Pfizer's (PFE) Tafamidis Gets Fast Track Status In The U.S.

Pfizer Inc. (NYSE:PFE) has been granted with fast track status by FDA for treating patients with transthyretin cardiomyopathy (TTR-CM). This rare disease is associated with progressive heart failure and is universally fatal. Currently tafamidis is in phase III study for TTR-CM.

Incidentally in 2011, tafamidis was first approved in the EU for treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) in adult patients under the brand name Vyndaqel. Presently, the drug is approved for TTR-FAP in 40 countries, including Europe, Japan, Brazil, Mexico, Argentina, Israel, Russia and South Korea.

Shares of Pfizer have underperformed the Zacks classified Large Cap Pharma industry so far this year. The stock has lost 1.3% compared to the broader industry’s 10.4% gain.



Investors should be reminded that in Jun 2012, FDA had issued a complete response letter to Pfizer with respect to its application to approve tafamidis for TTR-FAP. The FDA has asked for additional information on the data within the current tafamidis new drug application (NDA). Subsequently in Dec 2013, the company had initiated a global phase III study to evaluate safety and tolerability profiles of tafamidis in patients with TTR-CM. This category also comprised those with TTR-FAC and wild-type cardiomyopathy (WT-CM). Data from the study is expected in 2018.

Notably, tafamidis became a part of Pfizer’s portfolio with its October 2010 acquisition of FoldRx.

Per the company’s press release, approximately 1,000 patients are diagnosed with TTR-CM globally. However, the disease is still believed to be largely under-diagnosed. Hence approval of the concerned drug for TTR-CM will cater to the development of critically needed treatment options for people living with this rare disease.

In an attempt to boost its rare disease and gene therapy pipelines, Pfizer has entered into an exclusive, worldwide collaboration and license agreement with Sangamo Therapeutics, Inc. (NASDAQ:SGMO) for developing and commercializing gene therapy programs for hemophilia A in May 2017. This deal covers SB-525, one of Sangamo’s four lead pipeline candidates, slated to enter the clinic this quarter.

Zacks Rank & Key Picks

Pfizer currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector include VIVUS, Inc. (NASDAQ:VVUS) , and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . While VIVUS sports a Zacks Rank #1 (Strong Buy), Regeneron carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed down from 50 cents to 39 cents for 2017 in last 60 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.

Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters with average beat of 0.45%.

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