DUBLIN and BOSTON, April 21,
2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a
leading global pharmaceutical company, today announced that it has
acquired Topokine Therapeutics, a privately held, clinical-stage
biotechnology company focused on developing topical medicines for
fat reduction. Under the terms of the agreement, Allergan acquired
Topokine Therapeutics for an upfront payment of $85 million and success-based development and
sales milestones for XAF5, a
first-in-class topical agent in late-stage development for the
treatment of steatoblepharon, also known as undereye bags.
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Applied to the lower eyelids once nightly, XAF5 penetrates the skin and acts
pharmacologically on fat cells to shrink undereye bags. An
estimated 40 million Americans have steatoblepharon,i
which can make the face look older, tired, stressed or sad. In
XOPH5-OINT-2, a Phase 2 randomized, placebo-controlled clinical
trial, XAF5 met the primary endpoint
achieving statistically significant and clinically meaningful
reductions in undereye bags. In January
2016 Topokine initiated XOPH5-OINT-3, a pivotal Phase 2b/3
study of XAF5.
"The acquisition of Topokine and its XAF5 technology adds an innovative technology to
Allergan's industry leading mid-to-late stage pipeline of more than
70 programs and bolsters our leadership in medical aesthetics,"
said David Nicholson, Executive Vice
President and President, Global Brands Research & Development
at Allergan. "XAF5 has the potential
to be the first topical fat reduction product for the treatment of
steatoblepharon, a condition with no current therapeutic options
available for patients. We look forward to continuing the
outstanding development work conducted by the Topokine team to
bring this innovative medical aesthetic treatment to market."
"Allergan is a leader in medical and facial aesthetics, with
unparalleled commercial and development expertise in the medical
aesthetics community and a laser-focus on innovation. These
characteristics make Allergan ideally suited to continue the
successful development and maximize the potential commercialization
of XAF5," said Murat Kalayoglu, MD,
PhD, Topokine's Chief Executive Officer and a board-certified
ophthalmologist. "I am deeply appreciative of the commitment and
dedication of our Topokine team that has championed the discovery
and development of XAF5. We look
forward to working with Allergan to ensure continued development
success for XAF5 and realize a
successful launch of the product."
"Physicians and their patients have been seeking an
FDA-approved, non-invasive treatment option to address undereye
bags where current treatment options are limited," said
Jeffrey Dover, MD, FRCPC, a
board-certified dermatologist and director of SkinCare Physicians
in Chestnut Hill, MA. "Adding a
topical treatment that physicians could offer to their patients
would be an important step forward in the treatment of
steatoblepharon."
Topokine's investors include Schooner Capital, a Boston-based private investment firm engaged
in venture capital, growth equity and alternate asset investments.
Leerink Partners LLC acted as financial advisor to Topokine.
Covington & Burling LLP acted as legal advisor to Allergan and
Foley Hoag LLP acted as legal counsel to Topokine.
About Steatoblepharon (Undereye Bags)
Steatoblepharon
affects a key focal point of the face which can make the face look
older, tired, stressed or sad. Steatoblepharon has been shown
to cause psychosocial distress, and treatment is associated with
sustained improvements in self-esteem. In contrast to many
aesthetic conditions, both women and men report feeling concerned
about steatoblepharon.
About Allergan
Allergan plc (NYSE: AGN), headquartered
in Dublin, Ireland, is a unique,
global pharmaceutical company and a leader in a new industry model
– Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
About Topokine
Topokine is a clinical-stage
biotechnology company developing topical prescription medications
that act pharmacologically on adipocytes to contour the face
and body. The company's lead program, XAF5, is in late-stage clinical development
for reduction of undereye bags (steatoblepharon). The
company's assets are protected by more than 75 issued and
pending patents worldwide.
Allergan Forward-Looking Statements
Statements
contained in this press release that refer to future events or
other non-historical facts are forward-looking statements that
reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2015 (certain of such periodic public filings having been
filed under the "Actavis plc" name). Except as expressly required
by law, Allergan disclaims any intent or obligation to update these
forward-looking statements.
i Sheety, Michael. Abstract: Topical XAF5 Ointment reduces excess eyelid fat: A Phase
2, randomized, double‐masked, placebo-controlled trial.
CONTACTS:
Allergan:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc; Topokine Therapeutics