– Lebrikizumab is a novel, investigational anti-IL-13 monoclonal antibody under development for the treatment of people with moderate-to-severe atopic dermatitis
– Dermira to receive an option exercise fee of $50 million and additional potential milestone payments and royalties
– Dermira expects to initiate Phase 3 program by end of 2019
BARCELONA, Spain & MENLO PARK, CA, USA I June 25, 2019 I Almirall, S.A. (BME: ALM) and Dermira, Inc. (NASDAQ: DERM) announced today that Almirall has exercised its option to license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and certain other indications in Europe. Almirall and Dermira previously entered into an option and license agreement in February 2019 pursuant to which Almirall was granted this exclusive option in exchange for an upfront option fee of $30 million. As a result of Almirall’s decision to exercise its option, the company will pay Dermira $50 million, and Dermira will be eligible to receive additional payments upon the achievement of certain milestones, including $30 million in connection with the initiation of certain Phase 3 clinical studies.
Almirall’s decision follows positive topline results reported by Dermira in March 2019 from a Phase 2b dose-ranging study that showed all three doses of lebrikizumab met the primary endpoint, and demonstrated dose-dependent improvements across a range of measures characterizing the signs and symptoms of moderate-to-severe atopic dermatitis, including itch and skin inflammation, compared to placebo. The safety profile observed in the study was consistent with prior studies of lebrikizumab. The findings suggest that lebrikizumab has the potential to be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis. Following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, Dermira plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.
“We are incredibly pleased to collaborate with Dermira on the lebrikizumab clinical development program and excited by the prospect of delivering what could be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis in Europe, which Almirall believes could achieve potential peak sales of around €450 million euros,” said Peter Guenter, chief executive officer of Almirall. “This transaction reinforces our shared commitment to the dermatology community and supports our vision of offering truly meaningful, new treatment advances to people living with chronic, life-altering skin conditions.”
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
Under the terms of the option and license agreement entered into between Almirall and Dermira in February 2019, Almirall paid Dermira an upfront option fee of $30 million in exchange for an option to acquire an exclusive license to develop lebrikizumab in dermatology indications and commercialize lebrikizumab in all indications in Europe. As a result of its decision to exercise its option, Almirall will pay Dermira an option exercise fee of $50 million. In addition, Almirall will make additional payments to Dermira upon the achievement of certain milestones, including $30 million in connection with the initiation of certain Phase 3 clinical studies and up to $85 million upon the achievement of regulatory milestones and the first commercial sale of lebrikizumab in Europe. Dermira will also be entitled to receive milestone payments upon the achievement of certain thresholds for net sales of lebrikizumab in Europe, as well as royalty payments representing percentages of net sales that range from the low double-digits to the low twenties.
“The unique characteristics of lebrikizumab and positive findings observed in our Phase 2b dose-ranging study suggest that we have the potential to offer people living with moderate-to-severe atopic dermatitis, and the healthcare practitioners who care for them, a differentiated treatment option that delivers a compelling combination of safety, efficacy, tolerability, convenience and ease of use,” said Tom Wiggans, chairman and chief executive officer of Dermira. “As we look to initiate our Phase 3 program by the end of this year, Dermira is pleased to partner with Almirall to potentially bring this exciting new treatment option to patients in Europe, while we continue to pursue development and potential commercialization in the United States.”
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and also includes redness, cracking, dryness and intense, persistent itching. The condition can have a negative impact on patients’ mental and physical functioning, limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.
About Lebrikizumab
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
About Almirall
Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients and future generations. Our efforts are focused on fighting skin health diseases and helping people feel their best. We support healthcare professionals in continuous improvement, bringing our innovative solutions where they are needed.
The company, founded almost 75 years ago and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its shareholders and its decision to help others by understanding their challenges and using Science to provide solutions for real life. Total revenues in 2018 were 811 million euros. Almirall has more than 1,800 employees.
For more information, please visit almirall.com
About Dermira
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, develop and commercialize leading-edge medical dermatology products. The company’s approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages 9 and older) with primary axillary hyperhidrosis (excessive underarm sweating). Please see the QBREXZA prescribing information. Dermira is evaluating lebrikizumab for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and plans to initiate a Phase 3 clinical development program by the end of 2019. Dermira also has early-stage research and development programs in other areas of dermatology. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow Dermira on LinkedIn, Instagram and Twitter.
