GTC says European approval of ATryn will help advance entire product portfolio

By Jennifer Lanning Drey

Eugene, Ore., July 12 - GTC Biotherapeutics, Inc. believes that gaining European approval of its lead product ATryn will "unlock the value of the entire portfolio" for the company, according to Geoffrey Cox, chief executive officer of GTC.

GTC expects to receive approval of market authorization for ATryn in September, Cox said Wednesday at the C.E. Unterberg Emerging Growth Opportunities Conference.

"Getting European approval obviously gives us some important leverage points. Clearly, the regulatory validation is very important, not only for ATryn, but for the whole portfolio of products, which we are developing and will be developing in the future," said Cox.

"We've established the benchmarks and procedures in which these products can be approved."

ATryn is a recombinant form of human antithrombin developed out of milk. Its launch indication will be for patients with acquired deficiencies who are undergoing surgical procedures.

GTC hopes to complete a pivotal study of ATryn in the United States to support a Biologics License Application (BLA) by the middle of next year.

In the U.S. trial, GTC will compare data from patients using ATryn to data previously generated by patients treated with plasma-derived antithrombin in the past.

The company hopes to complete enrollment in both the active and historical arm by the end of the year and file the BLA in the middle of 2007, which could put the product on the market in the United States by the middle of 2008, Cox said.

GTC also plans to use data from the European studies to support its application for ATryn in the United States, Cox said.

"The U.S. is a critical market for us. It's the largest, most valuable market in the world with very little product available at this moment to be able to supply into the market," Cox said.

The company hopes to capture a significant amount of the market currently using existing plasma-derived products.

Once the U.S. study is complete, the company also plans to apply for a label expansion that would allow ATryn to be used for patients undergoing childbirth.

"We also contemplate at that stage, to start to initiate the development of our own U.S. commercial infrastructure. Our sense is that's an important moment for us to develop our own commercial capabilities, and we want to take that opportunity with a relatively small indication at the start," Cox said.

In Europe, GTC has a collaboration with Leo Pharma, a privately held company based in Denmark.

Once GTC gains market approval for ATryn, the company will transfer marketing authorization to Leo, which will begin reimbursement discussions in the individual countries.

Leo expects to have fully launched ATryn by the second quarter of 2007, Cox said.

"We are very anxious to support that launch activity," he said.

GTC also hopes to expand ATryn's indications to include patients with acquired deficiencies and views the European approval as an important step in doing so.

"We're now doing those studies with an approved product, which will obviously be a significant risk reduction," Cox said.

GTC develops and commercializes therapeutic proteins through transgenic animal technology. The company is based in Framingham, Mass.

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