who will examine “the research portfolio and policies and procedures for managing that portfolio.”
Carlsbad-based company Alphatec Holdings has received the CE Mark for two of its spinal treatment implants, allowing it to begin selling the devices in the European Union and other areas that recognize the CE Mark.
Barney & Barney LLC, one of the nation’s 40 largest insurance brokerages, is pleased to announce the creation of a new international position. Client Executive Bevin Melody will be based out of Stuttgart, Germany where she will continue to grow the firm’s International Practice from her home office. Bevin’s primary focus will be International Reverse Flow business and new business development. Her unique location will enable her to work with clients and partners in many time zones within Europe, the East Coast, West Coast as well as Asia.
IMS Health provides insight about healthcare reform’s affect on innovation and the state of California’s biopharmaceutical pipeline in two new thought leadership papers: "Healthcare Reform: Sustaining the Flow of Innovative Products" and "Product Development: California's Biopharmaceutical Pipeline." In the Healthcare Reform report, authored by IMS’s Murray Aitken, senior vice president, Healthcare Insight, Aitken explains that national healthcare reform may lead to significant changes in the way the biomedical ecosystem operates. While he says measures such as comparative effectiveness research and changes to reimbursement and incentives have the potential to encourage innovation in the diagnosis and treatment of a broad range of patient conditions, he warns that they also can stop innovation in its tracks – if they create an environment in which private capital is no longer attracted because the potential returns are low or come with greater levels of risk.
In its budget plan for 2011, the White House said it will seek a $1 billion, or a 3.2 percent, increase in funding for the National Institutes of Health, even though the overall budget for the fiscal year plans a freeze on non-military discretionary spending as part of an effort to reign in the federal deficit.
Adventrx Pharmaceuticals said Odysseas D. Kostas will join its board as a representative of activist investor Carl Icahn, who has held shares of the San Diego company since 2005.
Employment in California’s biomedical industry has remained fairly stable through the recession, according to a new industry study. The report from the California Healthcare Institute says the biomedical work force shrank slightly in the 12 months through March 2009 but was still up by more than 1,000 jobs from 2007. Altogether there were 272,181 jobs in areas that ranged from biopharmaceuticals and medical devices to academic research and laboratory services, according to the report. The industry employed 24,123 people in San Diego County.
Avrio Biopharmaceuticals, LLC, a wholly-owned subsidiary of Irvine Pharmaceutical Services, Inc., received approval to manufacture and ship pharmaceutical products by the California Department of Public Health, Food and Drug Branch (Cal FDB), completing the organization’s portfolio of product development services in support of its pharmaceutical, biopharmaceutical, and medical device clients.