Alkermes Inc. ended deals by mutual agreement with Johnson & Johnson (J&J) and Schering-Plough Corp., and advanced a third collaboration with J&J by completing a probative human study of a sustained-release formulation of the blood booster erythropoietin (EPO), for non-dialysis indications.
The EPO collaboration using Alkermes ProLease drug-delivery technology is "the one that's in everybody's model," said Richard Pops, CEO of Cambridge, Mass.-based Alkermes. "We've been giving everybody guidance that these [others] were not moving ahead very quickly."
The completion of the study triggers a $2 million milestone payment to Alkermes by the R.W. Johnson Pharmaceutical Research Institute (PRI), of Raritan, N.J., which is the research and development division of Ortho Pharmaceutical Corp., a subsidiary of J&J.
Ending are a separate deal with PRI to develop a sustained-release formulation of an undisclosed compound being studied for the treatment of hormone-mediated disorders; and a deal with Schering-Plough, of Madison, N.J., for a sustained-release formulation of Intron A (interferon alfa-2b).
The PRI collaboration was disclosed in December 1996. With its dissolution, Alkermes has discontinued development of the product.
"It was not a marketed product, just an early-stage research project," Pops said. "The ProLease formulation delivered the drug for the appropriate period of time," he added, but J&J opted not to proceed with its development.
The Schering-Plough deal began in 1992 and was extended in 1995. With its end, Alkermes regains rights licensed to Schering-Plough for a sustained-release formulations of alpha interferon.
ProLease is a polymeric microsphere that works in a way similar to self-dissolving sutures.
J&J licensed EPO from Amgen Inc., of Thousand Oaks, Calif., which sells its own brand of EPO, called Epogen, for use with dialysis patients. Alkermes' deal with J&J for EPO is potentially worth more than $30 million. (See BioWorld Today, Jan. 23, 1998, p. 1.)
The marketing of EPO has been a war zone, in which Amgen and Ortho battled over dividing spillover revenues, from sales to customers using brands of EPO sold by both companies.
Amgen's Epogen is for use with dialysis patients; Ortho's brand, Procrit, is for non-dialysis use. Last fall, a judge ruled that Amgen owed $96 million to Ortho, which had estimated the amount due at $423 million. (See BioWorld Today, Sept. 16, 1997, p. 1.)
"Our collaboration has been focused on development for [J&J's] field of use," Pops said.
The trial for which Alkermes won the milestone payment was "the first clinical trial," Pops said. "It was to establish safety, duration of response and pharmacodynamic response."
Alkermes' stock (NASDAQ:ALKS) closed Monday at $19.875, up $0.625. n