GSK withstands Advair generics, thanks to new respiratory meds and Shingrix

Fiercepharma | July 24, 2019

GlaxoSmithKlines been dreading generic Advair for years, but thanks to its newer respiratory meds and the fast-launching Shingrix vaccine, the companys top line is so far managing to hold its own. Mylan launched Wixela Inhub, the first true Advair copycat, in February, and sales of the GSK behemoth plummeted a whopping 61% in the U.S. in the second quarter, to merely £105 million ($131 million). And the new generic put pricing pressure on all similar products, dealing a blow to the rest of GSK's respiratory franchise. Overall, sales of newer respiratory drugs—not counting established meds such as Advair and Ventolin—dropped 2% in the U.S. for the quarter. Still, strong growth from triple-combo Trelegy and biologic Nucala helped push GSK's newer respiratory therapies up by 12% to £752 million. That, along with Shingrix's continued surge and aid from its HIV franchise pushed GSK sales up 5% at constant exchange rates to £7.8 billion. Nucala racked up £195 million in the quarter, up 33% at unchanged currencies and 10% ahead of analysts’ consensus as quoted by Jefferies. In June, the FDA approved two new self-administered versions of Nucala—an autoinjector and a prefilled syringe—helping level the ground in its competition with AstraZeneca’s rival med Fasenra. But the AZ drug, which already boasts a dosing frequency advantage over Nucala—once every eight weeks for Fasenra versus once every four weeks for Nucala—is not far behind. A few days ago, it received EMA backing for its own autoinjector option and is expecting an FDA decision soon this year.

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Pharmaceutical companies face a ‘digital imperative’ to engage with healthcare professionals through their preferred mix of channels if they are to bridge the gap between the value a company can offer and an HCP’s needs.

Spotlight

Pharmaceutical companies face a ‘digital imperative’ to engage with healthcare professionals through their preferred mix of channels if they are to bridge the gap between the value a company can offer and an HCP’s needs.

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BUSINESS INSIGHTS

Fosun Pharma and Insilico Medicine Announce a Strategic, AI-driven Drug Discovery and Development Collaboration to Jointly Advance Multiple Targets

Insilico Medicine | January 18, 2022

Shanghai Fosun Pharmaceutical Co., Ltd, a leading innovation-driven international healthcare group in China and Insilico Medicine, an end-to-end artificial intelligence (AI)-driven drug discovery and development company, entered into a collaboration agreement to advance the discovery and development of drugs targeting a number of different targets globally through the use of AI technology. This strategic collaboration includes an AI-driven drug discovery research and development (R&D) collaboration on four biological targets, as well as the co-development of Insilico's QPCTL program. Insilico will receive a total upfront payment of $13 million for the R&D collaboration projects and the co-development of the QPCTL program, potential milestone-based payments, and share commercialization profits from the QPCTL program. In addition, Fosun Pharma will make an equity investment in Insilico. "We are pleased to enter into strategic collaboration with Insilico. Fosun Pharma is committed to promoting innovative R&D, and is oriented towards fulfilling unmet clinical needs and improving products' accessibility. We look forward to working with Insilico to leverage the technological and clinical development strengths of both companies, jointly improving the efficiency of innovative drug R&D, and benefiting more patients worldwide," Yifang Wu, Chairman and CEO of Fosun Pharma The collaboration aims to combine Insilico's end-to-end AI-driven drug discovery platforms and Fosun Pharma's clinical development and commercial expertise to discover and develop a portfolio of novel therapeutics. Pursuant to the collaboration agreement, Insilico will take responsibility for delivering a preclinical candidate for the QPCTL program and advancing it to IND stage, after which, Fosun Pharma will then conduct human clinical studies and co-develop the candidate globally. In parallel, Fosun Pharma's R&D team will nominate four therapeutic targets to be assessed by Insilico's AI platform and R&D team, who are responsible of advancing drug candidates to IND stage. As part of the collaboration, Fosun Pharma will secure access to Insilico's PandaOmics and Chemistry42 platforms in order to advance Fosun Pharma's internal AI-powered discovery and development efforts. "In partnering with Fosun Pharma, a leading pharmaceutical company, we begin a new era of AI-powered end-to-end drug discovery and development as human-machine collaboration becoming the new normal in precision drug discovery and development. We previously demonstrated that AI can be used to discover novel targets and generate novel molecules that can be tested in humans in record time. Now, we are partnering with one of the leading scientific teams in the pharmaceutical industry to take this technology to the next level for the benefit of patients worldwide", said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical Co., Ltd. is a leading innovation-driven international healthcare group in China. Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through equity participation in Sinopharm Co., Ltd., Fosun Pharma's business extends to pharmaceutical distribution and retail. About Insilico Medicine Insilico Medicine, an end-to-end AI-driven drug discovery and development company, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. Insilico Medicine has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques to discover novel targets and to design novel molecular structures with desired properties. Insilico Medicine is delivering breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases and aging-related diseases.

