Pharmaceutical Technology Editors

Jazz Pharmaceuticals announced on Feb. 3, 2021 that it will acquire GW Pharmaceuticals, a UK-based biopharmaceutical company, for $7.2 billion.

Under the terms of the agreement, Jazz will gain access to GW’s novel cannabinoid platform including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy, Jazz said in a company press release. Together, the companies plan to combine their portfolios to form a pipeline of 19 clinical development programs across neuroscience and oncology, including in sleep, epilepsy, movement disorders, psychiatry, hematology, and solid tumors.

"Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW's industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue, and drive sustainable, long-term value creation opportunities," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, in the press release. "We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate a successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies' shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company."

"Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs," added Justin Gover, CEO of GW Pharmaceuticals, in the press release. "We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before."

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Through the acquisition, Jazz will gain access to GW’s novel cannabinoid platform, including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy.

Jazz Pharmaceuticals to Acquire GW Pharmaceuticals for $7.2 Billion

Element Materials Technology, a UK-based testing, inspection, and certification services company, announced on Feb. 3, 2021 that is acquiring Avomeen, an analytical testing services company located in the US, to expand its life sciences business unit in North America.

Through the acquisition, Element will have access to Avomeen’s expertise in formulation chemistry, product manufacturing, extractables and leachables, and large molecule testing, thus strengthening its technical range across several scientific disciplines, Element said in a company press release.

“We are thrilled to be joining the Element global family and combining our complementary capabilities to offer an even wider array of services and value to our clients,” said Mark Harvill, Avomeen CEO, in the press release. “Element’s focus on scientific excellence and quality, coupled with its partnership with clients and employees, aligns well with Avomeen’s values and what we will collectively continue to do as one company.”

“This is our third acquisition of 2021 and helps to build Element’s growing position in the life sciences sector, expanding our presence in the American pharmaceutical market,” added Jo Wetz, Element CEO, in the press release.

Through the acquisition, Element will have access to Avomeen’s expertise in formulation chemistry, product manufacturing, extractables and leachables, and large molecule testing.

Element Materials Technology to Expand its North American Presence with Avomeen Acquisition

Big Pharma companies—including some with their own vaccine candidates in development—are taking on the production demands for COVID-19 vaccines by establishing manufacturing partnerships with sponsors of approved or late-stage vaccine candidates.

Novartis announced on Jan. 29, 2021 an agreement to fill vials with the bulk mRNA active ingredient for the Pfizer-BioNTech messenger RNA (mRNA) vaccine at its aseptic manufacturing facility in Stein, Switzerland. The filled vials will be shipped back to BioNTech for distribution.

When the agreement is finalized, Novartis will commence production in the second quarter of 2021 with initial shipment of finished product expected in the third quarter, the company said in a press statement.

Novartis also reported that it is in discussion with other companies about assuming additional manufacturing work including production of mRNA, therapeutic proteins, and raw materials for COVID-19 vaccines and therapeutics.

On Jan. 27, 2021, Sanofi and BioNTech announced an agreement in which Sanofi will give BioNTech access to its established infrastructure and expertise with the goal of producing more than 125 million doses of COVID-19 vaccine in Europe. The first supplies will be produced by Sanofi’s Frankfurt, Germany facility in the summer of 2021.

Scaling up for CureVac vaccine production

Although the company has not produced vaccines in its 160-year history, Bayer announced on Feb. 1, 2021 that in 2022 it would produce 160 million doses of CureVac’s mRNA vaccine, which is currently in Phase IIb/III trials. Initial doses produced at Bayer’s Wuppertal, Germany facility are expected by the end of 2021.

The manufacturing announcement expands on a January 2021 announcement that Bayer would provide CureVac with development, supply, and key territory operations support, leveraging Bayer’s expertise and infrastructure in clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain management, ­­­­­and country operations within the European Union and selected additional markets.

GlaxoSmithKline (GSK) announced on Feb. 3, 202 an agreement to support the manufacture in 2021 up to 100 million doses of CureVac’s first generation COVID-19 vaccine using GSK’s established manufacturing network in Belgium. The €150 million (US$180.4 million) agreement also expands an existing relationship for the companies to co-develop mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine, GSK reports in a press statement.

The agreement provides that GSK and CureVac will immediately contribute resources to develop and manufacture novel mRNA vaccine candidates, including multi-valent and monovalent approaches, designed to offer broader protection different SARS-CoV2 variants, and respond to future new variants. The target is to introduce the first next-generation vaccine in 2022.

Under the terms of the agreement, GSK will be the marketing authorization holder for the next-generation vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialize the next-generation COVID-19 vaccine in all countries except for Germany, Austria, and Switzerland, the company reported.

