Pharmaceutical Technology Editors

As the United Kingdom government gathers in Manchester for its annual conference, vaccine access campaigners have made their point clear in 8-foot lettering on the walls of One Manchester Tower, where the conservative party’s annual conference is being held. On Oct. 3rd, 2021, The People’s Vaccine Alliance projected “The world is watching. 10,000 people die every day from Covid-19 while the UK defends vaccine monopolies. Boris Johnson, waive vaccine patents and vaccinate the world” onto the building.

Attempts to waive IP ownership rights at the World Trade Organization (WTO) have been consistently blocked by the UK government. Germany has also blocked this measure, while the United States lent support to its passage in May after pressure from low and middle income countries.

A newly formed German coalition government may favor its passing, which would then leave the UK in a state of isolated opposition. The WTO’S intellectual property council will meet on Oct. 4th, 2021.

“Right now, Boris Johnson is enforcing a system of vaccine apartheid,” said Nick Deard, director of Global Justice Now, in a press release from the organization. “At [the] Conservative Party conference this week, he must finally get out of the way of countries producing their own vaccine. Failing to act will shame the UK for a generation or more.”

“The UK Government must tackle COVID-19 monopolies and push pharmaceutical companies to share their manufacturing know-how through the World Health [Organization],” said Saoirse Fitzpatrick, advocacy manager at STOPAIDS, in the press release. “The Oxford/AstraZeneca vaccine was 97% publicly funded, - including a significant contribution from UK taxpayers. The Government must work with AstraZeneca and the WHO to make this vaccine a global public good.”

Articles

Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.

“Waive Vaccine Patents” is Projected onto Hotel Hosting UK’s Annual Conservative Conference

Thermo Fisher Scientific announced that it had opened a new biologics manufacturing site in Lengnau, Switzerland on Oct. 1, 2021. Thermo Fisher assumed operational responsibility of the facility as a result of their strategic partnership with CSL Limited, a biotechnology company, that was announced in 2020.

The Lengnau site is a 1.5 million ft² biologics facility with up to 12,500 L of bioreactor capacity. It joins Thermo Fisher’s biologics manufacturing network that includes Princeton, NJ, St. Louis, MO, Groningen, The Netherlands, Brisbane, Australia, and Hangzhou, China.

Following completion of on-site construction in 2022, the facility will initially manufacture CSL’s next-generation recombinant factor IX product Idelvion for patients with hemophilia B. In addition to this production, Thermo Fisher plans to expand site use to accommodate other biopharma customers in the future.

"We are excited to add the new Lengnau site to our global biologics manufacturing network and we are thrilled to welcome more than 200 new colleagues to Thermo Fisher," said Michel Lagarde, executive vice-president of Thermo Fisher Scientific, in a company press release. "Through our partnership with CSL, this site further strengthens our unique customer value proposition to leverage our scale and depth of capabilities for pharma and biotech customers. With the addition of new high-volume stainless-steel capabilities in Lengnau, we are enabling our customers to start their projects with us and stay with us as their manufacturing requirements grow."

Thermo Fisher’s new Swiss facility will initially produce CSL Limited’s recombinant factor IX product Idelvion.

Thermo Fisher Scientific Opens Biologics Manufacturing Site in Lengnau, Switzerland

SGS announced the completion of expansions to its bioanalytical laboratory in Poitiers, France on Sept. 30, 2021. The addition consists of a new 800 m² building that houses additional drug development equipment and extra office space.

Included in the expansion are chromatography and immunoassay laboratories that are intended to dramatically increase production capacity. Additional capacities such as mass spectrometry, immunoanalysis, and cell-based bioassays will be added to the site’s existing capabilities.

The facility also adds new digital tools, such as customer relationship management and configure, price, quote software for contracting and monitoring. A large sample storage combined with bar code systems allows for storage of up to 800,000 samples at a time.

“The expansion comes at an exciting time,” said Walid Elbast, SGS’s general manager in France, in a company press release. “It allows us to meet increased demand in the area and shorten processes for our pharmaceutical clients. For me, this is a testimony to the outstanding teamwork of everyone involved and SGS’s continued investment in supporting innovation in the life sciences sector.”

The expansion to SGS’s Poitiers facility in France is expected to improve the company’s drug development capabilities.

