Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage
biopharmaceutical company committed to transforming the care of
people living with rare genetic diseases of obesity, today
announced the appointments of Pamela Cramer as Chief Human
Resources Officer and Linda Shapiro Manning, M.D., Ph.D., as Senior
Vice President, Clinical.
“We are excited to welcome Pam and Linda to the Rhythm team at a
transformational time for the company, as we work to deliver
IMCIVREE™ (setmelanotide) to patients with certain rare genetic
diseases of obesity in the United States and Europe and expand our
reach with a multi-faceted, global clinical development strategy,”
said David Meeker, M.D., Rhythm Chairman, Chief Executive Officer
and President. “Pam brings deep talent management and
organizational development experience and a strong track record as
an effective business partner, and Linda comes with significant
clinical experience in obesity, both as a practicing physician and
clinical development leader in industry. We are thrilled both
senior leaders chose to join us and look forward to their
contributions as we execute on our mission.”
Ms. Cramer joined Rhythm as Chief Human Resources Officer,
effective July 26. She brings 20 years of leadership experience in
organizational effectiveness, talent development and human
resources (HR) transformation with globally diverse life sciences
and financial services companies. She joins Rhythm from Foundation
Medicine, where she most recently served as Head of People
Solutions and was responsible for leading HR delivery for its more
than 1700 employees. Prior to that, Ms. Cramer held senior HR
positions at Cambridge Associates, PAREXEL International and
Epsilon Data Management. Earlier in her career, Ms. Cramer served
in a wide range of positions at Bank of America Merrill Lynch and
General Electric, where she began her career as a graduate of the
Human Resources Leadership Program. She holds an M.B.A. from
Georgetown University.
Dr. Shapiro joined Rhythm earlier in July, bringing more than 20
years of experience in obesity medicine. For the past ten years,
she has worked in the biopharmaceutical industry, with clinical
development and medical affairs roles at Applied Therapeutics,
Boehringer Ingelheim, Merck and Novo Nordisk. In these roles, she
led clinical development for assets in type 2 diabetes and
cardiometabolic conditions and, at Novo Nordisk, she served as head
of medical science and international medical director for the
company’s GLP-1 and obesity global development programs. Prior to
joining industry, Dr. Shapiro practiced medicine in Colorado,
obtaining certification and specializing in obesity medicine. She
holds a Ph.D. and completed a post-doctoral research fellowship in
kinesiology and applied physiology from the University of Colorado,
an M.D. from Tulane University School of Medicine, and a bachelor’s
degree in exercise science from the University of Southern
California.
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), was approved in 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
and by the European Commission (EC) in July 2021 for the treatment
of obesity and the control of hunger associated with genetically
confirmed loss-of-function biallelic POMC, including PCSK1,
deficiency or biallelic LEPR deficiency in adults and children 6
years of age and above. IMCIVREE is the first-ever FDA-approved and
EC-authorized 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.
IMCIVREE®
(setmelanotide) IndicationIn the United States,
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 (VOUS).
In the EU, IMCIVREE is indicated for
the treatment of obesity and the control of hunger associated with
genetically confirmed loss-of-function biallelic POMC, including
PCSK1, deficiency or biallelic LEPR deficiency in adults and
children 6 years of age and above. IMCIVREE should be prescribed
and supervised by a physician with expertise in obesity with
underlying genetic etiology.
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, our expectations
surrounding potential regulatory submissions, approvals and timing
thereof, our business strategy and plans, including regarding
commercialization of setmelanotide, and management changes.
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
Photos accompanying this announcement are available at:
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