Pharmaceutical Technology Editors

Eurofins Scientific announced on Feb. 18, 2021 that it is acquiring Beacon Discovery, a US-based drug discovery and contract research organization, to expand its drug discovery capabilities.

According to a Eurofins press release, the company decided to acquire Beacon because of its experience in drug discovery and development, along with its knowledge of G-protein coupled receptor (GPCR) research and its compound library.

“Beacon Discovery is very excited to join Eurofins,” said Dr. Sunny Al-Shamma, Beacon Discovery’s CEO, in the press release. “Joining the Eurofins Discovery organization expands our opportunity to continue our drug discovery efforts and provide integrated drug discovery services with the additive and complementary capabilities provided by Eurofins Discovery.”

“Beacon Discovery adds the expertise in GPCR targets and drug discovery and development experience that will advance our offering in integrated drug discovery services for our clients,” said Dr. Gilles Martin, Eurofins’ CEO, in the press release. “This transaction is another demonstration of Eurofins’ commitment to provide the most comprehensive portfolio of laboratory services in the discovery pharmacology field which enjoys a strong outsourcing growth trend.”

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With the acquisition, Eurofins gets Beacon’s G-protein coupled receptor research knowledge and its compound library. 

Eurofins to Expand Drug Discovery Capabilities Through Beacon Discovery Acquisition

Sanofi announced on Feb. 22, 2021 that it has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacturing of Janssen’s single-dose COVID-19 vaccine.

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month, Sanofi said in a company press release.

Sanofi entered into a similar agreement with Pfizer-BioNTech in 

 to support the manufacturing and supply of more than 125 million doses of their COVID-19 vaccine.

“Today’s agreement is the second of its kind and demonstrates Sanofi’s ongoing commitment to the collective effort to ending this crisis as quickly as possible,” said Paul Hudson, CEO, Sanofi, in the press release. “While our priority remains advancing our two COVID-19 vaccine programs, we recognize there are opportunities to increase supply and expand access to COVID-19 vaccines. As such, without compromising other essential medicines and vaccines, and where we have the right manufacturing capabilities, we are stepping forward to show solidarity in the industry and continue doing our part in the fight against COVID-19.”

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month.

Sanofi to Support the Manufacturing of Janssen’s Single-Dose COVID-19 Vaccine

Regis Technologies, a US-based contract development and manufacturing organization, announced on Feb. 17, 2021 that it has completed the expansion of its laboratory facilities in Morton Grove, IL to accommodate the development of APIs.

The 9000-ft.2 expansion features additional process chemistry and analytical laboratories, an Inductively coupled plasma mass spectrometry suite, added climate-controlled storage,14 new fume hoods, new kilo-scale reactors, and process safety equipment for reaction calorimetry measurements for secure control and scale-up, the company said in a press release. Additionally, the laboratories come equipped with an advanced variable air volume air system for clean energy-efficient operations.

“Our investment in this new capacity broadens Regis’ capabilities and our flexibility to support the growing need for US-based custom pharma services,” said Joe Miller, PhD, chief technology officer at Regis Technologies, in the press release. “The desire to reduce supply chain risk, ensure quality, and maintain intellectual property is driving a surging interest in domestic on-boarding of API development and manufacturing. This timely expansion allows us to meet this demand, enabling our scientists to support additional API projects as our customers advance their novel drugs to market.”

The company has completed the expansion of its laboratory facilities to accommodate the development of APIs. 

Regis Technologies Completes Expansion of its Illinois Lab Facilities 

Catalent announced on Feb. 18, 2021 that it has entered into a multi-year commercial supply agreement with Aurinia Pharmaceuticals, a Canadian pharmaceutical company, for LUPKYNIS (voclosporin), a drug for the treatment of adult patients with lupus nephritis, a complication that stems from the autoimmune disease systemic lupus erythematosus.

The drug, which was approved by FDA in January 2021, will be manufactured as a softgel dosage form at Catalent’s pharmaceutical softgel center of excellence in St. Petersburg, FL, Catalent said in a company press release.

“Catalent has a long track record in bringing novel drugs to market and has supported over 80% of all prescription pharmaceutical softgel brand launches in the U[nited] S[tates]. It has nearly 90 years of experience in the formulation and manufacturing of softgels for both pharmaceutical and consumer health products, which it has drawn upon to jointly develop LUPKYNIS with Aurinia,” said Dr. Aris Gennadios, president, Softgel and Oral Technologies, Catalent, in the press release. “We know the benefits that the dosage form offers developers and patients and look forward to working with Aurinia on the commercial production of this innovative therapeutic option for patients with lupus nephritis going forward, having previously partnered on its development.”

