Acadias Nuplazid flops schizophrenia trial on the heels of DOJ marketing probe

Fiercepharma | July 23, 2019

Acadias controversial antipsychotic med Nuplazid has faced its share of scrutiny after a safety controversy drew federal eyeballs in March. Now, the drug has to contend with a trial setback in its pursuit of a first-ever add-on approval in schizophrenia. In a phase 3 trial testing Nuplazid as an add-on to antipsychotic treatment, the drug fell short of both its goals, Acadia said Monday. Collected after six weeks of treatment, the data did show a “consistent trend” in improving psychotic symptoms over placebo in adults who did not respond to previous treatment, Acadia said. It also improved patients’ Clinical Global Severity Score, the trial’s secondary endpoint, the company said. But in both cases, the numbers fell short of statistical significance. The trial was meant to support a new indication as the first schizophrenia med approved as an add-on to patients’ current antipsychotic therapy. The slip-up puts a damper on hopes for Nuplazid, which has been churning up sales growth despite a black box warning that drew media scrutiny after the drug’s approval in 2016.

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Porton Advanced and Royaltech Announce Strategic Collaboration to Accelerate the Development of Bacterial Drugs and mRNA Drugs

Porton Advanced Solutions | August 29, 2022

Porton Advanced Solutions.announced a strategic cooperation with Suzhou Royaltech Med Co., Ltd. This strategic collaboration will further integrate the resources and capabilities of both parties, jointly promote the establishment of microbial vectors used for gene therapy and mRNA drug platform technology, and accelerate the R&D process of bioinnovative drugs. Porton Advanced provides an end-to-end gene and cell therapy CDMO service platform covering plasmids, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and viable bacteria therapy. Suzhou Royaltech focuses on the development of vaccines for tumor immunotherapy with its proprietary technologies, and fast transition from clinical to market . Its R&D pipeline covers the attenuated non-integrated Listeria platform, mRNA platform, and cell therapy platform. All these platforms are in the leading position not only in China but also abroad, and have a complete layout of invention patents. "We are very pleased to enter into this strategic collaboration with Royaltech. The core management team of Royaltech is from the top pharmaceutical companies, with an average of 15 years of R&D and management experience and is advancing an internationally competitive R&D pipeline. Porton Advanced's end-to-end gene and cell therapy CDMO platform with rich project experience and comprehensive quality system will help Royaltech the development of Listeria and mRNA drugs, push its R&D pipeline in a quick, efficient manner, and accelerate the development and implementation of innovative drugs, so that good medicines can benefit the public earlier." Dr. Yangzhou Wang, CEO of Porton Advanced Dr. Chun Xu, Chairman of Royaltech, said: "As a Biotech company, we are grateful to work with Porton Advanced, a very professional CDMO company, to jointly build a unique Listeria and mRNA tumor vaccine platform technology, and constantly develop leading tumor immunotherapeutic biological drugs in China and abroad." About Porton Advanced Solutions Established in Suzhou Industrial Park in December 2018, by its parent company Porton Pharma Solutions Ltd. Porton Advanced has built a CDMO platform integrating plasmid, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and microbial vectors used for gene therapy providing end-to-end services from cell banking, process development and analytical development, cGMP production to final Fill and Finish , investigator-initiated clinical trials (IIT), investigational new drugs (IND), clinical trials to commercial production. Porton Advanced is dedicated to support sponsors advance their GCT drug development and market launches. Porton Advanced focuses solely on gene and cell therapy services. Built on the professional experience of its cohort of world-class professionals, as well as on the successes of its parent company, Porton Advanced insists on "Customer First" and the tenet of "Compliance, Expertise, Focus, Open Collaboration". With its key focus on protecting IP for its sponsors, through its comprehensive project management and quality systems, Porton Advanced strives to bring gene and cell therapy products to the clinic and the market through its quality CDMO services, and help bring the best medicine to the public sooner. About Royaltech Headquartered in Suzhou Industrial Park, Suzhou Royaltech Med Co., Ltd. was founded in July 2016. In July 2017, a wholly-owned subsidiary, Shanghai Royaltech Co., Ltd. was set up in Shanghai International Medical Zone. As a high-standard innovation center of biological drugs, Shanghai Royaltech focuses on CMC development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Since establishment, Royaltech has submitted several patents for invention to the State Intellectual Property Office. It focuses on the development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Its R&D pipeline covers mRNA, oncolytic virus, bacteria, AAV, cell therapy platform and so on. Its core management team is from top universities in US and top 10 big pharma, with an average of 15 years of R&D and management experience. Our scientists have excellent capability on molecular biological engineering, target discovery and verification, pre-clinical R&D, quality control and assurance, and clinical trials of cell immunotherapy. On the strength of our rich experience on target biomarker, target discovery and verification, and global multicenter clinical trials, we are advancing an internationally competitive R&D pipeline.

