Moberg Pharma decides on fully guaranteed rights issue of approximately SEK 150 million

Moberg Pharma | November 06, 2020

The Board of Directors of Moberg Pharma AB (publ) (OMX: MOB) ("Moberg Pharma" or "the Company") has today resolved to carry out a fully guaranteed issue of new ordinary shares and warrants ("Units") with preferential rights for existing shareholders (the "Rights Issue") of approximately SEK 150 million before transaction costs. The Rights Issue requires the approval of an extraordinary general meeting (the "Extraordinary General Meeting"). The proceeds will be used for registration activities and clinical work for MOB-015. When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement. By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021.

Spotlight

After you’re diagnosed with epilepsy, you have several ways to get treatment. Medication, a special diet, an implant that works on your nerves, and surgery could all help you feel better.

Spotlight

After you’re diagnosed with epilepsy, you have several ways to get treatment. Medication, a special diet, an implant that works on your nerves, and surgery could all help you feel better.

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PHARMA TECH

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant

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 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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BUSINESS INSIGHTS

Merck Enters Collaboration and Option to License Agreement with Nerviano Medical Sciences to Develop Next-Generation PARP1 Selective Inhibitor

Merck | September 22, 2022

Merck, a leading science and technology company, announced a collaboration agreement with licensing option with Nerviano Medical Sciences S.r.l. for the next-generation highly selective and brain-penetrant PARP1 inhibitor, NMS-293. NMS-293 has strong potential in combination with a wide variety of DNA-damaging agents, including systemic or targeted chemotherapy or with DNA damage response inhibitors, in numerous tumor types. NMS-293 is in early clinical development for the treatment of patients with BRCA-mutated tumors as a single agent and in combination with temozolomide in recurrent glioblastoma. “Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile. The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients.” Victoria Zazulina, M.D., Head of Development Unit Oncology for the Healthcare business of Merck PARP is key in the repair of DNA damage, and PARP inhibitors have been shown to be highly efficacious in the treatment of patients with tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers with BRCA-mutations. Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to $65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293. During the option period, NMS and Merck will collaborate on the clinical development of NMS-293, with NMS designing, sponsoring, conducting, and funding global clinical trials. About NMS-293 NMS-293 is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ). About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 60,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

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PHARMACY MARKET

Eyenovia's Novel Optejet® Dispenser Puts People's Eyes First

Eyenovia | September 06, 2022

Eyenovia, Inc. an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics, brings human-centric design to ophthalmology with its novel Optejet® dispenser. Traditional eye drops normally overdose the patient's eye with medication and preservatives. Eyenovia's easy-to-use, novel Optejet® dispenser administers precisely 8µL of medication to the eye, effectively treating the patient's condition while creating a more gentle dosing experience. "The unique delivery mechanism of the Optejet® will fundamentally change how we think about eye medication. Right now, traditional eye drops can result in significant dose-related side effects for the treatment of chronic illnesses like glaucoma. The Optejet® dispenser is designed for patients to experience easier administration and fewer side effects with similar efficacy." Michael Rowe, CEO of Eyenovia The Optejet® dispenser administers ophthalmic solutions horizontally using Eyenovia's proprietary Microdose Array Print (MAP™) technology. The system functions similar to an inkjet printer, delivering accurate microdoses through a precision spray. Traditional eye drops deliver four to five times larger volume than the human eye can actually hold, which causes eye drops to roll down the face and overdose the eye with preservatives. Poor delivery of eye drops is more than an inconvenience; it can prevent patients from using necessary medication because of the side effects. For example, with medication to help dilate the pupils for eye exams, up to 23% of patients experienced stinging and burning with the eye drops, causing patients to forgo eye exams. In Eyenovia studies, less than 1% of patients experienced stinging and burning. "Medications only work if patients take them, and with the Optejet, we have designed a way for patients to benefit from an easy-to-use, appropriate, lower dose spray that results in similar efficacy. We're excited for physicians and providers to be able to offer this revolutionary technology in the near future to patients who deserve a more positive experience," said Rowe. Eyenovia's first marketed invention is expected to be MydCombi™, a first-in-class drug-device combination microdose for in-office pupil dilation. This potentially will help save physician's chair time, eliminating the traditional three eyedrops used for a patient's eye exam. Other exciting innovations in the Eyenovia pipeline include MicroLine and MicroPine. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

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