Pharmaceutical Technology Editors

The BioIndustry Association (BIA) and Clarivate have released new data that show there was a jump of 60% in investments into biotech and life sciences companies in the United Kingdom during 2021, with £4.5 billion ($6.02 billion) raised in public and private financings over the 12 months.

Key findings from the data include the fact that the total amount of venture capital financings increased by 81% from 2020; there was an increase in initial public offerings of 434% from year prior; and other public financings raised £684 million ($916 million) between Dec. 1, 2020 and Nov. 30, 2021. Additionally, given the number of companies from the UK being listed on trans-Atlantic markets, it is suggested that the sector ecosystem is reaching maturity, while the level of venture investments demonstrates a strong pipeline of upcoming companies.

“The UK is a global hub for life sciences, with a world leading academic base, global pharmaceutical players, an increasing manufacturing footprint, and a thriving pipeline of innovative SMEs and entrepreneurs,” said Steve Bates, OBE, chief executive of the BIA, in a Jan. 26, 2022 press release. “There is an obvious gap that we must plug in the UK’s financing environment. The large fundraises seen in 2021 are largely the result of welcome overseas investment, meaning that significant value creation will also be offshored. History has handed the UK two world-leading sectors: life sciences and finance. A symbiosis should exist between these two, but it doesn’t, yet. There is great opportunity to turbo-charge the UK’s biotech and life sciences sector and capture more of its economic value for the UK by building better connections between the UK’s financial institutions and our innovative scaling businesses.”

“In 2021, the global biotech industry was able to attract the kind of funding and support needed to maintain sustainable progress. With continuing focus on the global COVID-19 pandemic, the global biopharma industry not only gained in public prominence but had one of its strongest years ever,” added Mike Ward, global head of Thought Leadership, Life Sciences & Healthcare, Clarivate, in the press release. “The UK life sciences and biotech sectors in particular reached new heights, with a strong academic tradition and deep industrial expertise as well as government and business support encouraging increased financing by venture and private investors in the biopharma industry.”

Articles

BIA and Clarivate have released new data that show there was a jump of 60% in investments into biotech and life sciences companies in the UK during 2021.

Investments in UK Biotech at An All Time High, According to New Data

Global provider of drug containment, drug delivery, and diagnostic solutions for pharma, biotech, and life sciences industries, Stevanato Group, has extended its licensing agreement with Haselmeier for its Axis-D pen injector technology, it was announced in a Jan. 26, 2022 press release.

Under the terms of the extended licensing agreement, Stevanato Group will be given exclusivity to offer the technology to support a broader range of drugs beyond diabetes. Using the Axis-D technology, Stevanato Group has developed a variable-dose and fixed-dose pen injector platform, Alina, which is compatible with established and innovative drug therapies aimed at diabetes care.

“The expansion of this agreement is an important step in enhancing and growing the opportunities in our drug delivery systems portfolio as we broaden our capabilities in this key market,” said Franco Moro, CEO, Stevanato Group, in the press release. “We are constantly working with our customers to satisfy their needs, as we continue to experience an increase in demand for our high-value solutions and a shift up of the product value chain.”

“The Alina pen injector platform combines ease of use for patients with faster time-to-market access for pharma organizations. Our patient-centric solutions aim to improve the lives of patients as they manage their complex health conditions,” added Adam Stops, head of Product Management for Drug Delivery Systems at Stevanato Group, in the press release. “The extension of our licensing agreement with Haselmeier enables us to offer this innovative technology for use in additional therapeutic areas—helping even more patients—as we continue the expansion of our integrated capabilities in the proprietary drug delivery space.”

Stevanato Group has extended its licensing agreement with Haselmeier for its Axis-D pen injector technology.

Stevanato Group, Haselmeier Extend Licensing Agreement for Pen Injector Technology

Dravet syndrome is a rare form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death as a result of epilepsy. According to a company press release, the condition appears in approximately 1 in 15,700 live births in the United States and 1 in 20,000 to 40,000 live births in Europe.

"The proposed acquisition of Zogenix reinforces UCB's sustainable patient value strategy and continued commitment to addressing unmet needs of people living with epilepsy with an increasing focus on those living with specific or rare forms of epilepsy, where few options exist,” said Charl van Zyl, executive vice-president, Neurology, and head of Europe/International Markets, UCB, in the press release. “Complementing UCB's existing therapeutic offerings, the Zogenix acquisition provides UCB with an approved medicine for a life-threatening, rare infant- and childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, that are particularly challenging to treat.”

In addition to its current approvals, fenfluramine is currently under regulatory review in Japan for treatment of seizures associated with Dravet Syndrome. Zogenix is currently pursuing indications for the use of fenfluramine in additional rare types of epilepsy, including Lennox-Gastaut syndrome and CDKL5 Deficiency Disorder.

