PHARMA TECH

PharmaJet partner Zydus Cadila Announces COVID-19 Vaccine Expansion Plan to Multiple Countries With Korean Firm

PharmaJet | January 05, 2022

PharmaJet®, the maker of innovative, needle-free injection technology, announced that its partner Zydus Cadila, is partnering with Enzychem Lifesciences to manufacture their COVID-19 plasmid DNA vaccine in Korea. The plan is to manufacture 80+ million doses of the ZyCoV-D vaccine, which was recently granted emergency use approval by India’s national regulatory agency for those aged 12 years and above. The vaccine will be manufactured in Korea and exported to several lower-middle income countries in Latin America and Asian New Southern Policy member countries. It is exclusively delivered by the PharmaJet Tropis® Needle-free Injection System.

Under the terms of this agreement, Zydus will transfer its manufacturing technology and provide technical assistance to Enzychem Lifesciences. The vaccine is administered intradermally using the PharmaJet needle-free system, which can be deployed more readily, especially in resource-poor populations where these are urgently needed.

This manufacturing agreement will enable people in lower-middle income countries access to a safe, well-tolerated and efficacious vaccine, delivered by a proven delivery system. Our systems have been successfully used to deliver millions of doses for polio immunization initiatives in Pakistan, Somalia, The Gambia, and numerous other countries. We are prepared for this commercialization initiative and have scaled our operations to meet the demand driven by COVID-19 vaccinations as we continue to fulfill our company mission of improving peoples’ lives through our needle-free delivery technology.”

Chris Cappello, President and CEO of PharmaJet

About PharmaJet
PharmaJet’s mission is to improve people’s lives through needle-free technology. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. 

About Enzychem
Headquartered in Seoul, South Korea, Enzychem Lifesciences is developing novel small molecule therapeutics to target fundamental pathways in inflammation, patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases. Enzychem lead candidate, EC-18, has successfully completed US FDA phase 2 clinical testing in cancer patients. In response to the Korean government pledge for a Vaccine Hub, Enzychem has formed a consortium with Hanmi Pharma and several domestic companies in Korea to manufacture vaccines against COVID 19. The company plans to leverage its expertise in lipid chemistry and manufacturing to establish itself as a regional producer of lipid-based formulations for improved delivery of nucleic acids and other biologicals and drugs. 

About Zydus
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 23,000 people worldwide, including 1,400 scientists engaged in R & D, and is dedicated to creating healthier communities globally.

Spotlight

The WHO reports the medication adherence rate only approaches 50%, even in developed nations. When compared to the top 15 most adherent countries on Medisafe, the U.S. healthcare system has some work to do in boosting its oncology adherence rate. It’s important for pharma companies to know which countries are leading the charge and which types of cancer are seeing the lowest adherence. What types of factors influence oncology drug adherence rates? How do rates vary by day and time? Condition? Number of medications taken simultaneously? Which pharma companies manufacture the top 10 most adherent cancer drugs on Medisafe.

Spotlight

The WHO reports the medication adherence rate only approaches 50%, even in developed nations. When compared to the top 15 most adherent countries on Medisafe, the U.S. healthcare system has some work to do in boosting its oncology adherence rate. It’s important for pharma companies to know which countries are leading the charge and which types of cancer are seeing the lowest adherence. What types of factors influence oncology drug adherence rates? How do rates vary by day and time? Condition? Number of medications taken simultaneously? Which pharma companies manufacture the top 10 most adherent cancer drugs on Medisafe.

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PHARMACY MARKET

CStone and LegoChem Biosciences Enter Global Licensing Agreement for New Antibody Drug Conjugate

