Almirall : Receives Positive CHMP Opinion for Dimethyl Fumarate for the Treatment of Patients with Moderate-to-Severe Chronic Plaque Psoriasis

• Dimethyl fumarate (DMF) is a fumaric acid ester indicated as an oral first-line treatment for adults with moderate-to-severe chronic plaque psoriasis
• Results from the randomised, double-blind, placebo-controlled Phase III trial (BRIDGE) showed the efficacy and safety of dimethyl fumarate (DMF)
• Dimethyl fumarate is due to be marketed in Europe from Q3 2017

Barcelona, 21st April 2017

'We are proud of the positive recommendation announced by the CHMP for dimethyl fumarate as this will provide European patients and healthcare professionals with a new therapeutic alternative in the systemic treatment of this chronic dermatological disease', commented Eduardo Sanchiz, Almirall's CEO. 'This is a new milestone in order to consolidate our leading position in Dermatology and maintains our focus on improving lives of psoriasis patients', he added.

In September 2016, Almirall presented positive results from the randomised, double-blind, placebo-controlled Phase III trial (BRIDGE) showing the efficacy and safety of dimethyl fumarate compared to Fumaderm, at a satellite symposium at the 25th EADV Congress, in Vienna, Austria. The BRIDGE study demonstrated non-inferiority of DMF to Fumaderm and a good efficacy and safety profile. These results, including co-primary and secondary endpoints, were accepted for publication in the British Journal of Dermatology.

'Thanks to its efficacy and safety profile, this new oral formulation will allow us to bring a new therapeutic alternative that covers unmet needs in the systemic treatment of moderate-to-severe psoriasis to many patients in Europe', explained Alfredo Barón de Juan, Almirall's Executive Vice President, Global Commercial Operations. 'We are convinced that DMF will provide an important addition to the available therapeutic arsenal in the treatment of this disease'.

Furthermore the regulatory approval of Skilarence will enable Almirall to give access to a new systemic therapy for the patients with moderate and severe psoriasis. 'From now on patients in Germany and in the rest of the European Union will have a new alternative for treating their psoriasis. We are proud to extend the access of this fumaric acid derivative (only available in Germany in a different composition), to the rest of the European Union and clearly give a new opportunity to improve psoriatic patients life', said Xavier Llaurado, Almirall's Regulatory Affairs Director.

The European Commission generally follows the recommendations of the CHMP (EMA) and delivers its final decision thereafter. Dimethyl fumarate is due to be marketed in Europe by Almirall from Q3 2017, under the trade name Skilarence in all EU Member states plus Iceland, Norway and Switzerland.

About Dimethyl fumarate (DMF)

Dimethyl fumarate (DMF) is a type of fumaric acid ester (FAEs), which are recommended in the European S3 psoriasis guidelines for both induction and long-term treatment of adults with moderate-to-severe chronic plaque psoriasis. A combination of FAEs is currently approved for the treatment of moderate-to-severe psoriasis in Germany, with a positive risk-benefit profile for long-term use. DMF is considered the main active component in this combination.

About Psoriasis

Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the U.S. and approximately 125 million people worldwide. It is a non-contagious disorder that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.

About Almirall

Almirall is a global pharmaceutical company with a strong focus in Dermatology and Aesthetics with the mission of providing valuable medicines and medical devices to you and future generations. Our R&D is focused on Dermatology, with a wide range of programs including key indications. Through our innovative products, agreements and alliances, our work covers the entire drug value chain. Almirall is continually growing as a specialist company in a wide range of skin diseases, in order to cover our customers unmet needs.

Founded in 1943, headquartered in Barcelona, Spain, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision and the commitment of its long-standing major shareholders. In 2016, its revenues totaled 859.3 million euros and, with more than 2,000 employees, it has gradually built up a trusted presence across Europe, as well as in the US.

For more information, please visit www.almirall.com

References

1. Mrowietz, U., Szepietowski, J.C., Loewe, R., van de Kerkhof, P., Lamarca, R., Ocker, W.G., Tebbs, V.M. and Pau-Charles, I. (2017), Efficacy and safety of LAS41008 (dimethyl fumarate) in adults with moderate-to-severe chronic plaque psoriasis: a randomized, double-blind, Fumaderm®- and placebo-controlled trial (BRIDGE). Br J Dermatol, 176: 615-623. doi:10.1111/bjd.14947
2. Nast A, Gisondi P, Ormerod AD et al. European S3-Guidelines on the systemic treatment of psoriasis vulgaris - Update 2015 - Short version - EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol 2015; 29:2277-94.
3. Mrowietz U, Altmeyer P, Bieber T et al. Treatment of psoriasis with fumaric acid esters (Fumaderm). J Dtsch Dermatol Ges 2007; 5:716-7.
4. Reich K, Thaci D, Mrowietz U et al. Efficacy and safety of fumaric acid esters in the long-term treatment of psoriasis, a retrospective study (FUTURE). J Dtsch Dermatol Ges 2009; 7:603-10.
5. Rostami-Yazdi M., Mrowietz U. Fumaric acid esters. Clin Dermatol 2008; 26:522-6.

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