Robert Waltermire Joins Madrigal Pharmaceuticals as Chief Pharmaceutical Development Officer

Rhea-AI Summary

Madrigal Pharmaceuticals has appointed Dr. Robert Waltermire as Chief Pharmaceutical Development Officer. With over 30 years of experience in pharmaceutical development, he will lead CMC development for resmetirom, Madrigal's lead candidate for treating NASH. This product is in two Phase 3 clinical studies aimed at addressing significant unmet medical needs. Dr. Waltermire's prior roles include Senior VP at VenatoRx and VP at Bristol-Myers Squibb, underscoring his extensive expertise. The company aims to achieve first-to-market status in the NASH treatment arena, potentially benefiting millions of patients.

Positive

• Appointment of Dr. Robert Waltermire strengthens leadership and expertise at Madrigal.
• Dr. Waltermire's extensive experience in pharmaceutical development enhances focus on commercial success.
• Resmetirom positioned as a first-to-market treatment for NASH, addressing a significant market need.

Negative

• None.

CONSHOHOCKEN, Pa., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, a clinical-stage biopharmaceutical company pursuing novel therapeutics for cardio-metabolic and fatty liver diseases with high unmet medical need, announced today that Dr. Robert

Waltermire has joined Madrigal as Chief Pharmaceutical Development Officer.

“We are pleased to announce that Dr. Robert Waltermire has joined the Madrigal R&D team. With over 30 years of experience in pharmaceutical development, Rob brings proven expertise in all aspects of chemistry, manufacturing and control (CMC) as well as experience in manufacturing new commercial products,” stated Becky Taub, M.D., President R&D and CMO of Madrigal.

Paul Friedman, CEO of Madrigal added, "We look forward to reconnecting with Rob at Madrigal after having worked with him at Dupont earlier in his career. Rob brings a wealth of experience to Madrigal, and helps us set the stage for commercial success."

“With resmetirom, Madrigal is positioned to achieve first to market in the substantial and unmet NASH arena and improve the quality of life and health for millions of NASH patients in America and worldwide” said Dr. Waltermire. “I look forward to working with Becky, Paul and the leadership team at Madrigal to contribute to the continued success and growth at Madrigal.”

Dr. Waltermire, is responsible for CMC development including preparation for the commercialization of resmetirom. Most recently, Dr. Waltermire served as Senior Vice President CMC at VenatoRx. From 1988 to 2020, Dr. Waltermire held positions of increasing responsibility at Bristol-Myers Squibb (and Dupont Pharmaceutical Company) including Vice President Chemical & Synthetic Development at BMS. Dr. Waltermire received his B.A. in Chemistry from Franklin & Marshall College in 1984, and his Ph.D. in Organic Chemistry from the University of Maryland in 1988.

About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO- NAFLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit www.madrigalpharma.com.

Forward-Looking Statements

This communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on our beliefs and assumptions and on information currently available to us but are subject to factors beyond our control. Forward-looking statements include but are not limited to statements or references concerning: our clinical trials; research and development activities; the timing and results associated with the future development of our lead product candidate, MGL-3196 (resmetirom); our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections; plans, objectives and timing for making a Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) submission to FDA; optimal dosing levels for resmetirom; projections regarding potential future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment or biomarker effects with resmetirom; the efficacy and safety of resmetirom for non-cirrhotic NASH patients and cirrhotic NASH patients; the predictive power of liver fat reduction measured by non-invasive tests on NASH resolution with fibrosis reduction or improvement; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; the predictive power of NASH resolution and/or liver fibrosis reduction with resmetirom using non-invasive tests, including the use of ELF, FibroScan, MRE and/or MRI-PDFF; the predictive power of non-invasive tests generally, including for purposes of diagnosing NASH, monitoring patient response to resmetirom, or recruiting a NASH clinical trial; potential NASH or NAFLD patient risk profile benefits with resmetirom; the potential for resmetirom to become the best-in-class and/or first-to-market treatment option for patients with NASH; and our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. Forward-looking statements: reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “allow,” “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expects,” “forecasts,” “future,” “goal,” “hopeful,” ”inform,” “intends,” “may,” “might,” “planned”, “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will be,” “would” or similar expressions and the negatives of those terms. Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward- looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: our clinical development of resmetirom; enrollment uncertainties, generally and in relation to COVID-19-related measures that may be continued for an uncertain period of time or implemented; outcomes or trends from competitive studies; future topline data timing or results; the risks of achieving potential benefits in studies that include substantially more patients than our prior studies; limitations associated with early stage, non-placebo controlled study data; the timing and outcomes of clinical studies of resmetirom; and the uncertainties inherent in clinical testing. Undue reliance should not be placed on forward- looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal's filings with the U.S. Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. We specifically discuss these risks and uncertainties in greater detail in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, as well as in our other filings with the SEC.

Investor Contact:
Alex Howarth, Madrigal Pharmaceuticals, Inc., IR@madrigalpharma.com

Media Contact:
Laura Morgan, Sam Brown Inc., lauramorgan@sambrown.com, tel +1-951-333-9110
Bob Conrad, Sam Brown Inc., bobconrad@sambrown.com, tel +1-703-980-0997

FAQ

Who is Dr. Robert Waltermire in relation to Madrigal Pharmaceuticals?

Dr. Robert Waltermire has been appointed as Chief Pharmaceutical Development Officer at Madrigal Pharmaceuticals.

What is resmetirom and its significance for Madrigal Pharmaceuticals?

Resmetirom is Madrigal's lead candidate targeting NASH and is currently in two Phase 3 clinical studies.

What experience does Dr. Waltermire bring to Madrigal Pharmaceuticals?

Dr. Waltermire has over 30 years of experience in pharmaceutical development, including leadership roles at VenatoRx and Bristol-Myers Squibb.

What unmet medical need does Madrigal address with resmetirom?

Madrigal aims to address the substantial unmet medical need for NASH treatment with resmetirom.

How does the appointment of Dr. Waltermire impact Madrigal Pharmaceuticals?

His appointment is expected to enhance the company's R&D capabilities and set the stage for commercial success with resmetirom.