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PHARMACY MARKET

Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

Evergreen Theragnostics, Inc. | July 17, 2021

Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility. Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227). Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing. The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment. About Evergreen Theragnostics, Inc. Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. About Tema Sinergie Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.

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PHARMA TECH

CPhI partners with Informa Pharma Intelligence to present the 2021 Hybrid Edition of CPhI - P-MEC Expo in the National Capital Region ( NCR)

Informa Pharma Intelligence | November 26, 2021

Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partners, is pleased to announce the 2021 hybrid edition of CPhI – P-MEC conducted by CPhI Conference. The Online Conference & Networking is being held between 15th to 30th Nov 2021, while the In-Person event is being held between 24th to 26th Nov 2021 at India Expo Centre– Greater Noida, Delhi. In a bid to stay afloat towards increasing contemporary demand towards high quality, low cost pharma solutions, CPhI & P_MEC India has curated a platform through this event for a gateway to latest trends and innovative solutions that the market has to offer. The event aims to build better pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally, and covering the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. The industry is anticipated to have a steady growth trajectory and the event organised by CHhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally the event aims to encourage the development of the research-based pharma fraternity. "The Indian pharmaceutical industry has been growing at double digits year-on-year, and remains committed to not only providing solutions to the healthcare needs of the country, but also to the world. As the world is battling the pandemic at different levels, here in India, we remain committed to ramping up production capabilities of some key medicines across infectious and non-infectious diseases to ensure their availability and accessibility to the country and the world. The CPhI – P-MEC India show is the single location for all pharmaceutical and allied companies to get together and share insights, techniques and technology that will help meet these demands." Speaking at the sidelines of the CPhI – P-MEC India show, Mr Yogesh Mudras, Managing Director, Informa Markets in India As a part of the management team of the CPhI – P-MEC 2021 event, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence said, "As a representative of the world's leading pharmaceutical business intelligence provider, its heart-warming to be a part of the CPhI – P-MEC event where we get to share meaningful insights drawn from real-time news, trends, market analysis, special reports, to key pharmaceutical companies in the country and the world. Globally we provide intelligence to over 10,000 customers and 3,000 of the top pharma, biotech and biosimilar companies with the collective support of more than 300 respected Business Intelligence subject matter analysts, editors, and thought leaders located across countries. The 2021 CPhI – P-MEC event will be a great opportunity to reconnect with the stakeholders of the pharmaceutical world and provide them with any form of data intelligence and analysis as needed." The Indian pharmaceutical market is growing at 15% annually, twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore, the platform by CPhI & P-MEC provides full access to the exhibitors to source new pharma solutions and find the right partners for your business with the ongoing hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization. The P-MEC event is the single destination in the country today for all things associated with the latest innovative pharma solutions that the world has to offer. The venue will also host the latest types of equipment associated with research and development and analytical solutions followed by cleanroom engineering design, certifications and the latest types of air purification solutions. The packaging technology on display will include a comprehensive range of glass, pouches, bottles, caps, tubes and plastic packages as well as printing and trademark solutions. CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already labelled as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020. About Informa Pharma Intelligence Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals and R&D activities, to deliver data needed to make decisions and create real-world opportunities for growth. About CPhI Conferences The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals. Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.

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