Pfizer Inc. PFE announced encouraging data from a phase III study - ATTR-ACT - evaluating its pipeline candidate, tafamidis, in patients with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM). Tafamidis achieved statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations.
The data were presented at the European Society of Cardiology congress in Munich and published online in the New England Journal of Medicine simultaneously.
However, the data failed to impress investors as the results did not show enough confidence to lead the market in the target indication. The candidate enjoys Orphan Drug, Fast Track and Breakthrough Therapy designations for ATTR-CM in the United States.
Pfizer's shares fell 1.9% on Aug 27 following the news. However, shares of Pfizer have increased 14.7% so far this year, comparing favorably with a 5.3% gain for the industry .
The ATTR-ACT study evaluated an oral daily dose of tafamidis meglumine capsules over a period of 30 months in all ATTR-CM patients, which include both types of the disease - a hereditary form and a wild-type form.
Data from the study showed that treatment with tafamidis reduced the risk of morality and rate of cardiovascular-related hospitalization by 30% and 32%, respectively, compared to placebo. Tafamidis also helped in reducing the rate of decline in functional capacity, as measured by six minute walk test distance and also the rate of decline in aspects of quality of life compared to placebo.
TTR-CM is a rare disease associated with progressive heart failure and is universally fatal. Due to lack of treatment options, Pfizer has expanded access treatment protocol to make tafamidis accessible prior to regulatory approval to patients who may benefit from the candidate.
The candidate will face competition from Alnylam Pharmaceuticals' ALNY Onpattro (patisiran) and Ionis Pharmaceuticals' IONS Tegsedi (inotersen). While Onpattro received approval earlier this month, a decision on Tegsedi is expected in October in the United States. Both the drugs have been developed for treating hereditary TTR amyloidosis. Both the companies are developing their drugs for ATTR-CM.
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Zacks Rank & Stock to Consider
Pfizer currently has a Zacks Rank #3 (Hold).
Eli Lilly and Company LLY is a better-ranked stock from the same space, carrying a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
Lilly's earnings per share estimates have increased from $5.37 to $5.42 for 2018 and from $5.62 to $5.69 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 10.15%.
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