-Canadian launch expected in September, 2012-
BELLEVILLE, ON, July 23, 2012 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the first of two canine oncology products has received approval by regulators in both the U.S. and Canada. Market launch activities are currently underway with an expectation to have product available in September, 2012 in Canada, followed by a U.S. launch before the end of the calendar year.
The product - ImmunocidinTM - is based on the Company's proprietary mycobacterial cell wall technology, the same platform from which its Phase III product for human bladder cancer (UrocidinTM) was derived. ImmunocidinTM is indicated as an immunotherapy for the intratumoral treatment of mixed mammary tumor and mammary adenocarcinoma in dogs.
"We are pleased to be nearing market launch for the first of two important canine oncology products in a market where there are few registered veterinary products," said Andrew Grant, President, Bioniche Animal Health (global). "Canine cancer is the leading disease-related cause of death in dogs, with approximately one in four dying of cancer. Human chemotherapies are commonly used for treatment, but this requires special handling and the side effects can vastly diminish the dog's quality of life."
About Canine Cancer
Where a treatment is used in dogs with cancer, it can involve surgery, radiation therapy or chemotherapy. Radiation therapy is difficult to access and chemotherapy is highly toxic, requiring handling by specially trained personnel, which many companion animal veterinary clinics do not have. These therapies have similar side effects in animals as in humans (anorexia, nausea, hair loss, anemia, major infections, etc.). Surgery and therapy costs for dogs with cancer can range from $3,000 to $15,000 and above, depending upon type and stage of cancer, number and type of primary and supportive treatments required, the age and condition of the dog, and the location of treatment (travel costs).
Second Bioniche Canine Cancer Therapy
Through the course of development of UrocidinTM for human bladder cancer, the mycobacterial cell wall technology was extensively tested in a number of human cancer cell lines, including bladder, ovarian, colon, gastric and breast, as well as in canine cancer cell lines, including osteosarcoma and mammary, where it was shown to possess direct anticancer activity with apoptosis (programmed cell death) in cancer cells. The technology has also been demonstrated to be synergistic with chemotherapeutic agents. Further, a large amount of toxicity work has been completed to ascertain the product's safety for human use. One of the safety studies involved a number of dogs in an intravenous (I.V.) safety study, required to support the Phase III UrocidinTM program and to support registration. After administration of large doses of the product to these dogs, there were few side effects.
This work has led to further analysis of an I.V. therapy for canine cancer based on the same technology. Chemotherapy treatment commonly causes cytopenia, a deficiency in the number of cellular elements in the blood, including white blood cells as well as erythrocytes and platelets.
Clinical studies show that a single dose of the second product following chemotherapy treatment in healthy dogs restores the number of white blood cells in the dog to normal levels within 24 to 48 hours with few side effects. The Company is undertaking dose confirmation studies prior to conducting final licensing studies. It is anticipated that this work will be completed over the next 6 to 9 months, after which regulatory approvals will be sought, first in North America, then in Australia and Europe.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop and commercialize products that advance human or animal health and increase shareholder value.
Bioniche Animal Health develops, manufactures and markets veterinary biopharmaceutical products worldwide. In North America, it has development, manufacturing and marketing facilities in Belleville, Ontario, Canada, Athens, Georgia, U.S.A. and Pullman, Washington, U.S.A. In Australia, business is conducted from two sites: Sydney, New South Wales, where sales and marketing, customer support and technical service are located; and Armidale, New South Wales, where research, development and manufacturing facilities are located.
Bioniche Life Sciences Inc. has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2011. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE Bioniche Life Sciences Inc.