Chiasma, Novartis, Roche deal

Chiasma was to announce on Feb. 18 that it granted Roche exclusive, worldwide rights to develop and commercialize Octreolin octreotide acetate for acromegaly and neuroendocrine tumors. Chiasma will receive $65 million upfront and is eligible for up to $530 million in milestones, plus tiered, double-digit royalties. Octreolin, an oral formulation of octreotide acetate, a somatostatin mimetic, designed using Chiasma's Transient Permeability Enhancer (TPE) technology, has Orphan Drug designation in the U.S. to treat acromegaly, for which it is in Phase III testing with data expected in 3Q13 followed by MAA and NDA submissions in 1Q14. A Phase II trial for neuroendocrine tumors is slated for later this year.

The company is developing the product under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. Evercore Partners advised Chiasma while Latham & Watkins LLP was the biotech's legal counsel. ...