Date: 2014-07-03
Type of information: Licensing agreement
Compound: Cimzia® (certolizumab pegol)
Company: UCB (Belgium) Dermira (USA - CA)
Therapeutic area: Autoimmune diseases - Dermatological diseases
Type agreement: licensing - development - commercialisation
Action mechanism:
- monoclonal antibody/TNF alpha inhibitor. Cimzia® is a Fc-free, pegylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Disease: psoriasis
Details:
- • On July 3, 2014, UCB, a global biopharmaceutical leader, and Dermira, a privately held US-based dermatology company, announced that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia® (certolizumab pegol) in dermatology. This collaboration aims to broaden patient access to Cimzia® and make it available to patients with psoriasis, a chronic autoimmune disorder. Cimzia® is not currently approved for the treatment of psoriasis by any regulatory authority. Under the terms of the agreement, UCB grants Dermira an exclusive license to develop certolizumab pegol in psoriasis in the US, Canada and the European Union.
Financial terms:
- Dermira will be responsible for Phase 3 development costs and will receive payments of up to $49.5 million on the achievement of development and regulatory milestones. Subject to regulatory approval of Cimzia® in psoriasis, Dermira is granted an exclusive commercial license to market Cimzia® to dermatologists in the US and Canada. UCB will record the sales and Dermira will receive tiered royalty payments on those product sales which are attributable to dermatologists in the US and Canada and up to $40 million upon the achievement of tiered commercial milestones. In support of the partnership, UCB has made a $5 million equity investment in Dermira and a commitment to invest up to an additional $15 million in future Dermira equity financings.
Latest news: • On July 25, 2017, UCB and Dermira announced the UCB submission of a supplemental Biologics License Application (sBLA) to the FDA for Cimzia® (certolizumab pegol). Separately, UCB also submitted a regulatory filing with the European Medicines Agency (EMA)
Is general: Yes
