Roches Hemlibra scores funding to treat much larger group of patients in England

FiercePharma | August 21, 2019

Roches Hemlibra has been storming out of the gate since its first approval in 2017. Now, its set to benefit a much wider patient group in England thanks to new funding from health authorities there. NHS England on Wednesday unveiled funding for Roches drug in hemophilia A patients without blood protein factor VIII inhibitors. Authorities last year approved the drug for people with the inhibitors, a much smaller group of patients. About 230 hemophilia A patients in England had inhibitors as of a 2015-2016 study, according to NHS England documents. The new development will allow about 2,000 patients to access the Roche drug, authorities said. Hemlibra is set to "change lives and lift a weight from thousands of parents," NHS chief executive Simon Stevens said in a statement. The hemophilia A med won its initial approval in Europe in February 2018 and in March 2019 scored approval to treat patients without inhibitors. Authorities in the U.S. approved the drug in November 2017.  Since it's been on the market, Hemlibra has been driving strong uptake and turning in big sales figures. During the first half of the year, the med turned in $545 million in global sales.

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Pfizer and IBM leaders discuss their collaboration to develop remote monitoring solutions that aim to transform Parkinson’s disease care. BlueSky configures wearable devices to recognize the activities of daily living, creating a unique technology scalable across all fields of medicine.

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Pfizer and IBM leaders discuss their collaboration to develop remote monitoring solutions that aim to transform Parkinson’s disease care. BlueSky configures wearable devices to recognize the activities of daily living, creating a unique technology scalable across all fields of medicine.

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BUSINESS INSIGHTS

Ligand and GSK Expand Global Collaboration and License Agreement

Ligand Pharmaceuticals | December 22, 2021

Ligand Pharmaceuticals Incorporated announced today the expansion of an existing collaboration and license agreement between its subsidiary, Icagen, and GlaxoSmithKline. The expansion will leverage Icagen’s ion-channel-based discovery technology and unique expertise in small molecule therapeutics targeting transmembrane proteins. This new agreement builds upon the initial December 2020 agreement to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases. “We are very pleased to expand our collaboration with GSK to include a second neurological target. Over the past year this has been a productive relationship combining our technologies and expertise with GSK’s history of successfully working with others to access innovation and deliver next-generation transformational medicines.” Matt Foehr, President and COO of Ligand “We look forward to strengthening our collaboration to identify genetically-validated targets for neurological diseases utilizing Icagen’s technology,” said John Lepore, Senior Vice President, Head of Research, GSK. “Our expanded collaboration provides a framework to advance drug discovery by maximizing the strengths of our two scientific organizations to develop novel drug candidates efficiently and effectively.” In addition to all payments available under the original 2020 collaboration and license agreement, under the terms of the expanded collaboration and license agreement, Ligand will receive an upfront payment of $10 million and is eligible for development and regulatory milestones up to $67.5 million. Furthermore, should the potential new medicine receive regulatory approval in major markets, the deal provides for commercial milestone payments to Ligand of up to $60 million at first commercial sale, and up to $120 million in sales-related milestone payments. Ligand will receive tiered royalties on net sales of any drug that is commercialized by GSK. Ligand will be responsible for most preclinical activities up to lead optimization, with Ligand and GSK collaborating to identify candidates for entry into IND-enabling studies. GSK has the exclusive option to license any identified molecules and will be responsible for the further development and commercialization of any drug candidates identified through the collaboration. About Icagen Ion Channel Technology The Icagen technology is focused primarily on ion channel and transporter novel drug discovery. Ion channels and transporters are key components in a wide variety of biological processes that involve rapid changes in cells and have broad therapeutic applicability including oncology, metabolic disease, pain, neurological diseases, infectious diseases and others. The Icagen technology leverages proprietary expertise in the combination of biological assays, medicinal chemistry, and in silico and computational chemistry applications to enable the discovery of ion channel targeting therapeutics. Partners in the pharmaceutical industry leverage Icagen’s platform to develop first-in-class therapies for patients in need, typically under collaborative arrangements through the time of clinical candidate selection, with partners responsible for subsequent clinical development and commercialization. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ab Initio™ technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier, Gilead Sciences and Baxter International.