In December 2020, GSK and Sanofi announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program following clinical trial results that showed a lower immune response in older adults compared with patients who recovered from COVID-19.In announcing the results, the companies said they would work to improve the antigen formulation and conduct additional trials in 2021.

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

Big Pharma Takes on Vaccine Production

Hovione Technology announced on Feb. 3, 2021 that it has received a grant for a patent describing an innovative method to improve particle size analysis methods by laser diffraction.

The patent, which covers a method that solves the problem of ensuring machine-to-machine test result reproducibility, has been granted or allowed in the US, Europe, Japan, and China. The solution requires an understanding of the process of deagglomerating powder particles before laser diffraction analysis, Hovione said in a company press release. Scientists at the company learned that deagglomeration techniques lose efficacy through equipment wear over time and developed a tactic that compensates for the wear and prepares an ideal sample for each particle size test.

“For years we had problems where the same batch of powder gave different results when tested in different laser diffraction testing machines, and this led to serious issues and challenges during method transfer,” said Constança Cacela, director of Analytical Development at Hovione, in the press release. “Drugs known to agglomerate, particularly fine powders used for inhaled pulmonary delivery, were a problem to test. We have implemented the improved method in different machines of different analytical laboratories, and everyone is now getting the same test data.”

“We saw the IP [intellectual property] potential of Hovione’s invention and went ahead with patent filing and prosecution. Even though our application went through vigorous scrutiny and an objection from a third party, it has now proceeded to grant in all jurisdictions where it was filed,” said Peter Villax, CEO of Hovione Technology, in the press release. “These patents are now being offered for licensing to several manufacturers of laser diffraction particle sizing machines and they could have an impact on this market.”

Scientists at the company learned that deagglomeration techniques lose efficacy through equipment wear over time and developed a tactic that makes up for the wear and prepares an ideal sample for each particle size test. 

Hovione Technology Granted Patent for Deagglomeration Method

GlaxoSmithKline (GSK) announced on Feb. 3, 2021 that it is entering into a EUR150 million (US$180 million) collaboration with CureVac to develop next-generation messenger RNA (mRNA) vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. Additionally, GSK will manufacture up to 100 million doses of CureVac’s current COVID-19 vaccine, CVnCoV, in 2021.

Under the terms of the agreement, GSK will provide an upfront payment of EUR 75 million (US$90 million) and an additional payment of EUR 75 million (US$90 million) if certain milestones are met, GSK said in a company press release. GSK will hold marketing authorization for the vaccine and will have rights to develop, manufacture, and commercialize the vaccine in all countries except for Germany, Austria, and Switzerland.

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches, according to the press release. The program will start immediately with the goal of producing a vaccine by 2022.

“We believe that next generation vaccines will be crucial in the continued fight against COVID-19,” said Emma Walmsley, CEO, GSK, in the press release. “This new collaboration builds on our existing relationship with CureVac and means that together, we will combine our scientific expertise in mRNA and vaccine development to advance and accelerate the development of new COVID-19 vaccine candidates. At the same time, we will also support the production of CureVac’s first generation vaccines with the manufacture of 100 million doses in 2021.”

“We are very pleased to build on our existing relationship with GSK with a new agreement to jointly develop next-generation mRNA-based vaccines, in addition to our current candidate CVnCoV,” added Franz-Werner Haas, CEO of CureVac, in the press release. “With the help of GSK’s proven vaccine expertise, we are equipping ourselves to tackle future health challenges with novel vaccines.”

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches. 

GSK and CureVac to Collaborate on Next-Generation COVID-19 Vaccines

Pfizer and Imcyse, a Belgium-based clinical-stage biopharmaceutical company, announced on Feb. 3, 2021 that they have entered into a research collaboration and license agreement for the potential treatment of rheumatoid arthritis (RA) via Imcyse’s RA program based on its Imotope technology.

Under the terms of the agreement, Imcyse will receive an undisclosed upfront payment and will receive up to $180 million in milestone payments, Imcyse said in a company press release. Pfizer will be responsible for the clinical development and commercialization activities for the program.

“This license agreement constitutes a great endorsement and a sign of confidence in our Imotope technology platform from one of the leading pharmaceutical companies in the world. We are excited to expand our successful collaboration to develop Imotopes for RA, a prevalent autoimmune disorder,” said Denis Bedoret, Imcyse CEO, in the press release. “It is our ultimate goal to develop curative treatments for autoimmune disorders for the benefit of patients worldwide. For diseases such as RA, this can be best accomplished with the help of partners such as Pfizer.”

“Pfizer is committed to addressing the needs of patients in [r]heumatology, and the Imcyse technology platform offers a unique scientific approach that we look forward to exploring further,” added Mike Vincent, chief scientific officer, Pfizer Inflammation and Immunology, in the press release.

The companies have entered into a research collaboration and license agreement for the potential treatment of rheumatoid arthritis via Imcyse’s RA program based on its Imotope technology.