Tetra Bio-Pharma Enters into Co-Development Agreement with MAKScientific

Send Press Releases with GlobeNewswire | February 27, 2020

Tetra Bio-Pharma Inc.  a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has signed a co-development definite agreement with MAKScientific.  This agreement provides Tetra with access to novel patented new molecules with CB1 and CB2 agonist or antagonist properties.  In the long term, this agreement secures patented new drug candidates for Tetra to develop after Caumz and QIXLEEF receive marketing approval. MAKScientific is a recognized world leader in endocannabinoid research and drug development.  MAKScientific has developed a pipeline of small molecule drugs that target the cannabinoid receptors (CB1 and CB2) as well as other targets implicated in the endocannabinoid system. Under this agreement, MAKScientific will develop new molecules that will be screened by Tetra for potential efficacy in various indications including cancer, pain and inflammation as well as other potential targets of interest to Tetra.

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Over 1.2 million cases of bacterial meningitis are estimated to occur worldwide each year. If not treated promptly, up to half of those cases will be fatal. This infographic from Datamonitor Healthcare provides a snapshot of the meningococcal vaccines market in the US and five major EU markets.


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PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies. "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world." Bryan Howcroft, CEO, MediPharm About MediPharm Labs Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

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BUSINESS INSIGHTS

Agilent Announces the Innovative Seahorse XF Pro Analyzer

Agilent Technologies Inc. | January 25, 2022

Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function. Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies. “With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.” Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses "The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.” The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ). About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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PHARMACY MARKET

Sunovion and Otsuka Initiate Phase 3 Clinical Development of Non-Racemic Amisulpride for the Treatment of People with Bipolar Depression

Sunovion Pharmaceuticals Inc. | February 10, 2022

Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development And Commercialization, Inc. announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride is being jointly developed and commercialized as part of a collaboration between Sunovion, its parent company Sumitomo Dainippon Pharma and Otsuka Pharmaceutical Co., Ltd. SEP380-301, named RELEASE 1 is a six-week, global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the efficacy, safety and tolerability of non-racemic amisulpride in adults with bipolar depression. Patients will be randomized to receive fixed-dose, non-racemic amisulpride or placebo. The primary endpoint for RELEASE 1 is the reduction of depressive symptoms, as measured by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, compared to placebo, after six weeks of treatment. Following participation in the six-week study period, patients who complete RELEASE 1 may enroll in RELEASE 3, a 12-month, open-label extension study assessing the long-term safety, tolerability and effectiveness of non-racemic amisulpride. “Major depressive episodes associated with bipolar I disorder have a profound impact on those living with the condition. Depressive episodes are associated with mood impairment, fatigue, loss of interest in activities or social situations and, in some cases, suicidality. We are encouraged by our Phase 2 clinical results and look forward to enhancing our understanding of non-racemic amisulpride and its potential to help address unmet needs in the treatment of bipolar depression.” Armin Szegedi, M.D., Ph.D., Senior Vice President, Chief Medical Officer at Sunovion “Randomizing the first patient in the RELEASE Phase 3 clinical development program is a significant step in our collaboration with Sunovion and our shared goal of expanding neuropsychiatric treatment options to patients living with serious mental conditions,” said John Kraus, M.D., Ph.D., Vice President, Clinical Development Therapeutic Head, CNS, Otsuka Pharmaceutical Development & Commercialization, Inc. “Through our collaboration with Sunovion, we hope to advance SEP-4199, which we believe shows promise for the treatment of people with bipolar depression.” About Non-Racemic Amisulpride (SEP-4199) Non-racemic amisulpride is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride was designed to enhance 5-HT7 receptor antagonist activity and reduce dopamine D2 receptor antagonist activity compared to racemic amisulpride. Lower D2 receptor occupancy associated with non-racemic amisulpride is intended to maintain overall effectiveness for patients with mood disorders, including bipolar depression, while reducing the burden of D2-related side effects, including movement-related symptoms, such as extrapyramidal symptoms and akathisia.1 About Bipolar Disorder Bipolar disorder affects approximately 12.6 million individuals in the United States and an estimated 29 million people worldwide.2,3 A person is usually diagnosed with bipolar disorder after experiencing at least one manic/hypomanic episode, with symptoms that are not better explained by another mental health condition, such as schizophrenia.4 Bipolar disorder is characterized by debilitating mood swings, interspersed with periods of stable mood and behavior.5 When individuals with bipolar disorder are experiencing symptoms, most tend to be depressed rather than manic.4 Bipolar disorder is associated with significant impairment in personal and professional relationships, quality of life and ability to function. About Sunovion Pharmaceuticals Inc. (Sunovion) Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate

