Pegvisomant. Pharmacia.

Abstract

Pegvisomant, a polyethylene glycol (PEG) derivative of human growth hormone (GH) that acts as a highly selective GH receptor antagonist, is under development by Pharmacia (formerly Sensus) as a potential treatment for acromegaly. By February 2001, Sensus had submitted an NDA for the treatment of acromegaly, and an approvable letter indicating outstanding issues had been received by July 2001. Pegvisomant was granted Orphan Drug status by the FDA and was designated for Priority Review. Pegvisomant also received Orphan Drug designation in the EU and Japan. In March 2001, additional regulatory filings were being planned for later in 2001. In October 2001, Pharmacia was preparing an NDA in Japan for the treatment of acromegaly. By September 1998, phase 1 trials of the treatment were underway for diabetic retinopathy, and were planned for diabetic nephropathy in 1999. By September 1997, a phase II trial to test the effects of pegvisonant an insulin sensitivity and secretion in type II diabetes patients was underway. However, no development has been reported for these indications since the dates given. By 1994, Sensus had licensed technology for development of GH receptor antagonists from Genentech and Ohio University. Sensus was to pay Genentech, and Genentech was to receive equity in Sensus and royalties from the commercialization of any product resulting from the agreement. In April 2000, the company entered into a licensing agreement with Shearwater Polymers for the PEGylation of pegvisomant using Shearwater's proprietary technology, which is now used to produce the 20-kDa PEG-derivative of pegvisomant. In June 1999, Pharmacia Corp (formerly Pharmacia & Upjohn) signed an agreement to purchase 19.9% of Sensus and to potentially acquire the remainder of the company at a later date. In March 2001, Pharmacia completed its purchase of Sensus. Analysts at Merrill Lynch predicted in February 2002 that the product would be launched in 2003, with US revenues of $20 million, rising to $115 million in 2006.