Regulatory updates: AstraZeneca's Brilinta; Merck KGaA' cladribine

European drug majors Anglo-Swedish AstraZeneca (LSE: AZN) and Germany’s Merck & Co (MRK: DE) gave updates this morning on products that have been stuck n the regulatory process, the former regarding the US filing for its blood thinner candidate Brilinta (ticagrelor) and the latter on its European filing for cladribine as an oral treatment for multiple sclerosis.

AstraZeneca says it has replied to the US Food and Drug Administration’s Complete Response Letter received for the Brilinta New Drug Application last month (The Pharma Letter December 17, 2010). The CRL did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA, and was issued after a positive seven to one vote to clear the drug by an FDA advisory committee.

Assuming final approval, Brilinta will compete with Sanofi-Aventis’ antiplatelet agent Plavix (clopidogrel), which last year generated turnover of $9.8 billion but is now facing patent expiry. Brilinta has been billed as having a $2.5 billion sales potential for the London headquartered drugmaker, which faces generic competition over the next four years to produces with revenues of some $9.8 billion, including the gastro-intestinal Nexium (esomeprazole) and antipsychotic Seroquel (quetiapine).