PHARMACY MARKET

AbCellera and Everest Medicines Announce Multi-Target Collaboration to Advance New Antibody Therapies

Everest Medicines | September 23, 2021

AbCellera and Everest Medicines Limited announced that they have entered into a multi-year collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest. The partnership will help to expand Everest’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology.

We are proud to partner with Everest as they build a robust pipeline of innovative medicines for patients in Asia and beyond, We believe our full-stack discovery engine, combined with Everest’s clinical development capabilities, creates synergy and the opportunity to speed the delivery of therapies to patients around the world.

- Carl Hansen, Ph.D., CEO and President of AbCellera.

By partnering with AbCellera, Everest will benefit from an operating system that supports many antibody modalities to unlock new target classes and open new disease areas to therapeutic access. The collaboration will leverage the full breadth of AbCellera’s technology stack, including sourcing fully humanized antibodies from the Trianni Mouse®, sourcing single domain antibodies from camelids, and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

This collaboration will allow us to gain access to AbCellera’s cutting edge, AI-powered antibody discovery platform, which will greatly accelerate and increase the efficiency of our internal discovery efforts.

- Jennifer Yang, Ph.D., Chief Scientific Officer of Everest Medicines.

Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

AbCellera Forward-looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

Spotlight

Will the Pharma R&D Annual Review 2018 from Citeline’s Pharmaprojects be music to your ears, or will it sound a sour note? Find out with the Pharma R&D Annual Review 2018 infographic, now available to you as a free download.". Tune in to this visual year in review – cleverly framed in a musical motif – which features the Top Ten in therapy groups, diseases/indications, pharma companies by size of pipeline, and many more critical stats about where the pharma industry stands at the start of 2018.

Spotlight

Will the Pharma R&D Annual Review 2018 from Citeline’s Pharmaprojects be music to your ears, or will it sound a sour note? Find out with the Pharma R&D Annual Review 2018 infographic, now available to you as a free download.". Tune in to this visual year in review – cleverly framed in a musical motif – which features the Top Ten in therapy groups, diseases/indications, pharma companies by size of pipeline, and many more critical stats about where the pharma industry stands at the start of 2018.

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BUSINESS INSIGHTS

Mikart and Nano PharmaSolutions have entered into a collaboration agreement to manufacture clinical trial materials using NanoTransformer™ Technology

Mikart, LLC Nano and PharmaSolutions, Inc. | October 12, 2022

Mikart, LLC a comprehensive contract development and manufacturing organization announced that it has entered into a collaboration agreement with Nano PharmaSolutions, Inc. an innovative nanotechnology company that has a proprietary NanoTransformer™ that enhances the solubility of pharmaceutical active ingredients. "We are excited to bring this new technology from preclinical stage to a GMP clinical phase manufacturing environment. This differentiated, solvent-free, nano-granulation process for drug development and manufacturing provides our customers with an alternative solubility enhancement technology." Nazar Elkarim, PhD, Vice President of Pharmaceutical Development Services at Mikart Kay Olmstead, PhD/MBA, Chief Executive Officer at NPS, added, "Nano PharmaSolutions is excited for this collaboration which will provide us with GMP manufacturing capabilities for development of nanomedicines, using our NanoTransformer™ technology at Mikart's facility." Louis Weber, Vice President of Business Development at Mikart, added, "Mikart is committed to offering innovative options for enhancing solubility and bioavailability to our customers. We feel this nanotechnology will further enhance our development, clinical, and commercial capabilities designed to bring value to our growing customer base." About Mikart, LLC Mikart, LLC is a privately held contract development and manufacturing organization founded in 1975. Mikart focuses on small molecules, potent compounds, solid oral, combination products, suspensions, liquids and serialized packaging services. The company has a full range of formulation, analytical, packaging and manufacturing services with a seamless development solution that minimizes the time-to-market from clinical work through commercial supply. About Nano PharmaSolutions, Inc. Nano PharmaSolutions, Inc. developed a NanoTransformer™ technology that generates nanoparticles of active pharmaceutical ingredients with physical vapor deposition (PVD), a nanocoating method without using any polymers or solvents. This robust and high drug loading technology increases bioavailability of poorly soluble drugs. The NanoTransformer™ Technology produces patient-centric dosage forms while accelerating drug candidates to the clinic by shrinking development time and R&D costs.

