MONTREAL, CANADA--(Marketwired - Sep 4, 2013) - Theratechnologies Inc. (TH.TO) announced today that it will resume production of EGRIFTA™ using its original manufacturing process (original process).
Until new lots of EGRIFTA™ are manufactured using the original process and available for resale, ongoing demand for EGRIFTA™ will be supplied from existing inventory. Based on current sales trend, it is estimated that there is enough supply to meet U.S. market demand until mid-December 2013 and that the new lots of EGRIFTA™ will be available for resale prior to this date.
As announced earlier this year, Theratechnologies halted production of EGRIFTA™ using the original process to rectify issues that were not linked to the product itself but rather related to the consistency of the lyophilization cycle. Corrective measures were developed and implemented and production resumed in May 2013. Quality issues were recently encountered with the revised manufacturing process. The Company decided to carry out further development work on its manufacturing process to optimize it prior to filing documents with the U.S. FDA seeking clearance to resell the new lots of EGRIFTA™ made with such revised manufacturing process. The manufacturing process to be developed will be submitted to the U.S. FDA prior to its implementation.
The Company has informed the U.S. FDA of its decision to resume production using the original process.
Theratechnologies (TH.TO) 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 at www.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 timing on the availability of new lots of EGRIFTA™ for resale, the capacity to meet market demand from the available inventory, the optimization of the manufacturing process and the submission to the U.S. FDA of such optimized manufacturing process.
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 the lots of EGRIFTA™ manufactured with the original process will meet the product specifications and will be available for resale prior to mid-December 2013, no event will occur delaying the beginning or preventing the completion of the manufacture of new lots of EGRIFTA™, current sales level will remain stable such that the inventory level will be high enough to meet market demand until mid-December 2013 or until new lots of EGRIFTA™ are available for resale, the Company will be able to optimize its manufacturing process and the FDA will not object to the use of the original process to resume the manufacture of EGRIFTA™.
These risks and uncertainties include, but are not limited to, the risk that a drug-shortage occurs because there is a delay in resuming or during the manufacture of EGRIFTA™, the lots of EGRIFTA™ manufactured with the original process are not within the specifications and may not be available for resale before mid-December 2013, demand for EGRIFTA™ increases and the inventory level is not large enough to supply such demand, the U.S. FDA does not accept that the Company resumes the manufacture of EGRIFTA™ with the original process and/or the risk that the Company is unable to optimize its manufacturing process if the lots manufactured from the original process fails to be within the specifications and are not available for resale.
We refer potential investors to the "Risk Factors" section of our Annual Report on Form 20-F dated February 26, 2013 available at www.sedar.com, www.sec.gov and www.theratech.com. 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 statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.
We undertake 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.