Helix BioPharma and Merck Terminate Material Transfer and License Option Agreement for Topical Interferon Alpha-2b Developmen...
15 December 2012 - 9:01AM
Marketwired
Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a
biopharmaceutical company developing drug candidates for the
prevention and treatment of cancer, today announced that Helix and
Merck, known as MSD outside the United States and Canada, have
agreed to terminate their collaboration under the Material Transfer
and License Option Agreement, originally entered into between Helix
and a Merck subsidiary in December 2000, for the development of
pharmaceutical products containing Topical Interferon Alpha-2b
("TIFN alpha-2b").
The termination of the agreement between Merck and Helix means
that Merck will no longer have the option to license Helix's
Biphasix™ technology and phases out Merck's supply commitment with
respect to interferon-alpha 2b. The termination allows Helix to
seek alternate suppliers of interferon-alpha 2b to meet supply
needs for Helix's planned U.S. Phase II/III and European Phase III
clinical trials. In addition, the termination allows Helix to seek
a strategic partner to whom Helix could grant rights to license and
commercialize any products developed using TIFN alpha-2b combined
with Helix's Biphasix™ technology.
Helix is developing products containing TIFN alpha-2b for the
treatment of certain skin/mucosal lesions caused by human papilloma
virus (HPV) infections. HPV is one of the most common sexually
transmitted infections, causing ano-genital warts and cervical
dysplasia and is linked to the development of a variety of cancers.
Helix's patented Biphasix™ technology is designed to facilitate the
dermatological delivery of macromolecules such as interferon.
About Helix BioPharma Corp.
Helix BioPharma Corp. is a biopharmaceutical company
specializing in the field of cancer therapy. The company is
actively developing innovative products for the prevention and
treatment of cancer based on its proprietary technologies. Helix's
product development initiatives include its novel L-DOS47 new drug
candidate and its Topical Interferon Alpha-2b. Helix is currently
listed on the TSX and FSE under the symbol "HBP."
Forward-Looking Statements and Risks and Uncertainties
This news release contains certain forward-looking statements
and information (collectively, "forward-looking statements") within
the meaning of applicable Canadian securities laws including,
without limitation, forward-looking statements regarding Helix's
prospective U.S. Phase II/III and European Phase III clinical
trials relating to Topical Interferon Alpha-2b (low-grade cervical
lesions), including seeking strategic partner support, funding,
alternative sources of supply for interferon alpha-2b and obtaining
regulatory approvals for such trials. Forward-looking statements,
which may be identified by words including, without limitation,
"will", "seek", "could", "may" and other similar expressions, are
intended to provide information about management's current plans
and expectations regarding future operations.
Although Helix believes that the expectations reflected in such
forward-looking statements are reasonable, such statements involve
risks and uncertainties that may cause actual results or events to
differ materially from those anticipated and no assurance can be
given that these expectations will be realized, and undue reliance
should not be placed on such statements. Risk factors that could
cause actual results or events to differ materially from the
forward-looking statements include, without limitation, (i) the
inherent uncertainty involved in scientific research and drug
development; (ii) the risks associated with delay or inability to
complete clinical trials successfully and the long lead-times and
high costs associated with obtaining regulatory approval to market
any product which may result from successful completion of such
trials; (iii) the need to secure additional financing on terms
satisfactory to Helix or at all; (iv) clinical trials that yield
negative results, or results that do not justify future clinical
development; (v) that Helix is unable to secure the necessary
strategic partner support or supply of interferon alpha-2b to
conduct the prospective Topical Interferon Alpha-2b trials; and
(vi) those risks and uncertainties affecting the company as more
fully described in Helix's most recent Annual Information Form,
including under the headings "Forward-Looking Statements" and "Risk
Factors", filed with the Canadian Securities Administrators at
www.sedar.com (together, the "Helix Risk Factors"). Certain
material factors or assumptions are applied in making the
forward-looking statements, including, without limitation, that the
Helix Risk Factors will not cause Helix's actual results or events
to differ materially from the forward-looking statements.
Forward-looking statements and information are based on the
beliefs, assumptions and expectations of Helix's management on the
date of this news release, and Helix does not assume any obligation
to update any forward-looking statement or information should those
beliefs, assumptions or expectations, or other circumstances
change, except as required by law.
Investor Relations: Helix BioPharma Corp. Tel: 905
841-2300 Email: ir@helixbiopharma.com
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