Bioniche Presents Data on Cystistat and Launches Product Web Site at Inaugural Multinational Interstitial Cystitis Association Annual Meeting
Belleville, ON, September 23, 2004 – Bioniche Life Sciences Inc. (TSX:BNC), a fully-integrated human and animal health biopharmaceutical company, is presenting data from studies related to the treatment of interstitial cystitis (IC) and other forms of cystitis with a Bioniche-developed product at the Multinational Interstitial Cystitis Association (MICA) Annual Meeting in Rome, Italy this week.
Intravesical Hyaluronic Acid for the Treatment of Interstitial Cystitis and Management of Chronic and Acute Cystitis
Dr. Claus Riedl, Professor of Urology and Chief Urologist at the Thermenklinikum Baden, in Baden, Austria presented the outcome of intravesical hyaluronic acid therapy (Cystistat®) in 103 IC patients treated in three specialized IC clinics in Vienna, Baden and Dornbirn. All patients were screened by the Comparative Cystometry Test (CCT) and received weekly instillations of 50 ml hyaluronic acid (HA - Cystistat) 40 mg until they were free of symptoms or significantly improved to their satisfaction. Each patient received questionnaires at the end of therapy and several months later in which they rated their pre- and post-treatment symptoms and were asked to comment on their personal benefit in terms of quality of life.
Major improvements in symptoms were reported by more than 80% of the patients. Eighty-three percent of patients confirmed that the treatment had improved their quality of life significantly.
“These results confirm the preliminary report published in the Journal of Urology in 1996 by Dr. Alvaro Morales demonstrating the efficacy of intravesical hyaluronic acid therapy in IC,” noted Dr. Riedl. “The results also confirm the relevance of the previously-published CCT. IC patients who test positive with the CCT have a greater than 80% chance of significant symptom remission with HA instillations and relief is maintained over several months: the longest period of documented symptoms remission is now more than two years.”
Dr. Riedl also presented international experience on the prophylactic use of intravesical HA in: acute radiation-induced cystitis (RIC); recurrent bacterial cystitis (RBC); and catheter-associated urinary tract infections (CAUTI), where Cystistat achieved major improvements in patients’ conditions. An excellent safety profile has been reported and confirmed by surveillance data, with more than 250,000 intravesical HA treatments recorded to date.
“This body of evidence points to the efficacy and safety of intravesical HA in IC as well as in additional inflammatory bladder conditions,” noted Dr. Riedl. “Controlled studies are ongoing in IC and RBC. There is momentum to further explore UTI management and to confirm the observations of the RBC study recently published in the British Journal of Urology. HA seems to restore the functions of the urothelium and sub-urothelial level of the bladder wall badly-damaged in these various conditions.”
New Cystistat® Web Site
Coinciding with the 1st meeting of MICA, Bioniche is launching a multilingual web site to inform patients about cystitis and how Cystistat has been shown to be effective in intravesical HA therapy. The site, located at www.cystistat.com, includes information on types of cystitis, the use of Cystistat, and other product details. It also features a patient self-test, links to IC support groups’ web sites, and more.
“Cystistat is our main product in the Urology sector, with sales growing by more than 30% annually,” noted Graeme McRae, President & CEO of Bioniche Life Sciences. “We reorganized our distribution channel in the past year by replacing our Canadian distributor with our own sales and marketing team. This has helped us to develop links with patient communities and to make better contacts with urological practitioners.”
Cystistat is a patented sodium hyaluronate solution approved in more than 20 countries (including Canada and the European Union). Cystistat is indicated for the temporary replacement of the glycosoaminoglyan (GAG) layer of the bladder. A defective GAG layer has been postulated to be one of the major causes of pain, urgency, and urinary frequency characterized in patients with IC. Recent research has suggested that GAG layer defects may be linked to recurrent bacterial cystitis. Cystistat was first approved in 1996 by Health Canada, and then in subsequent jurisdictions.