Pfizer (PFE) recently received EU approval for Vyndaqel (tafamidis) for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) in adult patients with stage I symptomatic polyneuropathy.
The approval was expected as Vyndaqel had received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in July 2011. Approval was granted on the basis of results from a pivotal clinical study and an open-label, 12-month extension study.
As far as US approval is concerned, Pfizer faced a stumbling block earlier this year when the US Food and Drug Administration (FDA) issued a “refusal to file” letter for the new drug application for Vyndaqel. The agency said that the application, which was submitted in February 2011, was incomplete. Pfizer is working with the FDA and intends to submit a response as soon as possible. Vyndaqel has orphan drug designation in the US.
Vyndaqel became a part of Pfizer’s portfolio with its October 2010 acquisition of FoldRx. TTR-FAP is a progressively fatal genetic neurodegenerative disease. Prior to the approval of Vyndaqel, liver transplant was the only option available for combating this progressively fatal genetic neurodegenerative disease. Pfizer expects to launch the product in European markets in early 2012. With Vyndaqel targeting a small patient population, we do not expect significant sales from this product.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer. While near-term earnings growth will come in the form of cost cutting and share repurchases, longer-term growth will depend on the success of drug development. Pfizer will face additional challenges later this year with the loss of US exclusivity on Lipitor on November 30.
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