Dermira, Inc and UCB announced the companies have agreed to end their development and commercialization agreement for CIMZIA (certolizumab pegol) in psoriasis. Following positive Phase 3 clinical trial results, UCB and Dermira announced U.S. and EU regulatory submissions for CIMZIA for the treatment of moderate-to-severe chronic plaque psoriasis in July of this year. Pending regulatory approval, UCB remains committed to commercializing CIMZIA in psoriasis worldwide.
Dermira expressed its intent to terminate the collaboration agreement, and Dermira and UCB have entered into a transition agreement to effect an orderly transition of the development and commercialization activities, pursuant to which UCB will regain U.S. and Canadian development and commercialization rights for CIMZIA for the treatment of psoriasis. Both parties will undertake a transfer of data and Dermira will not participate in any future development or commercialization activities for the product. The collaboration agreement will terminate on February 15, 2018 and the companies anticipate the completion of the transition by such date.
“This decision reflects a careful review of Dermira’s strategic priorities and our focus on our other late-stage product candidates, in particular, on the launch preparedness and execution for glycopyrronium tosylate,” said Tom Wiggans, chief executive officer at Dermira. “We are proud of our partnership with UCB and the development objectives that we achieved to date, and we remain committed to the millions of patients with skin conditions and the healthcare professionals who serve them. If approved, we believe that CIMZIA will be an important treatment option for patients with moderate-to-severe plaque psoriasis.”
“We would like to thank Dermira for their commitment to helping successfully develop CIMZIA in psoriasis and for a fruitful partnership over the past three years,” said Emmanuel Caeymaex, UCB’s Head of Immunology and Executive Vice President. “UCB has a strong expertise in auto-immune disorders and psoriasis is an indication we are aiming to add to our portfolio. The regulatory filings of CIMZIA in psoriasis in the EU and the US bring us one step closer to helping women and men living with this difficult-to-treat, chronic skin condition. We will use the experience we have gained with existing CIMZIA indications to best serve the needs of psoriasis patients, caregivers, physicians and other healthcare stakeholders.”
Pursuant to the collaboration agreement, there are no termination or penalty payments required by either party. In consideration for the repurchase of all product rights, licenses and intellectual property relating to CIMZIA, UCB will pay to Dermira $11.0 million by November 13, 2017 and, upon approval of CIMZIA in psoriasis in the United States, an additional $39.0 million within 30 days of such approval. Dermira is obligated to reimburse UCB for up to $10.0 million of development costs incurred by UCB in connection with the development of CIMZIA between January 1, 2018 and June 30, 2018. If the aggregate development costs reimbursed by Dermira to UCB during this six-month period are less than $10.0 million, Dermira will pay to UCB the difference between such aggregate costs and $10.0 million.
In addition, Mr. Caeymaex, a Dermira director, has resigned from his position as a member of the board and, pursuant to the transition agreement, UCB will no longer have a right to designate a director nominee to Dermira’s board of directors.
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), for which a Phase 3 program has been completed for the treatment of primary axillary hyperhidrosis (excessive underarm sweating beyond what is needed for normal body temperature regulation); olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris; and lebrikizumab, for which Dermira plans to initiate a Phase 2b dose-ranging study for the treatment of moderate-to-severe atopic dermatitis. Dermira is headquartered in Menlo Park, Calif.
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB).
For full prescribing information on CIMZIA, please visit www.ucb.com
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