Bioniche Life Sciences Inc. Announces Key Corporate Updates
BELLEVILLE, ON, March 4, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) announced today key corporate updates:
- The establishment of Monday, April 14, 2014 as the date of the Shareholder Meeting for consideration of the C$61 million acquisition offer for Bioniche's Animal Health business;
- The scheduling of a Shareholder Conference Call on Thursday, March 13, 2014, with Bioniche CEO, Dr. Michael Berendt, to provide an update on Bioniche's corporate strategy including the sale of Animal Health, the partnering of One Health, and the focus on human oncology therapeutics;
- The engagement of PharmaBioSource to assist in the sale and/or partnering of Bioniche's One Health business including the Econiche® vaccine technology and associated Vaccine Manufacturing Centre in Belleville, Ontario; and
- Continuing dialogue with the U.S. FDA regarding the regulatory pathway for Urocidin™.
Shareholder Meeting to Vote on Proposed Animal Health Sale Transaction
Further to last week's news release announcing the signing of a share purchase agreement for the sale of the Company's Animal Health business to Vétoquinol for cash consideration of C$61 million, the Company will be holding a Special Meeting of Shareholders as follows:
Monday, April 14, 2014
9:00 .m. EST
Norton Rose Fulbright Canada
Board Rooms D, E, and F
Royal Bank Plaza, South Tower, Suite 3800
200 Bay Street
Individuals holding Common Shares of Bioniche Life Sciences Inc. as of Monday, March 11, 2014 will be eligible to vote at the meeting. A management information circular (the "Circular") containing a detailed description of the transaction, pro forma financial statements, use of proceeds, and the meeting agenda will be mailed to shareholders in advance of the meeting. All shareholders are encouraged to vote in person or by proxy. Voting instructions will be contained in the Circular.
The Company has retained Laurel Hill Advisory Group ("Laurel Hill") to act as proxy solicitation agent and to respond to inquiries from Bioniche shareholders. Laurel Hill may be contacted by telephone at 1-877-452-7184 toll-free in North America and at 416-304-0211 for collect calls outside of North America, or by email at firstname.lastname@example.org.
"The divestment of our Animal Health division is a key step in our declared strategy to focus on human oncology, centred around our bladder cancer therapeutic, Urocidin™," said Dr. Michael Berendt, Chief Executive Officer of Bioniche Life Sciences Inc. "We are pleased with the outcome of the Animal Health divestment process, which we believe was comprehensive. We are confident that we have been in contact with all significant potential buyers across the globe and, in the end, we have accepted what we believe is a solid and fair offer. Our Board of Directors and senior management are recommending its acceptance by shareholders at the upcoming meeting."
The Company has retained Bloom Burton & Co., Canada's leading investment bank dedicated solely to healthcare and biotechnology, to provide a fairness opinion, details of which will be provided in the Circular to shareholders.
Shareholder Conference Call and Audio Webcast
Company representatives, including CEO Dr. Michael Berendt, will provide an update on Bioniche's corporate strategy including the sale of Animal Health, the partnering of One Health, and the focus on human oncology therapeutics during a:
Conference Call & Audio Webcast
Thursday, March 13, 2014
5:00 p.m. EST
To participate in the conference call from North America, call (888) 231-8191 (conference ID: 7767236). A listen-only audio webcast will be available at:
A replay of the conference call will be available until March 20, 2014 at midnight by calling 1-855-859-2056 (passcode: 7767236). The webcast will be available for replay using the above link until March 13, 2015.
PharmaBioSource Appointed to Find a Partner for One Health/VMC
The Company is implementing its previously announced strategic plan to sell or partner its One Health business unit, including the Econiche® vaccine technology and the Vaccine Manufacturing Centre (VMC) in Belleville, Ontario. The Company has now engaged PharmaBioSource, Inc. (www.pharmabiosource.com) to lead this process. PharmaBioSource is a specialized U.S.-based pharmaceutical and biotech capacity and facility transaction services and consulting company with a long and unique track record in selling and licensing pharmaceutical facilities and technologies. To facilitate the transaction, Bioniche will be establishing a stand-alone One Health legal entity, as a wholly-owned subsidiary of Bioniche Life Sciences Inc., that will own Bioniche's entire Belleville campus, including the VMC, the leading Econiche® vaccine technology, and associated debt and tax assets.
Commenting on the announcement, Pharmabiosource CEO, Bill Wiederseim, stated, "We are very excited by this mandate and believe that there will be a lot of third-party interest in this technology and leading edge vaccine facility. While we will be exploring opportunities with groups that may be interested in a package that involves both the Econiche® vaccine technology and the manufacturing facility, we also know that there will be interest in each of the assets on a stand-alone basis and that the VMC can be used to produce a range of biological therapeutics for both human and animal use."
Urocidin™ Regulatory Update
As announced last quarter, a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential for accelerated approval of Urocidin™ was postponed to allow the Company additional time to gather information required by the regulator. The Company submitted the required information with a request for the FDA to consider whether or not the data generated to date on Urocidin™ was sufficient to file a Biologics Licensing Application (BLA) under the accelerated approval policy. The FDA responded that the data generated from the single open-label study was not sufficient on its own to support accelerated approval. As a result, the Company will be discussing with the FDA potential regulatory approval paths for Urocidin™. This dialogue includes issues related to accelerated approval, as well as clinical trial protocol design, potentially treatable patient populations, and the FDA's special protocol assessment (SPA) procedure.
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a clinical stage Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary and innovative products for the global human health oncology market. The Company's primary goal is to develop and commercialize products that advance human health and increase shareholder value. 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.