Through the agreement, Catalent will manufacture LUPKYNIS (voclosporin), Aurinia’s drug for the treatment of adult patients with lupus nephritis, at its pharmaceutical softgel center of excellence in St. Petersburg, FL.

Catalent Announces Multi-Year Supply Agreement with Aurinia Pharmaceuticals

GlaxoSmithKline (GSK) and Vir Biotechnology announced on Feb. 17, 2021 that they are expanding their existing COVID-19 therapies agreement to include the research and development of new therapies for influenza and other respiratory viruses.

Under the terms of the agreement, GSK will provide an upfront payment of $225 million, along with a further equity investment of $120 million, GSK said in a company press release. Vir will initially fund the development of VIR-2482, its intramuscularly administered investigational monoclonal antibody (mAb) designed as a universal prophylactic for influenza A, through to Phase II trials, after which, GSK will have the option to co-develop the mAb and will pay a fee of $300 million. GSK will also pay up to $200 million if certain predefined regulatory milestones are met.

The companies previously established an agreement in 

 to research and develop solutions for coronaviruses, including SARS-CoV-2, according to the press release. Currently, the collaboration is focused on the development of VIR-7831 and VIR-7832, two mAbs that have shown the ability to block viral entry into healthy cells and clear infected cells, and to provide a high barrier to resistance.

“We believe, now more than ever, that it is very important to develop new therapies to treat and ideally prevent infectious diseases,” said Dr. Hal Barron, chief scientific officer and president R&D, GSK, in the press release. “I am delighted that we are expanding our collaboration with Vir whose focus on novel antibodies, expertise in functional genomics, unique technology, and talented scientists will further strengthen GSK’s position as a world leader in infectious diseases.”

“GSK has been a valuable strategic partner and scientific collaborator in the fight against COVID-19,” added George Scangos, PhD, CEO, Vir Biotechnology, in the press release. “As part of our functional genomics collaboration directed at COVID-19, we have turned up multiple targets that have the potential to treat influenza and other respiratory viruses, and it makes sense to extend the scope of our collaboration to include these new targets. This expanded collaboration supports the rapid advancement of multiple promising investigational compounds in our pipeline, increasing the likelihood that these potential life-saving treatments will reach patients sooner, and will advance our shared goal of developing single drugs that can address multiple ‘bugs.’”

The companies have expanded their agreement to include the research and development of new therapies for influenza and other respiratory viruses.

GSK and Vir Expand COVID-19 Therapeutics Collaboration to Include Influenza Therapies

On Feb. 15, 2021, biotechnology company Novavax and SK Bioscience, a vaccine business subsidiary of SK Group, announced an expanded collaboration and license agreement for SK Bioscience to add significant production capacity for Novavax’s COVID-19 vaccine, currently in Phase III clinical trials.

This new agreement follows an already existing manufacturing arrangement under which SK Bioscience obtained a license to manufacture and commercialize NVX-CoV2373, Novavax’s COVID-19 vaccine, for sale to the Korean government. Novavax recently reported positive interim efficacy results for the vaccine candidate in an ongoing Phase III clinical trial in the United Kingdom and is also currently conducting a Phase III trial in the United States and Mexico.

The new agreement calls for technology transfer related to the manufacturing of Novavax’s protein antigen, supply of Matrix M adjuvant, and support to SK Bioscience as needed to secure regulatory approval. SK Bioscience has concurrently finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021.

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the SARS-CoV-2 virus. According to Novavax in a company press release, it was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the UK and South Africa. The product is shipped in a ready-to-use liquid formulation and is stable at 2 °C to 8 °C (refrigerated), which means that the existing vaccine supply chain channels can be used for its distribution.

“SK Bioscience shares our sense of urgency to deliver a safe and effective COVID-19 vaccine to protect the global population, including the people of South Korea,” said Stanley C. Erck, president and CEO, Novavax, in the company press release. “We are proud to expand our partnership, which is another great milestone for both companies toward increasing the supply of NVX-CoV2373.”

“We are honored to continue to manufacture Novavax’[s] innovative COVID-19 vaccine and provide a supply to the Korean Government through this agreement,” said Jaeyong Ahn, CEO, SK Bioscience, in the press release. “We appreciate the collaboration of the Korean Government and Novavax to make possible this momentous step forward.”

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.