UCB and Dermira enter into strategic collaboration in dermatology to broaden patient access to Cimzia® (certolizumab pegol)
- Dermira obtains exclusive rights to develop Cimzia® in psoriasis in the US, Canada and the European Union
BRUSSELS and REDWOOD CITY, Calif., July 3, 2014 /PRNewswire/ — UCB, a global biopharmaceutical leader (Euronext: UCB), and Dermira, Inc., a privately held US-based dermatology company, announced today 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.
“The Dermira team has a track record in dermatology drug development and commercialization and we look forward to our collaboration. Since the first US approval of Cimzia(® )in 2008, we continue to evaluate its potential across severe immunological diseases with the goal of bringing this treatment option to more patients,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB. “The exploratory Phase 2 studies in patients with plaque psoriasis have shown promising data that support further clinical development.(1 )In addition, the improvement in psoriasis skin symptoms observed in patients with significant skin involvement in the pivotal RAPID(TM)-Psoriatic Arthritis study, were consistent with those seen in our Phase 2 study in patients with plaque psoriasis.(1,2) The RAPID(TM) study supported the approval of Cimzia(®) in psoriatic arthritis in US and EU in 2013. With Dermira, we now have a strong specialized partner with whom to move forward to make Cimzia(®) available to patients living with psoriasis and their physicians.”
“Dermira is proud to partner with UCB given their global leadership in inflammatory disease research and therapy, and product expertise with this important TNF-alpha inhibitor. If successfully developed and approved, Cimzia(® )would bring a new therapy option to adult patients with moderate to severe psoriasis. Cimzia(®) for psoriasis is our most advanced program and an important addition to our existing pipeline of dermatology products,” said Tom Wiggans, Chairman and Chief Executive Officer, Dermira.
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. 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.
Psoriasis is a common, chronic, relapsing, immune-mediated, inflammatory disorder with primary involvement of the skin.(3) It affects two to three per-cent of the world’s population -approximately 125 million people worldwide.(3) Psoriasis signs and symptoms can vary from person to person but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.(3)
In 2012, the psoriasis market (US, Japan, France, Germany, Italy, Spain and the UK) was valued at $5.5 billion, with TNF-alpha inhibitors representing 63%.(4)
CIMZIA(®) is the only 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.
About CIMZIA(®) in the US(5)
In the US, CIMZIA(®) is approved for the treatment of adults with moderately to severely active rheumatoid arthritis, for the treatment of adults with active psoriatic arthritis (PsA) and for adults with active ankylosing spondylitis (AS). In addition, it is approved for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Important Safety Information about CIMZIA(®) in the US
Risk of Serious Infections and Malignancy
Patients treated with CIMZIA(®) are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA(®) should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: