Canadian Product Offers Hope to Sufferers of Severe Bladder Disease.

TORONTO--(BUSINESS WIRE)--Feb. 15, 1995--BIONICHE INC. (TSE:BNC) Bioniche Inc. has announced the availability of its product Cystistat(TM) (sterile sodium hyaluronate solution) for the treatment of interstitial cystitis (IC).

Cystistat has performed extremely well in a pilot study conducted at Queen's University in Kingston, leading to optimism that a better treatment for IC is now available.

IC is a severe bladder disease affecting an estimated 50,000 Canadians. A relatively unknown condition, it often completely disrupts the lives of those who suffer from it. Patients experience intense pelvic pain, an increased frequency of urination (up to 60 times throughout each day and night) and urgency (an urgent need to urinate immediately) as a result of the inflammation of the bladder wall and reduced capacity of the bladder.

IC is diagnosed more frequently in women than men, is difficult to diagnose and treat, and often becomes a disabling condition. The average IC patient may go as long as four years before the problem is identified. Available treatments help some, but not others. No one knows what causes it; theories include a virus, a bacterial infection, an immune system disorder, an irritating substance in the urine, and a bladder-wall defect.

"This is not to be confused with a common bladder infection or cystitis," said Sheila Holmes, Vice President of the Interstitial Cystitis Association of Canada (ICA). "IC can be devastating."

A 1987 survey of IC sufferers conducted by the Urban Institute of Washington showed that -

- 40 per cent were unable to work

- 27 per cent were unable to have sex due to pain

- 27 per cent had marriage breakdown

- 55 per cent contemplated suicide

- 12 per cent had actually attempted suicide

"We are very hopeful about Cystistat, because there are so few effective treatments available and because it has performed so well for the people who have tried it," said Ms. Holmes.

A Canadian discovery

Cystistat was developed in Canada by London-based Bioniche, a Canadian biopharmaceutical company. The original idea for its use came from researchers at Queen's University in Kingston, Ontario. It has demonstrated positive results in an open-label pilot study conducted by Dr. Alvaro Morales of the Department of Urology, Queen's University.

"Of the 21 patients treated at our clinic with Cystistat, positive response was experienced by 70 per cent of patients, with the remaining 30 per cent experiencing at least some symptomatic relief," said Dr. Morales. "While these are only preliminary results, we are extremely encouraged," he added.

Bioniche is preparing now to conduct a large, multi-centre, double-blind clinical trial on Cystistat with Dr. Morales as the lead clinical investigator. The results from this study will allow Bioniche to file international registrations, making Cystistat available to IC patients around the world.

Introduced to the bladder through a catheter, Cystistat is a medical device and is registered with the Health Protection Branch (HPB) of Health Canada. It works by temporarily replenishing the deficient lining of the bladder.

The active substance in Cystistat is a highly purified hyaluronic acid of a specific molecular weight. A key component of connective tissue, hyaluronic acid is normally found in the bladder lining. Because hyaluronic acid is a product natural to the body, Cystistat's side effects are rare and mild in nature.

Cystistat is supplied in the form of a kit. The doctor instils it into the bladder using a catheter. When it is infused into the bladder, it acts as a temporary replacement for the defective layer. It is recommended that it be instilled once weekly for four treatments and then monthly until symptoms resolve. Experienced patients can be taught to handle the instillation themselves.

Cystistat is sold through drug wholesalers to selected hospital pharmacies and physicians. It will cost approximately $800.00 for the first month and $200.00 for each subsequent month. Bioniche offers patients a Cost Protection Program should the treatment be unsuccessful.

Bioniche Inc. is a Canadian biopharmaceutical company active in three areas -- the research and development of treatments for conditions involving the immune system -- namely cancer and infectious diseases; the development and marketing of licensed medical products; and the manufacturing and marketing of pharmaceuticals, primarily sterile injectables.

CONTACT: Veritas Communications Inc.

John Crean/Jennifer Spencer, 416/482-2248