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
PharmaceuticalsRhythm 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
PharmaMedison 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)
IndicationIMCIVREE 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
UseIMCIVREE 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
POPULATIONSDiscontinue 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
StatementsThis 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 ConnollyHead of
Investor Relations and Corporate CommunicationsRhythm
Pharmaceuticals, Inc.857-264-4280dconnolly@rhythmtx.com
Investor Contact:Hannah DeresiewiczStern
Investor Relations,
Inc.212-362-1200hannah.deresiewicz@sternir.com
Media Contact:Adam DaleyBerry & Company
Public Relations212-253-8881adaley@berrypr.com
Medison
Contact:Maya NixCorporate Communications
Lead+972-3-925-0349mayan@medison.co.il
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