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Silverback Therapeutics and ARS Pharmaceuticals Announce Merger

Silverback Therapeutics and ARS Pharmaceuticals | July 22, 2022

Silverback Therapeutics, Inc. and ARS Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. ARS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector. “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy. neffy is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. This merger positions ARS and our experienced team to execute on the potential launch of neffy in 2023 by providing the requisite capital needed for launch. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.” Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS Data across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature and comparable to injection products. Based on the totality of data, ARS is preparing to submit its NDA for neffy for use in adults and pediatric patients who are 30 kg or greater in the third quarter of 2022. If approved, ARS is planning to launch neffy in the United States in 2023. “This transaction represents the result of a thorough and thoughtful strategic review process by Silverback,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “ARS is an exciting late-stage company with compelling clinical data demonstrated with neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as NARCAN. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at-risk for Type I severe allergic reactions.” About the Proposed Merger Under the terms of the merger agreement, assuming that Silverback’s net cash at closing is $240 million, Silverback equity holders are expected to own approximately 37% of the combined company and pre-merger ARS equity holders are expected to own approximately 63% of the combined company on a fully-diluted basis on a treasury stock method. The percentage of the combined company that Silverback’s equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback’s net cash at closing. Upon closing of the transaction, Silverback will be renamed ARS Pharmaceuticals, Inc. and will be headquartered in San Diego, California. Richard Lowenthal, M.S., MBA, will serve as chief executive officer and president of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of ten members, including seven from ARS and three from Silverback. The merger agreement has been approved by the Board of Directors of each company, and the transaction is expected to close in the fourth quarter of 2022, subject to approvals by the stockholders of each company and other customary closing conditions. About Silverback Therapeutics, Inc. Silverback Therapeutics, Inc. is a biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Silverback Therapeutics is located in Seattle, Washington.

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Cadence Expands into Molecular Simulation with Acquisition of OpenEye Scientific, a Pioneering Leader in Computational Molecular Design

