Worldwide Blockbusters’ Movements during Feb., 2013


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Worldwide Blockbusters’ Movements during Feb., 2013

GlaxoSmithKline (GSK) has joined up with investigators at Vanderbilt University to quick march their preclinical work on a new obesity drug into clinical studies. The pharma giant has been warming up to Roger Cone and his Vanderbilt team. With significant backing from the NIH, they have identified a series of positive allosteric modulators, or PAMs , that "gently increase" the activity of the melanocortin-4 receptor, a target now in the sights of several developers. Under the deal, the university team will stay focused on the preclinical work while GSK investigators narrow down the compounds, with an eye to launching a Phase I study in 2016.

One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies. So when Janet Woodcock , the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization . Biotechs have been paying particularly close attention to this new, infinitely shorter path to the marketplace.

Merck has essentially doubled down on its discovery deal with Ann Arbor, MI-based Lycera, a biotech spinout from the University of Michigan following their own unique pathway to mount a therapeutic assault on autoimmune diseases. Close to two years ago Merck (MRK) paid $12 million upfront and promised up to $295 million in milestones to buy into Lycera's development work on small molecules that target T-helper 17--or Th17--cells, which they believe offer a new, first-in-class approach to treating major autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease and multiple sclerosis. Today Lycera announced that Merck has doubled its promised milestone package to close to $600 million, expanding the original deal to add new targets to its roster.

As Amgen (AMGN ) pursues a new strategy of picking pipeline winners, the biotech giant and partner antibody to speed up healing of bone fractures. Yet the companies are moving along with Phase III studies of AMG 785 for treating post-menopausal osteoporosis, which Bloomberg noted as a juicer market for the drug. Amgen clearly has bigger market opportunities on its R&D agenda, which the Thousand Oaks, CA-based biotech rolled out to Wall Street types last week, touting its multibillion-dollar prospects with biosimilars based on blockbuster protein drugs.

Lux Capital has nailed down a new fund, its first since 2007, to back startups in healthcare as well as energy and tech. With $245 million in commitments, more than the $200 million it originally targeted, Lux is closing its largest fund to date and staying the course with investments in biopharma. The news comes after ex-Pfizer ( $PFE ) Chairman and CEO Jeff Kindler, the man who pulled the trigger on the $68 billion merger with Wyeth , joined Lux last year as a venture partner, adding his high-profile name in pharma to the firm's roster.

Article Link: Worldwide Blockbusters’ Movements during Feb., 2013

Tags: PAM,  FDA,  Lycera and Merck,  Amgen and UCB,  Antibody,  Biosimilar

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