AURORA, ON--(Marketwire - December 14, 2012) - 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.