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PHARMACY MARKET

Regis Expands Facilities to Support Rising Demand for U.S.-Based Custom API Pharmaceutical Development and Manufacturing

Regis | February 18, 2021

Regis Technologies, Inc. today reported the culmination of a significant extension of their laboratory facilities for the development of dynamic pharmaceutical ingredients (APIs) situated in Morton Grove, Illinois. The extension, which pairs the organization's ability to take on new development projects, is currently completely operational. It expands capacities across Regis' custom pharmaceutical service contributions, including analytical development, process chemistry, solid state chemistry, validation, stability studies, and commercialization. Regis works in serving the API development and assembling needs of medium sized and arising pharmaceutical and biotechnology organizations. Their blend of top notch, full-service CDMO contributions and individualized client consideration has energized developing demand for their services. The new lab extension activity was dispatched two years prior in light of this demand, empowering Regis to give the new limit something to do during this period of uncommon scarcity for U.S.- based exhaustive, experienced API development and assembling services. The new 9,000-square-foot development incorporates extra process chemistry and analytical research centers, a committed ICP-MS suite, extra environment controlled capacity, 14 extra smoke hoods, a few new kilo-scale reactors, and process security hardware for reaction calorimetry estimations to guarantee safe control and scale-up. What's more, the new labs have an advanced variable air volume (VAV) air framework for clean energy-efficient operations. “The boom in biotechnology firms developing novel small molecule drugs has contributed to our robust growth in recent years,” said Joe Miller, PhD, CTO at Regis Technologies. “We provide top quality end-to-end API development and manufacturing services for clinical-stage companies and for commercial-stage firms serving medium-sized, rare disease and other specialty markets. This focus enables us to provide a comprehensive range of services that are tailored to our customers’ individual needs.” Dr. Miller continued, “Our investment in this new capacity broadens Regis’ capabilities and our flexibility to support the growing need for U.S.-based custom pharma services. The desire to reduce supply chain risk, ensure quality, and maintain intellectual property is driving a surging interest in domestic on-boarding of API development and manufacturing. This timely expansion allows us to meet this demand, enabling our scientists to support additional API projects as our customers advance their novel drugs to market.” About Regis Regis Technologies, Inc. is a U.S.-based CDMO specializing in small molecule APIs. We offer a full range of services to support the development of our clients' lead molecules from preclinical and clinical API through commercialization, including process research and development, solid state chemistry, analytical development, stability services, GMP API manufacturing, and micronization. In addition, Regis also offers an innovative line of proprietary chromatography products sold throughout the world. Regis is privately owned and operated and has been in business in the Chicago area since 1956.

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BUSINESS INSIGHTS

Actinium Pharmaceuticals, Inc. And Immedica Have Signed a Commercialization Agreement for Iomab-b (131i Apamistamab)Apamistamab)

Actinium Pharmaceuticals, Inc. | April 13, 2022

Actinium Pharmaceuticals, Inc., a leader developing targeted radiotherapies for patients and Immedica Pharma AB announced that they signed a license and supply agreement for Iomab-B. It is being developed for targeted conditioning to facilitate bone marrow with topline data expected in the third quarter of 2022. For individuals with active, relapsed, or refractory acute myeloid leukemia, BMT is the only possibly curative therapy option. "Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant." Sandesh Seth, Actinium's Chairman and CEO "We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa", says Anders Edvell, CEO at Immedica. Actinium will receive a $35 million upfront payment and will be eligible for an additional $417 million in regulatory and marketable milestone payments and royalties in the mid-twenty percent range on net sales, per the terms of the agreement. Immedica has been granted commercialization rights in Europe and, the Middle East and North Africa (MENA). Actinium will maintain all rights to Iomab-B in the United States and around the world and will be accountable for clinical and regulatory operations, as well as Iomab-B manufacturing.

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