Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

Mayne Pharma, Mithra | June 24, 2020

Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.

Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy. Following more than 20 years of research and development, Mayne Pharma's development and manufacturing partner, Mithra, can synthesise E4 at scale through a complex plant-based production process.

Spotlight

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. Existing smartphone interfacing devices now record health parameters and metrics on diseases such as diabetes, cancer, respiratory diseases, heart failure, sleep disorders and more.

Spotlight

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. Existing smartphone interfacing devices now record health parameters and metrics on diseases such as diabetes, cancer, respiratory diseases, heart failure, sleep disorders and more.

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BUSINESS INSIGHTS

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant

Astellas Pharma Inc | August 19, 2022

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has accepted the company's New Drug Application for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Astellas booked ¥13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022. "The FDA's acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS. We look forward to the FDA's review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas The NDA is supported by results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience VMS.3,4,5,6 VMS can have a disruptive impact on women's daily activities and overall quality of life. About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.7,8,9 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

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PHARMACY MARKET

Vipergen and LEO Pharma Partner for DNA Encoded Library (DEL)-Based Drug Discovery for Dermatology Indications

Vipergen | June 20, 2022

Vipergen, a leading provider of small-molecule drug discovery services based on DNA-encoded library technologies, announced a multi-target drug discovery partnership with LEO Pharma focused on novel treatments for dermatology indications. Under the terms of the agreement, Vipergen will apply its high-fidelity DNA-encoded library (DEL) screening technologies, including its new in-living-cell DEL platform, to discover novel small-molecule compounds that bind to selected LEO Pharma targets. LEO Pharma will select hits for potential development into innovative drugs for dermatology applications. LEO Pharma will retain exclusive rights to globally commercialize any products resulting from the collaboration. Financial details of the agreement were not disclosed. "Driving our mission to rapidly bring better treatments to people with skin conditions, we continue to explore ways to discover novel small-molecule compounds for innovative and challenging targets while shortening development timelines. Partnering with Vipergen gives us access to the only technology capable of screening DEL libraries inside living cells, under physiologically relevant conditions. We look forward to a productive partnership." Thorsten Thormann, Vice President of Research & Early Development at LEO Pharma "We are very pleased to partner with LEO Pharma in its mission to develop first-in-class and best-in-class treatments for the millions of patients around the world suffering with psoriasis, eczema, acne, skin infections, and other serious skin conditions," said Nils Hansen, PhD, Chief Executive Officer of Vipergen. "We look forward to applying our full suite of DEL screening technologies to accelerate and advance LEO Pharma's efforts to discover novel, high-quality small molecules for development into innovative new treatments." About Vipergen ApS Vipergen is a world-leading provider of small-molecule drug discovery services based on DNA-encoded library technologies and is the first and only company capable of screening DELs inside a living cell. Vipergen provides its proprietary suite of leading-edge DEL technologies through funded discovery partnerships with leading pharmaceutical and biotechnology companies, including top pharmaceutical companies in the U.S., EU, and Japan.

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BUSINESS INSIGHTS

Amylyx Pharmaceuticals Announces ALBRIOZA™ is Now Available in Canada for the Treatment of ALS

Amylyx Pharmaceuticals, Inc | August 01, 2022

Amylyx Pharmaceuticals, Inc. announced that ALBRIOZA™ is now commercially available in Canada for people living with amyotrophic lateral sclerosis. ALBRIOZA is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to existing treatments. In a clinical trial, ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with ALS. “We have remained steadfast in our commitment to ensure ALBRIOZA would be available in Canada as quickly as possible following Health Canada’s decision to approve ALBRIOZA, with conditions, in June,” said Margaret Olinger, Chief Commercial Officer at Amylyx. “We are pleased that starting this week, we are ready to fill prescriptions for ALBRIOZA.” Amylyx filed reimbursement submissions to the Canadian Agency for Drugs and Technologies and Institut national d’excellence en santé et en services sociaux in Quebec as part of an aligned Health Technology Assessments (HTA) review with Health Canada in parallel with the regulatory process to reduce the timelines required for patient access. The Company is continuing to work with the pan-Canadian Pharmaceutical Alliance, Federal, Provincial, and Territorial public drug plans, and private insurers to expeditiously achieve listing and reimbursement, so that eligible Canadians living with ALS can have access to ALBRIOZA as quickly and efficiently as possible. “In Canada, prescription drugs undergo a thorough and often long review and approval process across regulatory, HTA, pricing negotiations, and formulary listing with public drug plans. In addition, private insurers have their own review and listing processes. We continue to work diligently to navigate reimbursement processes to pursue broad and equitable access to ALBRIOZA across all provinces in Canada.” Chris Aiello, General Manager and Head of Canada at Amylyx “Market availability is an important milestone in the available treatment options for people living with ALS,” said Tammy Moore, CEO of the ALS Society of Canada. “As we look forward, we do not want to see coverage decisions become a barrier to access, and we urge the decision-makers throughout the drug access and reimbursement process to work expeditiously to provide equitable access for all eligible Canadians living with ALS who are in desperate need.” As part of Amylyx’ continued commitment to the ALS community, through the Amylyx Care Team Support Program, Amylyx provides insurance navigation, treatment coordination and educational support for people living with ALS who have been prescribed ALBRIOZA in Canada and their caregivers. Eligibility and enrollment into the ACT Support Program can be discussed with prescribing health care professionals. About ALBRIOZA™ ALBRIOZA™ is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada and with marketing applications pending in the United States and European Union. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction. ALBRIOZA is also being explored for the potential treatment of other neurodegenerative diseases. About Amylyx Pharmaceuticals Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA.

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