FDA approves AstraZeneca’s Farxiga for type 2 diabetes patients with risk of CVD

Pharmaceutical Technology | October 21, 2019

AstraZeneca has announced the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in patients with type 2 diabetes and either established cardiovascular disease (CVD) or at serious risk of CV outcomes. This follows a similar decision by the European Union in August 2019, when the medicines agency updated its marketing authorisation for Farxiga. The FDA’s decision was based upon results from the DECLARE-TIMI 58 trial, which evaluated 58 CV outcomes, making it the largest of its kind for a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Full results of the Phase III, randomised control trial were published in January in the New England Journal of Medicine. AstraZeneca subsidiary BioPharmaceuticals’ Business Unit executive vice-president Ruud Dobber said: “Farxiga is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalisation for heart failure in type-2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors.

Spotlight

This paper, authored by Alireza Shabani, Founder & CEO of Qulab, describes the necessary computational architecture for pharmaceutical firms to accelerate R&D and drug discovery, especially utilizing special purpose silicon and quantum processors.

Spotlight

This paper, authored by Alireza Shabani, Founder & CEO of Qulab, describes the necessary computational architecture for pharmaceutical firms to accelerate R&D and drug discovery, especially utilizing special purpose silicon and quantum processors.

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BUSINESS INSIGHTS

MilliporeSigma Invests $ 286 Million in U.S. Drug Safety Testing Capacity

MilliporeSigma | November 16, 2022

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that its Life Science business sector is investing more than $ 286 million in its biosafety testing capacity at the company's site in Rockville, Maryland, USA. This will significantly increase the company's ability to conduct biosafety testing and analytical development services. Biosafety testing and analytical development are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines. Global demand for these services is growing at a double-digit rate. "MilliporeSigma is harnessing its broad portfolio of modern technologies and enabling services to help ensure the safety of the world's medicines. These significant investments in Rockville and other sites across our global network will help us meet growing demand for the robust testing studies that biologics manufacturers depend upon to comply with stringent regulatory guidelines. This is a prime example of our focus on sustainable growth in areas with strong underlying upwards dynamics." Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany "This is the largest investment in contract testing in Merck KGaA, Darmstadt, Germany's history. Our Rockville campus has a long track record of testing for both traditional and novel therapies. We have been driving innovation in biosafety testing for 75 years and this expansion enables our Life Science business sector to lead in shaping the future of testing," said Matthias Heinzel, Member of the Executive Board of Merck KGaA, Darmstadt, Germany and CEO Life Science. "We thank the State of Maryland and Montgomery County, Maryland, for their collaboration in making this new campus a reality for our employees and clients. Together, we are impacting life and health with science." The BioReliance® contract testing portfolio from MilliporeSigma provides best-in-class biosafety testing and analytical development methods for both traditional and novel therapies. The new state-of-the-art, 250,000-square-foot facility at MilliporeSigma's Rockville site will house biosafety testing, analytical development, viral clearance suites, and cell bank manufacturing services. Currently, about 600 employees work at the site. Over the next four years, the expansion will create more than 500 new jobs. With more than 30 years of drug development, material science and process technology expertise, Millipore® CTDMO Services offerings span pre-clinical development to commercial manufacturing, including testing, across multiple modalities including mAbs, highly potent active pharmaceutical ingredients, antibody-drug conjugates, viral vector therapies, mRNA, and lipid nanoparticle formulation. Contract testing and the newly formed Millipore® CTDMO Services are part of the Life Science Services business unit, which together with the Process Solutions business is one of Merck KGaA, Darmstadt, Germany's "Big 3" growth drivers. The company aims to increase its Group sales to approximately € 25 billion by 2025. Recently, the company's Life Science business sector announced investments in Martillac and Molsheim, France; Shanghai, China; Sheboygan and Verona, Wisconsin, USA; Cork, Ireland; Wuxi, China; Carlsbad, California, USA; Jaffrey, New Hampshire and Danvers, Massachusetts, USA; Buchs, Switzerland; and Darmstadt, Germany. These expansions are part of an ambitious, multi-year program. It aims to increase the capacity and capabilities of Merck KGaA, Darmstadt, Germany's Life Science business sector to support the growing global demand for lifesaving medications and to make significant contributions to public health. About the Life Science business of Merck KGaA, Darmstadt, Germany The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 26,000 employees and more than 55 manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck KGaA, Darmstadt, Germany generated sales of € 19.7 billion in 66 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription to this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

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PHARMACY MARKET

Pfizer Completes Acquisition of Biohaven Pharmaceuticals

Pfizer and Biohaven Pharmaceuticals | October 04, 2022

Pfizer Inc. announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults. The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide receptor antagonists including Rimegepant Approved in the United States under the trade name NURTEC® ODT, in adults for both the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine Approved in the European Union under the trade name VYDURA® for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month Zavegepant New Drug Application for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration review, with a Prescription Drug User Fee Act goal date in 1Q 2023 "We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders. The success of NURTEC® ODT coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s innovative Internal Medicine pipeline through 2030, and beyond. Combined with Pfizer’s global reach, this acquisition increases our potential to bring new treatment options to patients with migraine – a disease which affects over 1 billion people worldwide. Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker “BHVN”. About Migraine Worldwide, more than one billion people suffer from migraine, which predominately affects women.i Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.ii Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound and sensitivity to light. About Rimegepant Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec® ODT for the acute treatment of migraine in adults in February 2020 and for the preventive treatment of episodic migraine in adults in May 2021. Nurtec® ODT is taken orally as needed, up to once daily for acute treatment, and every other day for preventive treatment. The maximum dose in a 24 hour period is 75 mg. About Zavegepant Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from the NOJECTION® Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The FDA has accepted for review a New Drug Application (NDA) for zavegepant nasal spray, with a PDUFA date in 1Q 2023. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

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PHARMA TECH

Additional US$ 4 Million Received for Next Development Steps of MedinCell's 6-Month Active Injectable Bioresorbable Subcutaneous Contraceptive

MedinCell | December 01, 2022

MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023 It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide About MedinCell MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.

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