Theratechnologies Inc. (TSX: TH)(NASDAQ: THER) today reported that the US Patent and Trademark Office (USPTO) has granted a patent (US Patent No. 8,361,964) for its second generation growth-hormone releasing factor (GRF) peptide, TH1173, providing for patent protection beyond 2030.
"While we are currently focusing all of our efforts and resources on revenue growth from tesamorelin as per our revised business plan, we still firmly believe in the long-term potential of TH1173. With this patent in place, we now have a secure timeframe during which we will be able to explore partnerships and licensing activities in certain territories to tap into this potential in the future," stated Luc Tanguay, President and Chief Executive Officer of Theratechnologies.
The preclinical phase for TH1173 is now completed. Results, including those from seven-day and 28-day toxicology trials, warrant the pursuit of the clinical stage development at the appropriate time.
TH1173 is unpartnered and wholly-owned by Theratechnologies.
Theratechnologies (TSX: TH)(NASDAQ: THER) is a biopharmaceutical company that specializes in innovative therapeutic peptide products, with an emphasis on growth-hormone releasing factor peptides. Further information about Theratechnologies is available on the Company's website atwww.theratech.com, on SEDAR at www.sedar.com and on the Securities and Exchange Commission's website at www.sec.gov.
This press release contains certain statements that are considered "forward-looking information" within the meaning of applicable securities legislation, which statements may contain such words as "may", "would", "could", "will", "intend", "plan", "anticipate", "believe", "estimate", "expect" and similar expressions. This forward-looking information includes, but is not limited to, information regarding the term of our patent, our capacity to grow our revenues, the medical potential of TH1173, the exploration of partnerships and licensing opportunities for TH1173 in certain territories and the pursuit of the clinical development of TH1173 at the appropriate time.
Forward-looking information is based upon a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Theratechnologies' control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include, but are not limited to, the fact that we will be successful in defending the validity and enforceability of our patent in the event it is challenged by a third party, that tesamorelin for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy will be approved, and, once approved, accepted by the marketplace, in jurisdictions where marketing authorization applications are pending, that we will succeed in resubmitting a marketing authorization application (MAA) for tesamorelin in Europe and that the MAA will be approved by European regulatory authorities, that we will have the human and financial resources, skills and know-how to pursue the development of TH1173 and that results from such research will be positive and allow us to continue the development of TH1173, and that third parties will be interested in entering into partnership or licensing agreements for TH1173 on commercial terms acceptable to us. These risks and uncertainties include, but are not limited to, the risk that we are unable to successfully defend the validity and enforceability of our patent in the event it is challenged by a third party, the risk that some or all of the pending marketing authorization applications for tesamorelin are not approved or that, if approved, the marketplace in the jurisdictions where approval is obtained do not accept the product, the risk that we are unable to resubmit an MAA for tesamorelin in Europe, the risk that we do not have, or lose, the necessary resources, skills and know-how to pursue the development of TH1173 or that results from further research on TH1173 do not warrant the pursuit of further development, and the risk that no third party is interested in entering into partnership or licensing agreements with us regarding TH1173 or that the terms of such agreements are not commercially acceptable to us.
Theratechnologies refers potential investors to the "Risks Factors" section of its Annual Information Form (AIF) dated February 27, 2012. The AIF is available at www.sedar.com and at www.sec.gov under Theratechnologies' public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking information reflects current expectations regarding future events and speaks only as of the date of this press release and represents Theratechnologies' expectations as of that date.
Theratechnologies undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.