Small Molecules Lead in Recent New Drug Approvals

DCAT Value Chain Insights | February 05, 2020

Small molecules still lead over biologics in recent drug approvals, accounting for nearly three-fourths of drug approvals over the past several years, but will small molecules' dominance continue? DCAT Value Chain Insights takes an inside look. One measure to evaluate the role of small molecules versus biologics is to look how they have fared in recent approvals of new molecular entities (NMEs) by the US Food and Drug Administration’s Center for Drug Evaluation and Research. Between 2015 and 2019, small molecules have accounted for nearly three-fourths of NME approvals by the FDA’s

Spotlight

UNAIDS and StarTimes sign partnership to leverage better health across Africa. 15 May 2017. UNAIDS and the Chinese media group StarTimes have signed a two-year memorandum of understanding to raise awareness about HIV in Africa and to work together to end the AIDS epidemic.

Spotlight

UNAIDS and StarTimes sign partnership to leverage better health across Africa. 15 May 2017. UNAIDS and the Chinese media group StarTimes have signed a two-year memorandum of understanding to raise awareness about HIV in Africa and to work together to end the AIDS epidemic.

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PHARMA TECH

Apollomics Inc., a Late-Stage Clinical Biopharmaceutical Company to be Listed on Nasdaq Through Business Combination

Apollomics, Inc. | September 15, 2022

Apollomics Inc. a late-stage clinical biopharmaceutical company, and Maxpro Capital Acquisition Corp. announced a definitive agreement for a business combination that would result in Apollomics becoming a publicly traded company on the Nasdaq Global Market. The business combination is expected to close in the first quarter of 2023 and Apollomics is expected to be listed on Nasdaq under the ticker symbol “APLM.” Apollomics’ broad pipeline of drug candidates includes late-stage clinical assets for the treatment of patients with difficult-to-treat cancers. Apollomics’ mission is to develop assets in critically important areas of unmet need. The Company’s leading drug candidates address certain subpopulations within lung cancer and leukemia. Globally, both lung cancer and leukemia affect over 2 million people annually. The Company is dedicated to discovering and developing oncology therapies of different mechanisms of action to inhibit cancer. Its diverse portfolio of innovative drug candidates for treating difficult-to-treat cancers includes precision therapy targeting tumors with specific mutations, as well as assets addressing broader cancer conditions. The Company’s pipeline of nine clinical, preclinical and discovery drug candidates has the potential to improve treatment of a number of tumor types. Upon the closing of the transaction, Apollomics will continue to be led by current Chairman and CEO, Dr. Guo-Liang Yu, Ph.D., a serial entrepreneur, and his team. Dr. Yu is a pharmaceutical researcher with more than 300 patents. “Apollomics’ announcement represents the next major milestone on our journey to provide solutions for patients with difficult-to-treat cancers,” Dr. Yu said. “We anticipate that the funds available to us from this transaction will help us accelerate development of our oncology pipeline.” Apollomics expects results from its global Phase 2 multi-cohort clinical trial of vebreltinib in NSCLC and other solid tumors with cMET dysregulation in 2023, which the Company believes may support its first New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) while generating clinical data for different indications. In addition, the Company expects to complete patient recruitment of its uproleselan Phase 3 study in China in 2023. “Our goal was to find an exciting company with a growing pipeline of innovative product candidates that could positively affect the lives of millions of people. Our team is excited to combine with Apollomics as it has met and exceeded all our key selection criteria. Together with Apollomics, Maxpro will do everything we can to support the Company’s vision of treating patients with difficult-to-treat cancers.” Moses Chen, CEO of Maxpro About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics currently has a pipeline of nine drug candidates across multiple programs, six of which are currently in the clinical stage of development. Apollomics’ lead programs include investigating its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and developing an anti-cancer enhancer drug candidate, uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. About Maxpro Capital Acquisition Corp. Maxpro is a blank check company formed for the purposes of effecting a merger, capital share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in the healthcare and technology industries. In October 2021, Maxpro consummated a $103.5 million initial public offering of 10.35 million units (including the underwriters’ full exercise of their over-allotment option), each unit consists of one share of Class A common stock and one redeemable warrant, each warrant entitles the holder to purchase one share of Class A common stock at a price of $11.50 per share. EF Hutton, division of Benchmark Investments LLC, served as the sole book-running manager of Maxpro’s initial public offering.

