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FDA Official Wants Rezulin Pulled
On January 24, Robert I. Misbion, MD, a medical officer for the U.S. Food and Drug Administration (FDA), emailed his FDA superiors saying that the type 2 drug Rezulin should be pulled from the market.
"I see no reason why any well-informed physician would continue to prescribe (Rezulin)," Misbion wrote. "Neither do I see any reason why (the) FDA should delay in taking steps to remove (Rezulin) from the market."
Misbion is a veteran diabetes specialist, whose job at the FDA is to evaluate the safety and efficacy of proposed and existing drugs. He was closely involved with the FDA's approval of Rezulin in January 1997.
In a story reported in the February 19 edition of The Los Angeles Times, Misbion warned of "additional cases of preventable liver failure" if Rezulin is not removed from the market.
Dr. Janet Woodcock, director of the FDA's drug-review center, said in a prepared statement to The Los Angeles Times that the FDA had received 85 reports of liver failure that are considered "possibly or probably related" to the use of Rezulin. Of those, 58 patients died and 10 required liver transplants. In March 1999, FDA officials acknowledged that 43 liver-failure cases, including 28 deaths, could be attributed to the use of Rezulin.
On February 24, Warner-Lambert issued a statement saying that it recently had productive meetings with the FDA regarding Rezulin.
"At the most recent meeting...the FDA has reaffirmed its belief that the benefits of Rezulin outweigh its risks and that the drug is safe and effective when used according to the label."
MAXIA Presents Preclinical Data of its Insulin Sensitizer
In a February 28 company press release, MAXIA Pharmaceuticals, Inc. announced the results of preclinical studies of its compound MX6054, a new small molecule insulin sensitizer in development for the treatment of type 2 diabetes.
In a presentation at the Keystone Symposium: Diabetes Mellitus: Molecular Mechanisms, Genetics and Prospects for New Therapy in Taos, New Mexico, MAXIA reported that MX6054 provided significant reductions in serum glucose and triglycerides, and improved insulin sensitivity. According to MAXIA, the results achieved with MX6054 were superior overall to those achieved with Avandia, another insulin sensitizer, at the same drug concentrations.
"These results demonstrate that MAXIA has discovered a new generation of novel insulin sensitizers with an excellent profile for the treatment of type 2 diabetes," said Magnus Pfahl, PhD, president and CEO of MAXIA. "MAXIA is conducting additional testing with the goal of initiating a Phase I clinical trial of MX6054."
Another Inhalable Insulin Patent for Aradigm
On February 15, Aradigm Corporation of Hayward, California, was issued another patent for its inhalable insulin analog. It has 57 patents so far.
"We believe that today's patent further positions us as a leader in the pulmonary delivery of insulin," said Richard Thompson, president and CEO of Aradigm, who is currently partnering with Novo Nordisk. "This patent describes potential benefits of delivering a certain type of insulin analog by inhalation."
Lilly and Novo Make Nice
On February 1, Novo Nordisk and Eli Lilly announced that they have settled their four-year-long patent disputes though an out-of-court settlement.
According to a Novo Nordisk press release, the settlement, which was offered by Lilly, will end all litigation worldwide relating to insulin analogues, insulin delivery systems and human growth hormone. Under the agreement, Novo has complete global freedom of operation for all of its diabetes and growth hormone products currently involved in litigation. These include NovoRapid and the growth hormone Norditropin. Novo will also receive a one-time payment and the companies have also exchanged certain worldwide rights relating to patents.
Additional terms of the agreement were not disclosed.
Metabolex Acquires Shaman
Metabolex, Inc. of Hayward, California, has acquired materials and certain exclusive licenses to the diabetes drug discovery program of Shaman Pharmaceuticals, Inc. for use within specific geographic territories and therapeutic applications.
Shaman's diabetes research and development program was principally focused on the identification of orally active, blood-glucose lowering compounds to treat type 2 diabetes. The company's compounds were identified from extracts derived from plants with a long history of medicinal use.
Diasensor.com Invests In MicroIslet, Inc. to Find a Cure for Diabetes
Diasensor.com of Pittsburgh, Pennsylvania, has made an initial equity investment of $500,000 in MicroIslet, Inc. of San Diego. As part of the agreement, Diasensor.com will receive a 10 percent stake with an option to purchase an additional 10 percent in the future.
MicroIslet has licensed several technologies from Duke University that have been developed over the last decade by Dr. Emmanuel Opara, PhD, director of islet transplant research at the Duke Medical Center. The Duke/MicroIslet technology is unique in that it is a comprehensive multi- disciplinary system developed with the goal of curing type 1 diabetes.
Diasensor.com owns the patent, marketing and distribution rights to the Diasensor(R)2000 noninvasive glucose monitor currently in the FDA approval process. Diasensor.com's parent company, Biocontrol Technology, developed and manufactures the monitor.
Fred E. Cooper, CEO of Biocontrol Technology, Inc., added that the early-stage investment in MicroIslet allows Diasensor.com to expand on its diabetes interests with a technology that may potentially provide a cure for insulin dependent diabetes.
Medi-Ject and Chronimed to Distribute Needle-free Injection Devices Together
Medi-Ject Corporation has entered into an agreement with Home Service Medical (HSM), the direct marketing division of Chronimed, for distribution of its needle-free injection devices and supplies in the U.S. diabetes market.
HSM will take over all of Medi-Ject's direct-to-patient sales of devices and disposable supplies for the U.S. diabetes market, while Medi-Ject retains its own retail pharmacy-based distribution and online selling alliance with drugstore.com.
"HSM is widely regarded as the leading mail-order supplier of diabetes products in the United States," says Franklin Pass, MD, chairman and CEO of Medi-Ject. "By outsourcing more of our distribution to industry leaders like HSM and drugstore.com, we can focus on what we do best, [which is] making the market's best needle-free injectable drug delivery systems for our customers."
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.