Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.
Melior Plans Diabetes Spinoff
Melior Pharmaceuticals, a company that specializes in repurposing compounds that have been discontinued for particular indications, is planning to spin off a diabetes unit. Melior has a collection of previously discarded candidates—notably lead compound MLR-1023 for type 2 diabetes—and also is working with biopharmaceutical partners to develop their pipelines. Within 2 months, it plans to establish a company incorporating MLR-1023 and a few other diabetes compounds that are in earlier stages of development. Over time, the spin-off will become increasingly independent of the parent company, said Melior CEO Andrew G. Reaume. Melior is now writing up the investigational new drug (IND) paperwork for MLR-1023, but no filing timetable has been set, he said.
Crestor Copromotion Announced
AstraZeneca Pharmaceuticals LP and Abbott Laboratories have agreed that Abbott will copromote AstraZeneca's Crestor (rosuvastatin). The agreement calls for Abbott to receive the nonexclusive right to promote Crestor with AstraZeneca in the United States, excluding Puerto Rico. Specific financial terms were not disclosed. “Abbott's dyslipidemia portfolio includes a number of therapies to help physicians manage a patient's total lipid profile,” said Nicole Mowad-Nassar, Abbott's divisional vice president for primary care. “With robust clinical data to support its use in managing cholesterol, Crestor is another important therapeutic option we can now offer physicians.” The agreement marks the second comarketing effort between the two companies; the first, announced in 2006, was for a combination of the ingredients in Crestor and fenofibric acid (TriLipix), an investigational cholesterol-lowering drug being developed by Abbott. A new drug application for TriLipix is now being reviewed by the FDA; the two companies plan to submit a new drug application for the combination medication next year.
ReceptorBio Licenses Diabetes Drugs
Start-up company ReceptorBio Inc. has licensed Telik Inc.'s entire program of insulin receptor activators and hopes to file an investigational new drug application for a once-daily oral type 2 diabetes treatment compound from the group sometime in 2009. The deal, announced last month, includes undisclosed milestone and royalty payments related to potential development of about 100 oral small-molecule insulin receptor activators from Telik's TRAP (target-related affinity profiling) technology. “We are very excited. It's not just a single compound—it's their [Telik's] whole portfolio,” Joseph Evans, president and cofounder, said in an interview. ReceptorBio said the pipeline drugs represent a novel class of insulin sensitizers that could be used solo or in combination with other treatments to lower glucose levels. In the next 2 months, the firm plans to identify a lead compound from the licensed group, along with at least two backups, for an IND filing tentatively planned for 2009, said Mr. Evans, a former Telik executive and cofounder of Leptogen Inc. The insulin receptor activators picked up in the new licensing agreement were originally developed in partnership with Sanwa Kagaku Kenkyusho Co. Sanwa originally had paid Telik to partner promising compounds in diabetes and inflammatory disease using TRAP technology, but later abandoned both programs, leaving ownership rights by default with Telik, according to the original deal.
Mylan to Enter Contraceptive Market
Mylan Laboratories Inc. will enter the women's generic health care market with a portfolio of 22 oral contraceptive products acquired through a development and supply agreement with India-based Famy Care Ltd. Financial terms of the deal, announced during a Mylan earnings call in early August, were not disclosed. Mylan plans to begin filing abbreviated new drug applications for the products within the next few months and to begin commercializing them in 2010, with the focus on the portfolio as a whole. “We believe that the strength in the OC market is to have a portfolio. That's what we went after and … what you should expect from us is a portfolio of products,” Mylan CEO Robert Coury said. Famy Care is the world's largest manufacturer of oral contraceptives. The firm also manufactures reproductive health care products including emergency contraceptives, intrauterine devices, and tubal ligation rings.
Oral Diabetes Meds Popular in Europe
Oral therapy for type 2 diabetes has become the treatment of choice in Western Europe, according to a study by GfK Market Measures' Roper Global Diabetes Group. The research firm surveyed more then 3,600 diabetes patients in France, Germany, Italy, the Netherlands, Spain, and the United Kingdom, and found that the percentage of people on oral antidiabetic agents—either exclusively or as part of a combination therapy—has increased from 54% in 2000 to 64% in 2008. The proportion of oral therapy users is lowest in Germany (46%) and highest in France (64%), according to the study. Overall, fewer than 15% of patients take no medication for their diabetes, down from 22% in 2000. And 30% of patients use insulin: two-thirds exclusively, with the remaining third using it in combination with oral medications. The overall percentage of insulin users has remained stable since 2000, according to the study. Oral medications also appear to be used at earlier stages in the disease, with more than 75% of those who use oral medications exclusively having been prescribed the pills at diagnosis. The study projects the total diagnosed diabetes population in Western Europe at nearly 16.5 million.