CStone | October 29, 2020

CStone Pharmaceuticals declared today a permitting concurrence with Lego Chem Bio sciences, Inc, for the turn of events and commercialization of LCB71, a likely first-in-class/top tier immunizer drug form ("ADC"). Under the understanding, CStone gets the selective worldwide option to lead advancement and commercialization of LCB71 outside the Republic of Korea. LCB will get a forthright installment of US$10 million, and up to US$353.5 million in combined achievement installments, in addition to layered eminences. Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone, said: "We are very pleased to form this partnership with LCB, a leading ADC platform company, to obtain global rights to an asset with highly differentiated attributes in an exciting new field of oncology. The agreement adds the first ADC to CStone's development pipeline, and bolsters our precision medicine franchise with a new modality. We look forward to harnessing its full potential and bringing it to patients around the world." LCB71 is a pre-clinical ADC going into Investigation New Drug ("IND") empowering contemplates. It targets ROR1 (receptor tyro sine kinase-like vagrant receptor 1), a high-potential ADC focus for different strong and hematological malignancies. ROR1 protein articulation is common in an assortment of malignancies including different types of leukemia, non-Hodgkin lymphoma, and bosom, lung, and ovarian tumors. LCB71 has a restrictive tumor-actuated pyrrolobenzodiazepine ("PBD") expert medication poison that tends to the ordinary poisonousness issue related with conventional PBD payloads. It has shown total tumor hindrance over a few pre-clinical disease models, which may convert into a wide helpful record for a scope of strong and hematologic malignancies. Moreover, it uses site-explicit formation for an exact medication counter acting agent proportion. This backings serum half-life and improves its pharmacokinetic profile, and furthermore empowers homogeneous creation and huge scope fabricating. Dr. Yong-Zu Kim, CEO and President of LCB, said: "We are pleased to have reached this agreement with CStone, which has demonstrated extensive oncology expertise, especially in global clinical development. This partnership puts LCB71 on a path to development and commercialization for patients worldwide. We are convinced that CStone is the right partner to secure the future of this important drug." About CStone CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 15 drug candidates, including five late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide. About LegoChem Biosciences LegoChem Biosciences (LCB) is a clinical-stage biopharmaceutical company focusing on the development of next-generation novel therapeutics utilizing its proprietary medicinal drug discovery technology LegoChemistry and ADC platform technology ConjuAll. Since its foundation in 2006, LCB has focused on the research and development of Antibody-Drug-Conjugates (ADCs), antibiotics, anti-fibrotic and anticancer therapeutics based on proprietary platform technologies. Forward-looking Statement The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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BUSINESS INSIGHTS

ARS Pharmaceuticals Expands Executive Leadership Team with Addition of Pharmaceutical Commercialization Veterans

ARS Pharmaceuticals, Inc. | February 10, 2022

ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the expansion of its executive leadership team with the appointments of Harris Kaplan as executive vice president, commercial strategy and Daniel Relovsky as senior vice president, sales and marketing. Mr. Kaplan and Mr. Relovsky, accomplished industry veterans with proven track records of commercial strategy and launch execution, will be responsible for preparing for and leading the commercialization of neffy™, once approved. neffy, a proprietary composition of epinephrine, is a small, reliable, easy-to-use option that allows for needle-free intranasal delivery of epinephrine, the only drug approved for the emergency treatment of Type I allergic reactions, including anaphylaxis. "The appointments of both Harris and Dan to the ARS team represent another building block in our ongoing commercialization preparations for neffy. We believe neffy's 'no needle, no pain' delivery, small size for convenient portability, and ease of use can provide a patient-friendly solution for individuals and caregivers to more easily and reliably administer epinephrine sooner, achieving more rapid symptom relief and preventing the allergic reaction from becoming severe or life-threatening. I'm excited to welcome Harris and Dan, both of whom bring decades of product launch and commercial leadership experience to our leadership team, and look forward to benefiting from their expertise as we progress toward our mission of being an innovative pharmaceutical leader in the treatment of severe allergy." Richard Lowenthal, founder, chief executive officer and president of ARS Harris Kaplan, MBA, executive vice president, commercial strategy, will join the ARS commercial team as lead for commercial strategy and oversee launch preparations for neffy. He brings more than 40 years of global experience across the pharmaceutical, biotechnology and healthcare consulting industries and most recently served as managing partner of Red Team Associates. Throughout his career, Mr. Kaplan has worked on the development, launch and commercialization of over 125 new products across more than 40 therapeutic categories, including LIPITOR®, Nexium, VIAGRA®, HUMIRA®, ALLEGRA®, HERCEPTIN® and Trikafta, and Yescarta. He has extensive experience in establishing and building new product planning initiatives, leadership and development programs and managing global strategic operations. Mr. Kaplan earned an MBA in marketing and operations research from Temple University where he also taught in the MBA program for several years. Daniel Relovsky, senior vice president, sales & marketing, will be responsible for leading the U.S. sales and marketing organization for neffy. He brings more than 30 years of commercial and operational experience, including product launch leadership in highly competitive markets and in establishing new standard-of-care therapies. Mr. Relovsky specializes in commercial planning and efficient team building to address complex executions, and brings a diverse background and success record in specialty, orphan, and major therapeutic markets. Prior to joining ARS, Mr. Relovsky held various senior commercial and operational leadership positions at MAIA Biotechnology, Inc., Clarity Global Solutions, LLC., Puma Biotechnology, Inc., Somaxon Pharmaceuticals, Inc., Cephalon, Inc. (now Teva Pharmaceuticals, Inc.), Salmedix, Inc., Maxim Pharmaceuticals, Inc., Agouron Pharmaceuticals, Inc. (now Pfizer, Inc.), Women First Healthcare, Inc., and IQVIA. Mr. Relovsky earned his B.S. in business administration, finance from Drexel University. About ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The company is developing neffy™, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient, and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