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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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BUSINESS INSIGHTS

Aptar Expands Pharmaceutical Services Announces Exclusive Collaboration Between Aptar Pharma and Fluidda

Aptar Pharma and Fluidda | September 23, 2022

Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration approvals for orally inhaled generic products via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process. Nanopharm has pioneered the development of the alternative bioequivalence regulatory pathway for U.S. FDA approval of generic OIDPs for Asthma and Chronic Obstructive Pulmonary Disease using its proprietary in vitro and in silico service platform, SmartTrack™. Fluidda’s proprietary in silico platform FRI delivers quantitative predictions of regional drug deposition in disease state lungs using Computational Fluid Dynamics. The FRI platform provides critical information to help understand the availability and activity of the drug at the site of action in the lungs, when complemented by Nanopharm’s local lung physiologically-based pharmacokinetic model platform and its in vitro data. This novel approach is intended to allow pharma companies to file Abbreviated New Drug Application dossiers without the need to perform time-consuming, costly and often unpredictable clinical end-point studies. Similarly, it can support 505(b)(2) filings, by derisking and abbreviating clinical studies. “We are pleased to solidify our relationship with Fluidda and its world-leading FRI technology. A company would have to spend several years to achieve the current combined expertise and experience of Nanopharm and Fluidda. The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway,” Dr. Jag Shur, Vice President, Science & Technology at Nanopharm Having already worked together closely for a number of years, Nanopharm and Fluidda have gained a unique insight into the complex and continually evolving regulatory requirements. This exclusive collaboration deepens the relationship between Fluidda and Nanopharm, benefiting both patients and customers with an uncompromised and holistic approach in developing the scientific rationale to demonstrate bioequivalence using only in vitro and in silico methodologies. The first potential approval of an OIDP using the alternative bioequivalence approach is pending, and, when approved, will further validate Nanopharm’s SmartTrack™ as the go-to solution for alternative bioequivalence studies and should accelerate demand for the companies’ collective services. With momentum building for the transition to new lower global warming potential (GWP) propellants for pMDIs, SmartTrack™ will also help companies to understand and modulate the impact of these new propellants on drug deposition and dissolution in the lungs, giving confidence in the performance of the reformulated product before embarking on any necessary clinical studies. Dr. Jan de Backer, CEO of Fluidda, stated, “Fluidda has already demonstrated the applicability of its FRI platform to provide more objective data for evaluating and administering inhaled drug products accurately. Nanopharm’s unique SmartTrack™ platform provides us with clinically-relevant input data without having to actually go into the clinic, which really adds another level of confidence to the models, and provides an integrated perspective.” Guillaume Brouet, Vice President, Analytical, Regulatory and Scientific Affairs at Aptar Pharma, commented, “Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help customers derisk and accelerate their drug product development programs.” About Aptar Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home care, food and beverage. Aptar Pharma’s analytical, laboratory and regulatory services add value at every stage of the drug development process, accelerating and de-risking the program along the way. Nanopharm, an Aptar Pharma company, is a leading provider of specialized analytical and product development services, with a focus on orally inhaled and nasal drug products. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. About Fluidda FLUIDDA, founded in 2005, is the world leader in the field of Functional Respiratory Imaging (FRI). This technique combines HRCT scans and Computational Fluid Dynamics technology (CFD), which offers vast improvements by making clinical trials shorter, faster and thus, more cost effective. FRI also helps patients and healthcare providers in offering a unique entry point in personalized medicine, by optimizing diagnosis, monitoring disease progression and the effects of therapy including accurate assessment of the deposition of inhalation medication. Fluidda’s mission is to optimize treatment pathways, reduce healthcare costs and to limit the go-to-market time of respiratory drugs, pulmonology medical devices and therapies. Fluidda has offices in Belgium, the United States and Portugal.

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