AstraZeneca rockets toward Tagrisso sales target with another survival win

AstraZeneca | August 09, 2019

AstraZeneca already has a Tagrisso approval for patients with previously untreated, EGFR-mutated lung cancer. But its shoring up its case with some clutch new data. Friday, the British drugmaker said Tagrisso had beaten out Roches rival drug Tarceva and AstraZenecas own Iressa at helping patients live longer. The showing came as part of the phase 3 Flaura trial the same study that helped net Tagrisso its approval last year based on a reduction in the risk of disease progression. That overall survival win could be a crucial stat for oncologists deciding which drug to pick. And thanks to the initial round of Flaura data, Tagrisso is already steamrolling. In the first half of 2019, it reeled in $1.41 billion in global sales, a 92% jump over the year-ago period at constant exchange rates. U.S. sales also ramped up between Q1 and Q2, swelling by 16% to reflect “continued underlying demand growth,” AstraZeneca said in a financial filing. That’s not to say it’s without competition, though. Just under a year ago, Pfizer snagged an FDA green light for once-failed Vizimpro in the first-line arena. While that drug is putting up tiny numbers, it’s still been a thorn in AstraZeneca’s side in the U.K., where cost watchdogs recently backed it for NHS use while shutting Tagrisso out.

Spotlight

The World Health Organization has determined that several neglected tropical diseases (NTDs) are able to be controlled, eliminated and even eradicated. But how do we know which approach is best to manage each NTD? Watch this video to find out.

Spotlight

The World Health Organization has determined that several neglected tropical diseases (NTDs) are able to be controlled, eliminated and even eradicated. But how do we know which approach is best to manage each NTD? Watch this video to find out.

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BUSINESS INSIGHTS

Cyclenium Pharma and Vuja De Sciences Announce Oncology Drug Discovery Collaboration

Cyclenium Pharma | January 06, 2022

Cyclenium Pharma, Inc. an emerging pharmaceutical company specializing in the discovery and development of novel therapeutic agents based on their proprietary macrocyclic chemistry, and Vuja De Sciences, Inc. a biotechnology startup dedicated to discovering therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence, have announced today the signing of a drug discovery collaboration agreement. The companies will screen and optimize lead candidates to advance treatments uniquely suited for preventing cancer metastatic recurrence, the biggest unmet need in oncology. The collaboration will exploit Vuja De’s proprietary anti-metastatic progression in vitro and ex vivo drug discovery screening platform and Cyclenium’s proprietary QUEST™ Library of next generation synthetic small-molecule macrocycles and associated optimization expertise to identify clinical candidates effective against dormant disseminated tumor cells for the prevention of metastatic cancer recurrence. Vuja De will be responsible for all screening efforts, while Cyclenium will be responsible for all medicinal chemistry efforts to generate new optimized macrocyclic compounds by employing its unique CMRT™ Technology. “We are very excited about entering this collaboration with Vuja De. We are confident that our CMRT™ Technology and proven success in the macrocycle area combined with the innovative anti-metastatic progression platform and excellent research team at Vuja De will enable the discovery and development of novel macrocyclic therapeutic agents to effectively control metastatic progression.” Helmut Thomas, Ph.D., President, Chief Executive Officer & Chief Scientific Officer of Cyclenium “We highly appreciate Cyclenium’s expertise in the macrocycle area and their technology platform that is based on over 20 years of pioneering experience in small molecule macrocyclic chemistry,” said David Warshawsky, Ph.D., Chief Executive Officer of Vuja De. “We are very pleased to work with Cyclenium on identifying and developing novel game-changing drug candidates that prevent metastatic recurrence, the most urgent need of most cancer patients,” he added. About Cyclenium Pharma Cyclenium Pharma is an emerging, privately held pharmaceutical research and development company exploiting its proprietary next generation CMRT™ macrocyclic drug discovery technology for the discovery and development of novel small molecule therapeutic agents to address areas of unsatisfied medical need. Cyclenium is creating value through progression of internal programs in oncology, infectious diseases and inflammation/pain. In addition, Cyclenium is providing its extensive experience and exploring its CMRT-based QUEST™ screening library in risk-sharing partnerships with leading academic and research driven non-profit organizations, as well as collaborations with innovative pharmaceutical and biotechnology companies world-wide seeking to modulate unique and difficult disease targets in diverse therapeutic areas. About Vuja De Sciences Vuja De is a biotechnology startup company dedicated to discovering and developing therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence. This vulnerability of DTCs stems from their dependence on a unique phenotype that includes stress adaptation, survival & dormancy, which we have coined “Metastatic Endurance”. ME enables DTCs to persist undetected at secondary sites like “ticking time-bombs” and eventually start to rapidly divide and form overt deadly tumors. We successfully created the first-ever cell-based and ex vivo drug screening platform that finds drugs that target ME. We are using the largely adolescent, orphan disease, osteosarcoma, as the best proof of concept model for developing anti metastatic progression drugs for many cancers such as breast, melanoma and kidney. We are testing repurposed drugs that have previously been in clinical trials, as well as novel preclinical drugs. About Osteosarcoma Osteosarcoma is an aggressive cancer of the bone and is the most common type of bone cancer in children and teens. Since metastatic recurrence has shared biological mechanism in many other cancer types, therapies that show promise in osteosarcoma can be developed in parallel for many other cancer types, such as breast, kidney and melanoma. Despite successful control of the primary osteosarcoma tumors and follow-up chemotherapy, metastasis continues to be the most common cause of mortality. The last 30 years have brought little improvement in survival outcomes for children with osteosarcoma, despite intensification of therapy. Due to lack of improved outcomes, new approaches to therapy are highly needed. Furthermore, if targeted therapeutics are found to prevent metastasis in this cancer, a strong biological rationale would exist for the evaluation of such a therapy in other human cancers.

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RESEARCH

Regeneron, following in Lilly's footsteps, wins FDA emergency nod for COVID-19 antibody cocktail

Regeneron | November 24, 2020

Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business. Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago. In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19. “The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others. Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday. Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution. The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab. Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.

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PHARMACY MARKET

AbCellera and Everest Medicines Announce Multi-Target Collaboration to Advance New Antibody Therapies

Everest Medicines | September 23, 2021

AbCellera and Everest Medicines Limited announced that they have entered into a multi-year collaboration and license agreement to discover therapeutic antibodies for up to 10 targets selected by Everest. The partnership will help to expand Everest’s portfolio of novel medicines across multiple indications, with the initial programs focusing on targets in oncology. We are proud to partner with Everest as they build a robust pipeline of innovative medicines for patients in Asia and beyond, We believe our full-stack discovery engine, combined with Everest’s clinical development capabilities, creates synergy and the opportunity to speed the delivery of therapies to patients around the world. - Carl Hansen, Ph.D., CEO and President of AbCellera. By partnering with AbCellera, Everest will benefit from an operating system that supports many antibody modalities to unlock new target classes and open new disease areas to therapeutic access. The collaboration will leverage the full breadth of AbCellera’s technology stack, including sourcing fully humanized antibodies from the Trianni Mouse®, sourcing single domain antibodies from camelids, and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform. This collaboration will allow us to gain access to AbCellera’s cutting edge, AI-powered antibody discovery platform, which will greatly accelerate and increase the efficiency of our internal discovery efforts. - Jennifer Yang, Ph.D., Chief Scientific Officer of Everest Medicines. Under the terms of the agreement, Everest will have the rights to develop and commercialize antibodies resulting from the collaboration. AbCellera will receive research payments and is eligible to receive from Everest downstream clinical and commercial milestone payments and royalties on net sales of products. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. AbCellera Forward-looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

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