Pharmaceutical Technology Editors

JSR Life Sciences announced on March 23, 2021 that it has launched its “JSR Life Sciences Corporate Venture Fund” to identify and accelerate novel therapies and technologies by investing in several deals within the next few years.

According to a company press release, the fund, which will be facilitated by Jason Yuanxin Zhang, PhD, will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

“JSR Life Sciences has extensive global knowledge and experience with early stage research, discovery, and technology that improves clinical outcomes. We are uniquely positioned to understand what works and what the market needs,” said Jean-Pierre Wery, PhD, chief technology officer for JSR Life Sciences, in the press release. “Initiating this fund and offering the ability to invest in the life sciences sector is a natural extension of our core expertise. [Zhang’s] ability to connect with contacts in many different facets of our industry, along with his experience in forging relationships and identifying promising assets, make him optimally qualified to identify opportunities for long-term value in our industry.”

“I look forward to working with JSR Life Sciences as the Company enters a major inflection point with its new corporate venture fund,” added Zhang in the press release. “I value JSR’s dedication to discovering new therapies and technologies and look forward to bringing my experience in leadership, growth, and business development to support their work.”

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The fund will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

JSR Life Sciences to Establish Corporate Venture Fund for the Acceleration of Novel Therapies and Technologies 

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Vaccines Europe have stressed the need for the European Council to avoid any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

European Union (EU) leaders are meeting via video conference on March 25–26, 2021 to discuss the COVID-19 epidemiological situation, among other items. EFPIA and Vaccines Europe have emphasized that any potential proposals to restrict exports by the commission at the meeting could lead to retaliations from other regions.

Owing to the nature of biological product manufacture, including vaccines, a global supply and effort is needed to source all the required component parts and materials. If export restrictions are put in place by the EU, it could lead to essential materials being prevented from importation into the region and, hence, placing EU citizens at risk due to a lack of available vaccines.

“Just one year on from the [World Health Organization] declaring COVID-19 a global pandemic, four vaccines have been approved for use by the [European Medicines Agency], 69.5 million doses distributed to EU/EAA countries and over 55 million doses administered to citizens across Europe. This is an incredible collaborative, scientific, manufacturing, and logistical achievement involving the EU institutions, governments, health-systems, regulators, and the research-based pharmaceutical industry. To take any measure that could be perceived as ‘vaccine nationalism’ at this critical moment would put this remarkable progress in severe jeopardy,” it was reported in a March 23, 2021 press release from EFPIA.

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

EFPIA, Vaccines Europe Emphasize Need to Avoid Reactionary Measures to Vaccine Exports

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine, AZD1222, in a March 25, 2021 press release. The analysis confirms vaccine efficacy is consistent with the interim analysis announced earlier in the week on March 22, 2021.

The results of the primary analysis have been presented to the independent Data Safety Monitoring Board (DSMB) and will form the basis for a regulatory submission for emergency use authorization to FDA. An accrued total of 190 symptomatic cases of COVID-19 from the 32,449 participants were included in the primary efficacy analysis, which is an additional 49 cases compared with the interim analysis.

Based on the data, vaccine efficacy for the prevention of symptomatic COVID-19 was found to be 76% when two doses were administered four weeks apart. The results of the primary analysis were comparable across all age groups, with increased efficacy of 85% in those aged 65 years and older. Additionally, the vaccine was found to be 100% effective for a secondary endpoint—the prevention of severe or critical disease and hospitalization. No safety concerns were identified in relation to the vaccine, which was well-tolerated by the participants.

“The primary analysis is consistent with our previously released interim analysis, and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, in the press release. “We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.”

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

AstraZeneca Confirms Vaccine Efficacy with Phase III Primary Analysis

Stelis Biopharma has closed its Series B and Series C fundraise for US $195 million, which will be used to progress the company’s growth initiatives and help scale its business. The fundraise was announced in a March 23, 2021 press release.

The Series B funding round was led by family office of promoters and was completed with money from existing investors. TPG Growth led the Series C funding round, with additional funds raised by other long-term investors, and through a primary infusion of money in the company and a secondary placement for existing shareholder, GMS Holdings. The business’ post money valuation is pegged at US $350 million.