SOURCE: Dermira
Post Views: 293
– Lebrikizumab is a novel, investigational anti-IL-13 monoclonal antibody under development for the treatment of people with moderate-to-severe atopic dermatitis
– Dermira to receive an option exercise fee of $50 million and additional potential milestone payments and royalties
– Dermira expects to initiate Phase 3 program by end of 2019
BARCELONA, Spain & MENLO PARK, CA, USA I June 25, 2019 I Almirall, S.A. (BME: ALM) and Dermira, Inc. (NASDAQ: DERM) announced today that Almirall has exercised its option to license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and certain other indications in Europe. Almirall and Dermira previously entered into an option and license agreement in February 2019 pursuant to which Almirall was granted this exclusive option in exchange for an upfront option fee of $30 million. As a result of Almirall’s decision to exercise its option, the company will pay Dermira $50 million, and Dermira will be eligible to receive additional payments upon the achievement of certain milestones, including $30 million in connection with the initiation of certain Phase 3 clinical studies.
Almirall’s decision follows positive topline results reported by Dermira in March 2019 from a Phase 2b dose-ranging study that showed all three doses of lebrikizumab met the primary endpoint, and demonstrated dose-dependent improvements across a range of measures characterizing the signs and symptoms of moderate-to-severe atopic dermatitis, including itch and skin inflammation, compared to placebo. The safety profile observed in the study was consistent with prior studies of lebrikizumab. The findings suggest that lebrikizumab has the potential to be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis. Following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, Dermira plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.
“We are incredibly pleased to collaborate with Dermira on the lebrikizumab clinical development program and excited by the prospect of delivering what could be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis in Europe, which Almirall believes could achieve potential peak sales of around €450 million euros,” said Peter Guenter, chief executive officer of Almirall. “This transaction reinforces our shared commitment to the dermatology community and supports our vision of offering truly meaningful, new treatment advances to people living with chronic, life-altering skin conditions.”
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
Under the terms of the option and license agreement entered into between Almirall and Dermira in February 2019, Almirall paid Dermira an upfront option fee of $30 million in exchange for an option to acquire an exclusive license to develop lebrikizumab in dermatology indications and commercialize lebrikizumab in all indications in Europe. As a result of its decision to exercise its option, Almirall will pay Dermira an option exercise fee of $50 million. In addition, Almirall will make additional payments to Dermira upon the achievement of certain milestones, including $30 million in connection with the initiation of certain Phase 3 clinical studies and up to $85 million upon the achievement of regulatory milestones and the first commercial sale of lebrikizumab in Europe. Dermira will also be entitled to receive milestone payments upon the achievement of certain thresholds for net sales of lebrikizumab in Europe, as well as royalty payments representing percentages of net sales that range from the low double-digits to the low twenties.
“The unique characteristics of lebrikizumab and positive findings observed in our Phase 2b dose-ranging study suggest that we have the potential to offer people living with moderate-to-severe atopic dermatitis, and the healthcare practitioners who care for them, a differentiated treatment option that delivers a compelling combination of safety, efficacy, tolerability, convenience and ease of use,” said Tom Wiggans, chairman and chief executive officer of Dermira. “As we look to initiate our Phase 3 program by the end of this year, Dermira is pleased to partner with Almirall to potentially bring this exciting new treatment option to patients in Europe, while we continue to pursue development and potential commercialization in the United States.”
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and also includes redness, cracking, dryness and intense, persistent itching. The condition can have a negative impact on patients’ mental and physical functioning, limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.
About Lebrikizumab
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
About Almirall
Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients and future generations. Our efforts are focused on fighting skin health diseases and helping people feel their best. We support healthcare professionals in continuous improvement, bringing our innovative solutions where they are needed.
The company, founded almost 75 years ago and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment with its shareholders and its decision to help others by understanding their challenges and using Science to provide solutions for real life. Total revenues in 2018 were 811 million euros. Almirall has more than 1,800 employees.
For more information, please visit almirall.com
About Dermira
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, develop and commercialize leading-edge medical dermatology products. The company’s approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages 9 and older) with primary axillary hyperhidrosis (excessive underarm sweating). Please see the QBREXZA prescribing information. Dermira is evaluating lebrikizumab for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and plans to initiate a Phase 3 clinical development program by the end of 2019. Dermira also has early-stage research and development programs in other areas of dermatology. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow Dermira on LinkedIn, Instagram and Twitter.
SOURCE: Dermira
Post Views: 293
