Coronavirus tracker: Gilead's remdesivir; White House's vaccine project; Pfizer, BioNTech's vaccine progress; AstraZeneca's pipeline

Fiercepharma | April 29, 2020

As headlines multiplied and analysts began sussing out Gilead Sciences' first controlled trial readout on remdesivir, NIAID director Anthony Fauci hailed the drug as real progress against the virus. Meanwhile, word emerged that the Trump administration is working up a Manhattan Project style vaccine initiative, bringing biotech, pharma and federal agencies together to speed up the work—and let the U.S. government take on the financial risks. Plus, Pfizer and BioNTech said they've dosed the first cohort in their COVID-19 vaccine trial, setting the shot well on its way to conducting full human trials in the coming months. And AstraZeneca is pooh-poohing the novel coronavirus' effect on clinical trials, saying its late-stage pipeline can weather any pandemic effects.  As of Wednesday, the number of global confirmed cases had passed 3.17 million, according to the Johns Hopkins University tracker, and more than 224,000 people had died.

Spotlight

The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution. The importance of successfully executing a digital health strategy, as well as creating new financial models and partnerships, cannot be understated. Nevertheless, this revolution is not often witnessed in current practice. While incorporation of digital practices has been slow, the future will move quickly. However, instead of fearing the future, the digital health transformation should have pharmaceutical leaders enthusiastic about the possibilities of the very near future. There are clear opportunities on the horizon, and those pharma organizations and leaders who are prepared for the potential, can soon capitalize on them.

Spotlight

The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution. The importance of successfully executing a digital health strategy, as well as creating new financial models and partnerships, cannot be understated. Nevertheless, this revolution is not often witnessed in current practice. While incorporation of digital practices has been slow, the future will move quickly. However, instead of fearing the future, the digital health transformation should have pharmaceutical leaders enthusiastic about the possibilities of the very near future. There are clear opportunities on the horizon, and those pharma organizations and leaders who are prepared for the potential, can soon capitalize on them.

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BUSINESS INSIGHTS

Astorg to Acquire Global Medical Communications and Market Access Platform OPEN Health From Amulet Capital Partners

