Lannett Signs Agreement To Be Exclusive Distributor Of Generic Flovent® Diskus®

Prnewswire | August 17, 2020

Lannett Company, Inc. today announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals Co. Ltd. According to the Orange Book, all patents covering Flovent Diskus have expired. U.S. sales of Flovent Diskus, which have been increasing in recent years, were $94 million for the 12 months ending June, 2020 according to IQVIA, although actual generic market values are expected to be lower. The company also said its previously announced exclusive U.S. distribution agreement with Respirent for the therapeutically equivalent generic of ADVAIR DISKUS® (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler) has been extended from 10 years to 12 years. The term of the agreement commences upon distribution of the product.

Spotlight

Pain is the most overpowering symptom that can be difficult to treat. And when we experience pain, most people reach for a pharmaceutical drug or visit a conventional doctor. But what if there’s a simpler way? What if we could use our Energy? Energy Medicine (eMed) complements the body’s biochemistry with the body’s energy fields. More patients are choosing this alternative approach for its pleasant and non-invasive techniques. The infographic below contains a list of studies that have effectively applied various approaches to eMed to treat illnesses.

Spotlight

Pain is the most overpowering symptom that can be difficult to treat. And when we experience pain, most people reach for a pharmaceutical drug or visit a conventional doctor. But what if there’s a simpler way? What if we could use our Energy? Energy Medicine (eMed) complements the body’s biochemistry with the body’s energy fields. More patients are choosing this alternative approach for its pleasant and non-invasive techniques. The infographic below contains a list of studies that have effectively applied various approaches to eMed to treat illnesses.

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BUSINESS INSIGHTS

Alira Health Expands North American Capabilities with the Acquisition of Artisan Healthcare Consulting

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.

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BUSINESS INSIGHTS

Stevanato Group and Gerresheimer AG Announce Collaboration on the Development of an Innovative Ready-To-Use Vial Platform

Gerresheimer and Stevanato Group | September 08, 2022

Stevanato Group S.p.A. a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, and Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, announce that they have jointly developed a high-end Ready-To-Use (RTU) solution platform with an initial focus on vials, based on Stevanato Group’s market-leading EZ-fill® technology. This collaboration is projected to help customers gain efficiencies, improve the quality standard, increase speed to market, reduce total cost of ownership (TCO) and help mitigate supply chain risk. Stevanato Group and Gerresheimer AG are addressing rising demand for RTU vials in the market and the partnership serves as a market enabler to fully support customers’ evolving needs and establish a gold standard in the industrial filling process. The collaboration aims to make RTU vials a standard, available to a wide number of pharma companies globally – offering premium quality solutions to patients and reducing complexity for pharma operations. The new solution will be available to other players in the market to standardize fill-finish operations from early phase drug development to commercialization. The new RTU solution platform from Stevanato Group and Gerresheimer AG will share the same secondary packaging, production process and sterilization method, ensuring consistent available capacity and a reliable double sourcing to the pharmaceutical industry. A hallmark of the new RTU platform is a significant reduction in particles, improving the overall quality and performance of the RTU solutions. In addition, customers can count on a high-end solution made by two major players in the drug containment industry with a long history of innovation. The new jointly developed vial platform and trademark will be presented in detail to the market at the CPhI Worldwide in Frankfurt in November 2022. “Our EZ-fill® vial platform is the market’s most established choice for pre-sterilized containers, and this enhanced version for RTU vials will bring to the market its full potential in terms of quality, flexibility and value for Pharmaceutical Companies and CMOs. Through our collaboration with Gerresheimer AG we are responding to market demand, and we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate and de-risk the conversion from bulk to EZ-fill® vials already underway in the market.” Mauro Stocchi, Chief Business Officer at Stevanato Group “The new developed RTU vial platform stands out in terms of quality, TCO and sustainability and takes the use of RTU solutions like vials and, in the future, cartridges to a new level,” said Dr. Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. "Due to the strong reduction of the particle load, the quality is significantly increased. Our new innovative solution will convince the market to significantly accelerate the conversion from bulk to RTU vials.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. About Gerresheimer AG Gerresheimer AG is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the commercial product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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Merck Enters Collaboration and Option to License Agreement with Nerviano Medical Sciences to Develop Next-Generation PARP1 Selective Inhibitor

Merck | September 22, 2022

Merck, a leading science and technology company, announced a collaboration agreement with licensing option with Nerviano Medical Sciences S.r.l. for the next-generation highly selective and brain-penetrant PARP1 inhibitor, NMS-293. NMS-293 has strong potential in combination with a wide variety of DNA-damaging agents, including systemic or targeted chemotherapy or with DNA damage response inhibitors, in numerous tumor types. NMS-293 is in early clinical development for the treatment of patients with BRCA-mutated tumors as a single agent and in combination with temozolomide in recurrent glioblastoma. “Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile. The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients.” Victoria Zazulina, M.D., Head of Development Unit Oncology for the Healthcare business of Merck PARP is key in the repair of DNA damage, and PARP inhibitors have been shown to be highly efficacious in the treatment of patients with tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers with BRCA-mutations. Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to $65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293. During the option period, NMS and Merck will collaborate on the clinical development of NMS-293, with NMS designing, sponsoring, conducting, and funding global clinical trials. About NMS-293 NMS-293 is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ). About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 60,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

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