Allelix Biopharmaceuticals Inc. and its long-time developmentpartner, Glaxo Canada Inc., announced Monday that they haveformed a joint venture to take parathyroid hormone (PTH) intoclinical trials for treating osteoporosis.
Allelix of Mississauga, Toronto, joined forces with Glaxo in 1988in a five-year research and development agreement on PTH.The joint venture is a separate agreement, meant to take theproduct into the clinic, explained John Dietrich, Allelix's(TSE:AXE) vice president of research and clinical development.It involves no separate investment in Allelix by Glaxo, whichcurrently holds a 9.7 percent equity position.
Allelix and Glaxo will share the costs of taking PTH thoughPhase I and II clinical trials, while Glaxo has the option toundertake worldwide clinical and commercial development ofthe product at the end of the Phase IIs. In this case, Allelix willreceive royalties and Canadian co-promotion rights.
Throughout, Allelix retains the right to supply PTH. The proteinis being manufactured for Allelix by Cetus V.V. (EuroCetus) ofAmsterdam under the terms of an agreement inked last year.EuroCetus, which uses an Escherichia coli production system toproduce PTH, will provide human-grade recombinant PTH toAllelix for the immediate future, said Dietrich. (Allelix is in theprocess of completing its own manufacturing facility.)
PTH is a protein that plays an important role in regulating bonemineral metabolism and stabilizing calcium levels in the body.Allelix researchers have determined in animal studies that PTHcan actually rebuild bone on the order of 5 to 10 percent overone year. Thus it could prove to be an effective therapeutic fortreating osteoporosis, a degenerative bone disease that affectsclose to 31 million people annually in the U.S. alone.
Allelix had also been developing PTH for treating heart attacksbut the results of a number of animal studies wereinconclusive. "We are no longer developing PTH forcardiovascular use," Dietrich said.
-- Jennifer Van Brunt Senior Editor
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