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BUSINESS INSIGHTS

MedX Health Announces Addition of Two New Screening Services Locations in Ottawa

MedX Health Corp | January 28, 2022

Teledermatology company MedX Health Corp. is pleased to announce the launch of MedX Screening Services to be offered at two locations in Ottawa, Canada – ProMed Pharmacy, an independent, pharmacist owned pharmacy enterprise, and Dura Wellness Clinic a retail, clinical focused esthetic services group. Both locations will now offer MedX scanning services and accept walk-in patients. "This represents the next step in our business plan for North America. ProMed Pharmacy, under the Leadership of Lubna Fawaz, is a perfect model of modern health care delivery as it integrates many services and, most importantly, telehealth services on demand for their patients. Patients can now enter the pharmacy and have a telemedicine consult with a General Practitioner and receive an immediate referral to the Dermsecure Screening Service on site. Incorporating a telemedicine consult with a General Practitioner is a vital step to make DermSecure screening services easily accessible to the public by facilitating both the referral and the screening at the same location." MedX VP of North American Sales, Paul Ziemer The addition of ProMed Pharmacy to MedX's Pharmacy network will allow for the "Walk-in-Patient" to get service for their Dermatology concerns if they do not have a Family Doctor or do not have time to get a direct referral. "MedX remains focused on expanding its footprint into existing and new target markets, and our team is continuing to establish and accelerate many new commercial relationships and partnerships," stated Mike Druhan, MedX President, Dermatology Services. "I remain confident in our team’s ability to expand MedX's teledermatology platform to new markets and greatly improve outcomes for those dermatology patients seeking high-quality, virtual services." Teledermatology is a subspecialty of dermatology that offers safe and effective virtual care – patient screening and assessment – eliminating the need for in-person appointments with a dermatologist. MedX is a global leader in teledermatology through its high-definition image capture technology, SIAscopy®, and its secure, cloud-based patient management system, DermSecure®, which transmits and stores patient data throughout the assessment process. MedX's SIAscopy® is the only technology globally that captures five high-resolution images of suspicious moles, lesions and skin conditions, including four spectrophotometric images 2mm below the skin's surface. This technology provides detailed patient scans for virtual dermatological assessment by a certified dermatologist within 72 hours. About MedX Health Corp MedX, headquartered in Ontario, Canada, is a leading medical device and software company focused on skin health with its SIAscopy® on DermSecure® telemedicine platform, utilizing its SIAscopy® technology. SIAscopy® is also imbedded in its products SIAMETRICS®, SIMSYS®, and MoleMate®, which MedX manufactures in its ISO 13485 certified facility. SIAMETRICS®, SIMSYS®, and MoleMate® include hand-held devices that use patented technology utilizing light and its remittance to view up to 2 mm beneath suspicious moles and lesions in a pain free, non-invasive manner, with its software then creating real-time images for physicians and dermatologists to evaluate all types of moles or lesions within seconds. These products are cleared by Health Canada, the U.S. Food and Drug Administration, the Therapeutic Goods Administration and Conformité Européenne for use in Canada, the US, Australia, New Zealand, the European Union, Brazil and Turkey.

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Spotlight

Over 1.2 million cases of bacterial meningitis are estimated to occur worldwide each year. If not treated promptly, up to half of those cases will be fatal. This infographic from Datamonitor Healthcare provides a snapshot of the meningococcal vaccines market in the US and five major EU markets.

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