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PHARMA TECH

Overland Pharmaceuticals Partners with ArisGlobal to Accelerate Safety Capabilities

ArisGlobal | December 08, 2021

ArisGlobal, the leading provider of life sciences software that automates core drug development with its end-to-end drug development technology platform LifeSphere® announced its partnership with Overland Pharmaceuticals. Overland, a premier biopharmaceutical company bringing innovative medicines to underserved patients in Asia and worldwide, selected ArisGlobal's LifeSphere Multivigilance program to centralize pharmacovigilance activities and further develop and commercialize advances in medicine. "Pharmacovigilance is evolving, with greater demands to save time and cost, maintain compliance with shifting global regulations, and effectively aggregate large amounts of data, among other vital tasks, which is why we're excited that Overland has adopted ArisGlobal's LifeSphere Safety platform to manage those challenges. With LifeSphere Multivigilance, Overland will realize efficiency gains and obtain real-time insights into risk-benefit profiles across the product life cycle." Beena Wood, Vice President of Safety at ArisGlobal LifeSphere Multivigilance is an end-to-end, automated system that helps pharmacovigilance teams save time and effort, ensure future-proof compliance, and keep global teams collaboratively aligned. The LifeSphere product suite is used by over 60% of the top 50 biopharma companies worldwide. "Through formative partnerships, such as working with ArisGlobal, Overland will move forward with our mission to develop and commercialize the most promising advances in medicine across carefully selected therapeutic areas," said Roger Luo, Ph.D, Chief Development Officer of Overland. "Our goals are to build innovation for patients, achieve flexibility with business partners, and develop program efficiency by centralizing key operations. We feel that by bringing pharmacovigilance centrally with LifeSphere, we are one step closer to accomplishing that vision." "Safely and rapidly accelerating the development of new medicines is at the core of what we do," adds Rong Zhu, M.D, Ph.D., Head of Drug Safety & Pharmacovigilance at Overland. "Now, by utilizing LifeSphere Multivigilance, we will be able to centralize and scale our pharmacovigilance efforts, strengthen our data fabric, and further utilize effective R&D technology to assist in the development of patient-centric, life-changing therapies." Another key area that sparked alignment across ArisGlobal and Overland includes shared values of global collaboration, agility, and integrity. ArisGlobal's 30+ year tenure in the R&D technology industry will support Overland to architect differing partnership models and bring innovative drugs to underserved patients in Asia and around the world. This news comes on the heels of ArisGlobal's recent Breakthrough Conference, acknowledgment for requirement readiness in Gens & Associates' August 2021 "IDMP Software Vendor Readiness and Capability" report, and accolades by Frost & Sullivan for Customer Value Leadership for 2021. About ArisGlobal ArisGlobal is transforming the way today's most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture. About Overland Pharmaceuticals Overland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging our resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine.

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