PHARMACY MARKET

Virpax Announces MMS019 Manufacturing and Supply Agreement

Virpax Pharmaceuticals | August 27, 2021

Virpax® Pharmaceuticals, Inc., a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has entered into a commercial manufacturing and supply agreement with Seqens, an integrated global leader in pharmaceutical solutions with 24 manufacturing sites worldwide and seven research and development facilities throughout the U.S. and Europe.

The agreement with Seqens provides for both the supply material for Virpax’s clinical studies as well as the long-term commercial supply of MMS019. Seqens will conduct process development and validation of additional large scale commercial quantities of MMS019 at its facilities in Devens and Newburyport, Massachusetts.

“Establishing a collaboration with a strong partner capable of supplying clinical and commercial scale quantities of MMS019 is another important advancement in our MMS019 product development strategy. Seqens has a demonstrated expertise in developing and manufacturing highly-complex molecules for large scale production,” said Anthony Mack, Chairman and CEO of Virpax. “Importantly, we expect this collaboration to support future development and supply additional Molecular Envelope Technology programs under development, including Envelta™ and PES200, our post-traumatic stress disorder product candidate,” concluded Mr. Mack.

About MMS019
MMS019 is a drug product candidate based on a type of nanotechnology that enables the exclusive delivery of a metabolically labile peptide drug into the brain via intranasal delivery. MMS019 is manufactured using industrially relevant equipment and processes (high pressure homogenization and spray drying). There is pharmacological evidence of activity of molecular envelope technology (MET) enabled enkephalin in morphine-tolerant animals. The MET nanoparticles are well tolerated via the nasal route at the dose administered. MMS019 demonstrated comparable preclinical activity to morphine in all animal pain models tested without the drug seeking and tolerance associated with opioids.

About Seqens
SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients. With 24 production sites and 7 R&D centers in Europe, North America and Asia, SEQENS develops and manufactures tailor-made solutions and ingredients for the most demanding industries such as healthcare, electronics, cosmetics, food and home care. Driven by a culture of excellence and a strong entrepreneurial spirit, our 3,200 employees are committed to providing our customers with the highest level of service and quality while acting ethically in accordance with our corporate social responsibility program.”

About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval using its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac metered-dose spray film formulation being developed to manage acute musculoskeletal pain and osteoarthritis. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal molecular-envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop its PES200 product candidate to manage post-traumatic stress disorder (PTSD) and its MMS019 product candidate to inhibit viral replication caused by influenza or SARS-CoV-2.

Spotlight

In the fight to eliminate the multi-billion dollar counterfeit drug problem, the Drug Supply Chain Security Act (DSCSA) will require pharmaceutical manufacturers to serialize their products by November 2017. Repackagers must serialize products by November 2018. To maximize profitability, you need to fight drug counterfeiting and improve operational efficiency by capturing serialized data in real-time. By providing your team with the tools to capture traceability and aggregated data, you can optimize many areas of your business—from production to the warehouse, and beyond.

Spotlight

In the fight to eliminate the multi-billion dollar counterfeit drug problem, the Drug Supply Chain Security Act (DSCSA) will require pharmaceutical manufacturers to serialize their products by November 2017. Repackagers must serialize products by November 2018. To maximize profitability, you need to fight drug counterfeiting and improve operational efficiency by capturing serialized data in real-time. By providing your team with the tools to capture traceability and aggregated data, you can optimize many areas of your business—from production to the warehouse, and beyond.

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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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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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PHARMA TECH

Porton Advanced and Royaltech Announce Strategic Collaboration to Accelerate the Development of Bacterial Drugs and mRNA Drugs

Porton Advanced Solutions | August 29, 2022

Porton Advanced Solutions.announced a strategic cooperation with Suzhou Royaltech Med Co., Ltd. This strategic collaboration will further integrate the resources and capabilities of both parties, jointly promote the establishment of microbial vectors used for gene therapy and mRNA drug platform technology, and accelerate the R&D process of bioinnovative drugs. Porton Advanced provides an end-to-end gene and cell therapy CDMO service platform covering plasmids, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and viable bacteria therapy. Suzhou Royaltech focuses on the development of vaccines for tumor immunotherapy with its proprietary technologies, and fast transition from clinical to market . Its R&D pipeline covers the attenuated non-integrated Listeria platform, mRNA platform, and cell therapy platform. All these platforms are in the leading position not only in China but also abroad, and have a complete layout of invention patents. "We are very pleased to enter into this strategic collaboration with Royaltech. The core management team of Royaltech is from the top pharmaceutical companies, with an average of 15 years of R&D and management experience and is advancing an internationally competitive R&D pipeline. Porton Advanced's end-to-end gene and cell therapy CDMO platform with rich project experience and comprehensive quality system will help Royaltech the development of Listeria and mRNA drugs, push its R&D pipeline in a quick, efficient manner, and accelerate the development and implementation of innovative drugs, so that good medicines can benefit the public earlier." Dr. Yangzhou Wang, CEO of Porton Advanced Dr. Chun Xu, Chairman of Royaltech, said: "As a Biotech company, we are grateful to work with Porton Advanced, a very professional CDMO company, to jointly build a unique Listeria and mRNA tumor vaccine platform technology, and constantly develop leading tumor immunotherapeutic biological drugs in China and abroad." About Porton Advanced Solutions Established in Suzhou Industrial Park in December 2018, by its parent company Porton Pharma Solutions Ltd. Porton Advanced has built a CDMO platform integrating plasmid, cell therapy, gene therapy, oncolytic virus, nucleic acid therapy and microbial vectors used for gene therapy providing end-to-end services from cell banking, process development and analytical development, cGMP production to final Fill and Finish , investigator-initiated clinical trials (IIT), investigational new drugs (IND), clinical trials to commercial production. Porton Advanced is dedicated to support sponsors advance their GCT drug development and market launches. Porton Advanced focuses solely on gene and cell therapy services. Built on the professional experience of its cohort of world-class professionals, as well as on the successes of its parent company, Porton Advanced insists on "Customer First" and the tenet of "Compliance, Expertise, Focus, Open Collaboration". With its key focus on protecting IP for its sponsors, through its comprehensive project management and quality systems, Porton Advanced strives to bring gene and cell therapy products to the clinic and the market through its quality CDMO services, and help bring the best medicine to the public sooner. About Royaltech Headquartered in Suzhou Industrial Park, Suzhou Royaltech Med Co., Ltd. was founded in July 2016. In July 2017, a wholly-owned subsidiary, Shanghai Royaltech Co., Ltd. was set up in Shanghai International Medical Zone. As a high-standard innovation center of biological drugs, Shanghai Royaltech focuses on CMC development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Since establishment, Royaltech has submitted several patents for invention to the State Intellectual Property Office. It focuses on the development of innovative tumor vaccine, and fast clinical application of up-to-date cell immunotherapy. Its R&D pipeline covers mRNA, oncolytic virus, bacteria, AAV, cell therapy platform and so on. Its core management team is from top universities in US and top 10 big pharma, with an average of 15 years of R&D and management experience. Our scientists have excellent capability on molecular biological engineering, target discovery and verification, pre-clinical R&D, quality control and assurance, and clinical trials of cell immunotherapy. On the strength of our rich experience on target biomarker, target discovery and verification, and global multicenter clinical trials, we are advancing an internationally competitive R&D pipeline.

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