BOSTON and PETACH TIKVA, Israel, July 22, 2021 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial–stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced an exclusive distribution agreement for Medison to commercialize Rhythm's melanocortin–4 (MC4) receptor agonist IMCIVREE (setmelanotide) in Israel.
IMCIVREE was approved on November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adults 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 confirmed by genetic testing.
"We are committed to delivering IMCIVREE to people living with rare genetic diseases of obesity around the world, and we believe Medison will be a strong partner as we extend our commercial footprint into Israel," said Yann Mazabraud, Rhythm's Executive Vice President and Head of International. "Medison has a robust platform and a track record of successfully advancing programs through the registration and reimbursement processes, and we look forward to working together to bring IMCIVREE to patients with POMC, PCSK1 and LEPR deficiency obesity."
"Our partnership with Rhythm reflects our shared commitment to improving the lives of patients who suffer from life–threatening, rare genetic diseases through highly innovative therapies", said Meir Jakobsohn, Founder and CEO of Medison Pharma. "IMCIVREE perfectly fits in our portfolio of novel medicines, and we look forward to providing patients and physicians with this much–needed treatment".
Obesity due to POMC, PCSK1 or LEPR deficiency are ultra–rare diseases caused by variants in POMC, PCSK1 or LEPR genes that impair the MC4 receptor pathway, which is a pathway in the hypothalamus that is responsible for regulating hunger, energy expenditure and consequently body weight. People living with obesity due to POMC, PCSK1 or LEPR deficiency struggle with extreme, insatiable hunger beginning at a young age, resulting in early–onset, severe obesity. As an MC4 receptor agonist, IMCIVREE is designed to restore impaired MC4 receptor pathway activity arising due to genetic deficits upstream of the MC4 receptor.
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 on November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or 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. The Company is leveraging the Rhythm Engine and the largest known obesity DNA database – now with approximately 37,500 sequencing samples – to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. The company is based in Boston, MA.
About Medison Pharma
Medison is a global pharma company focusing on commercializing highly innovative therapies for patients in international markets. Leveraging a track record of over 25 years and partnerships with leading biotech companies, Medison provides a complete spectrum of integrated services for companies interested in establishing presence in international markets. Medison also runs a corporate venture arm with a dedicated research and evaluation team boasting deep scientific and commercial expertise.
For more information, visit https://www.medisonpharma.com.
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 the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, activities under the exclusive distribution agreement with Medison Pharma, and our business strategy and plans, including regarding commercialization of setmelanotide. Statements using word 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 March 31, 2021 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
Medison Contact:
Maya Nix
Corporate Communications Lead
+972–3–925–0349
mayan@medison.co.il
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