Clinical Investigator Dr. Lawrence
Bass is a Featured Hot Topics Speaker
DUBLIN, May 17, 2019 /PRNewswire/ -- Endo International
plc (NASDAQ: ENDP) today announced that clinical data from a Phase
3 investigational study of collagenase clostridium histolyticum
(CCH) for the treatment of cellulite will be presented by
Lawrence Bass, M.D., a
board-certified plastic surgeon with a practice in New York City. Dr. Bass will present the Phase
3 data during the Premier Global Hot Topics session, which takes
place today from 1:00pm –
6:00pm (Central Time) at the New
Orleans Ernest N. Morial Convention Center. The Hot Topics session
is considered to be a highlight of The Aesthetic Meeting 2019, the
annual meeting of the American Society for Aesthetic Plastic
Surgery (The Aesthetic Society).
"Last year at Hot Topics, my colleagues expressed great interest
in the data that I presented on CCH for cellulite," said Dr. Bass.
"An injectable option to treat cellulite, if approved, would be
very meaningful to our patients, which is why I am thrilled to be
back this year to share the positive results from the Phase 3
studies."
The RELEASE-1 and RELEASE-2 Phase 3 studies, which were
identically designed, randomized, double-blinded and
placebo-controlled, assessed the efficacy, safety and tolerability
of CCH for the treatment of cellulite in women. A greater
percentage of the 843 women treated during the studies (CCH vs.
placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met
the primary endpoint of response with CCH versus placebo in both
the RELEASE-1 (P=0.006) and RELEASE-2 (P=0.002) studies.
In addition, statistically significant improvements with CCH
versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8
(RELEASE-2) secondary endpoints. Other patient-centric endpoints
were also evaluated, including improvement in the Subject Global
Aesthetic Improvement Scale (S-GAIS), a 5-point scale rating global
aesthetic improvement in appearance, compared to pretreatment, as
judged by the subject. Most adverse events observed in
CCH-treated patients were mild/moderate and injection-site related
(e.g., bruising, pain, nodule, pruritus, erythema, and
discoloration).
"As a Premier Partner of The Aesthetic Society, we could not be
more pleased that our data is a Hot Topic at their annual meeting,"
said Matthew Davis, M.D., R.Ph., Endo's Senior Vice
President and Chief Medical Officer. "We greatly appreciate
investigators like Dr. Bass who have helped further our
understanding of the potential for CCH by participating in these
studies and presenting their scientific findings to their
peers."
About Cellulite
Cellulite is a localized alteration in
the contour of the skin that has been reported in 85 to 98 percent
of post-pubertal females and affects women of all races and
ethnicities.1,2 The primary cause of the condition is a
thickening of the collagen septae that attach the skin to the
underlying fascia layers with additional contributing protrusions
of subcutaneous fat. The septae tether the skin, which causes the
surface dimpling characteristic of cellulite.2,3
Cellulite clinically presents on the buttocks, thighs, lower
abdomen and arms.
It is known that cellulite is different from generalized
obesity. In generalized obesity, adipocytes undergo hypertrophy and
hyperplasia that are not limited to the pelvis, thighs, and
abdomen.4 In areas of cellulite, characteristic large,
metabolically stable adipocytes have physiologic and biochemical
properties that differ from adipose tissue located elsewhere.
Weight gain makes cellulite more noticeable, but it may be present
even in thin subjects. Genetics may also play a role, since
cellulite tends to run in families.
Despite multiple therapeutic approaches for the attempted
treatment of patients with cellulite, there are currently no
FDA-approved injectable treatments on the market.5
About Endo International plc
Endo International plc
(NASDAQ: ENDP) is a highly-focused generics and specialty branded
pharmaceutical company delivering quality medicines to patients in
need through excellence in development, manufacturing and
commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
About The Aesthetic Society
The American Society for
Aesthetic Plastic Surgery (The Aesthetic Society) is
recognized as the world's leading organization devoted entirely to
aesthetic plastic surgery and cosmetic medicine of the face and
body. The Aesthetic Society is comprised of more than 2,600
members in North America and internationally; Active
Members are certified by the American Board of Plastic Surgery
(USA) or by the Royal
College of Physicians and Surgeons of Canada and
have extensive training in the complete spectrum of surgical
and non-surgical aesthetic procedures. International Active
Members are certified by equivalent boards of their respective
countries. All members worldwide adhere to a strict Code of Ethics
and must meet stringent membership requirements. The Aesthetic
Society is at the forefront of innovation in aesthetic plastic
surgery and cosmetic medicine globally.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and Canadian securities legislation, including, but not
limited to, the statement by Drs. Davis and Bass, and other
statements regarding research and development outcomes, efficacy,
adverse reactions, market and product potential and product
availability. Statements including words such as "believes,"
"expects," "anticipates," "intends," "estimates," "plan," "will,"
"may," "look forward," "intend," "guidance," "future" or similar
expressions are forward-looking statements. Because these
statements reflect Endo's current views, expectations and beliefs
concerning future events, they involve risks and uncertainties.
Although Endo believes that these forward-looking statements and
information are based upon reasonable assumptions and expectations,
readers should not place undue reliance on them, or any other
forward-looking statements or information in this news release.
Investors should note that many factors, as more fully described in
the documents filed by Endo with the Securities and Exchange
Commission and with securities regulators in Canada on the System for Electronic Document
Analysis and Retrieval, including under the caption "Risk Factors"
in Endo's Form 10-K, Form 10-Q and Form 8-K filings, and as
otherwise enumerated herein or therein, could affect Endo's future
results and could cause Endo's actual results to differ materially
from those expressed in forward-looking statements contained in
this communication. The forward-looking statements in this press
release are qualified by these risk factors. Endo assumes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise, except as may be required under applicable securities
laws.
References
- Avram M. Cellulite: a review of its physiology and treatment,
Journal of Cosmetic Laser Therapy 2004; 6: 181–185.
- Khan MH et al. Treatment of cellulite: Part I.
Pathophysiology. J Am Acad Dermatol. 2010
Mar;62(3):361-70.
- Querleux B et al. Anatomy and physiology of subcutaneous
adipose tissue by in vivo MRI and spectroscopy: Relationship with
sex and presence of cellulite, Skin Research and Technology;
8: 118-124.
- Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite:
Part I. Pathophysiology. J Am Acad Dermatol
2010;62(3):361-370.
- Zerini I et al. Cellulite treatment: a comprehensive literature
review. J Cosmet Dermatol. 2015 Sep 14(3):224-40