UCB and Zogenix have agreed to an acquisition deal totaling nearly $2 billion.

UCB Acquires Zogenix for $1.9 Billion

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced the signing of a long-term supply agreement with the United Nations Children’s Fund (UNICEF) on Jan. 18, 2022. The agreement will see Merck allocate up to 3 million capsules of its COVID-10 medicine, molnupiravir, to UNICEF throughout the first half of 2022. UNICEF intends to distribute these in more than 100 low- and middle-income countries.

Developed in conjunction with Ridgeback Biotherapeutics, molnupiravir is an investigational oral antiviral medicine designed to treat symptoms of COVID-19. It is a nucleoside analog that is designed to inhibit the replication of SARS-CoV-2, the causative agent of COVID-19. Currently, it is authorized for use in over 10 countries, including the United States, the United Kingdom, and Japan.

“Merck is delivering on our commitment to make molnupiravir available — widely, quickly and equitably. Through this groundbreaking agreement with UNICEF, millions of patients in more than 100 low- and middle-income countries will gain access to molnupiravir through UNICEF and the ACT Accelerator Therapeutics Partnership in the first half of 2022,” said Robert M. Davis, CEO and president, Merck, in the press release. “I am proud of the fact that patients in these low- and middle-income countries will gain access at the same time as patients in countries with higher incomes.”

“As part of our commitment to ensuring access to critical medicines, we picked Merck as our partner for molnupiravir because of our shared commitment to ensuring global, affordable availability. Molnupiravir, which can be efficiently delivered to low- and middle-income countries, can play a significant role in global efforts to address the pandemic,” said Wendy Holman, CEO, Ridgeback Biotherapeutics, in the press release. “We are proud of this agreement with UNICEF to help address global health challenges and inequities by making molnupiravir accessible to patients around the world.”

Merck and Ridgeback Therapeutics will supply UNICEF with up to three million capsules of molnupiravir through the first half of 2022.

Merck Enters into Molnupiravir Supply Agreement with UNICEF

A published report details discussions by international regulators on the effectiveness of the COVID-19 vaccines on the omicron variant, regulatory requirements for a variant vaccine, and clinical study design. The International Coalition of Medicines Regulatory Authorities (ICMRA) organized the Jan. 12, 2022 workshop on the global response to the COVID-19 omicron variant, which was co-chaired by the European Medicines Agency (EMA) and FDA.

Workshop participants reviewed data on the impact of the variant and concluded that while the current vaccines offer less protection against infection with the COVID-19 omicron variant and mild disease, they do offer protection against severe disease and hospitalization, especially with a booster dose.

“When looking at possible vaccination approaches against Omicron and other virus variants, the meeting participants agreed that the administration of multiple booster doses at short intervals is not a sustainable approach in the longer term. There is a need to develop a long-term strategy on the types of vaccines needed to manage COVID-19 in the future. This is an ongoing global discussion that sits at the crossroads of science, public policy, and public health and will require coordination among public health decision-makers at all levels,” EMA stated in a press release.

According to EMA, regulators are encouraging developers to look for alternative approaches to monovalent vaccines and explore the possibility of developing bivalent or multivalent variant vaccines. Workshop participants stressing that clinical studies should be performed to support the use of a new vaccine. “These studies should be designed to demonstrate that the immune response, measured as neutralizing antibodies, generated by the updated vaccine is superior to that achieved with current vaccines. The ability of the updated vaccines to cross-neutralize other variants of concern would be an additional feature with respect to the breadth of protection provided by the updated vaccine,” EMA stated in the release.

A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.

COVID-19 Vaccination Offers Protection from Hospitalization due to Omicron Variant, According to Report

Mylan Pharmaceuticals, a Viatris company, announced on Jan. 18, 2022, that it is voluntarily recalling one batch of non-interchangeable Semglee (insulin glargine injection), 100 units/mL (U-100), 3mL prefilled pens because of a possible missing label in the batch. The recalled batch was manufactured by Biocon Sdn Bhd and distributed by Mylan Specialty L.P. in the United States between May 11, 2021 and Nov. 11, 2021. The recall does not apply to interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

Non-interchangeable Semglee (insulin glargine injection) is a long-acting human insulin analog used to improve glycemic control in patients with type 1 and type 2 diabetes mellitus. According to the company, a missing label could cause a mix-up of products/strengths and lead to administration of the incorrect insulin.

There have been no reports of adverse events related to the recall as of the date of the recall notice. Adverse events may be reported to FDA via the agency’s MedWatch Adverse Event Reporting program.

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.