LONDON - Protherics plc won its first FDA endorsement, getting approval for CroFab, a treatment for rattlesnake bites, the first new antivenom against the North American rattlesnake in 50 years. CroFab will be manufactured at Protherics' facility in Blaenwaum, Wales.
CEO Andrew Heath told BioWorld International, "This is of huge commercial significance, absolutely huge. The company has been working toward it for many years. We are one of a few UK biotechnology companies that have an FDA approval and an FDA-approved manufacturing facility for a product we have developed ourselves from scratch. This separates us from the pack.
"From a commercial perspective, this transforms us from an R&D business to a going concern. It will completely alter the perception of investors."
About 8,000 people a year are bitten by rattlesnakes, and the current drugs are priced at $6,000 to $ 9,000 per treatment. Heath said CroFab will be priced similarly. He expects to be able to grow the current market of $40 million per annum as CroFab has fewer side effects, and will be administered sooner, as the trials showed that early administration following a bite rapidly controlled the effects of the venom.
Shares in the company rose 5.5 pence to 43 pence when the approval was announced last week.
CroFab will be marketed and distributed in the U.S. by Savage Laboratories, a division of Altana Inc., of Melville, N.Y. Stock of the product has been built up and Heath said Protherics expects revenue before the end of 2000.
CroFab consists of antibody fragments, derived by injecting rattlesnake venom into sheep and harvesting the antibodies produced. The antibodies bind to the toxins in the venom of most rattlesnakes. Protherics has a similar product, ViperaTAb, a European viper antivenom, with current sales of around $2 million per year in Europe. It has also filed for FDA approval of a second antibody product for the treatment of overdoses of the heart drug digoxin, and anticipates approval in summer 2001.
"The FDA approval of CroFab is a vindication of our sheep monoclonal technology, and is a feather in the cap for our manufacturing facility in Wales," Heath said.
Protherics was formed in September 1999 from the merger of Therapeutic Antibodies and Proteus International plc. All the company's immunotherapeutics carry the suffix "TAb," for Therapeutic Antibodies. However the FDA requested a name change from CroTAb because the name implies that the product, which is administered by injection, is a tablet.
"Whether we change the name of all our products will be negotiated on a one-on-one basis, but the change has no commercial significance," Health said.
At the same time the company, based in Macclesfield, Cheshire, announced plans to divest its computer-aided molecular design (CAMD) business, the core technology around which Proteus was formed. Heath said the move would allow the company to concentrate on immunotherapeutics.
"We think that by divesting it we have the potential to increase the value of the technology," he said. "Our two interests [CAMD and immunotherapeutics] have completely different business cycles, and different investment requirements. Each requires a focus from management and the ability to fund and finance it appropriately."
"When you talk to investors, they are interested in one or the other. Those with an interest in immunology do not want to see half their money going into CAMD and vice versa."
The CAMD business has 40 of Protherics' 135 staff. It may be divested by a management buyout or a trade sale. Either way, Heath said Protherics will maintain a significant stake and retain access to the CAMD technology.