AstraZeneca scouts replacements for longtime chairman Johansson

fiercepharma | June 04, 2019

During his seven-year stint as AstraZeneca chairman, Leif Johansson weathered some ups and downs and helped fend off one major hostile takeover attempt. Now, the drugmaker is getting ready to scout for successors, Sky News reports. The company hasn't set a timetable for a transition, but its nomination and governance committee is taking a closer look, the British publication reports, citing people familiar with the matter. AstraZeneca declined to comment on the report.In England, board members are no longer considered "independent" after nine years of service. AstraZeneca could be positioning itself to keep an independent chair as Johansson nears that point.AstraZeneca officials aren’t sure whether Johansson or AstraZeneca CEO Pascal Soriot would leave first, Sky News reports; both started their jobs back in 2012. One investor believes Johansson would depart within 18 months, allowing his successor to scout out Soriot’s replacement, Sky News reports. In an interview with Swedish business publication Di, Johansson explained the "comply or explain" rule in England. Under the rule, "nine years is a suitable time as chairman" and "if you stay longer you must give an explanation," Johansson told Di, according to a translation.

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RESEARCH

Corium Announces Publication of ADLARITY® Clinical Trial Data: Drug Exposure Equivalent to Oral Donepezil With Favorable GI Side Effect Profile

Corium, Inc. | September 20, 2022

Corium, Inc., a fully-integrated biopharmaceutical company leading the development and commercialization of novel central nervous system therapies, announced publication of its phase 1 healthy volunteer study results for ADLARITY in the peer-reviewed Journal of Alzheimer's Disease. The article, "Comparison of Steady-State Pharmacokinetics of Donepezil Transdermal Delivery System with Oral Donepezil," reports that Corium's novel once-weekly Alzheimer's dementia treatment delivered drug exposure equivalent to oral donepezil while presenting lower gastrointestinal (GI) adverse events overall compared to oral donepezil. The article is currently available online and expected to be published in the hardcopy of the Journal of Alzheimer's Disease, Volume 90, Issue 1, on October 25, 2022. "Transdermal delivery offers meaningful potential benefits over oral administration, including ease of use, maintenance of steady concentrations of drugs, reduced gastrointestinal adverse effects, and better treatment compliance. The availability of a transdermal formulation of donepezil gives clinicians, patients, and their caregivers an important new option to consider when treating dementia of the Alzheimer's type," said study co-author Pierre N. Tariot, M.D., director of the Banner Alzheimer's Institute in Phoenix, AZ. "The study demonstrated the equivalent exposure of Adlarity to oral donepezil and supports the use of ADLARITY as a compliant and safe once-weekly dosing regimen for treatment of patients with dementia of the Alzheimer type. The trial also shows Corium's commitment to addressing the unmet needs of patients with CNS disorders." Charles Oh, M.D., Chief Medical Officer of Corium ADLARITY Transdermal System: Equivalent to Oral Donepezil Exposure, Fewer GI Adverse Events Overall In the trial, investigators compared the extent of donepezil exposure from the once-weekly ADLARITY to a once-daily oral donepezil formulation in 60 healthy adults (NCT04617782). The trial included three treatment periods of 5 weeks each. In the first period, all the participants received ADLARITY weekly, which provided 5 mg/day of donepezil. In the second period, participants were randomized to receive either 10 mg/day once-weekly ADLARITY or 10 mg/day daily oral donepezil, followed by switching to the alternative treatment, ADLARITY or oral donepezil, in the third period. All the participants knew which treatment they received in this open-label trial. Investigators examined the amount of donepezil in the participants' blood, including the maximum plasma concentration (Cmax) and the total amount of drug exposure (area under the curve or AUC). About Alzheimer's Disease Alzheimer's disease is a progressive and irreversible brain disorder. It involves changes in brain tissue including abnormal buildup of proteins as well as loss of neuron function. The resulting damage leads to the loss of remembering, reasoning, and thinking abilities. The related behavioral changes include the loss of independence in activities of daily living and self-care. Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to moderate, to severe, when the person must depend on others for the basic activities of day-to-day life. Patients with advanced Alzheimer's disease may be unable to chew and swallow easily. About Corium Corium, Inc., is a fully-integrated biopharmaceutical company that is leading the development and commercialization of CNS therapies that provide physicians with innovative treatment options for patients, their families, and their caregivers. Corium is commercializing two U.S. FDA approved products, ADLARITY and AZSTARYS. About Gurnet Point Capital Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, GPC is able to deliver differentiated results for its investors and partners.

