Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy

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About the ATTR-ACT Study¹ 
ATTR-ACT is a Phase 3 international, multicenter, double-blind, placebo-controlled, randomized, 3-arm clinical study in 441 patients that investigated the efficacy, safety, and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo. The study included both patients with the variant, or hereditary, form of the disease, and those with the wild-type form, which is not hereditary and may occur as people age. The primary analysis of the study, which compared tafamidis to placebo, was the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations over a 30-month period in patients with transthyretin cardiomyopathy.

For more information on the ATTR-ACT study, go to www.clinicaltrials.gov. These results are preliminary topline data and are subject to further analysis. The full data and detailed results will be submitted for presentation at an upcoming scientific congress as well as for publication in a peer-reviewed journal.

Tafamidis is an investigational treatment for transthyretin cardiomyopathy and is not approved for this indication.

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Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

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DISCLOSURE NOTICE: The information contained in this release is as of March 29, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a potential indication for tafamidis for the treatment of transthyretin cardiomyopathy (the “Potential Indication”) and Pfizer’s rare disease portfolio, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new or supplemental drug applications may be filed in any jurisdictions for tafamidis for the Potential Indication; whether and when regulatory authorities in any such jurisdictions where applications for tafamidis may be pending (including the application pending with the FDA for the potential treatment of transthyretin familial amyloid polyneuropathy, for which the company received a complete response letter in 2012) or filed may approve any such applications, which will depend on the assessment by such regulatory authority of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted, and, if approved, whether tafamidis will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of tafamidis, including for the Potential Indication; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.