– Dermira plans to develop and commercialize lebrikizumab, a monoclonal antibody targeting IL-13, for moderate-to-severe atopic dermatitis
– Initiation of a Phase 2b clinical study is expected in the first quarter of 2018
– Management will host webcast and conference call today at 5:30 a.m. PT / 8:30 a.m. ET
MENLO PARK, CA, USA I August 08, 2017 I Dermira, Inc. (NASDAQ:DERM), 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, today announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (together Roche). Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications, except Roche will retain certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.
Under the terms of the agreement, Dermira will make an initial payment of $80 million to Roche and payments totaling $55 million in 2018. Dermira will also be obligated to make additional payments upon the achievement of certain milestones, comprising $40 million upon the initiation of Dermira’s first Phase 3 clinical study, up to $210 million upon the achievement of regulatory and first commercial sale milestones in certain territories and up to $1.025 billion based on the achievement of certain thresholds for net sales of lebrikizumab for indications other than interstitial lung disease. Upon potential regulatory approval, Dermira will make royalty payments representing percentages of net sales that range from the high single-digits to the high teens. The effectiveness of the agreement is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended (HSR).
“Atopic dermatitis is one of the most common skin diseases in the world, affecting millions of adults and children, and moderate to severe forms of this condition present a tremendous burden for patients,” said Tom Wiggans, chairman and chief executive officer of Dermira. “We believe atopic dermatitis is one of the greatest unmet needs in dermatology, and lebrikizumab, if successfully developed and approved, could represent a meaningful advancement in the treatment of this disease. The addition of this program to our development portfolio represents an important step toward our goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions.”
Dermira plans to initiate a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018. The objective of the Phase 2b dose-ranging study will be to optimize the dose of lebrikizumab for the design of a Phase 3 program. Preliminary design elements of the Phase 2b dose-ranging study include evaluating a loading dose and higher dose regimens of lebrikizumab than were explored in previous atopic dermatitis studies.
“Lebrikizumab is a potent and specific inhibitor of IL-13 with a differentiated mechanism of action and attractive pharmacokinetic properties,” said Eugene Bauer, M.D., chief medical officer of Dermira. “Data from preclinical and clinical studies, including pharmacokinetic and pharmacodynamic results from early clinical experience in atopic dermatitis, are encouraging and suggest higher doses of lebrikizumab could lead to greater efficacy in atopic dermatitis, while potentially offering a less frequent and therefore more convenient dosing regimen relative to existing therapies. If successfully developed, we believe that lebrikizumab could be a best-in-class IL-13 inhibitor and could have a best-in-disease profile.”
The transaction is expected to close in the third quarter of 2017 subject to the expiration or termination of the waiting period under HSR. Upon the close, Dermira expects to record a charge related to the acquisition of in-process research and development for a total of $135 million, consisting of the $80 million initial payment and $55 million of payments due in 2018. In addition, Dermira estimates it will incur up to $10 million in operating expenses in 2017 for costs related to transferring the lebrikizumab program to Dermira and preparing for the initiation of the Phase 2b dose-ranging study. Including the payments to Roche and costs related to the program, Dermira anticipates that it will spend approximately $200 million to obtain the topline results for the Phase 2b study. Assuming the close of the transaction, Dermira anticipates that its cash and cash equivalents and investments would be sufficient to meet its anticipated cash requirements into the first half of 2019, consistent with previously issued financial guidance.
Leerink Partners, LLC acted as financial advisor, and King & Spalding LLP and Fenwick & West LLP acted as legal counsel to Dermira, Inc.
Webcast and Conference Call Information
Dermira will host a webcast and conference call today to review details of the agreement beginning at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. Analysts and investors can participate in the conference call by dialing (877) 359-9508 for domestic callers and +1 (224) 357-2393 for international callers using the conference ID# 67835410. The webcast can be accessed live on the Investor Relations page of Dermira’s website, http://investor.dermira.com, and will be available for replay for 30 days following the call. A telephone replay of the call will be available by dialing (855) 859-2056 for domestic callers or +1 (404)-537-3406 for international callers and entering the conference code: 67835410.
About Lebrikizumab and Phase 2 Exploratory Clinical Studies
Lebrikizumab is a novel, humanized monoclonal antibody designed to specifically block the action of IL-13, a cytokine that is a central pathogenic mediator in atopic dermatitis. Two exploratory Phase 2 clinical studies, TREBLE and ARBAN, evaluated the safety and efficacy of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis. TREBLE was a double-blind, placebo-controlled study that evaluated the safety and efficacy of lebrikizumab in combination with topical corticosteroids. ARBAN was an open-label study designed to assess the safety of lebrikizumab as a monotherapy, with an exploratory assessment of efficacy. In both studies, clinical improvements were observed in patients treated with lebrikizumab. Adverse event rates were generally similar between treatment groups in each trial and most were mild or moderate in severity. Additional studies are needed to fully assess the potential benefits and risks of lebrikizumab.
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 can include redness, cracking, dryness and intense, persistent itching. Moderate-to-severe atopic dermatitis has a profound negative impact on patients’ mental and physical functioning, limiting their 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 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 and develop leading-edge medical dermatology programs. Dermira’s pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: CIMZIA® (certolizumab pegol), for which marketing applications have been submitted for potential approval for the treatment of moderate-to-severe chronic plaque psoriasis, in collaboration with UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com.
