PHARMA TECH

CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021.

Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022.

"Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care."

About CareRx Corporation
CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

Spotlight

Gene therapy, the modification of genetic information in living cells to address a mutated gene, has the ability to dramatically change the way diseases are treated, or even cured. First conceptualized in the early 1970s, the seminal paper on the subject was published in Science by Theodore Friedmann and Richard Roblin, suggesting the great potential for gene therapy techniques in human genetic disease.

Spotlight

Gene therapy, the modification of genetic information in living cells to address a mutated gene, has the ability to dramatically change the way diseases are treated, or even cured. First conceptualized in the early 1970s, the seminal paper on the subject was published in Science by Theodore Friedmann and Richard Roblin, suggesting the great potential for gene therapy techniques in human genetic disease.

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PHARMA TECH

Iktos Announces Deployment of Their AI for Drug Design Software Makya™ by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Iktos | December 09, 2021

Iktos, a company specialized in Artificial Intelligence for new drug design today announced recent collaboration agreement in AI for new drug design with Jiangsu Hengrui Pharmaceuticals Co., Ltd., a leading global pharmaceutical company based in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Under the agreement, Iktos’ de novo generative design software Makya™ will be used by Hengrui scientists to facilitate rapid and cost-effective design of novel compounds and accelerate hit-to-lead/lead optimisation for undisclosed Hengrui Pharma’s drug discovery programmes. Iktos has released Makya™, a generative AI-driven de novo design software for Multi-Parametric Optimization (MPO), available either as a SaaS platform or for implementation on customer premises or in the customer’s Virtual Private Cloud (VPC). Makya’s user-friendly interface enables it to be used by medicinal or computational chemists. Makya™ can also be operated as a Python package through a Jupyter notebook interface. Iktos’ AI technology, based on deep generative models, helps bring speed and efficiency to the drug discovery process, by automatically designing virtual novel molecules that have desired activities for treating a given disease. This tackles one of the key challenges in drug design: rapid identification of molecules which simultaneously satisfy multiple bioactivity and drug-like criteria for drug discovery and development. “Innovation is the core development strategy. Hengrui has a strong interest in exploring and utilizing enabling technologies, such as AI, to transform and accelerate the discovery of innovative medicines. We are excited about the opportunity to use Iktos’ proprietary AI platform to beef up our drug design and discovery capability to better address unmet clinical needs”. Dr. Weikang Tao, Vice President of Hengrui Pharma and CEO of R&D Centers "We are very pleased to collaborate with Hengrui Pharma, a leading global pharmaceutical company based in China. We are excited and proud to announce our first collaboration deal in China pharma sector and to have Hengrui Pharma scientists use our software in their early discovery programs", said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "It is our ultimate goal to facilitate our technology usage by expert drug discovery scientists, who have deep knowledge and understanding of their discovery programs. This way, the promise of AI to dramatically improve drug discovery will have a better chance to be realized and impact therapeutic development. At Iktos, we strive to build an innovative technology platform capable of improving the efficiency of drug discovery by combining our powerful algorithmic technology, our know-how derived from the experience of the many collaborations we have established to date, and an intuitive and user-friendly user interface which is essential to an optimal user experience.” About Iktos Incorporated in October 2016, Iktos is a start-up company specializing in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, the design of molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. About Jiangsu Hengrui Pharmaceuticals Co., Ltd. Jiangsu Hengrui Pharmaceuticals Co., Ltd. is a leading global pharmaceutical company based in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma has 8 innovative products marketed and more than 50 clinical-stage innovative candidates, of which 20 are currently under global clinical development. Hengrui Pharma ranked 21st among the top 1,000 global pharma companies announced by Torreya in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

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PHARMA TECH

MyMD Pharmaceuticals Announces Issuance of U.S. Patent Covering Lead Drug Candidate MYMD-1 in a Method of Extending Lifespan

MyMD | November 24, 2021

MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent 11,179,382 B2, titled “Methods of Reversing Normal Aging Process and Extending Lifespan.” The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual. “This patent is a timely addition to our IP portfolio as we advance toward the launch of our fully funded Phase 2 trial of MYMD-1 for aging. After a comprehensive review by USPTO, we are pleased with the broad scope of the granted claims which offer further protection for our lead drug candidate, which we believe has the potential to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging healthy lifespan,” Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD “Our primary focus for MYMD-1 is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan,” Dr. Chapman added. “It’s also important to note that MYMD-1 shows promise in pre-clinical studies as a treatment for immune diseases including rheumatoid arthritis, multiple sclerosis, and Hashimoto’s thyroiditis, and as an anti-fibrotic and anti-proliferation therapeutic.” The latest patent adds to MyMD’s intellectual property portfolio of 14 granted patents (12 U.S. and two foreign) covering MYMD-1 in methods of treating chronic inflammation, autoimmune disorders, diabetes, multiple sclerosis, viral infections, addictions, fibrosis, asthma, and other disorders. MyMD also holds two patents for its synthetic cannabidiol (CBD) derivative Supera-CBD. An additional 30 patent applications are pending worldwide. About MYMD-1 Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic. MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. About MyMD Pharmaceuticals, Inc. MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.

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PHARMACY MARKET

Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Avacta | November 29, 2021

Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States. AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression. The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enroll eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101. As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrollment in US clinical trial sites is expected to begin in early 2022. “We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000. This is a major milestone in our development of pre|CISION™ chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000. Dr. Alastair Smith, Chief Executive of Avacta Group Provided that the study shows that the pre|CISION™ technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION™ chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272. We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK.” Neil Bell, Chief Development Officer of Avacta Life Sciences, commented: “We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK.”

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