GE, Intel Form Alliance
GE and Intel Corporation are forming an alliance to develop products to help elderly patients manage their chronic illnesses, the companies announced. They will invest $250 million over the next 5 years for research and development of home health technologies in areas such as diabetes, cardiovascular disease, medication compliance, and sleep apnea. The market for telehealth and home health monitoring is predicted to grow from $3 billion in 2009 to an estimated $7.7 billion by 2012. GE Healthcare also will sell and market the Intel Health Guide, a personal health system that includes vital sign collection and communication tools, in the United States. “This partnership offers the potential to lower costs by keeping people out of hospitals while giving health professionals the data they need to deliver the best possible care,” Jeff Immelt, GE's board chairman and CEO, said in a statement.
Immuron Buys Hasadit's Technology
Immuron, a biopharmaceutical company, has agreed to acquire a novel oral immune modulation technology from Hadasit, the commercial arm of Hadassah Medical Center in Jerusalem. The combination of oral immune modulation with Immuron's existing oral protein and antibody technology could yield “a convenient, all-natural, side effect-free approach to address serious diseases which have multibillion-dollar markets, including metabolic syndrome, hepatitis C, and type 2 diabetes,” the company said in a statement. Immuron will focus its initial clinical development effort with this platform technology on metabolic syndrome, chronic hepatitis C, and liver cancer. Hadasit also will provide discounted clinical and laboratory services to Immuron. In return, Hadasit shall be issued 19.99% of Immuron's equity at the time of the approval of the transaction by Immuron's shareholders, as well as royalties on certain Immuron products. Professor Yaron Ilan of Hadassah Medical Center will become the medical director of Immuron.
Quest Pays Government $302 Million
Quest Diagnostics will pay the government $302 million to settle False Claim Act allegations that a former subsidiary knowingly sold a parathyroid hormone test kit with inaccurate performance claims, the Justice Department reported. The investigation was initiated by a whistleblower lawsuit filed by a Quest competitor in 2004. The payout is one of the largest recoveries in a case involving a medical device, according to the Justice Department. “This settlement provides further evidence that the department will vigorously prosecute cases involving violations of the Food, Drug, and Cosmetic Act, and will pursue recovery of taxpayer dollars resulting from fraudulent marketing campaigns by medical device manufacturers,” said Michael F. Hertz, acting assistant attorney general for the civil division.
Novocell Receives Endoderm Patent
Novocell Inc., a stem cell engineering company, has received a patent for its work with human definitive endoderm cells, an essential cell for generating pancreatic-type cells and other endoderm lineage-derived tissues and organs, including lung, intestine, liver, thymus, and thyroid cells. Novocell is developing pancreatic-type cells for use in diabetes therapy. “This composition patent is a milestone achievement for Novocell and is the culmination of extensive research that opened the door to the endoderm lineage,” said Fred Middleton, Novocell's chairman and acting CEO. “The efficient production of endoderm represents the first critical step in the creation of a renewable islet source derived from [human embryonic stem] cells that is targeted at restoring normal glucose regulation in diabetic patients.”
Biodel Plans VIAject NDA
Biodel Inc. plans to submit a new drug application to the Food and Drug Administration for approval to market its VIAject ultrarapid-acting injectable human insulin for the treatment of diabetes, the company announced last month. VIAject is intended for mealtime use by type 1 or type 2 diabetes patients. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed phase III studies. Now that the company has cleared up some issues surrounding patient data from India, “We are … comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of this year,” said Solomon Steiner, Ph.D., Biodel's chairman and CEO. “This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal phase III clinical trials, which we believe met the end point of noninferior change in HbA1c over 6 months.”
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.