Dive Brief:
- Menlo Park, CA-based dermatology company Dermira, Inc. has handed back the rights for Cimzia in psoriasis to UCB. The decision is described as "reflecting both companies' strategic priorities."
- There are no termination or penalty payments involved by either party, but UCB will pay Dermira $11 million by Nov. 13, 2017 to repurchase the product rights, licenses and intellectual property.
- Once Cimzia gains approval in the U.S., UCB will pay out an additional $39 million. In turn, Dermira will pay UCB $10 million as a reimbursement for development costs over the first six months of 2018. The collaboration agreement will terminate on February 15, 2018.
Dive Insight:
Dermira and UCB signed the Cimzia deal in July 2014, for development and commercialization in dermatology. This gave Dermira the rights to develop Cimzia (certolizumab pegol) for psoriasis in the U.S., Canada and Europe, and exclusive marketing rights in North America.
By 2017, however, Dermira has two pipeline drugs in pivotal clinical trials taking its attention. Its lead product, glycopyrronium tosylate, has completed clinical trials as a topical, once daily treatment for excessive underarm sweating (primary axillary hyperhidrosis), and Dermira plans to file a New Drug Application before the end of 2017.
Olumacostat glasaretil is in two pivotal Phase 3 trials and an open label long-term study, with topline results on topical treatment of moderate-to-severe acne vulgaris expected in the first half of 2018. This could be the first topical acne treatment to specifically target excessive sebum production.
The payments from UCB will increase Dermira's cash holdings and allow it to move its lead drugs closer to the market.
"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, CEO of Dermira.
UCB submitted a supplemental Biologics License Application to the Food and Drug Administration and a regulatory filing to the European Medicines Agency earlier this year to expand Cimzia's label to include moderate-to-severe chronic plaque psoriasis. The applications were based on data from the CIMPASI-1, CIMPASI-2 and CIMPACT Phase 3 trials. These evaluated the efficacy and safety of Cimzia in adults with moderate-to-severe chronic plaque psoriasis. UCB remains committed to commercializing Cimzia in psoriasis worldwide.
"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 U.S. bring us one step closer to helping women and men living with this difficult-to-treat, chronic skin condition," said Emmanuel Caeymaex, UCB’s head of immunology.
Cimzia was first approved in 2008 for the treatment of rheumatoid arthritis, and will have to face up to biosimilar competition. Pfenex, Inc. is developing a biosimilar version dubbed PF688. Cimzia's sales were $1 billion in the first nine months of 2017, up 10% year-on-year.