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VIEWS AND ANALYSIS

Altamira Therapeutics Provides Business Update and First Half 2022 Financial Results

Altamira Therapeutics Ltd | December 01, 2022

Altamira Therapeutics Ltd. a company dedicated to developing therapeutics that address important unmet medical needs, today provided a business update and reported its first half 2022 financial results. “We continue to make good progress with the transformation of Altamira into an RNA delivery technology company. We are optimistic of reaching an agreement to divest or partner our Bentrio nasal spray for key markets in North America and Europe by year end. Last month, we agreed to divest part or all of our inner ear therapeutics programs to a European family office. Following some delay and under slightly amended terms, we expect that transaction to close in December. Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO “Heading towards 2023, we look forward to focusing exclusively on the many emerging opportunities in the fast-growing RNA therapeutics market. We are increasingly well positioned to advance our RNA delivery technology throughout 2023.” As Altamira is going through the final stages of a major corporate transformation, management intends to hold its next investor call upon finalization of its partnering / divestiture projects. On that call, the Company will also provide its outlook for 2023. RNA delivery platform update Altamira continued to make solid progress with the development of its patented, peptide-based platform for RNA delivery to extrahepatic tissues. In recent months, the RNA team led by Chief Development Officer Covadonga Pañeda, Ph.D., and Chief Scientific Officer Samuel Wickline, MD, have advanced various projects, including selection and optimization of siRNA sequences, formulation, process development and manufacturing. Starting with project AM-401 for the treatment of KRAS-driven tumors, the Company added a second project, AM-411 for the treatment of rheumatoid arthritis. AM-411 nanoparticles comprise siRNA targeting NF-kB a key checkpoint in RA inflammation. The Company is developing both AM-401 and AM-411 with the objective of out-licensing the drug products at a later stage. They serve as a “showcase” for the application of Altamira’s RNA delivery technology; the Company’s strategy will be to out-license the technology to pharma and biotech companies for use with their own RNA molecules. In this context, Altamira has been intensifying its efforts to raise awareness about OligoPhore/SemaPhore within science and industry. In recent months, members of Altamira’s leadership team gave oral presentations at multiple international conferences, highlighting the ability to deliver RNA molecules to extrahepatic tissues and achieve efficient and rapid endosomal release inside target cells. Concurrently, further data on RNA delivered with Altamira’s delivery technology has been published by independent research groups in peer-reviewed scientific journals. Altamira anticipates entering into its first partnering agreements in 2023. Bentrio Update Earlier today, Altamira reported that its licensee and distribution partner Nuance Pharma has launched Bentrio nasal spray in Hong Kong to help provide protection against airborne viruses as well as allergens. This will be the first step to distributing Bentrio in the other Nuance-licensed territories which is comprised of mainland China, Macau and South Korea. As part of its strategy to focus exclusively on RNA delivery, Altamira has been in discussions with several well-established OTC consumer health companies for the partnering of Bentrio. Those discussions intensified following the 510(k) clearance of the product by the FDA and have advanced well, including due diligence by interested parties. The Company anticipates entering into a partnering transaction before year end. In the context of those partnering discussions, Altamira suspended preparations for launching the product in the US on its own as well as pausing major marketing initiatives in Europe. This restraint provides the prospective strategic partner for Bentrio with maximum flexibility to fit the product into its business plan. Beginning in early October, the Bentrio nasal spray was relaunched in Europe for allergic rhinitis. Previously, the Company had ceased marketing the product for the indication of viral infection in the EU and Switzerland although Bentrio’s mode of action is the same regardless of whether it provides a barrier against airborne virus or allergen particles. This had been demonstrated in various relevant in vitro assays. However, certain countries and regions require specifically clinical performance data to clear Bentrio for this indication, in particular related to COVID-19. Such data are expected to become available through the COVAMID trial. In September, Altamira announced that it had reached its extended enrollment target of 160 confirmed subjects in its COVAMID clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio nasal spray in patients with acute COVID-19. The read-out of top-line data remains on track for the current quarter. The Company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data. In September, the Company also announced that its “NASAR” clinical trial in seasonal allergic rhinitis (SAR) resumed enrollment as the new pollen season started in Australia. The NASAR trial is expected to enroll a total of 100 patients suffering from SAR and is designed to compare the safety and efficacy of Bentrio against a (control) saline nasal spray. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score under treatment with Bentrio against control. The NASAR trial was initiated in the fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US FDA. Unless an interim analysis performed upon reaching 50% of the enrollment target to check the validity of the statistical powering assumptions requires a change to the target size of 100 patients, the Company expects to complete enrollment into the NASAR trial by year-end or in early 2023 with a read-out of top-line data in late 1Q-23.

