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Talecris releases letter to Alpha-1 community outlining research strategy, including recombinant alpha-1 protein
Lawrence Stern, Chairman and CEO of Talecris Biotherapeutics, today released a “letter to the Alpha-1 community” with an update on the company’s research program.
Among other announcements, the letter says the company is investing in a “new, recombinant technology” for producing augmentation therapy for Alpha-1, possibly for both intravenous and inhaled forms of therapy.
“Recombinant technology” refers to alpha-1 protein made by genetic engineering of cells in a lab. All of today’s augmentation therapies for Alpha-1, such as Prolastin-C from Talecris, are made from purified human blood plasma. Recombinant alpha-1 protein, if eventually approved, could be made in virtually unlimited quantities, since no human plasma donations would be needed.
The text of the Talecris letter follows.
Dear Alpha-1 Community:
I am writing to update the community on Talecris’ Alpha-1 research program. The relationship we have with the Alpha-1 community is important to us and we want to keep you informed of several changes as we prioritize our research program.
- We are in the final stages of planning studies with our intravenous, plasma-derived alpha-1 proteinase inhibitor that will evaluate safety and efficacy in a large patient population. We plan to evaluate a higher dose in these studies, as we know this is an important issue for the community. These studies are a commitment to regulatory authorities, but are also based on our commitment to furthering scientific knowledge in Alpha-1.
- Talecris is also investing in a new, recombinant technology for producing alpha-1 antitrypsin protein from cells in culture, as opposed to human plasma. While still several years from being considered for human studies, we plan to evaluate the protein produced by these cells for both intravenous and inhaled forms of therapy.
- Because of the above commitments, which include studies that are required by the regulatory authorities, we have decided not to pursue studies evaluating inhaled, plasma-derived alpha-1
antitrypsin. At this time, Talecris has decided to focus on the research programs described above.
We hope you agree that the research path we have chosen is the best one for Talecris and the Alpha-1 community. We continue to increase our investment in the Alpha-1 and respiratory therapeutic areas. With your ongoing support, we will continue to advance the science and therapeutic options for Alpha-1.
Sincerely,
Lawrence Stern
Chairman and CEO
Talecris Biotherapeutics
