Pharmaceutical Technology Editors

Moderna announced on Aug. 26, 2022 that it was filing patent infringement lawsuits against Pfizer and BioNTech over a dispute concerning the company's Comirnaty vaccine. Moderna alleges that Pfizer and BioNTech infringed on patents Moderna filed between 2010 and 2016 concerning the company’s mRNA technology, which they allege the companies copied without permission in the creation of Comirnaty.

"We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic," said Stéphane Bancel, CEO, Moderna, in a company press release. "This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck.”

In October 2020, Moderna pledged not to enforce its COVID-19-related patents while the pandemic was ongoing. The company updated this pledge in March 2022, when they deemed that vaccine supply was no longer a barrier to access in many parts of the world.

According to the release, Moderna is not looking to remove Comirnaty from the market and is not seeking damages for sales prior to March 8, 2022 or that the United States government would be responsible for. The company also indicated that it will not enforce these patents in 92 low- and middle-income (AMC 92) countries.

"We believe that Pfizer and BioNTech unlawfully copied Moderna's inventions, and they have continued to use them without permission," said Shannon Thyme Klinger, chief legal officer, Moderna, in the release. "Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty's ongoing use of Moderna's patented technologies. Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation."

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Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

Moderna Files Suit Against Pfizer and BioNTech

Flexicon Liquid Filling, part of Watson-Marlow Fluid Technology Solutions (WMFTS) and Franz Ziel GmbH announced the launch of Cellefill on August 24, 2022, a turnkey, vial fill/finish system with an integrated barrier solution.

Cellefill integrates the features of Flexicon’s FPC60 aseptic vial filling machine with barrier technologies from Franz Ziel. According to a company press release, it is a good manufacturing practice compliant solution that delivers enhanced levels of process flexibility to accelerate the production of advanced therapy medicinal products including cell, gene, and biological therapies. Cellefill’s process design also includes the use of asepticsu single-use systems and pre-steralized ready-to-use product containers. 

“Through process flexibility, Cellefill enables the scale out and process repeatability our customers need to assure product quality at all levels of manufacturing,” said Steve Adams, product manager for Cellefill at WMFTS in the press release. “Providing expert guidance and support through a single point of contact, we are a committed project partner to biopharmaceutical companies at the cutting-edge of personalized medicine.”

Watson-Marlow and Franz Ziel GmbH have launched a new integrated solution to fast-track cell, gene, and biological therapies.

Watson-Marlow and Franz Ziel GmbH Launch Cellefill

ChargePoint Technology announced on August 25, 2022 that it had acquired PuroVaso, a company focused on the design, development, and manufacture of single-use containers.

According to a company press release, the acquisition is designed to complement ChargePoint’s existing portfolio of containment and sterile transfer technology. When combined with PureVaso’s single-use solutions, ChargePoint believes it can give pharmaceutical manufacturers a broader choice of powder and liquid transfer, storage, and handling products.

"PuroVaso has vast technical expertise in pharmaceutical processing, transfer, handling and storage, with a broad portfolio of products that customers rely on for critical process applications,” said Chris Eccles, CEO of ChargePoint, in a company press release. “With its extensive process knowledge, application engineered solutions, and relentless customer focus, PuroVaso offers leading solutions to highly regulated pharma and biopharma landscapes along with several other process critical markets. We are very excited to have PuroVaso join the ChargePoint portfolio of solutions.”

ChargePoint Technology has acquired single-use container company PuroVaso.

ChargePoint Technology Acquires PuroVaso

Anthony Fauci announced on Aug. 22, 2022 that he will be stepping down as the director of the National Institute of Allergy and Infectious Diseases (NIAID) in December 2022. In the statement, he indicated that he would also be stepping down as chief of the NIAID Laboratory of Immunoregulation, as well as the position of Chief Medical Advisor to President Joe Biden.

In the statement, Fauci indicated that he would not be retiring, but instead “[pursuing] the next phase of my career while I still have so much energy and passion for my field.” Fauci did not comment directly on any specific roles, but indicated that he intends to advance public health and mentor future scientific leaders.

