Savient Pharmaceuticals, Inc. (Nasdaq :SVNT), formerly Bio-Technology General Corp., today announced that the US Food and Drug Administration had approved a new manufacturing site for the manufacture of Delatestryl (testosterone enanthate injection), Savient's injectable testosterone product for the treatment of hypogonadism.
Savient has entered into a supply agreement with the new manufacturer, Sabex, a Canadian manufacturer and marketer of pharmaceutical products, to manufacture Delatestryl for Savient for the US market.
"This is very good news for our company," stated Sim Fass, chairman and CEO of Savient. "As a result of the timing of this approval, we expect to be able to continue to meet full market demand for Delatestryl this year without interruption. Through our exclusive agreement with Sabex, we have secured an approved Delatestryl manufacturing supply source adequate to meet the projected future growth in demand for our product."
With this FDA approval of its new manufacturer for Delatestryl, the company intends to now enhance sales and marketing support for the product to increase its historical sales level and realize its full growth potential.
According to Savient, Delatestryl holds an important position among a number of available product presentations within the US testosterone replacement market, a sector that has enjoyed significant growth over the past several years and is anticipated to continue to expand. Delatestryl is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
Leader & Co. pharmaceuticals analyst Ori Hershkovitz told “Globes” that the news was not of great significance to Savient, as the company recorded annual revenues of about $10 million from sales of the drug.
Published by Globes [online] - www.globes.co.il - on 8 September, 2003