AZ, Forty Seven to test triple immunotherapy combo for lymphoma

pharmatimes | May 13, 2019

AstraZeneca and Forty Seven are evaluating a new triple combination therapy clinical trial that has the potential to create additional opportunities to further optimise treatment for patients with diffuse large B-cell lymphoma. Forty Seven’s CD47 antibody, ‘5F9’, will be tested in combination with rituximab and Calquence (acalabrutinib) for the aggressive form of non-Hodgkin’s lymphoma (NHL). The study aims to build upon the promising results already reported from a Phase Ib study of 5F9 in combination with rituximab in NHL patients by including a third agent, acalabrutinib, to further optimise the treatment of patients. The collaboration will “expand the breadth of our 5F9 development program to include an additional triplet regimen, with the potential to offer patients a treatment option that is more easily administered and the benefit of multiple distinct approaches to treating cancer,” said Craig Gibbs, chief business officer at Forty Seven Inc.

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Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

Spotlight

Merck & Co, known as MSD outside of the United States and Canada, is a global pharmaceutical company whose mission is to discover, develop and provide innovative products and services that save and improve lives around the world.

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PHARMA TECH

Leading Pharmaceutical Company in Brazil Chooses ValGenesis iRisk to Redefine and Automate Risk-Based Validation Processes

prnewswire | May 30, 2023

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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BUSINESS INSIGHTS, PHARMA TECH

Indivior Announces Its Successful Acquisition of Opiant Pharmaceuticals

Indivior | March 06, 2023

Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl. Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023. OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA). About Indivior A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.

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BUSINESS INSIGHTS, PHARMA TECH

Endo Announces Agreement with Slayback Pharma to Distribute Prevduo™ the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination

prnewswire | April 28, 2023

Endo International plc announced that its subsidiaries Endo Ventures Limited and Par Pharmaceutical, Inc. have executed an agreement with Slayback Pharma LLC to distribute Slayback's Prevduo™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe on an exclusive basis in the U.S. The U.S. Food and Drug Administration (FDA) approved Prevduo™ in February 2023 for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration. Endo will commercialize Prevduo™ through its Par Sterile Products business and expects to launch the product in June 2023. When launched, Prevduo™ will be the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S. Both neostigmine methylsulfate and glycopyrrolate have been approved in the U.S. as single, active ingredient drug products. Neostigmine is always administered in conjunction with glycopyrrolate, and currently, its administration requires two syringes. "Prevduo™ further strengthens our commitment to supporting healthcare providers and their patients through ready-to-use products that streamline operations," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "We're proud to partner with Slayback to bring this critical care product to market and help hospitals deliver quality patient care." "Following the development and FDA approval of Prevduo™, we're pleased to partner with Endo and tap into Endo's proven capabilities in commercializing injectable solutions, including ready-to-use products," said Ajay Singh, Founder and CEO of Slayback Pharma. Ready-to-use, or RTU, products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care. About Endo Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them.

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