FDA approval ofEGRIFTATM paves theway to growth strategy
Montreal, Canada - May18, 2011 - TheratechnologiesInc. (TSX: TH) ("Theratechnologies" or the "Company")today held its annual and special meeting of shareholders in Montreal. It wasan opportunity to celebrate a milestone year and to review the Company'sprospects as it develops the full potential of its flagship product, EGRIFTATM.
In his remarks to shareholders, Mr. Paul Pommier, Chairman of the Board of Theratechnologies, expressed his satisfaction over the Food and Drug Administration's ("FDA") approval of EGRIFTATM.
"Earning FDA approval is a significant achievement. Theratechnologies is one of the few Canadian biotech companies to have successfully steered amolecule from discovery to marketing approval," said Mr. Pommier.
Mr. Pommier explained that the FDA's approval set the stage for two important partnership agreements, with Sanofi and with Ferrer InternacionalS.A. These partnerships support Theratechnologies'objective of maximizing the commercial value of EGRIFTATM in markets around the world. He also announced that Theratechnologiesis applying to list its shares on the NASDAQ market in the United States.
Mr. Pommier read the prepared address of President and CEO John-Michel Huss, who was not able to attend the meeting. Mr. Huss' absence was due to ophthalmic surgery that he underwentyesterday to treat a detached retina in his right eye. His doctors expect ashort recovery; however, the surgery could not have been delayed withoutcausing additional risk to Mr. Huss. (Quotations from Mr. Huss in this newsrelease were taken from his prepared remarks.)
"The launch of EGRIFTATM in the United States is a success by any standards. We are tracking at 100 additional prescriptions per week," declared John-Michel Huss. "Royalty revenues are nowstarting to flow and several important regulatory filings are slated in thecoming months with EGRIFTATMnow licensed in most major markets around the world," he added.
Shareholders were also updated on the upcoming clinical program using tesamorelin to treat muscle wasting in chronic obstructive pulmonary disease (COPD).
"We know from our past clinical work that tesamorelin has potential to do more than reduce abdominal fat. It has also been shown toincrease muscle mass, which makes it a potential treatment for muscle wasting,"said Mr. Huss. "If the increase in lean body mass translates into animprovement of functionality, that will be a huge step forward forCOPD-patients suffering from muscle wasting," he added. The COPD clinicalprogram is expected to begin in September 2011.
The COPD clinical program is part of a four-pronged strategy aimed at growing the Companyand building value for shareholders. This strategy is based on:
- Maximizing global commercialo pportunities for EGRIFTATM
- Developing tesamorelin to treat muscle wasting
- Solidifying our position as a leader in the field of novel GRF products
- Pursuing external growth opportunities
In his prepared remarks, Mr. Huss announced that the Company is working on synthesizing a second generation GRF analog that may have the potential foradministration methods other than injection. "If we succeed, this will be amajor improvement for patients", he stated.
Theratechnologies' Senior Executive Vice-President and Chief Financial Officer, Mr. Luc Tanguay,provided an overview of the Company's financial position, commenting on theresults for the first quarter of 2011, which were announced earlier in April.He reminded shareholders that Theratechnologies hadcompleted the first quarter with $56.3 million in liquidities. He also addedthat consolidated revenues were up significantly for the quarter, reflectingearly product sales to the Company's U.S. partner. "With $56.3 million in liquidities,the Company is well positioned to pursue its organic growth," noted Mr. Tanguay. Company expenses for 2011 are expected to be inthe range of $26 million, excluding the cost of goods sold and depreciation.
At the meeting, Company's shareholders re-elected current members of the Board of Directors, designated KPMG LLP as auditors of the Company for the ensuing yearand passed a resolution to amend the Articles of the Corporation to enable theBoard of Directors to name up to one-third of the number of directors electedat each annual meeting of shareholders.
Theratechnologies(TSX: TH) is a specialty pharmaceutical Corporation that discovers and develops innovative therapeutic peptide products, with an emphasis on growth-hormonereleasing factor peptides. Its first product, EGRIFTATM (tesamorelin forinjection), was approved by the United States Food and Drug Administration inNovember 2010. To date, EGRIFTATMis the only approved therapy for the reduction of excess abdominal fat inHIV-infected patients with lipodystrophy.
EGRIFTATM is currently marketed in the United States by EMD Seronopursuant to a collaboration and licensing agreement executed in October 2008.In addition, the Corporation has signed distribution and licensing agreementswith a subsidiary of Sanofi granting them the exclusive commercializationrights for EGRIFTATM forthe treatment of excess abdominal fat in HIV-infected patients with lipodystrophy in Latin America, Africa and the Middle Eastand with Ferrer InternacionalS.A. granting them the exclusive commercialization rights for EGRIFTATM for the treatment ofexcess abdominal fat in HIV-infected patients with lipodystrophyin Europe, Russia, South Korea, Taiwan, Thailand and certain central Asiancountries.
Additional Information about Theratechnologies
Further information about Theratechnologies is available on the Company's website at www.theratech.com. Additional information, including the Annual InformationForm and the Annual Report, is also available on SEDAR at www.sedar.com.