Cadence | July 26, 2022

Cadence Design Systems, Inc. announced that it has entered into a definitive agreement to acquire privately held OpenEye Scientific Software, Inc., a leading provider of computational molecular modeling and simulation software being widely and increasingly used by pharmaceutical and biotechnology companies for drug discovery. The addition of OpenEye’s technologies and experienced team with its deep scientific expertise accelerates Cadence’s Intelligent System Design™ strategy and expands its total addressable market bringing Cadence’s computational software expertise to apply proven algorithmic, simulation and solver advances to life sciences. Technological advancements, coupled with the rising demand for new drugs across a range of diseases, are driving increased demand for computational drug design. The growing utilization of computational techniques in drug discovery for pharmacology, chemical synthesis and drug screening to study the 3D structure of molecules is a major factor fostering the growth of the global biosimulation market, which has an estimated TAM of $2B and predicted to have a compound annual growth rate (CAGR) of approximately 15% over the next five years. Biosimulations are a critical tool for pharmaceutical research as they provide atomic-level insight into molecular interactions, and there’s a growing demand for high-performance simulation of larger biological systems over longer time scales. Cadence continues executing its Intelligent System Design strategy and has successfully leveraged its computational software expertise to expand into the system analysis space to address the electromagnetics, thermal and computational fluid dynamics (CFD) challenges in the high-tech electronics, aerospace and defense, and automotive sectors. Cadence is now extending that computational software core competency to molecular modeling and simulation that is targeted to life sciences. OpenEye, an industry leader in computational molecular design, has pioneered physics-based approaches and the cloud-native Orion® software platform to accelerate advances in human health. The acquisition allows pharmaceutical and biotechnology companies to benefit from more robust drug discovery solutions that combine OpenEye’s innovative molecular modeling and simulation software solutions for drug discovery with Cadence’s algorithmic and solver expertise, efficient large data management infrastructure, and leading AI/ML and cloud solutions. OpenEye’s products are used by 19 of the top 20 pharmaceutical companies globally—including Pfizer and AstraZeneca—as well as numerous biotechnology companies and academic institutions. Orion, OpenEye’s market-leading cloud-native software-as-a service (SaaS) platform, is growing rapidly as pharmaceutical and biotechnology users embrace its flexibility and scalability to perform complex molecular calculations on a large scale. “Drug discovery is an increasingly complex process that requires significant investment in research and development. The pending acquisition of OpenEye, with its scientifically tested methodologies and expertise, accelerates Cadence’s Intelligent System Design strategy with our entry into a new system domain of life sciences. Cadence’s deep computational software expertise drives further innovation in algorithms that enhance the reliability, efficiency and speed of molecular simulations. We look forward to welcoming such an accomplished team and are delighted to accelerate innovation and improve research and development productivity in the pharmaceutical and biotechnology industry.” Dr. Anirudh Devgan, president and CEO of Cadence “We founded OpenEye to stretch the boundaries of what’s possible in computational drug discovery,” said Dr. Anthony Nicholls, CEO of OpenEye Scientific. “Our 3D search technology, programming toolkits, and more recently, our cloud platform, Orion, have led the industry for more than 25 years, and this opportunity to join with Cadence to pursue even greater scale and accuracy is simply amazing. We foresee a time when pharmaceutical design, no matter the modality, is predominantly computational. The realization of that goal with our skills and Cadence’s resources and expertise is going to have a profound impact on human health.” Under the terms of the definitive agreement, Cadence will pay approximately $500 million in cash. The acquisition is expected to contribute immaterial revenue this year and about $40 million in fiscal 2023. It is expected to close in the third quarter of 2022, subject to completion of Hart-Scott-Rodino regulatory review and customary closing conditions. About Cadence Cadence is a pivotal leader in electronic systems design, building upon more than 30 years of computational software expertise. The company applies its underlying Intelligent System Design strategy to deliver software, hardware and IP that turn design concepts into reality. Cadence customers are the world’s most innovative companies, delivering extraordinary products from chips to boards to complete systems for the most dynamic market applications, including hyperscale computing, 5G communications, automotive, mobile, aerospace, consumer, industrial and healthcare. For eight years in a row, Fortune magazine has named Cadence one of the 100 Best Companies to Work For. About OpenEye Scientific OpenEye Scientific is an industry leader in computational molecular design through rapid, robust and scalable software, toolkits, technology and design services, and Orion®, the only cloud-native fully integrated software-as-a-service molecular modeling platform that runs on Amazon Web Services. Combining unlimited computation and storage with powerful tools for data sharing, visualization and analysis in an open development platform, Orion offers unprecedented capabilities for the advancement of pharmaceuticals, biologics, agrochemicals, and flavors and fragrances. Founded in 1997, OpenEye Scientific is a privately held company headquartered in Santa Fe, N.M., with offices in Boston, Mass.; Cologne, Germany; and Tokyo, Japan.

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