GTC Biotherapeutics is gearing up to take its first “pharming” product, a drug harvested from genetically modified goats, to the U.S. market. The Framingham, MA-based company said today it signed an exclusive partnership with Ovation Pharmaceuticals to develop and market ATryn in the United States. Currently, ATryn is only sold in Europe.
GTC stands to collect as much as $257 million in payments from Ovation if it can meet certain clinical, regulatory, and sales goals, with extra potential cash flow from royalties on product sales, according to the company’s statement. Ovation, a privately-held drug company based in Deerfield, IL., has 14 marketed products for neurological disorders, hematology/oncology, and hospital use, according to the company’s website. It will pay for GTC’s anticipated clinical trial costs, and handle the marketing.
ATryn is approved in Europe, and marketed there by LEO Pharma, for patients undergoing surgery who also have a rare genetic disorder that makes blood clot. The drug is a genetically engineered form of antithrombin, a protein in the blood with anti-clotting and anti-inflammatory characteristics, GTC said. The really unusual part is it’s manufactured through “pharming,” by separating it from the milk of genetically modified goats.
GTC has already submitted part of its U.S. application to market ATryn, and plans to turn in the rest to the FDA for review before the end of September, the company said in a statement. If the FDA gives it the expedited six-month review the company has requested, the drug could be approved for sale in the U.S. before the end of March.
The opportunity in the U.S., GTC and Ovation, hope, is much bigger than just selling it for a rare hereditary disorder. The companies plan to develop ATryn for patients with resistance to the blood thinner heparin who undergo heart bypass surgery, as well as people with clotting associated with severe sepsis, a deadly inflammatory disease.
The boost from Ovation comes during some lean times for GTC. The company reported a loss of $8.2 million in the first quarter, and said it had $11.7 million in cash and investments left at the end of March. Times will surely get tougher if the FDA says it isn’t ready yet for this brand of “pharming.”