San Diego-based Phenomix Corp. has signed a deal with Italy's Chiesi Farmaceutici to develop and market its diabetes drug candidate dutogliptin in Europe, bringing in $28 million up front for a total of $163 million with milestones, plus royalties.
The initial payment is not earmarked for any particular purpose, though Phenomix is likely to funnel that money toward dutogliptin activities, CEO Laura Shawver said.
In addition to the U.S., the agreement also covers Brazil, Russia and all other members of the Commonwealth of Independent States, Turkey and Northern Africa. Chiesi will be responsible for product development, regulatory approval and commercialization in those territories.
Phenomix also is looking to secure another partner for the Asian market as part of its goal to commercialize dutogliptin worldwide. Ideally, the company would like to launch dutogliptin in the foreign markets around the same time frame as any U.S. launch. But Shawver indicated that there is a possibility that Phenomix "may wait a bit" before moving ahead on an Asia partnership.
The company is in early stage partner discussions for a preclinical hepatitis C compound, she said.
In the U.S., dutogliptin is partnered with Forest Laboratories Inc. under a 2008 deal valued at $340 million. (See BioWorld Today, Oct. 24, 2008.)
Oral dutogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, currently is undergoing five Phase III trials, and top-line data from the first trial are expected to be available in the second quarter of 2010, according to New York-based Forest Labs.
Forest and Phenomix, which are splitting development costs 50-50, have not said publicly when they expect enrollment to complete for the Phase III trials or when they plan to file for U.S. regulatory approval of dutogliptin.
Phenomix also is conducting a cardiovascular safety study of dutogliptin as required by the FDA for new anti-diabetic agents, and the company has been in discussions with the agency for that study, Shawver said. "We are quite optimistic, as dutogliptin, and DPP-4 inhibitors as a class, may be the first class to show improvements in cardiovascular benefits," Shawver said.
Chiesi also will likely conduct some clinical studies of dutogliptin, she said.
Two DPP-4 inhibitors currently are approved for the U.S. market. Whitehouse Station, N.J.-based Merck & Co.'s Januvia was the first DPP-4 inhibitor to reach the market, gaining approval in 2006. Bristol-Myers Squibb Co.'s Onglyza (saxagliptin) also has been FDA-approved. And Novartis AG's Galvus, a DPP-4 inhibitor, is approved in Europe. Osaka, Japan-based Takeda Pharmaceutical Co. Ltd.'s alogliptin, filed for approval in January 2008.
Paris-based Ipsen said Wednesday that its partner Swiss drugmaker Roche AG has disclosed the results of the second and third of eight T-emerge Phase III studies of taspoglutide in patients with diabetes, saying that the study met its primary endpoints in a head-to-head study with with Januvia (sitagliptin). Taspoglutide is the first human once-weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen's research and developed by Roche. T-emerge 1 (subcutaneous weekly taspoglutide vs. placebo in treatment-naïve patients) and T-emerge 4 (subcutaneous weekly taspoglutide vs. sitagliptin vs. placebo) both met their respective primary endpoints of change in HbA1c. In both studies, taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide-treated patients were nausea and vomiting.
Shawver acknowledged the "great inroads" that have been made with DPP-4 inhibitors, but she said glycosylated hemoglobin levels (A1C), which indicate how well blood glucose is controlled, are still rising and diabetes patients are still ending up on injectable insulin. She said there was definitely a need for oral antidiabetic agents and said the market has room for multiple DPP-4 inhibitors.
As a class, the DPP-4 inhibitors represent a $10 billion market opportunity.
Leerink Swann analyst Gary Nachman wrote in a research note that Forest Labs has a good level of activity in its pipeline, citing the 2010 read-out of Phase III dutogliptin data among the upcoming catalysts for the drugmaker. But he said "we are still not convinced of the commercial value of the pipeline and think more deals are needed." The note was issued following Leerink's investor meeting with Forest executives Dec. 1.
Shares in Forest Labs (NYSE:FRX) were up 55 cents, closing at $31.56.