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.
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.
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.
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.
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SOURCE Allergan plc; Topokine Therapeutics