SGS Completes Expansion of Bioanalytical Testing Laboratory in France

DRI announced on Sept. 30, 2021, that its wholly owned subsidiary, DRI Healthcare Trust, has acquired a royalty interest in Oracea (doxycycline) for a net purchase price of $46.4 million. As part of the transaction, DRI also acquired royalty interests in two additional products. Upon closing, DRI received its first royalties of approximately $3.5 million, which were relative to the sales in the quarter that ended on June 30, 2021.

Doxycycline is an oral prescription medication for inflammatory lesions (papules and pustules) of rosacea in adult patients. Marketed by Galderma Laboratories, sales of Oracea commenced in 2006 once approved by FDA.

"We are very pleased to announce the addition of Oracea to our portfolio," said Behzad Khosrowshahi, CEO of DRI Healthcare Trust, in a company press release. "It has an established commercial track record and is among the top available treatment options for managing papulopustular rosacea, which can have a substantial negative quality of life impact. This transaction is expected to be immediately accretive to the trust and further benefits unitholders through diversification of DRI’s portfolio by therapeutic area and marketer."

DRI’s subsidiary has acquired a royalty interest in Oracea (doxycycline) for $46.4 million.

DRI Healthcare Acquires Rosacea Treatment for $46.4 Million

On Sept. 29, 2021, Appili Therapeutics, a biopharmaceutical company specializing in infectious diseases, and AiPharma Global Holdings, a private pharmaceutical research, development, and commercialization company, announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form, Avigan/Reeqonus (favipiravir), for the treatment of COVID-19 and other infectious diseases.

FUJIFILM Toyama Chemical developed Avigan/Reeqonus (favipiravir), and favipiravir was approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. The Japanese government also agreed to purchase more than 65 million tablets. In addition, Russia, Thailand, Indonesia, India, and Malaysia approved favipiravir-based antiviral medications for the emergency treatment of COVID-19 after promising clinical trials.

There are other ongoing clinical trials for favipiravir for the treatment of COVID-19 in several countries, including the United States, China, India, and the United Kingdom. Appili is conducting a Phase III COVID-19 treatment trial (PRESECO). Favipiravir has been studied in human trials outside of North America and has a known safety profile. In authorized countries, hundreds of thousands of patients have received favipiravir during the COVID-19 pandemic.

The alliance between the companies includes:

Accelerated and strengthened development of Avigan/Reeqonus

Access to cash flows tied to growing worldwide sales

Establishment of a joint scientific steering committee to coordinate the rapid development of Avigan/Reeqonus

Equity transaction, under which a stock swap will align both companies more closely, demonstrating their shared interest in increasing sales of the antiviral oral medicine worldwide and to further develop both organization's pipelines

Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.

Antiviral Oral Medicine Emerges as Potential COVID-19 Treatment and Companies Make Strategic Alliance

AstraZeneca’s Alexion, a group within AstraZeneca focused on rare diseases, announced on Sept. 29, 2021, that it had exercised its option to acquire all remaining equity in Caelum Biosciences. This acquisition gives them rights to CAEL-101, a drug candidate fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis.

AL amyloidosis is a rare disease caused by defective plasma cells in one’s bone marrow, causing misfolded amyloid proteins to build up in organs such as the heart and kidneys. This causes significant organ damage and failure, which can be fatal. According to a company press release, approximately 20,000 people in the United States, France, Germany, Italy, Spain, and the United Kingdom live with AL amyloidosis classified as Mayo stage IIIa or IIIb disease.

CAEL-101 is a mAb designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. It is designed to bind to misfolded light chain proteins and amyloid and has shown binding to both kappa and lambda subtypes. It received orphan drug designation from both FDA and the European Commission.

CAEL-101 is currently being evaluated in a Phase III clinical program in combination with standard-of-care therapy in patients with AL amyloidosis. Two parallel studies for patients with Mayo stage IIIa disease (n=270) and Mayo stage IIIb disease (n=110) are ongoing.

“With a median survival time of less than 18 months following diagnosis, there is an urgent need for new treatments for this devastating disease,” said Marc Dunover, CEO, Alexion, in the press release. “CAEL-101 has the potential to be the first therapy to target and remove amyloid deposits from organ tissues, improve organ function, and, ultimately, lead to longer lives for these patients.

AstraZeneca’s acquisition of Caelum Biosciences gives them access to CAEL-101, a promising light chain amyloidosis treatment.