Astellas Pharma Inc. | September 30, 2022
Astellas Pharma Inc. announced the European Medicines Agency has accepted for regulatory review the company's marketing authorization 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
"More than half of women 40 to 64 years of age experience hot flashes during menopause, with limited nonhormonal treatment options. The EMA's acceptance of our MAA for fezolinetant brings us one step closer to advancing a potential first-in-class nonhormonal treatment option for women in Europe who experience VMS associated with menopause, similar to the FDA acceptance of our NDA for women in the U.S."
Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas
The MAA 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 Europe, the U.S. and Canada. 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 MAA, Astellas proposes a 45 mg daily dose, which is subject to the EMA's review.
Fezolinetant is an investigational nonhormonal selective neurokinin 3 receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.
This acceptance will have no impact on Astellas' financial forecasts of the current fiscal year ending March 31, 2023.
About the BRIGHT SKY™ Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ 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 Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.3,4,5 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.6 VMS can have a disruptive impact on women's daily activities and overall quality of life.1
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.
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.
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.
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.
Pharma Tech | August 09, 2022
Pharma Tech Holding SA announced it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries.
Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food.
This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA a JV between PTH and listed company IGEA PHARMA NV IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extraction technology by super critical CO2 and will be energy self-sufficient through the use of solar photovoltaic panels and district heating. BSS will grant for highest CBD quality also due to a proprietary extraction process, starting from the farming performed under strict control and culminating with the immediate freezing of the flowers after harvest, with the target to also sell “all natural” formulations to increase bioavailability thus enhancing the possible applications. Last, but not least, BSS will invest in the agricultural raw material chain and will create an aeroponic green house in Ticino, to deliver a high quality GMP Pharmaceutical CBD oil.
LDA Capital agreed to commit an amount of up to CHF 30 million in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by PTH, that PTH has the right to exercise at its sole discretion.
“We’re thrilled with this partnership and are so glad that LDA Capital recognizes the value of PTH and its portfolio company, with the aim of creating one of the most innovative hub for health-tech, agri-tech and functional food,”
Sabina Del Nigro, CEO at PTH
About Pharma Tech Holding
Pharma Tech Holding SA is a holding company based in Lugano, Switzerland, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food.
About LDA Capital
LDA Capital is a global alternative investment group with expertise in cross border transactions worldwide. Our team has dedicated their careers to international & cross border opportunities having collectively executed over 250 transactions in both the public and private middle markets across 43 countries with aggregate transaction values of over US$11 billion.