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BUSINESS INSIGHTS

AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderate to Severe Crohn's Disease

AbbVie | September 19, 2022

AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. "We continue to raise the bar in researching treatments for immune-mediated gastroenterological conditions through more stringent and innovative clinical trial design, such as the first time a Phase 3 trial has reported co-primary endpoints, endoscopic response and clinical remission. With the recent CHMP recommendation for risankizumab in Crohn's disease, we're getting closer toward helping patients find sufficient disease control for this disruptive condition." Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study).1,2 Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.1,2,5-10 This includes statistically significant improvements in these endpoints at week 12 compared to placebo with 600 mg intravenous infusions for the ADVANCE and MOTIVATE induction studies.1,8,9 Additionally, a significantly greater proportion of patients treated with risankizumab 360 mg subcutaneous injections achieved endoscopic response and clinical remission at 52 weeks compared to placebo (patients treated with placebo after risankizumab induction) in the FORTIFY maintenance study.2,10 Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.1,2,8-13 "Living with Crohn's disease can pose many challenges and significantly impact a patient's health-related quality of life," said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. "Risankizumab could be an encouraging option for adult patients that continue to have moderately to severely active Crohn's disease and I look forward to the European Commission's final decision." Use of risankizumab in Crohn's disease is not approved in the European Union, and its safety and efficacy remain under evaluation. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About Crohn's Disease Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.3,4 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.3,4 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.14,15 About the ADVANCE and MOTIVATE Inductions Studies, and the FORTIFY Maintenance Study1,2,8-10 The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of risankizumab 600 mg and 1200 mg as induction therapy, and risankizumab 180 mg and 360 mg as maintenance therapy in subjects with moderately to severely active Crohn's disease. Topline results of the ADVANCE and MOTIVATE induction studies were announced in January 2021 and topline results of the FORTIFY maintenance study were announced in June 2021. About SKYRIZI® (risankizumab) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.11,16 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.11,16 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg prefilled syringe injections or one 150 mg prefilled pen or prefilled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.11 The use of risankizumab in Crohn's disease is not approved in the European Union and its safety remains under review with the global regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.12,13,17 EU Indications and Important Safety Information about SKYRIZI® (risankizumab)11 SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs. SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment. The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions. About AbbVie in Gastroenterology With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.

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PHARMA TECH

Pace® Life Sciences Acquires Biopharma Global, Expanding FDA Regulatory Affairs Strategy and Consulting Capabilities

Pace® Life Sciences | September 09, 2022

Pace® Life Sciences, LLC, a full-service contract development and manufacturing organization and a subsidiary of Pace®, a science and technology company, announced today that it has acquired Biopharma Global. Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs. "Pace® provides great value in our marketplace through our technical expertise and by meeting the strong commitments we make to our clients that rely on us to successfully advance their programs through development. The acquisition of Biopharma Global extends our reach further into regulatory strategy, guidance, and support in key therapeutic areas and greatly extends the reach of Pace® into our markets." Eric Roman, CEO of Pace® ABOUT BIOPHARMA GLOBAL BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical needs. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects. BIOPHARMAGLOBAL.com ABOUT PACE® LIFE SCIENCES Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. Part of the Pace® Science and Technology Company, Pace® Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and regulatory and manufacturing support service centers across the United States. ABOUT PACE® Pace® makes the world a safer, healthier place. For decades, Pace® people have been committed to advancing the science of the pharmaceutical and biotechnology industries in our Life Sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more through our Analytical Services laboratories. Pace® offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with customers by providing the service, science, and the data they need to make critical decisions that benefit us all. Learn how Pace® people are working to advance science through sustainable practices and continuous innovation.

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