No single manufacturer can meet coronavirus vaccine global demand, says Moderna CEO

Cnbc | May 13, 2020

  • Moderna CEO Stephane Bancel said Tuesday that he hopes many coronavirus vaccines from multiple manufacturers will be approved to enter the market, because no single manufacturer can meet global demand.

  • Regeneron CEO Leonard Schleifer, whose company is developing an antibody drug against Covid-19, told CNBC that the problem isn’t with the physical distribution of a potential coronavirus drug but rather with the ability to meet demand.

  • Experimental vaccines will need to be mass produced and administered to more than 7.6 billion people around the world.


Moderna CEO Stephane Bancel said he hopes U.S. and international regulators approve several coronavirus vaccines from multiple companies, because no single manufacturer will be able to meet global demand.


“The odds that every program works are really low, obviously, but I really hope we have three, four, five vaccines, because no manufacturer can make enough doses for the planet,” Bancel said during CNBC’s Healthy Returns Virtual Summit.


Moderna has developed one of the leading coronavirus vaccine candidates in the world. The company is currently wrapping up phase one human trials on it in Seattle and is about to start phase 2 two trials, it announced last week. If it’s effective and safe to use, it could be ready for market in early 2021, the company said.


Bancel said Moderna is working closely with Dr. Anthony Fauci’s team at the National Institute of Allergy and Infectious Diseases as well as the Centers for Disease Control and Prevention to determine the best plan to distribute the vaccine, which could be ready in 12 to 18 months within the U.S.


On Tuesday, the U.S. Food and Drug Administration granted “fast track” designation to Moderna’s coronavirus vaccine, a move that speeds up the regulatory review process. Other companies racing to develop a vaccine include Pfizer and Inovio, which have already started clinical trials.


On Thursday, Moderna said it will soon begin phase two trials with 600 participants and is finalizing plans for a phase three trial as early as this summer.


Read More: U.S. STATES BUILD STOCKPILES OF MALARIA DRUG TOUTED BY TRUMP
 

Even as the company ramps up its manufacturing capacity so it can rapidly distribute doses if the vaccine proves effective against the virus and safe for humans, it won’t immediately have enough for everyone, Bancel told CNBC on Friday.


Regeneron CEO Leonard Schleifer, whose company is developing an antibody drug against Covid-19 with plans to enter human trials in June, told CNBC that the problem isn’t with the physical distribution of a potential coronavirus drug, which could be made available by major retail chains, but rather with the ability to meet demand. There are more than 7.6 billion people in the world, and it could take years to vaccinate enough people to achieve so-called herd immunity.


“The physical distribution aspect I think is more than adequate. I do think there will be a capacity issue,” Schleifer said.


Schleifer said multiple companies will need to succeed in the development of their coronavirus therapeutics because “the demand will far exceed the capacity.”


We simply cannot do this on an auction basis, whatever state and local area or company wants to pay the highest amount to get access, we can’t do it that way, it’s the role of federal, state and other global governments to ensure the drugs are distributed equitably.

-Regeneron CEO Leonard Schleifer


He said the company is trying to get its drug into patients within five months, which would be the fastest it’s ever done so. It took the company nine months to develop an antibody drug for Ebola, he said.


During a congressional hearing Tuesday, Fauci told lawmakers, “There’s no guarantee that the vaccine is actually going to be effective.” There are currently no proven treatments or vaccines against Covid-19.


“One of the big unknowns is, will it be effective? Given the way the body responds to viruses of this type, I’m cautiously optimistic that we will with one of the candidates get an efficacy signal,” Fauci said.


Read More: COVID-19 ANTI-VIRAL DRUG REMDESIVIR EFFECTIVE ON MONKEYS AND PEOPLE

Spotlight

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

Spotlight

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

Related News

PHARMA TECH

Ginkgo Bioworks and Centrient Pharmaceutical Announce Expansion of Partnership Following Success of initial Project to Bring Innovation to Generic API

PR Newswire | May 26, 2023

Centrient Pharmaceuticals ("Centrient"), the global business-to-business leader in sustainable antibiotics, next-generation statins and anti-fungals, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced they are expanding their existing partnership aimed at broadening Centrient's portfolio of environmentally friendly active pharmaceutical ingredients (APIs), following the success of previous work together. Ginkgo's ongoing partnership with Centrient focuses on improving the sustainability of fermentation and enzymatic syntheses of beta-lactam antibiotic APIs. In the first phase of this project, Ginkgo delivered an enzyme with significantly improved efficiency, reducing the environmental footprint of enzymatic production of amoxicillin and cephalexin APIs. These semi-synthetic beta-lactam antibiotics are widely prescribed to both children and adults and are on the World Health Organization's List of Essential Medicines. Centrient aims to build on these improvements through ongoing strain projects on Ginkgo's platform which focus on reducing carbon emissions and waste production compared to traditional chemical routes. "Our partnership with Ginkgo is fully aligned with our main purpose: to improve lives through innovative and sustainable manufacturing of medicines," said Jorge Gil-Martinez, Chief Scientific Officer at Centrient. "The initial success of this collaboration has led us to expand our joint efforts to design new ways of producing essential medicines, minimizing the environmental impact of antibiotic manufacturing. Moreover, as we design and execute our Open Innovation business model, this strategic collaboration creates synergies to accelerate the diversification of our portfolio, a strategic pillar for the future of our company. Access to external disruptive technologies, focusing on enzymes and fermentation, contributes to our vision to be a diversified and integrated partner of choice for generic medicines." "Our partnership with Centrient, which began in 2021, underscores Ginkgo's commitment to supporting biopharma companies in bringing much-needed innovation to the field," said Kevin Madden, SVP of Platform Commercialization at Ginkgo Bioworks. "We are inspired by the early success we've already seen in our partnership and look forward to expanding our joint efforts to ultimately support better patient outcomes." About Centrient Pharmaceuticals Centrient Pharmaceuticals is the global business-to-business leader in sustainable, enzymatic antibiotics, next-generation statins, and anti-fungals. We are a pharmaceutical company with a clear Purpose: to improve lives through innovative and sustainable manufacturing of medicines - saving the lives of millions of people around the world annually. Regarding our portfolio, we produce and sell intermediates and active pharmaceutical ingredients (APIs), as well as finished dosage forms (FDFs). Our world-leading proprietary enzymatic technology PureActives® ensures an unmatched eco-friendly production process for our high-quality products. Driven by our Purpose and Sustainability through our ESG vision, we aim to create value for Centrient and our stakeholders. Centrient is a Board Member of the AMR Industry Alliance and a long-time advocate for industry responsibility in manufacturing. Founded 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', our company was known as Gist Brocades and more recently DSM Sinochem Pharmaceuticals. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States and Mexico. Centrient Pharmaceuticals is owned by Bain Capital Private Equity, a leading global private investment firm. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.

Read More

PHARMACY MARKET

Asieris Deepens Strategic Partnership with UroViu to Further Develop Integrated Diagnosis and Treatment Platform for Bladder Cancer

PRNewswire | May 19, 2023

Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging. Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope. Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau. "There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients." "We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu. About Asieris Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

Read More

VIEWS AND ANALYSIS, PHARMACY MARKET

Telix to Supply Bayer with Illuccix® for Global Phase III Prostate Cancer Study

prnewswire | May 08, 2023

Telix Pharmaceuticals Limited announces that it has entered into an agreement with Bayer AG to supply Illuccix® kit for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer's androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline. The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans. Telix Chief Medical Officer, Dr Colin Hayward stated, "We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix's unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool." 022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.

Read More