People and Places in the News

FDA/EU Approvals

The U.S. Food and Drug Administration (FDA) has recommended approval of Human Genome Sciences’ and GlaxoSmithKline’s Benlysta, the first new drug to treat patients who suffer from lupus.The drug works by inhibiting the production of antibodies that attack and destroy healthy tissue.

Octapharma USA’s octaplex (human prothrombin complex, freeze dried) has been approved as a fast track product for reversal of anticoagulation therapy in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.

NxStage Medical Inc. has received FDA clearance to market its Therapeutic Plasma Exchange (TPE) cartridge for use with the NxStage System One in a clinical environment. TPE is an extracorporeal blood purification technique to remove part of a patient’s plasma, while replacing it with another substance such as fresh frozen plasma or a solution containing albumin. TPE may be performed to treat immunological, hematological and neurological disorders.

The U.S. Food and Drug Administration has approved Roche’s new test for human papilloma virus (HPV), the first one-pass test to specifically identify the two HPV strains that cause 70 percent of cervical cancers. Current HPV tests can detect the presence or absence of more than a dozen HPV types linked to cancer. But, Roche’s new cobas 4800 test does that, as well as identifies whether a woman has HPV-16 or HPV-18.

CSL Behring has been granted orphan drug designations by the European Commission for the development of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP), a novel therapy to treat hemophilia A and B patients with inhibitors.

Kedrion has received U.S. Food and Drug Administration approval to sell its albumin (Kedbumin) in the U.S. Kedrion will produce albumin for the U.S. market at its production plant in Bolognana, Lucca, Italy.

Appointments

Sanofi has appointed Greg Irace, currently president and CEO of Sanofi’s U.S. operations, to the newly created role of senior vice president, global services, and Anne C. Whitaker as president, North America, Pharmaceuticals.

The Clinical and Laboratory Standards Institute (CLSI) has hired Luann Ochs, MS, as the new vice president of standards development. Ochs will oversee the CLSI standards development process, including the creation, delivery and oversight of medical testing consensus standards, guidelines and other related laboratory reference products.

Portola Pharmaceuticals has named Michael M. Kitt, MD, as the company’s senior vice president and chief medical officer. Dr. Kitt has clinically developed a number of novel compounds in multiple therapeutic areas.

Xencor Inc., a company using Fc engineering for the discovery and development of next-generation antibodies, has appointed Edgardo Baracchini, PhD, to chief business officer. Baracchini has more than 15 years of transactional experience, most recently as senior vice president of business development at Metabasis Therapeutics until its merger with Ligand Pharmaceuticals in 2009.

Dr. Hilton Klein has been named global vice president of science and new product introduction for the research models and services operating group at Harlan Laboratories.

NKT Therapeutics Inc., a privately held biotechnology company, has appointed Barbara Finck, MD, as chief medical officer. Finck was recently the senior VP research and development and chief medical officer at Osprey Pharmaceuticals.

Dr. Miroslav Backonja has joined Lifetree Clinical Research and Lifetree Center for Neuroscience Research as medical director. He was previously professor of neurology, anesthesiology and rehabilitation medicine at the University of Wisconsin Medical School in Madison, Wis., and a staff physician at the University of Wisconsin and Pain Treatment and Research Center.

Acquisitions/Alliances

Sanofi-Aventis has joined the Massachusetts Life Sciences Center’s Corporate Consortium Program, a quasi-public agency tasked with implementing the state’s 10-year, $1 billion Life Sciences Initiative, which makes loans available to early-stage life sciences companies engaged in promising translational science and research.

GlaxoSmithKline and Amplimmune have entered a development agreement to focus on experimental drugs that target molecules that mask tumors and disease pathogensfrom the immune system.Early studies suggest the potential treatment can induce immune responses.

Sanofi-Aventis has established an alliance with the Massachusetts Institute of Technology Center for Biomedical Innovation, which will be known as the Sanofi-Aventis Biomedical Innovation Program (SABIP). SABIP will allow Sanofi-Aventis to develop therapeutic, diagnostic and prognostic applications based on the discoveries made during the alliance.

Roche Holding AG’s Genentech unit is buying rights to NovImmune SA’s early stage compound, a so-called antiIL-17 fully human monoclonal antibody, that may be developed to treat inflammatory and autoimmune diseases.

Intellikine, a La Jolla, Calif., biotechnology research company, has sold the global rights to develop treatments from molecules that target a family of immune system enzymes to Infinity Pharmaceuticals, Cambridge, Mass.

Emergent Biosolutions, a vaccines manufacturer, has purchased Trubion Pharmaceuticals to allow it to diversify its infectious diseases research pipeline.

Immunovaccine Inc. and IRX Therapeutics have entered into a preclinical research collaboration to evaluate the combination of IRX’s primary cellderived biologic, IRX-2, and DepoVaxbased therapeutic cancer vaccines to generate a superior anti-tumor immune response and provide the foundation for the development of the next generation of therapeutic cancer vaccines.