BOSTON, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced the appointments of Camille L. Bedrosian, M.D., and Lynn Tetrault, J.D., to its Board of Directors.
“I am thrilled to welcome both Camille and Lynn to our Board of Directors, as both leaders have tremendous experience building and leading teams that work effectively to bring new medicines to patients in need,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
“With her experience on the senior executive team of a top-10, multi-national pharmaceutical company, Lynn brings a unique perspective on developing global operations, leadership and culture,” Dr. Meeker said. “And with an unwavering commitment to patients and families as both a clinician and biopharmaceutical executive, Camille has demonstrated success in developing and delivering new medicines for rare diseases.”
Dr. Bedrosian brings significant rare and ultra-disease experience to the Rhythm Board. As Executive Vice President (EVP) and Chief Medical Officer (CMO) at Ultragenyx Pharmaceutical, she provides strategic leadership for translational research, global clinical development and medical affairs for a company with three commercial products and a deep pipeline of product candidates. On joining the Rhythm Board, she said, “This is an exciting time for Rhythm as it brings the first-ever approved precision medicine to people with rare genetic diseases of obesity. I look forward to supporting the Company’s unique integrated approach in leveraging the largest known genetic obesity database to advance the scientific understanding of and potential treatments for obesity due to genetic causes.”
Ms. Tetrault spent more than 20 years at AstraZeneca, including seven years as EVP for Human Resources and Corporate Affairs and a member of the company’s senior executive team. She is currently Lead Independent Director of Neo Genomics Clinical Laboratories, a cancer diagnostics company. On joining the Rhythm Board, she said, “Rhythm is forging new ground in rare genetic diseases of obesity with a commitment to organizational excellence and a true partnership with the community of patients, caregivers, advocacy groups and health care providers. I look forward to joining Camille on the Board and supporting Rhythm as it transforms into a global, commercial-stage company.”
About Camille L. Bedrosian, M.D.
Dr. Bedrosian serves as EVP and CMO at Ultragenyx Pharmaceutical, a rare disease company with a diverse portfolio of approved therapies and product candidates, where she provides strategic leadership to the clinical development and translational research programs. She oversees Medical Affairs, Global Clinical Development groups, Clinical Operations and Drug Safety/Pharmacovigilance. In addition, she is a member of the MIT Corporation Visiting Committee for the Department of Biology. Previously, Dr. Bedrosian served as SVP and CMO at Alexion Pharmaceuticals, Inc., where she provided leadership for the development of drugs and drug candidates including those designed to address devastating rare diseases such as Soliris® (eculizumab). She also had served as CMO at ARIAD Pharmaceuticals, and previously in the Clinical Research and Development Department of Genetics Institute, Inc. Before transitioning to industry, Dr. Bedrosian was an Assistant Professor of Medicine at Duke University Medical Center where she was a member of the Duke Comprehensive Cancer Center. Dr Bedrosian holds an A.B. from Harvard University, M.D. from Harvard Medical School, and M.S. in Biophysics from the Massachusetts Institute of Technology.
About Lynn A. Tetrault, J.D.
Ms. Tetrault is a global business leader with more than 25 years of experience in the health care industry. Ms. Tetrault spent most of her career with Astra Zeneca PLC, serving in a variety of senior roles, including as EVP of Human Resources and Corporate Affairs for seven years. She joined the Board of Neo Genomics Clinical Laboratories in 2015 and is currently Lead Independent Director. Ms. Tetrault is the founder of Anahata Leadership, an advisory firm focused on supporting the leadership and development of executive women. She is a Fellow of Simmons University’s Institute for Inclusive Leadership and is a Director of Paradigm for Parity, a non-profit organization whose mission is to close the gender parity gap in corporate leadership by 2030. She began her career as a lawyer in private healthcare practice in Boston. Ms. Tetrault holds a B.A. from Princeton University and a J.D. from the University of Virginia.
About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity. The company’s precision medicine, IMCIVREE™ (setmelanotide), has been approved by the U.S. FDA for chronic weight management in people with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing. IMCIVREE is the first-ever FDA approved therapy for these rare genetic diseases of obesity. Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity and expects to report topline pivotal Phase 3 data in Bardet-Biedl and Alström syndromes in late 2020 or early 2021. The Company is leveraging the Rhythm Engine and the largest known obesity DNA database - now with more than 30,000 sequencing samples - to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. For healthcare professionals, visit www.UNcommonObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information. The company is based in Boston, MA.
IMCIVREE™ (setmelanotide) Indication
IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The condition must be confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).
Limitations of Use
IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
- Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign;
- Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.
Important Safety Information
WARNINGS AND PRECAUTIONS
Disturbance in Sexual Arousal: Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE. Instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
Depression and Suicidal Ideation: Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.
Skin Pigmentation and Darkening of Pre-Existing Nevi: IMCIVREE may cause generalized increased skin pigmentation and darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.
Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants.
ADVERSE REACTIONS
- The most common adverse reactions (incidence ≥23%) were injection site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting, depression, upper respiratory tract infection, and spontaneous penile erection.
USE IN SPECIFIC POPULATIONS
Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.
Treatment with IMCIVREE is not recommended for use while breastfeeding.
To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See Full Prescribing Information for IMCIVREE.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our business strategy and plans, including regarding commercialization of setmelanotide, and our market opportunity. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, the impact of our management transition, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com
Investor Contact:
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com
Source: Rhythm Pharmaceuticals, Inc.