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However, the acquisition seems to be paying off for ViroPharma. In October, the FDA approved Lev Pharma's Cinryze as a prophylactic (preventive) treatment for hereditary angioedema, or HAE, a rare and potentially life-threatening genetic disease. Lev Pharma had sought FDA approval of Cinryze, both as prophylactic and acute treatments of HAE attack. But the FDA approved Cinryze only as a prophylactic treatment and sought additional data to approve the drug in acute treatment of HAE.
Cinryze is the first product to be approved in the U.S. for HAE, which affects about 6,000 to 10,000 Americans. HAE is characterized by rapid swelling of the hands, feet, limbs, face, intestinal tract or airway.
Being an orphan drug, Cinryze will get seven years of marketing exclusivity. According to analysts, an HAE drug approved as a prophylactic treatment brings in more revenue per patient, compared to an acute treatment setting.
In January 2010, we obtained expanded rights to commercialize Cinryze in certain countries in Europe and ROW as well as rights to develop future C1-INH derived products for additional indications. We intend to commercialize Cinryze in Europe when the product has received the EMA commission approval which we anticipate during 2011. HAE affects between 1 in 30,000 and 1 in 50,000 individuals in Europe. We are seeking approval to market Cinryze IV to patients in Europe for the treatment and routine prophylaxis against attacks in adolescent and adult patients with HAE. Part of this commercialization plan was obtaining Orphan Drug designation for Europe which was granted in October 2009.
C1-INH concentrate has been marketed to HAE patients for acute treatment in Europe for 25 years. Our ability to compete in this marketplace is contingent upon our success in differentiating Cinryze IV over existing CI-INH products.
We are currently in the early stages of identifying the steps necessary to launch in territories outside of the US and EU.
groet Camobs