SOURCE: Dermira
Post Views: 27
– Dermira plans to develop and commercialize lebrikizumab, a monoclonal antibody targeting IL-13, for moderate-to-severe atopic dermatitis
– Initiation of a Phase 2b clinical study is expected in the first quarter of 2018
– Management will host webcast and conference call today at 5:30 a.m. PT / 8:30 a.m. ET
MENLO PARK, CA, USA I August 08, 2017 I Dermira, Inc. (NASDAQ:DERM), 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, today announced that it has entered into a licensing agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (together Roche). Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications, except Roche will retain certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.
Under the terms of the agreement, Dermira will make an initial payment of $80 million to Roche and payments totaling $55 million in 2018. Dermira will also be obligated to make additional payments upon the achievement of certain milestones, comprising $40 million upon the initiation of Dermira’s first Phase 3 clinical study, up to $210 million upon the achievement of regulatory and first commercial sale milestones in certain territories and up to $1.025 billion based on the achievement of certain thresholds for net sales of lebrikizumab for indications other than interstitial lung disease. Upon potential regulatory approval, Dermira will make royalty payments representing percentages of net sales that range from the high single-digits to the high teens. The effectiveness of the agreement is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended (HSR).
“Atopic dermatitis is one of the most common skin diseases in the world, affecting millions of adults and children, and moderate to severe forms of this condition present a tremendous burden for patients,” said Tom Wiggans, chairman and chief executive officer of Dermira. “We believe atopic dermatitis is one of the greatest unmet needs in dermatology, and lebrikizumab, if successfully developed and approved, could represent a meaningful advancement in the treatment of this disease. The addition of this program to our development portfolio represents an important step toward our goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions.”
Dermira plans to initiate a Phase 2b dose-ranging study assessing lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018. The objective of the Phase 2b dose-ranging study will be to optimize the dose of lebrikizumab for the design of a Phase 3 program. Preliminary design elements of the Phase 2b dose-ranging study include evaluating a loading dose and higher dose regimens of lebrikizumab than were explored in previous atopic dermatitis studies.
“Lebrikizumab is a potent and specific inhibitor of IL-13 with a differentiated mechanism of action and attractive pharmacokinetic properties,” said Eugene Bauer, M.D., chief medical officer of Dermira. “Data from preclinical and clinical studies, including pharmacokinetic and pharmacodynamic results from early clinical experience in atopic dermatitis, are encouraging and suggest higher doses of lebrikizumab could lead to greater efficacy in atopic dermatitis, while potentially offering a less frequent and therefore more convenient dosing regimen relative to existing therapies. If successfully developed, we believe that lebrikizumab could be a best-in-class IL-13 inhibitor and could have a best-in-disease profile.”
The transaction is expected to close in the third quarter of 2017 subject to the expiration or termination of the waiting period under HSR. Upon the close, Dermira expects to record a charge related to the acquisition of in-process research and development for a total of $135 million, consisting of the $80 million initial payment and $55 million of payments due in 2018. In addition, Dermira estimates it will incur up to $10 million in operating expenses in 2017 for costs related to transferring the lebrikizumab program to Dermira and preparing for the initiation of the Phase 2b dose-ranging study. Including the payments to Roche and costs related to the program, Dermira anticipates that it will spend approximately $200 million to obtain the topline results for the Phase 2b study. Assuming the close of the transaction, Dermira anticipates that its cash and cash equivalents and investments would be sufficient to meet its anticipated cash requirements into the first half of 2019, consistent with previously issued financial guidance.
Leerink Partners, LLC acted as financial advisor, and King & Spalding LLP and Fenwick & West LLP acted as legal counsel to Dermira, Inc.
Webcast and Conference Call Information
Dermira will host a webcast and conference call today to review details of the agreement beginning at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time. Analysts and investors can participate in the conference call by dialing (877) 359-9508 for domestic callers and +1 (224) 357-2393 for international callers using the conference ID# 67835410. The webcast can be accessed live on the Investor Relations page of Dermira’s website, http://investor.dermira.com, and will be available for replay for 30 days following the call. A telephone replay of the call will be available by dialing (855) 859-2056 for domestic callers or +1 (404)-537-3406 for international callers and entering the conference code: 67835410.
About Lebrikizumab and Phase 2 Exploratory Clinical Studies
Lebrikizumab is a novel, humanized monoclonal antibody designed to specifically block the action of IL-13, a cytokine that is a central pathogenic mediator in atopic dermatitis. Two exploratory Phase 2 clinical studies, TREBLE and ARBAN, evaluated the safety and efficacy of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis. TREBLE was a double-blind, placebo-controlled study that evaluated the safety and efficacy of lebrikizumab in combination with topical corticosteroids. ARBAN was an open-label study designed to assess the safety of lebrikizumab as a monotherapy, with an exploratory assessment of efficacy. In both studies, clinical improvements were observed in patients treated with lebrikizumab. Adverse event rates were generally similar between treatment groups in each trial and most were mild or moderate in severity. Additional studies are needed to fully assess the potential benefits and risks of lebrikizumab.
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 can include redness, cracking, dryness and intense, persistent itching. Moderate-to-severe atopic dermatitis has a profound negative impact on patients’ mental and physical functioning, limiting their 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 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 and develop leading-edge medical dermatology programs. Dermira’s pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: CIMZIA® (certolizumab pegol), for which marketing applications have been submitted for potential approval for the treatment of moderate-to-severe chronic plaque psoriasis, in collaboration with UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com.
SOURCE: Dermira
Post Views: 27