Astorg and Amulet Capital Partners | June 01, 2022

Astorg and Amulet Capital Partners announce that they have signed a binding agreement whereby Astorg will acquire OPEN Health, a leading global provider of scientific communications and market access services to the pharmaceutical industry. Established in 2011 and headquartered in London, UK, OPEN Health is a key partner to its customers in helping them develop strategies for evidence generation and data communication by leveraging their extensive scientific knowledge and relentless focus on quality. Together, this approach consistently delivers best-in-class scientific communications, health economics and outcomes research (HEOR) and market access services to an ever-increasing audience. OPEN Health has more than 1,000 employees in 15 locations and six countries, across North America, Europe and Asia. OPEN Health serves over 170 life sciences customers, including 48 of the top 50 pharmaceutical companies. OPEN Health’s existing management team, led by CEO Rob Barker, will continue to lead the organization, building on a strong track-record of organic growth and strategic acquisitions. "We are excited to build on the momentum across our business and to continue executing with our new partners at Astorg on a shared long-term vision to bring deep scientific solutions that support our clients in driving positive health outcomes. We are grateful for the strong partnership of the Amulet team over the last three and a half years and for all that we have accomplished in expanding our industry-leading capabilities across disciplines. We continue to be very well positioned to drive innovation and growth, and we look forward to embarking on this next chapter for OPEN Health." Rob Barker, CEO, OPEN Health Building on OPEN Health’s leading service offerings, Astorg will invest in the development of the business across its main existing offerings, and beyond, to continue delivering best-in-class scientific content to OPEN Health’s customer base and help them harness the full value of their most important assets. "OPEN Health is a very impressive company. We have been following the development of the medical affairs space for a long time as the function evolved from a supportive to a central role and identified OPEN Health as a global leader in the making. We have been impressed with its outstanding reputation and the trust it benefits from its customer base,” said Judith Charpentier, Partner and Head of Healthcare, Astorg. “We look forward to supporting Rob and the OPEN Health management team in continuing to build a global leading scientific focused medical affairs platform, expanding the platform through both organic initiatives and additional strategic acquisitions,” said Olivier Lieven, Director, Astorg. Ramsey Frank, President and Managing Partner of Amulet, said, “OPEN Health was built around Amulet’s investment thesis in medical affairs: the current generation of drugs is fundamentally different from prior generations, and these therapies need to be brought to market with the support of high science communications and data analytics. We brought OPEN Health together very intentionally via three acquisitions to create a purpose-built suite of services to meet pharma’s evolving needs.” Amulet Partner Nick Amigone continued, “We could not be more grateful to Rob Barker and his team for the outstanding job they have done in building a true industry leader.” The terms of the transaction were not disclosed. The transaction is subject to customary regulatory approvals. Houlihan Lokey served as financial advisor to OPEN Health and Rothschild & Co advised Astorg on the transaction. About OPEN Health OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support our clients in improving health outcomes and patient wellbeing. We are united as one flexible organization, harnessing the power of the collective to solve complex challenges. About Astorg Astorg is a European private equity firm with over €17 billion of assets under management. Astorg works with entrepreneurs and management teams to acquire market leading global companies headquartered in Europe or the US, providing them with the strategic guidance, governance and capital they need to achieve their growth plans. Enjoying a distinct entrepreneurial culture, a long-term shareholder perspective and a lean decision-making body, Astorg has valuable industry expertise in healthcare, software, technology, business services and technology-based industrial companies. Astorg has offices in London, Paris, New York, Frankfurt, Milan and Luxembourg. About Amulet Capital Partners, LP Amulet Capital Partners, LP is a middle-market private equity investment firm based in Greenwich, CT, focused exclusively on the healthcare sector. Amulet seeks to achieve long-term capital appreciation through privately negotiated investments in companies. Amulet Capital Partners focuses on those segments it believes have the most attractive long-term fundamentals with a target investment size generally between $25 million to $150 million.

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PHARMA TECH

WuXi ATU Announces Licensing Agreement with Janssen for TESSA™ Technology

WuXi AppTec | August 12, 2022

WuXi Advanced Therapies a wholly owned subsidiary of WuXi AppTec, announced a licensing agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Under this agreement, WuXi ATU will license to Janssen its TESSA™ technology, a high-performance system that can produce 10 times more adeno-associated viral vectors than traditional AAV manufacturing systems. Janssen will also have access to work on WuXi ATU's proprietary clonal suspension HEK293 cell line. This agreement was facilitated by Johnson & Johnson Innovation. AAV vectors are commonly used for the delivery of gene therapies to patients due to their ability to transduce numerous cell and tissue types. WuXi ATU's TESSA™ technology responds to industry demand for large scale AAV manufacturing by producing higher quality AAV particles more efficiently. WuXi ATU has also successfully scaled up the TESSA™ technology to 200L; this achieved a 10-fold higher yield and a significantly higher percentage of full AAV capsids, greatly reducing overall AAV production costs compared to traditional plasmid-based AAV production systems. "We are honored that Janssen selected WuXi ATU's TESSA™ technology. We remain committed to improving the TESSA™ platform to produce faster and more cost-effective AAV products for patients." Dr. David Chang, Chief Executive Officer of WuXi Advanced Therapies As a Contract Testing, Development and Manufacturing Organization with global operations, WuXi ATU will continue to enhance its capability and capacity to help customers develop and deliver life-changing cell and gene therapies faster for patients in need. About WuXi Advanced Therapies (WuXi ATU) As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,850 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."

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BUSINESS INSIGHTS

Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine,

Novavax, Inc. | August 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 and older. "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations. Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants." Stanley C. Erck, President and Chief Executive Officer, Novavax Authorized Use The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. About Matrix-M™ Adjuvant Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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