“It has been the honor of a lifetime to have led the NIAID, an extraordinary institution, for so many years and through so many scientific and public health challenges,” said Fauci in the statement. “I am very proud of our many accomplishments. I have worked with — and learned from — countless talented and dedicated people in my own laboratory, at NIAID, at NIH and beyond. To them I express my abiding respect and gratitude.”

The full statement can be read on the National Institute of Health’s website 

Anthony Fauci announced that he plans to step down as Director of the National Institute of Allergy and Infectious Diseases in December 2022.

Anthony Fauci to Step Down in December

Alcon, an ophthalmology company, and Aerie Pharmaceuticals, a pharmaceutical company specializing in ophthalmologic therapies, announced a definitive merger agreement on Aug. 22, 2022. The agreement will see Alcon purchase Aerie for approximately $770 million in equity, granting it the rights to two recently commercialized medicines, Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution). The transaction is set to close in the fourth quarter of 2022.

According to a company press release, netarsudil and latanoprost ophthalmic solution is a fixed dose combination of the Rho kinase inhibitor, netarsudil, and a prostaglandin F2α analogue, latanoprost. It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Netarsudil ophthalmic solution is a Rho kinase inhibitor indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Additionally, the transaction grants Alcon rights to Aerie’s development pipeline, which contains AR-15512, a Phase III product candidate for dry eye disease.

“Alcon is passionate about innovative treatments in eye care, especially in core disorders such as glaucoma and dry eye, which have significant patient impact,” said David Endicott, CEO, Alcon, in the release. “Aerie is a natural fit with on-market and pipeline products, and R&D capabilities that offer the infrastructure needed to expand our ophthalmic pharmaceutical presence. As we continue to broaden our portfolio across glaucoma, retina, and ocular surface disease, we are excited to help even more patients see brilliantly.”

“We are excited to be joining Alcon, a recognized leader in eye care. I am so proud of the Aerie team and the innovation we’ve pioneered,” said Raj Kannan, CEO, Aerie Pharmaceuticals, in the release. “Alcon is the right strategic and financial partner to maximize the potential of Aerie’s commercial franchise and our growing portfolio of pipeline assets. Alcon’s global infrastructure, financial resources, and commercial capabilities will accelerate the standard of care by helping more patients have access to Aerie’s innovative products.”

Aerie to be purchased by Alcon after recently bringing two glaucoma drugs to market.

Alcon to Purchase Aerie Pharmaceuticals for $770 Million 

The National Institute for Health and Care Excellence (NICE) has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen as a treatment for adults with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the two main forms of ANCA-associated vasculitis (AAV).

Announced by Vifor Fresenius Medical Care Renal Pharma (VFMCRP) in an Aug. 18, 2022 press release, the decision by NICE follows on from the authorization by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022. Both decisions, of NICE and MHRA, were based on findings from a comprehensive development program that ended with the results from a Phase III trial, which demonstrated non-inferiority of Tavneos when compared with prednisolone at remission of disease over 26 weeks and then superiority of the former when sustaining remission at 52 weeks.

“ANCA-associated vasculitis is a rare, systemic disease which can be rapidly fatal if not appropriately and promptly treated. The variable nature of the disease and its course along with challenging side-effects of current treatment options can severely affect subsequent quality of life for patients,” said John Mills, vice-chair of Vasculitis UK, in the press release. “We very much welcome NICE’s decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.”

“NICE’s decision represents a major advancement for the treatment of GPA/MPA in the UK,” added David Jayne, professor of Clinical Autoimmunity, University of Cambridge, in the press release. “Patients will now have access to a new therapy option that could help them optimize their treatment outcomes.”

“We are delighted about this recommendation for patients in England, Wales, and Northern Ireland living with GPA/MPA,” said Klaus Henning Jensen, chief medical officer of CSL Vifor. “It means that an underserved patient population will have access to a first-in-class treatment aiming to meet major unmet medical needs. We look forward to continue working with the National Health Service to ensure access to this important medicine for patients across the UK as quickly as possible.”

NICE has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen.