Pfizer's Rare Disease Candidate Meets Endpoint in Phase III
Pfizer Inc. PFE announced that a phase III study evaluating its pipeline candidate tafamidis for the treatment of transthyretin cardiomyopathy (TTR-CM) met its primary endpoint.
Top line data from the ATTR-ACT study showed that treatment with tafamidis led to a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations – the primary endpoint - compared with the placebo at 30 months. The safety data also demonstrated that tafamidis was generally well tolerated by patients.
After Pfizer revealed strong late-stage results from the tafamidis study, shares of Alnylam Pharmaceuticals ALNY and Ionis Pharmaceuticals IONS declined more than 8% and 4%, respectively, on Friday. Both these biotechs have made competing drugs to tafamidis.
TTR-CM is a rare disease associated with progressive heart failure and is universally fatal. Presently, no treatment is approved to treat this fatal disease. According to Pfizer’s press release, less than 1% of people with the disease are diagnosed with life expectancy averaging three to five years from diagnosis.
There are two types of TTR-CM, a hereditary form and a wild-type form of the disease, which is not hereditary. The ATTR-ACT study included both types of patients. However, Alnylam and Ionis have developed their candidates, patisiran and inotersen, respectively, for hereditary TTR amyloidosis, or hATTR. Both patisiran and inotersen are under review in the EU and United States and could be launched this year.
Tafamidis has been granted fast track status by FDA for TTR-CM. Meanwhile, tafamidis also enjoys orphan drug designation for TTR-CM in both the EU and United States.
Tafamidis is already approved for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) in 40 countries except United States. In the United States, Pfizer received a complete response letter (CRL) from the FDA on for TTR-FAP in 2012.
Shares of Pfizer have declined 1.1% so far this year, comparing favorably with a 2.7% decrease for the industry.
Zacks Rank & Key Pick
Pfizer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Another top-ranked large-cap pharma stock is H. Lundbeck HLUYY with the same Zacks Rank as Pfizer.
Shares of H. Lundbeck have returned 12.9% this year so far. Estimates for 2018 increased 8.5% over the past 60 days.
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