BELLEVILLE, ON,
March 4, 2014 /CNW/ - 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
Toronto, Ontario
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
assistance@laurelhill.com.
"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:
http://event.on24.com/r.htm?e=761997&s=1&k=061B492D7BD50C4151A38BCBB36EC027
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.