Memorandum

Amylin and Takeda discontinue development of pramlintide/metreleptin – August 24, 2011

Executive Highlights

  • Amylin and Takeda have discontinued development of pramlintide/metreleptin, an investigational therapy for the treatment of obesity.

Late last week, Amylin and Takeda announced that they have discontinued development of pramlintide/metreleptin, an investigational therapy for the treatment of obesity, following a commercial reassessment of the therapy. In the commercial reassessment, the companies took into consideration “a revised development plan” and “evolving dynamics with the obesity therapeutic area.” As we understand it, the decision to discontinue pramlintide/metreleptin was not due to the previously reported antibody-related lab finding associated with metreleptin in two patients in a phase 2 study (clinicaltrials.gov ID: NCT00673387) (see March 16, 2011 Closer Look). While no specifics were provided, Amylin and Takeda were jointly working on co-formulating pramlintide and metreleptin, such that it would require less than four separate injections per day. It remains unclear whether the “revised development plan” Amylin/Takeda considered involved co-formulation studies, an unexpected requirement by the FDA, or the antibody-related finding. Meanwhile, regarding the “evolving dynamics with the obesity therapeutic area,” we suspect the high hurdles for approval (evidenced by the FDA’s recent decisions to deny approval of Vivus’ Qnexa, Arena’s lorcaserin, and Orexigen’s Contrave) did not help the commercial reassessment to support continuing development of pramlintide/metreleptin. To add to the regulatory uncertainty in obesity drug development, the FDA is intending to hold an advisory committee meeting in 2012 to discuss the risk/benefit evaluation of obesity medications. Although Amylin and Takeda have discontinued the development of pramlintide/metreleptin, they will continue to investigate the antibody-related lab finding associated with metreleptin, and continue to evaluate other potential candidates for the treatment of obesity.

Since Amylin and Takeda entered into their global obesity partnership in November 2009, the companies have dropped their only two late-stage clinical stage candidates, davalintide and pramlintide/metreleptin, without advancing either beyond phase 2 trials. The companies are not currently disclosing the status (or anticipated timelines for INDs) of earlier stage obesity candidates. As a reminder, after Takeda paid Amylin $75 million upfront, Amylin was responsible for completing phase 2 studies, while Takeda was responsible for 80% of US phase 3 costs and 100% of international phase 3 costs, registration costs, and commercialization costs. While this “commercial reassessment” that resulted in discontinuing pramlintide/metreleptin may highlight the difficult regulatory environment for obesity drugs, we believe it also highlights a significant scientific challenge of developing a commercially viable obesity drug.

--by Vincent Wu and Kelly Close