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Bristol-Myers Squibb Latest To License DPP-4 Patents From OSI

This article was originally published in The Pink Sheet Daily

Executive Summary

OSI "owns the patent estate" on DPP-4 inhibitors and has licensed the medical use patents to Merck, Novartis and others.

Bristol-Myers Squibb licensed a suite of intellectual property from OSI Pharmaceuticals that includes dipeptidyl peptidase-4 as a drug target and combining DPP-4 inhibitors with other anti-diabetes drugs, OSI announced Dec. 14.

OSI's metabolic disease subsidiary Prosidion granted Bristol worldwide non-exclusive license to a platform of issued medical use patents and pending patent applications in return for an up-front payment as well as potential future milestone and royalty payments. Additional financial terms were not disclosed.

"A number of non-exclusive licenses to our DPP-4 technology have now been granted, and OSI expects to grant additional non-exclusive licenses in the future," Prosidion President Anker Lundemuse said.

"We do own the patent estate on DPP-4 inhibitors," OSI told "The Pink Sheet" DAILY. Seven or eight drug developers have already licensed the patents from us "so obviously that is being validated," the company said. "It is a very solid patent estate."

The agreement covers Bristol's investigational DPP-4 inhibitor saxagliptin, which is in Phase III clinical trials for type 2 diabetes, OSI said.

During a third quarter analyst call Nov. 7, OSI CEO Colin Goddard noted that OSI is in line to receive approximately 2% royalties from Merck and Novartis on DPP-4 medical use patents (1 (Also see "OSI Seeks Partner For DPP-4 Inhibitor Paused At Phase III Gate" - Pink Sheet, 9 Nov, 2006.)).

Merck's DDP-4 inhibitor Januvia (sitagliptin) was approved Oct. 16 (2 (Also see "DPP IV Inhibitor Januvia First Out Of The Gate" - Pink Sheet, 17 Oct, 2006.)). The company has an NDA pending for a Januvia/metformin combination, recently branded Janumet (3 (Also see "Merck’s Januvia/Metformin Combo To Be Branded Janumet" - Pink Sheet, 1 Dec, 2006.)).

Novartis had a late November user fee date for its DPP-4 candidate Galvus (vildagliptin), but FDA extended the review period so it could examine data from a primate dermatological study (4 (Also see "Galvus Review Delayed For Safety Analysis Of Primate Skin Data" - Pink Sheet, 13 Nov, 2006.)).

In 2004, Melville, N.Y.-based OSI bought the patent estate as well as a DPP-4 candidate from German pharmaceutical company Probiodrug for $32.8 million. "It was a real find. Each time an additional company signed on to the patent estate it validated the importance of the estate more and more. It validated the importance of DPP-4 in diabetes also," OSI said.

OSI is now seeking a licensing partner for that candidate, PSN9301, which is ready to go into Phase III studies.

- Shirley Haley ([email protected])

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