“We are delighted with the current round of capital raise at Stelis led by TPG Growth along with Route One, Think Investments and the Mankekar family. I am extremely thankful to Matt Hobart and Ankur Thadani from TPG Growth, Bill Duhamel and Justin Maletsky from Route One, Shashin Shah from Think Investments, Shivanand and Kedar from the Mankekar family for their trust in our leadership,” said Arun Kumar, founder of Strides Group—a principal shareholder of Stelis—in the press release. “We are pleased that GMS will continue to be our shareholder post the secondary placement. Stelis is now getting into its growth phase and is witnessing strong customer traction for its CDMO [contract development and manufacturing organization] offerings including vaccines. We are confident to build a sustainable business and deliver significant value for our shareholders.”

Stelis Biopharma has closed its Series B and Series C fundraise for US $195 million, which will be used to progress the company’s growth initiatives and help scale its business. 

Stelis Concludes Fundraise Worth $195 Million

In a March 23, 2021 press release, the Association of the British Pharmaceutical Industry (ABPI) has responded to the publication of the UK government’s plans for the future of clinical research.

“We’ve seen the power of clinical research in bringing us the vaccines that are now edging us closer to the end of this pandemic,” said Richard Torbett, CEO of ABPI. “[The government’s] vision reflects the shared priorities we have for the future of clinical research. This welcome framework sets out how we can work together to get clinical research up and running again and build an even stronger research environment in the UK.”

The government’s vision, which was developed in collaboration with the UK’s devolved administrations, lays out plans on the how the country will be able to deliver faster, more efficient, and more innovative research. Built around five key themes, the vision aims to embed clinical research in the national health service, make access and participation in research as easy as possible for patients, put the UK at the forefront of innovation in the field, ensure the most advanced and data-enabled tools are available for use, and create a sustainable and supported research workforce.

ABPI has responded to the publication of the UK government’s plans for the future of clinical research.

Industry Responds to UK Government’s Vision for the Future of Clinical Research

Global healthcare private equity investor, Nordic Capital, has invested in medical dermatology company, Leo Pharma, becoming an active minority owner and partner to the Leo Foundation.

According to a March 23, 2021 press release, Nordic Capital’s investment will be used to support Leo Pharma in strengthening its position in medical dermatology and help speed up innovation and growth. The €450 million (US $532 million) investment from Nordic Capital in partnership with the Leo Foundation, which remains the company’s majority shareholder, will back Leo Pharma’s 2030 strategy to become a global leader in medical dermatology.

“The partnership with Nordic Capital is a strong confirmation that Leo Pharma is an exceptional company with a valuable heritage in topical dermatology that has clear potential to grow into a leader in innovative therapies,” said Jesper Mailind, CEO of the Leo Foundation, in the press release. “I am very enthusiastic about the opportunity to welcome Nordic Capital onboard. With Nordic Capital we have secured a supportive and seasoned partner going forward with deep medical expertise and a strong track record supporting value creation in innovative healthcare businesses globally.”

“We could not be more pleased that Nordic Capital is partnering with the Leo Foundation and Leo Pharma,” added Jonas Agnblad, partner, co-head of Healthcare, Nordic Capital Advisors, in the press release. “Dermatology is one of the fastest growing therapeutic areas within pharmaceuticals. We see scientific advances addressing significant unmet needs in the coming years, resulting in tremendous value for patients and healthcare systems.”

“I am delighted to welcome Nordic Capital as our new co-owner and partner in our ambitious endeavors to make Leo Pharma a global leader in medical dermatology,” commented Catherine Mazzacco, CEO of Leo Pharma, in the press release. “I am confident that we, with our new ownership model, have paved the way for further acceleration of our strong growth ambitions, and that this will enable us to further strengthen our dedication to dermatology, with a sustained focus on building a strong pipeline and innovating across science and technology to the benefit of patients.”

Nordic Capital has invested in medical dermatology company, Leo Pharma, becoming an active minority owner and partner to the Leo Foundation.