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LICENSING: AMGEN IN BROAD $1.2-BILLION DEAL WITH TAKEDA
Amgen and Takeda Pharmaceutical said they have entered into an agreement under which Takeda will develop and commercialize for the Japanese market up to 13 molecules from Amgen’s pipeline, one of which is included as an option. Amgen said the collaboration “validates the significant value” of its clinical stage pipeline. The collaboration includes early to mid-stage clinical-stage candidates across a range of therapeutic areas, including oncology, inflammation, and pain. Under the terms of the agreement, Takeda will make an upfront cash payment to Amgen of $200 million. Takeda will also pay to Amgen up to $340 million in expected worldwide development costs for these molecules over the next several years, $362 million in success-based milestone payments, and double-digit royalties on sales in Japan. Additionally, Takeda plans to acquire all the shares of Amgen’s Japanese subsidiary, Amgen KK. In addition, Takeda will become Amgen’s worldwide partner for its anti-tumor drug motesanib diphosphate (AMG 706), and will pay Amgen $100 million upfront, $175 million in success-based milestones for the first two indications, and double-digit royalties on sales in Japan. Takeda will also pay 60 percent of ongoing clinical development expenses outside Japan and share potential

EXERCISE: HAND-HELD COMPUTERS PROD OLDER ADULTS TO WORK OUT
Specially programmed PDAs, or personal digital assistants, can prod middle-aged and older Americans—the most sedentary segment of the U.S. population—into increasing their physical activity levels, according to researchers at Stanford University. The study, published in the American Journal of Preventive Medicine, follows an earlier study from the researchers that showed automated computer calls were almost as effective as live health educators in coaxing people previously less active to get more of a spring in their step. The PDA’s were outfitted with a program that twice a day asked participants about what exercise they did, their goals, and any barriers they faced. The device traced their activity and offered feedback on how well they met their goals. After eight weeks, the researchers found that while participants assigned to the PDA group devoted approximately five hours each week to exercise, those in the control group spent only about two hours on physical activities. In other words, the PDA users were more than twice as active.

NEURODEGENERATIVE DISEASE: TARGETING ASTROCYTES SLOWS PROGRESSION OF ALS
Scientists at the University of California, San Diego School of Medicine have shown that targeting neuronal support cells called astrocytes sharply slows disease progression in mice, a promising development in the effort to find a therapy to slow the progression of amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease. The researchers, who report their findings in a study on Nature Neuroscience's website, argue that the mutant genes that cause ALS are expressed widely and not just in the motor neurons. By targeting the partner cells like astrocytes, which live in a synergistic environment with the neuron cells, they said it may help stop the cascade of damage. ALS is a progressive disease that attacks the motor neurons, long and complex nerve cells that reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body, which act to control voluntary movement. Degeneration of the motor neurons in ALS leads to progressive loss of muscle control, paralysis, and untimely death.

REGENERATIVE MEDICINE: GERON GETS SECOND U.S. PATENT FOR PRODUCTION OF PANCREATIC ISLETS FROM HUMAN EMBRYONIC STEM CELLS
Menlo Park, California-based Geron said it received a U.S. patent with claims covering a widely used method for producing endoderm cells from human embryonic stem cells, or hESCs. The production of endoderm cells is a critical step in generating pancreatic islet cells from hESCs, which Geron is developing for potential use in treating diabetes. The company said that the method covered by the patent has been validated in a number of published studies by Geron and others. These studies, it said, have shown that hESC-derived islet cells produced using this differentiation procedure and transplanted into severely diabetic animals prolong their survival and produce detectable human insulin in their bloodstream. 

CARDIOVASCULAR STENTS: CV THERAPEUTICS SIGNS AGREEMENT WITH MEDLOGICS FOR COATING TECHNOLOGY
Santa Rosa, California-based Medlogics Device agreed to license Palo Alto, California-based CV Therapeutics’ biopolymer stent-coating technology to develop a drug-eluting stent. CV Therapeutics received Medlogics stock and is entitled to development milestone payments, royalties, and other potential payments on future sales of any products incorporating the technology. Medlogics recently received a CE Mark from European regulatory authorities for its Cobalt Super Alloy stent and expects to launch the stent in Europe in the first quarter of 2008. Medlogics expects to utilize CV Therapeutics' biopolymer stent-coating technology to develop a next-generation drug-eluting stent based on the CV Therapeutics stent platform. Stents are small metal mesh devices which can be inserted into clogged blood vessels to reopen them. The use of drug-eluting stents has been shown to reduce the frequency of restenosis, which is the reclosure of the vessel after the stent has been implanted. 

DIABETES: LIPOMICS ENTERS PARTNERSHIP WITH JOSLIN TO STUDY INSULIN RESISTANCE RESEARCH
West Sacramento, California-based Lipomics Technologies said that it is engaged in a research collaboration with Joslin Diabetes Center to study insulin resistance in patients with a family history of type 2 diabetes. The primary objective of the work will be to identify predictive markers of the disease that can be translated into blood-based diagnostics. A second study will focus on understanding the effects of gastric bypass surgery on insulin sensitivity. Lipomics is developing diagnostic monitoring tools for the management of type 2 diabetes. The company will retain certain rights to develop diagnostic applications based on data emerging from these studies.

CANCER: LPATH GETS GREEN LIGHT FROM FDA TO BEGIN CLINICAL TRIALS
San Diego-based Lpath said the U.S. Food and Drug Administration told the company it would allow it to begin early-stage clinical trials of its ASONEP in human cancer patients. ASONEP is a first-in-class humanized monoclonal antibody that neutralizes Sphingosine-1-Phosphate (“S1P”), a bioactive lipid that stimulates tumor cell migration, invasion, and survival, while also promoting in vivo angiogenesis. Investigators will assess the safety and tolerability of the intravenous infusion of ASONEP in patients with refractory advance solid tumors. Other endpoints include ASONEP’s pharmacokinetics, pharmacodynamics, and immunogenicity, as well as exploration of the molecule’s mechanism of action. Doses will be given for a four-week period, with an option for an additional four weeks of therapy if disease improvement or stabilization is observed. 

DIAGNOSTICS: VERMILLION RENEWS LONG-STANDING COLLABORATION WITH JOHNS HOPKINS
Fremont, California-based Vermillion said it has renewed a long-standing collaboration with Johns Hopkins University on the development of biomarkers that can be applied toward disease detection, classification and monitoring of prevalent cancers, including ovarian, breast and prostate. Vermillion will have access to exclusive commercial rights to the discoveries made through the partnership. The collaboration has existed for more than seven years. As part of the collaboration, Vermillion will continue to provide financial support, technical assistance, and access to its advanced technology platforms, while Johns Hopkins will continue to contribute cancer serum samples and the clinical and scientific expertise of its physicians and scientists.