CASI Pharmaceuticals, Inc. | September 26, 2022
CASI Pharmaceuticals, Inc. a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products announced that CASI Biopharmaceuticals Co., Ltd, a subsidiary of CASI Pharmaceuticals, Inc. entered into an Equity Transfer Agreement with Shenzhen Jiadao Gongcheng Equity Investment Fund, LLP pursuant to which CASI Wuxi agreed to transfer its equity interest in Juventas Biotechnology Co., Ltd. amounting to 12.0098% total Juventas equity to Jiadao Gongcheng for RMB 240.87 million. The Equity Transfer Agreement states there will be two even payment installments from Jiadao Gongcheng; one payment to be made after the Equity Transfer Agreement is signed and the second payment to be made after the completion of the equity transaction.
"We are confident in CNCT-19, and we expect Juventas to submit for NDA to the NMPA in 2022 for the B-ALL indication. CASI and Juventas will continue to maintain a working partnership, focusing on product launch and co-marketing for CNCT-19."
Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer
Dr. He continued, "The completion of the equity transfer transaction will strengthen CASI's balance sheet by providing CASI with sufficient cash to operate until, at least, the end of 2023. This transaction will allow CASI to advance the development of our other pipeline projects while augmenting the efforts of our sales and marketing team."
CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma. CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program's joint steering committee.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals Co., Ltd., located in Beijing, China. The Company has built a commercial team of more than 100 hematology and oncology sales and marketing specialists based in China.
Juventas is a biopharmaceutical company headquartered in China dedicated to the development and commercialization of cell therapies globally. Utilizing innovative and integrated technology platforms, the company has developed a diverse pipeline of cellular immunotherapies for treatment of hematological malignancies, solid tumors, and other non-oncological conditions both in China and globally. At present, the company is conducting two pivotal clinical trials of CNCT19 for treating adult r/r-B-ALL and r/r-B-NHL in China. CNCT19 has the potential to become the first launched domestically developed CD19 CAR-T therapy in China and the first CAR-T product for the treatment of adult R/R B-ALL in China.
BUSINESS INSIGHTS, PHARMACY MARKET
Innovation Pharmaceuticals Inc | November 29, 2022
BT BeaMedical Technologies a private company developing a next-generation laser-based platform for epilepsy and cancer surgery, has notified Innovation Pharmaceuticals that it has received U.S. Food and Drug Administration clearance for its MANTA surgical laser family. The clearance is an important milestone for BeaMed in its development of an advanced laser technology with respect to shaping energy and matching it to patient specific anatomy, a novel concept that BeaMed is proving a reality. Innovation Pharmaceuticals made a strategic investment to acquire a minority stake in BeaMed in June 2022.
BeaMed is the inventor and developer of the StingRay Laser System a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast, and lung cancers. The StingRay Laser System will utilize the MANTA laser family as its core energy generation devices coupled to new fiber optic technology, allowing a perfect match between the exact structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage.
The MANTA surgical laser family was cleared by the FDA including five different wavelengths and soft tissue use in a very wide set of clinical specialties, including Neurosurgery, Spinal Surgery, Urology, Thoracic Surgery, Pulmonary Surgery, Gynecology, General Surgery, ENT/Head and Neck, Plastic Surgery, Orthopedics, Arthroscopy, Ophthalmology, Radiology, and Oral Surgery.
BeaMed expects to soon make requisite submissions to the FDA for clearance of its fiber optics for use in multiple medical indications.
“We are excited with the speed of progress BeaMed is making towards introduction of its new platform product with the potential to help millions of patients globally suffering from epilepsy and cancer in multiple specialties. The execution of this submission and the speed of clearance speaks volumes to the commercialization strategy and the exceptional capabilities of the regulatory team at BeaMed,”
Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals
“This is an exciting and important milestone for our company. This clearance gives us two key achievements. First, U.S. market access to a wide range of potential laser energy sources, each allowing us different and unique tissue interaction, an achievement which will have wide clinical implications. The second is a very wide set of intended uses covering many key potential markets for our technology. This underscores the clear regulatory strategy of BeaMed, which goes hand in hand with our broad impact business vision of revolutionizing key treatments, including brain tumors, epilepsy, lung cancer, prostate cancer, breast cancer and more,” said Gil Shapira, co-founder of BeaMed.
BeaMed was founded by Moshe Eshkol and Gil Shapira, both highly experienced specialists in surgical lasers and medical devices. BeaMed and the development of the StingRay system are also supported by a special prestigious grant from the BIRD Foundation a bi-national organization supporting Israel-US collaboration. Gil Shapira brings forward 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology.
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio.
Alira Health and Artisan Healthcare Consulting | September 07, 2022
Alira Health, a patient-centric, global health care advisory, clinical research and technology company, announced the acquisition of Artisan Healthcare Consulting, a US-based consulting firm that provides strategic insights to healthcare companies. Artisan serves 12 of the top 15 pharmaceutical companies in the US, supports the C-Suite of leading biotechnology companies, and has deep expertise in over 30 therapeutic areas.
The acquisition of Artisan strengthens and extends Alira Health’s Market Access and Management Consulting advisory practices in North America and globally. Clients of Alira Health and Artisan Healthcare Consulting now have access to the full breadth of advisory offerings from both firms. Alira Health clients can leverage Artisan’s deep expertise in brand strategy and analytics, new product differentiation, US market access, go-to-launch strategies, and product lifecycle management. Artisan Healthcare Consulting clients can benefit from Alira Health’s clinical operations, real-world evidence, and patient-centric technology offerings, including decentralized clinical trials (DCT), patient support programs (PSP) and digital therapeutics (DTx).
“Artisan Healthcare Consulting is recognized for delivering the highest level of strategic and quantitative analysis to help healthcare leaders act decisively across their business. Artisan Healthcare Consulting’s leadership has decades of experience serving as a long-term partner to healthcare executives. We welcome them to the Alira Health team.”
Jean-Francois Ricci, Chief Access Officer at Alira Health
“We are delighted to join a company with such a broad and complementary set of capabilities,” said Bob Delise, CEO and Founder of Artisan Healthcare Consulting. “It is a pleasure to work with our new colleagues, and we now have access to an international team of strategists and experts who can help our customers succeed. We embrace Alira Health’s mission to humanize healthcare and look forward to offering new capabilities to all our clients.”
Artisan Healthcare Consulting partners Bob Delise, Brad Ship, and Greg Wolfe will join Alira Health’s global consulting leadership team as they continue to work with their long-term clients.
About Artisan Healthcare Consulting, Inc.
Artisan Healthcare Consulting Inc. was founded in 2009 on the principle that outstanding client service differentiates a great consulting firm from a good one. Artisan provides strategic and analytic advice to a wide range of healthcare product companies. Artisan works across the biopharma industry to help clients steer emerging therapies through clinical development, launch them successfully, and drive success throughout the life cycle of their products.
About Alira Health
Alira Health is an international patient-centric, global health care advisory, clinical research, and technology company, whose mission is to humanize healthcare. We work with healthcare and life sciences organizations looking for support across their entire solutions lifecycle. From development to medical care, we complement our clients’ expertise with a full spectrum of services including research and clinical development solutions, technology-powered consulting, and real-world evidence.
Our integrated and multidisciplinary team of over 600 scientists, strategists, economists, clinicians, and biostatisticians collaborate across our North American, European, and Asian offices and advise 80% of the top 50% of MedTech companies and 75% of the top 50% of Pharma companies.