AstraZeneca (AZN) recently announced that Caprelsa has been approved in the EU for the treatment of aggressive and symptomatic medullary thyroid cancer (“MTC”) in patients with unresectable locally advanced or metastatic disease. In Europe, Caprelsa is the first approved therapy for this indication.
The approval comes after the Committee for Medicinal Products for Human Use (“CHMP”) gave a positive opinion in November 2011. Caprelsa is already approved in the US where it was launched in April 2011. The product is also approved in Canada and is under regulatory review in Russia, Switzerland, Brazil, Mexico, Argentina and Australia.
Caprelsa’s approved indication also states that a lower benefit should be considered for patients in whom Rearranged during Transfection (“RET”) mutation is not known or is negative. Although currently available trial data shows that patients benefit from treatment with Caprelsa regardless of their RET status, as per the European Commission’s requirement, AstraZeneca will conduct an additional study to evaluate the benefits in RET negative patients.
The approval was based on data from AstraZeneca’s phase III program for Caprelsa, including the ZETA study. Data from the ZETA study showed that Caprelsa led to a 54% reduction in the risk of disease progression compared to placebo.
Neutral on AstraZeneca
We currently have a Neutral recommendation on AstraZeneca. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
Even though we are encouraged by the strong cardiovascular franchise at AstraZeneca and the company’s focus on the high-potential emerging markets, we remain concerned about the generic competition faced by its key products. AstraZeneca is looking to lessen the impact of genericization by revamping its cost structure through restructuring initiatives.
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