Novavax, Inc. | January 31, 2022
Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.
The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.
"We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic. I'd like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today's milestone of EUA request submission."
Stanley C. Erck, President and Chief Executive Officer, Novavax
Novavax conducted two pivotal Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico and published results in the New England Journal of Medicine (NEJM) and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed in authorized markets. As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12-17.
NVX-CoV2373 has been granted conditional authorization by multiple regulatory agencies worldwide, including the European Commission, and emergency use listing (EUL) from the World Health Organization (WHO), with additional filings currently under review.
NVX-CoV2373 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. NVX-CoV2373 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. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine 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.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).
A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.
PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.
About Matrix-M™ Adjuvant
Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and generally 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.
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. NVX-CoV2373, the company's COVID-19 vaccine, received Conditional Marketing Authorization from the European Commission, Emergency Use Listing from the World Health Organization, Emergency Use Authorization in Indonesia and the Philippines, and has been submitted for regulatory authorization in multiple markets globally.
CELL AND GENE THERAPY
PerkinElmer | September 18, 2021
PerkinElmer, Inc.a global leader committed to innovating for a healthier world, today announced it has completed its acquisition of BioLegend, a leading, worldwide provider of life science antibodies and reagents for a total consideration of approximately $5.25 billion.
The acquisition, the largest in PerkinElmer’s history, further expands the Company’s life science franchise into high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing.
BioLegend’s stellar leaders, teams and technologies will play a critical role in our combined companies’ ability to provide new, innovative solutions to scientists -- helping drive novel therapeutic discovery and development. We also look forward to BioLegend significantly enhancing our leading reagents portfolio as we partner together to innovate and advance science for our customers.
- Prahlad Singh, president and chief executive officer of PerkinElmer
We are very excited to roll up our sleeves and work together with our new PerkinElmer colleagues to mutually leverage our portfolios, people and shared passion for innovation and science to accelerate the discovery and development of novel therapeutics. PerkinElmer’s broad life science platform and strong global infrastructure will help BioLegend continue to extend our mission of enabling our customers to do legendary discovery.
- Gene Lay, founder, president and chief executive officer of BioLegend
As previously communicated, it is expected that BioLegend will contribute an incremental $380 million of revenue and $0.30 of adjusted earnings per share accretion to PerkinElmer in fiscal year 2022. Additional commentary regarding its expected financial contribution to the remainder of the current fiscal year will be provided on the Company’s upcoming third quarter 2021 earnings call. PerkinElmer’s expectations for incremental adjusted earnings per share accretion for fiscal year 2022 attributable to BioLegend is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measure without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items PerkinElmer excludes from this non-GAAP measure. The timing and amounts of such events and items could be material to PerkinElmer’s results prepared in accordance with GAAP.
PerkinElmer enables scientists, researchers, and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life science, food, and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 15,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index.
Amyris, Inc. | January 25, 2022
Amyris, Inc. a leading synthetic biotechnology company accelerating the world's transition to sustainable consumption through its Lab-to-Market™ operating platform announces that it has agreed to exclusive terms to acquire the assets of MenoLabs, LLC, a women-founded company to treat menopause symptoms, drive research for women's health and improve society's understanding of menopause.
Amyris previously communicated its intention of launching a new consumer brand to provide science-backed, wellness and personal care products for the high growth menopause market in 2022. The acquisition of MenoLabs will serve as a catalyst to accelerate growth and establish a leadership position in the fast-growing menopause market.
MenoLabs, a growing women's wellness brand is focused on addressing perimenopause and menopause symptoms. MenoLabs is one of few companies offering research-backed all-natural treatments of menopause symptoms. Over the past two years, MenoLabs has developed and launched eight products, including its lead product, MenoFit, an all-natural menopause relief supplement. MenoLabs generates a subscription-based, recurring revenue stream via its website, in addition to the Subscribe & Save option offered via the Amazon channel. The company is further expanding its omnichannel by penetrating retail channels in 2022. Additionally, MenoLabs launched MenoLife, a highly rated perimenopause and menopause health tracker app which helps users track and analyze more than 40 menopause-related symptoms. MenoLife also has created an online forum where users can comment and react to posts.
Menopause symptoms impact the lives of approximately 25 million women per year and 6,000 women in the U.S. enter perimenopause every day (2.2 million each year). By 2025, there will be over one billion people experiencing menopause in the world or around 12% of the entire world population. Stigma, lack of open discussion, and a small product offering at an affordable price are barriers to care for women. The menopause market was valued at around $15 billion in 2020 and is expected to reach approximately $23 billion by 2028.
"We are very impressed with the MenoLabs offering which is synergistic with our science-based approach to real-world health and wellness issues. We are committed to empowering women and creating a platform to support them with our leading science and wellness technology platform. Women deserve products and solutions that work during this period in their lives. Our acquisition of the products and app that the MenoLabs team has built accelerates Amyris' entry into the menopause market. We expect the combination of MenoLabs and the previously announced menopause brand with Naomi Watts to have the potential to deliver an estimated $30 million in revenue in their first year and expect significant growth potential in the years ahead. We continue to execute on our growth strategy diversifying our consumer offering in Clean Beauty, Health and Wellness end-markets, continuing the strong growth momentum from 2021 into the current quarter."
John Melo, President and Chief Executive Officer of Amyris
Amyris is a leading synthetic biotechnology company, transitioning the Clean Health & Beauty and Flavors & Fragrances markets to sustainable ingredients through fermentation and the company's proprietary Lab-to-Market™ operating platform. This Amyris platform leverages state-of-the-art machine learning, robotics and artificial intelligence, enabling the company to rapidly bring new innovation to market at commercial scale. Amyris ingredients are included in over 20,000 products from the world's top brands, reaching more than 300 million consumers. Amyris also owns and operates a family of consumer brands that is constantly evolving to meet the growing demand for sustainable, effective and accessible products.
MenoLabs was founded to fundamentally change how menopause is addressed. The brand's mission is to provide options to treat menopause symptoms, drive research for women's health and change how society approaches, views and educates around the topic of menopause. MenoLabs has developed a line of all natural, proprietary supplements focused on treating perimenopause and menopause symptoms, in addition to MenoLife, a leading menopause health tracker app that provides women a voice and community. MenoLife also provides symptom tracking to further fuel research and advancements in women's health.