|
1-3 of 3 messages
|
Page 1 of 1
|
|
New rattlesnake antivenom - CroFab approved
|
Reply
|
|
by Charper on October 4, 2000
|
Mail this to a friend!
|
Press Release 4th October 2000
CROFABTM, CROTALIDAE POLYVALENT IMMUNE FAB (OVINE), RATTLESNAKE ANTIVENIN RECEIVES FDA APPROVAL
DIVESTMENT OF CAMD TECHNOLOGY
Protherics PLC announced today that its rattlesnake antivenin (antivenom), CroFabTM, developed under the trademark of CroTAb, has been granted approval for marketing by the U.S. Food and Drug Administration (FDA). This successful outcome to the regulatory review process is the first major market approval for a Protherics product. CroFabTM will be marketed and distributed by Savage Laboratories, a division of Altana Inc., Melville, New York.
CroFabTM is the first new product marketed for the treatment of North American rattlesnake envenomation for more than 50 years. With this approval, Protherics can now capitalise on a market opportunity estimated to be worth in excess of $40 million per year.
Chief Executive, Andrew Heath commented:
"This, our first FDA approval, is a major achievement which transforms the basis of our business. With our second product approval (for the treatment of digoxin overdose) anticipated in the summer of 2001, we are now beginning to see a promising return on our investment in immunotechnology."
CroFabTM consists of specific antibody fragments that bind to toxic substances in the venom of most rattlesnakes. Early administration of CroFab following a bite has been shown to rapidly control the harmful effects of the venom.
The FDA has at the same time approved the Establishment License Application for the manufacturing of CroFabTM at Protherics' state of the art manufacturing facility in Blaenwaun, Wales. This facility currently produces ViperaTAb®, a European viper antivenin, and will be used to manufacture other Protherics products as regulatory approvals are achieved.
In order to focus on its immunotherapeutics business, including CroFabTM and the clinical development of the Angiotensin Vaccine for the treatment of high blood pressure, Protherics intends to divest the computer aided molecular design (CAMD) technology business.
CAMD is a leading edge drug discovery technology that is now generating significant interest. A major collaborative deal with Eli Lilly & Co. to develop anti-thrombotic drugs was followed by the successful demonstration of the DockCrunch virtual screening capability, which resulted in new drug leads being identified. A new business providing virtual screening and compound library design services to the pharmaceutical, agrochemical and biotechnology sectors has been established.
Andrew Heath commented:
"Our CAMD business has also made strong progress this past year. Therefore, the time is now right for us to separate these two parts of our business, to provide an optimal environment for each to grow."
For further information please contact:
Andrew Heath Protherics PLC 07768 256595
+1 212 661 2070 (12.00 to 1.00pm)
Barry Riley Protherics PLC +44 (0) 1625 500 555
William Clutterbuck
Simone Cheetham The Maitland Consultancy +44 (0) 20 7379 5151
Further information regarding DockCrunch can be found on the DockCrunch webpages.
|
| |
|
Email Subscription
You are not subscribed to this topic.
Subscribe!
My Subscriptions
Subscriptions Help
Check our help page for help using
, or send questions, comments, or suggestions to the
Manager.
|
