DUBLIN, Sept. 6, 2019 /PRNewswire/ -- Endo
International plc (NASDAQ: ENDP) announced today that the
Company has submitted a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) for collagenase clostridium
histolyticum (CCH) for the treatment of cellulite in the
buttocks. The submission is based on positive results from two
identical Phase 3 RELEASE* studies that were were presented at the
2019 Annual Meeting of the American Academy of Dermatology (AAD)
in Washington, DC and subsequently at the The Aesthetic
Meeting 2019 in New Orleans,
LA.
The RELEASE-1 and RELEASE-2 Phase 3 studies, which were
identically designed, randomized, double blinded and
placebo-controlled, assessed the efficacy and safety 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. All patient-centric endpoints,
evaluated using validated patient-reported scales like Patient
Reported Photonumeric Cellulite Severity Scale (PR-PCSS), Subject
Global Aesthetic Improvement Scale (S-GAIS), Patient Reported
Cellulite Impact Score (PR-CIS) and Subject Self Rating Scale
(SSRS), showed statistically significant improvement in the CCH
group when compared to the placebo group. Most adverse events
observed in CCH-treated patients were transient, mild/moderate and
injection-site related (e.g., bruising, pain, induration, pruritus,
erythema, and discoloration).
The FDA has a 60-day filing review period to determine
whether the BLA is complete and acceptable for filing. Endo
will communicate the FDA's decision.
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.
Forward Looking Statements
This press release may contain certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 and Canadian securities legislation, including statements
regarding research and development outcomes, regulatory, marketing
and reimbursement approvals, 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 as well as the risks that the FDA will accept the BLA
submitted for CCH, whether and when the BLA or any such other
applications may be approved by the FDA and the general
unpredictability of the regulatory process. 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.
*Randomized EvaLuation of
CEllulite Reduction by CollAgenaSE Clostridium
Histolyticum (RELEASE)
- 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