Celtrix Pharmaceuticals Inc. announced Monday that it hassigned an agreement with the Japanese company SantenPharmaceutical Co. Ltd. to commercialize the growth factorBetaKine for ophthalmic therapy in Japan.

The agreement brings together Santen's position as the leadingophthalmic company in Japan and its links with Japaneseophthalmic surgeons with Celtrix's experience with BetaKine inhuman clinical trials and its manufacturing operation.

Under the terms of the agreement, Celtrix (NASDAQ:CTRX) willmanufacture BetaKine and will share equally with Santen anyprofits resulting from commercialization. For its part, Santen isresponsible for preclinical and clinical testing of BetaKine inJapan, as well as regulatory filings. Santen will market BetaKinein Japan and other Asian countries yet to be determined.

BetaKine is a naturally occurring growth factor, TGF-beta-2,that Celtrix of Santa Clara, Calif., is developing for variousapplications, particularly for treating macular holes, which arenon-traumatic wounds of the eye. No reliable therapy isavailable for this condition.

Macular holes occur in the central region of the retina anddamage fine vision, often leading to blindness. The condition isage-related, and scattered reports have suggested that it mayhave a genetic component. However, it's still not well-understood what actually causes macular holes, said SandraMcNamara, Celtrix's chief financial officer.

Celtrix's Phase II U.S. clinical trials on more than 400 patientsindicate that treating with BetaKine during the standardsurgical procedure, called vitrectomy, enables macular holes toheal. From 85 percent to 90 percent of the treated eyes regaina significant amount of lost vision, the company said. The PhaseII trials are nearly complete. It will be about six to eight weeksuntil "the last patients have crossed the one-year followuppoint," McNamara told BioWorld.

The BetaKine used to date in these trials is the native variety,but Celtrix is "in the process of switching its manufacturing tothe recombinant material," said McNamara. The company isnow doing toxicity profiles as part of the bridging studiesrequired when such a switch is made.

"The beauty of BetaKine is that it is highly conserved species-to-species. This gives us a lot of confidence that we won't seeany biological differences as we move from one form (ofBetaKine) to the other," McNamara told BioWorld. "Santen willstart right away with the recombinant version of BetaKine."

Celtrix's stock closed unchanged Monday at $6.13 a share.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.