Biomatrix Inc. today reports that its treatment forosteoarthritis reduced pain and increased mobility in patientsin clinical trials in Germany.
Synvisc, the Ottawa, Ontario, company's first medical product,is a chemically modified version of the naturally occurringbiomaterial hyaluronan, found in bacterial wall and in mostbody tissue. Hyaluronan functions as a lubricant, protectantand shock absorber in the joint.
"We are confident that Synvisc will significantly improve thelives of those who suffer from this chronic degenerativedisease," said Endre Balazs, chief executive officer and co-founder of BioMatrix. He is scheduled to address a symposiumat the Royal College of Physicians and Surgeons annual meetingin Ottawa today.
The drug, which has been approved for marketing in Canada,targets a patient population of about 8 million in Canada andthe U.S.
BioMatrix's treatment involves a series of three injections oneweek apart into the affected arthritic joint. Synvisc is moreelastic than naturally occurring hyaluronan and stays in thejoints longer, reducing the number of treatments andimproving the treatment's effectiveness.
The German studies involved four different clinical trials and400 patients, representing more than 1,000 injections ofSynvisc. Trials are also under way in five Canadian centers andin the U.S.
Carol Winslow, an analyst with Vector Securities in Deerfield,Ill., said that Synvisc is a big product for BioMatrix because itwill make the company profitable. She cautioned that U.S.clinical trials have not yet been completed.
"Conceptually, Synvisc is good," Winslow said, "but theprotocol required for U.S. trials is different than in Germany,so until we see U.S. results, we won't know." Winslow addedthat no other company is working on injecting hylan into theknee for osteoarthritis.
The company last month reported a net loss of $2.86 million,or 32 cents a share for the first six months of the yearcompared with a loss of $1.67 million, or 28 cents per share,in 1991. Revenues for the first six months of 1992 were $1.36million compared with $1.26 million for 1991.
Biomatrix stock closed unchanged on Thursday at $10 a share.
Synvisc provides a virtually natural solution without the sideeffects often associated with current osteoarthritismedications, such as anti-inflammatories and analgesics. Themolecular protective network of hylan-based Synvisc reducespain caused by movement and side effects from chemical painmediators.
"This is a completely new approach to treating osteoarthritis,"said Balazs, "and although it doesn't necessarily replace othertreatments, it has its own place in the disease treatment,especially in the early disease stages, when the patient isquite active."
Founded in 1981, BioMatrix began as a research anddevelopment company supplying its hyaluronan to the skin-careindustry. Balazs and his team were the first to develop amedically usable hyaluronan extracted from tissues. Theydeveloped a new class of patented biopolymers called hylans,which are modified forms of naturally occurring hyaluronan.
"We modified hyaluronan and made it more efficacious bycross-linking the molecule which makes it stay longer in thetissue -- an improved version of naturally occurring product,"Balazs said.
Hylans are compatible with the body and are non-allergenic.They are available as gels, fluids and solids, which makesthem more useful in medical applications than hyaluronan.
According to Balazs, BioMatrix has worldwide patentprotection for an entire technology covering hylans. Thecompany has several other applications in clinical trials forother forms of hylan for use in tissue augmentation and asanti-adhesives.
The company's core hylan technology has been used in a broadrange of applications, including urinary incontinence and thecontrol of adhesions and excessive scarring in connection withsurgery. BioMatrix has 11 products in U.S. clinical trials.
Synvase first will be marketed in Canada, and Belazs expectsit to reach the market in the U.S. some time next year. "This isour first product which will make us profitable," said Balazs.
-- Michelle Slade Associate Editor
(c) 1997 American Health Consultants. All rights reserved.