French drugmaker Ipsen and US pharmaceutical firm Medicis say they will not pursue a commercialization deal for the former's product Reloxin (botulinum type A toxin), used in the field of cosmetic surgery, outside the USA, Canada or Japan. The decision, the firms explained, is based on the likely impact of official pricing and reimbursment policies on revenues derived from the agent in regions outside those mentioned, particularly in Europe.
The statement is in reference to a collaborative agreement that the firms entered into earlier this year (Marketletter March 20), under which the Arizona-headquartered Medicis was granted rights to develop and commercialize the product in the USA. Medicis has already paid an upfront fee of $90.1 million for the product, and is committed to making further developmental and regulatory-approval based milestone payments. As a result of the decision to focus on North America and Japan, the US company is required to pay its French partner an additional $35.0 million.
Ipsen also said that the product, which is in US Phase III clinical trials for the treatment of glabellar lines, has been approved for esthetic indications in 18 countries, and added that it would be seeking further European Union approvals in the near future.
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