The action of Montreal biopharmaceutical company Theratechnologies lost 15% of its value on Wednesday after receiving bad news from American health authorities.
The company says it has received a letter of non-approval from the United States Food and Drug Administration (FDA) regarding the new formulation of its product aimed at the treatment of a medical problem associated with the human immunodeficiency virus (HIV). ).
Theratechnologies maintains that it will respond to the FDA’s requests and that it intends to pursue approval of the new formulation of its product tesamorelin.
The company notes that the current formulation of tesamorelin injection, also known as Egrifta, remains the only drug approved in the United States for the reduction of excess abdominal fat in adults with HIV, and the management assures that it will continue to market this product.
Theratechnologies specifies that the FDA – the American equivalent of Health Canada – is requesting additional information to understand the potential impact of the proposed new formulation on the risk of immunogenicity.
Theratechnologies’ Senior Vice President and Chief Medical Officer, Christian Marsolais, says he is disappointed to receive a letter containing questions that were not raised during the review process.
“We intend to respond to these new comments as quickly as possible,” he said.
“We remain focused on bringing this new formulation to market as part of our commitment to innovate and simplify treatments for people living with HIV. »
Theratechnologies shares lost 15% on Wednesday to close at $1.97 on the Toronto Stock Exchange. The stock had already lost 6% during each of the two previous sessions.
The company first received marketing authorization from the FDA in the United States for its product Egrifta in 2010.
The product was first marketed in the US market by a third-party commercial partner before Theratechnologies reviewed its business model in 2014 and regained its US marketing rights.
Founded in 1993, Theratechnologies says it now employs more than 100 people in Canada, the United States and Europe.
Investissement Québec became Theratechnologies’ largest shareholder last fall after releasing $12.5 million for the company, a move that gave the state-owned company a 19.9% stake.
Besides Investissement Québec, the largest shareholders of Theratechnologies are the specialized funds Soleus and AIGH.
