BELLEVILLE, ON, Oct. 7, 2013 /CNW/ - Bioniche Life Sciences Inc. (TSX:
BNC) (ASX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today provided an update on its plans for a
New Drug Submission filing in Canada for Urocidin™, the Company's Phase III bladder cancer product.
As announced in July, the Company had a meeting in late June with Health
Canada, at which time the Company discussed the filing of a regulatory
submission for Urocidin™ under Health Canada's Notice of Compliance with Conditions (NOC/c)
policy. At that time, Health Canada advised the Company that the data
from the first Phase III clinical trial with Urocidin™ may be sufficient to qualify for filing under the NOC/c policy, but the
regulator asked the Company to submit a clinical assessment package
addressing some clinical questions as part of the request to file a New
Drug Submission (NDS) under the NOC/c policy.
The Company initially anticipated that all of the requested materials
could be submitted to Health Canada before the end of calendar 2013.
However, based on subsequent discussions with Health Canada, additional
information will be required to finalize the submission, which will
result in a delay. The Company now believes that it will have these
materials ready for submission by June 30, 2014.
An early registration in Canada would generate revenues from commercial
sales to offset the cost of additional clinical trial work that may be
required for the U.S. and other jurisdictions.
The Company will also be seeking a meeting with the U.S. Food and Drug
Administration (FDA) to discuss a clinical development plan to achieve
U.S. registration. Such meeting is being sought at the earliest
As indicated in its year-end financials news release of September 27,
2013, the Company is focused on licensing Urocidin™ rightsfor major markets such as the U.S. and Europe, as well as preparations
for its launch in Canada. In June, 2013, the Company announced a
license agreement with Paladin Labs Inc. for the Canadian, Mexican and
South African markets. For the U.S. and other market licenses, the
Company began receiving unsolicited requests for information on
possible regional licenses for Urocidin™ early in 2013. To date, the Company has a list of 9 companies in the
U.S. and 18 companies in Europe that have requested to be considered as
license partners for Urocidin™, and a list of 9 companies for smaller markets.
Treatment of non-muscle-invasive bladder cancer in patients who failed
BCG therapy is the first target indication for Urocidin™.