Roche pushes back Spark merger deadline as U.S., U.K. antitrust reviews drag on

fiercepharma | July 08, 2019

Roche and Spark Therapeutics road to a 4.3 billion dollars merger has been a rocky one, with various delays pushing the long-gestating agreement back four times. Now, in order to get all its regulatory ducks in a row, Roche is moving its own deal-close deadline back as well. Roche moved its Spark closing deadline from Jan. 31, 2020 to April 30, 2020, according to a Monday regulatory filing. The move is a precautionary one, meant to give the deal partners time to clear any hurdles that may come up as U.S. and U.K. antitrust regulators review the companies’ marriage. In a note to Spark investors, Roche CEO Severin Schwan said the plan was still to close the merger in 2019 despite the new deadline. “While we still expect this transaction to close in 2019, we want to ensure that we proactively identify and remove any potential future obstacles to achieving this outcome,” he said. “Good things almost always take time, so as we work to bring this agreement to a close, I ask for your continued patience.” The new deadline is just the latest delay in the two companies’ star-crossed affair after U.S. regulators asked for a “second review” of the agreement on anti-competition grounds. In early June, Roche pushed back its June 14 tender offer date to July 31 after the Federal Trade Commission filed for an extended investigation.

Spotlight

Pharmacists are highly valued members of the healthcare team thanks in part to their depth of drug information and therapeutic knowledge. Ericka, a residency trained pharmacist, explains what drew her to work in Medical Information at Lilly.

Spotlight

Pharmacists are highly valued members of the healthcare team thanks in part to their depth of drug information and therapeutic knowledge. Ericka, a residency trained pharmacist, explains what drew her to work in Medical Information at Lilly.

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Resilience Establishes Multi-Product Development and Manufacturing Collaboration with Takeda’s Plasma-Derived Therapies Business Unit

Resilience | February 16, 2022

National Resilience, Inc. a technology-focused manufacturing company dedicated to broadening access to complex medicines, announced a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit. As part of the agreement, Resilience will focus on supporting the development and manufacture of multiple products in Takeda’s plasma-derived medicines portfolio out of its facility in Mississauga, Ontario. “I’m proud to establish this relationship with Takeda, a company that has been pioneering plasma-derived therapies for more than 75 years. By bringing new technologies and innovation to biomanufacturing, we aim to help companies like Takeda reach more patients in need.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience Resilience’s 136,000 sq ft (12,800 m2) biomanufacturing facility in Mississauga provides process and analytical development, scale up, drug substance and drug product / fill finish manufacturing for a variety of medicines. “We are delighted to form this strategic collaboration with Resilience, leveraging their expertise in both plasma therapy development and manufacturing to complement our current infrastructure and capabilities,” said Andreas Liebminger, Head of Pharmaceutical Sciences and Devices for the Plasma-Derived Therapies Business Unit at Takeda. “Our partnership will allow us to optimally use our combined assets to continue to bolster our portfolio, drive innovation and help more patients around the world realize the benefits of plasma medicines.” About Resilience Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.

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PHARMACY MARKET

Lilly Collaborates with Samsung to boost COVID-19 antibody manufacturing amid supply concerns

Lilly | November 18, 2020

Seven days after Eli Lilly won a FDA crisis approval for its COVID-19 counter acting agent, worries over restricted supplies are as of now springing up, and the organization is getting an accomplished assembling accomplice to help with the worldwide scale-up. Under a drawn out arrangement with Samsung Biologics, the organizations are set to "incredibly quicken the worldwide gracefully" for Lilly's COVID-19 antibodies, Samsung Biologics said in a delivery. Lilly would like to make up to 1 million dosages this year and a lot more in 2021, Reuters reports. The accomplices entered an underlying assembling association back in May, and, from that point forward, Samsung created a first clump of dynamic drug fixing in spite of struggling getting crude materials. The organizations took care of the tech move in under a quarter of a year, a consequence of routine collaborations between specialists at both medication creators, Samsung Biologics said. Lilly's bamlanivimab scored a FDA crisis use approval a week ago in gentle to-direct COVID-19 patients who are at a high danger of advancing to extreme illness. The FDA said the medication isn't approved in hospitalized patients, and Lilly is instructing imbuement inside 10 days concerning manifestation beginning. Before the crisis gesture, the organization entered a flexibly manage the U.S. government for 300,000 dosages at $1,250 per portion. All things considered, the stock could last only multi week dependent on current disease patterns, Reuters reports. While the arrangement incorporates a possibility for additional portions, specialists told the news administration they expect the medications will turn into a business drug sooner or later.

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BUSINESS INSIGHTS

Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA (srRNA)

Curia | June 10, 2022

Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), today announced that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics. As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales. “Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins,” said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. “This customization has important therapeutic. advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients.” “The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases. Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach.” Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia About Curia Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com. About Replicate Bioscience Replicate Bioscience, an ATP company, is designing and delivering srRNA immunotherapies to revolutionize the practice of medicine and improve and save lives. Replicate applies advanced srRNA technology in its work to prevent drug resistance in cancers. The company is also developing srRNA injections for sustained therapeutic protein expression to treat autoimmune and inflammatory disorders and other conditions. Replicate believes that srRNA will bring about the next big breakthroughs in RNA therapeutics and is working to realize the promise of srRNA for all patients.

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