Dr. Michael Berendt reports
BIONICHE LIFE SCIENCES INC. ANNOUNCES KEY CORPORATE UPDATES
Bioniche Life Sciences Inc. has made the following key corporate updates.
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The establishment of Monday, April 14, 2014, as the date of the shareholders meeting for consideration of the $61-million acquisition offer for Bioniche's animal health business;
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The scheduling of a shareholder conference call on Thursday, March 13, 2014, with Bioniche chief executive officer, 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;
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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, Ont.;
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Continuing dialogue with the U.S. Food and Drug Administration 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 Vetoquinol for cash consideration of $61-million, the company will
be holding a special meeting of shareholders as follows:
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Monday, April 14, 2014;
- 9 a.m. EST;
- Norton Rose Fulbright Canada;
- Board rooms D, E and F;
- Royal Bank Plaza, South Tower, Suite 3800;
- 200 Bay St.;
- Toronto, Ont.
Individuals holding common shares of Bioniche Life Sciences as of
Monday, March 11, 2014, will be eligible to vote at the meeting. A
management information 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 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 e-mail 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. "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 health care 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:
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Conference call and audio webcast;
- Thursday, March 13, 2014;
- 5 p.m. EST.
To participate in the conference call from North America, call 888-231-8191 (conference ID: 7767236).
A replay of the conference call will be available until March 20, 2014,
at midnight by calling 1-855-859-2056 (passcode: 7767236).
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, Ont. The company has now engaged PharmaBioSource Inc.
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 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, 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 were 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 were 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.
We seek Safe Harbor.
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