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PHARMACY MARKET

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Astellas Pharma Inc. | September 05, 2022

Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied 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. MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study's primary endpoint is the frequency and severity of adverse events which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future. "The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas Fezolinetant is an investigational selective neurokinin-3 receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™. About the MOONLIGHT Phase 3 Clinical Trials MOONLIGHT 1™ is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3™ is a 52-week single-arm Phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China. 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™ 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 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS.3,4 VMS can have a disruptive impact on women's daily activities and overall quality of life.1 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.5,6,7 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

ICON selected by BARDA to conduct anthrax vaccine clinical trial

ICON plc | October 07, 2022

ICON plc. a world-leading healthcare intelligence and clinical research organisation, announces that it has been selected by the US Biomedical Advanced Research and Development Authority part of the Administration for Strategic Preparedness and Response in the Department of Health and Human Services to execute an anthrax vaccine clinical trial. BARDA is providing funding to the Government and Public Health Solutions team at ICON to develop and execute a clinical trial that will evaluate the immune response to the next-generation anthrax vaccine AV7909. The team will support the evaluation of AV7909 immunogenicity kinetics by conducting clinical trial activities including but not limited to project management, clinical operations and quality assurance. ICON has extensive experience in supporting vaccine clinical trials. It has participated in over 160 vaccine studies in the past five years. ICON’s vaccine clinical research professionals are therapeutically aligned with a leadership team that brings more than 200 years of combined experience in vaccine clinical development for commercial businesses, government, NGOs and multinational health organisations. “We are pleased to have been selected to execute this important clinical trial. The potential for an anthrax attack is still a very real and serious threat, and we are proud to be playing our part to increase the understanding of treatment options for anthrax exposure, ultimately supporting human health.” Edward Wright, President, ICON Government and Public Health Solutions This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur. The clinical studies will not expose participants to anthrax. The trial will enrol healthy adults aged 18 and older and will be conducted in the United States starting in early 2023. BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network is responsible for planning and executing clinical studies to support medical countermeasure development. Bacillus anthracis, the agent that causes anthrax, is a serious bioterrorism threat due to the delivery of aerosolised spores that can cause high-mortality disease through gastrointestinal, cutaneous, inhalational or injection routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. Inhalational anthrax infection usually develops within a week after exposure but can take up to two months. Without treatment, only about 10% to 15% of patients survive after exposure to inhaled B. anthracis spores. Since 2015, BARDA has supported the late-stage development of AV7909, a next-generation anthrax vaccine which uses the U.S. Food and Drug Administration licensed anthrax vaccine Biothrax in combination with an immune system stimulant or adjuvant. The vaccine is being developed in partnership with its manufacturer Emergent Biosolutions Inc. to protect against anthrax post-exposure when used in combination with the recommended antibiotics. About ICON plc ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 40,500 employees in 119 locations in 53 countries as at June 30, 2022. About ICON Government & Public Health Solutions ICON Government & Public Health Solutions is ICON's business unit focused on direct US Government engagement, Non-Government Organisations (NGOs) and academia, providing full service and functional research solutions. In addition, ICON GPHS coordinates a Government Centre of Excellence (CoE) to lend internal federal government subject matter expertise that can be leveraged by other ICON business units when commercial clients receive federal funding on ICON awarded contracts. About BARDA’s Medical Countermeasures Clinical Studies Network (CSN) The CSN provides BARDA partners and medical countermeasure developers with essential tools and services to develop vaccines, therapeutics, diagnostics, and medical devices. The CSN provides comprehensive (Phases 1-4) clinical study services.

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PurCann Pharma: new world leader in the extraction and purification of cannabis and hemp interest molecules Over the past 25 years, SiliCycle has developed, manufactured and marketed extraction and purification products for the pharmaceutical industry in more than 85 countries.

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