Rajeev Venkayya, President of Global Vaccines Business, discusses the latest on the coronavirus and Takeda including recently announced plan to develop a new plasma-derived-therapy to help treat high-risk individuals with COVID-19. Takeda Pharmaceutical Co is developing an experimental therapy for the novel coronavirus or Covid-19 with the goal of making it available in 9 to 18 months, Japan’s largest drugmaker said.
"We will do all that we can to address the novel coronavirus threat, ” Dr Rajeev Venkayya, president of Takeda’s vaccine business unit and head of the response team, said in a statement.
Oboljelima od koronavirusa na raspolaganju je tek ograničena terapija, jer pravog lijeka zasad nema pa se liječe simptomi. No, znanstvenici diljem svijeta pokušavaju u što kraćem roku doći i do lijeka i do cjepiva pa su informacije o tome sve češće. Najnovija govori da je japanska farmaceutska tvrtka Takeda na putu da krene u masovnu proizvodnju lijeka čiji bi temelj bila plazma oporavljenih pacijenata.
Naime, Japanci su razvili lijek koristeći plazmu, odnosno dijelove imunosnog sustava ljudi koji su oboljeli od koronavirusa i uspješno se oporavili. Terapija djeluje tako da antitijela oporavljenih pacijenata smanjuju utjecaj virusa i potiču brži oporavak.
U plazmi oporavljenih pacijenta nalaze se antitijela koja onda uništavaju virus ako organizam dođe s njim u doticaj. No, onaj tko nikad nije bio izložen nekom virusu ili bakterijama, kao što je to slučaj s koronavirusom, nema antitijela i velika je vjerojatnost da će se razboljeti. Kad se oboljelom unese plazma s antitijelima nekoga tko je prebolio koronavirus, ona će pomoći da se organizam lakše i brže oporavi. Stručnjaci se slažu da vrijedi pokušati s plazmom, ali to neće biti terapija za sve, već samo za one najteže pacijente, kažu u Takedi.
Takeda is closely monitoring the novel coronavirus (COVID-19) outbreak and the global response. As a company dedicated to the health and well-being of people around the globe, we are committed to taking steps to help those impacted by the coronavirus and try to lower the risk of transmission.
To this end, we announced today that we are initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19, which we’re calling TAK-888. SARS-CoV-2 is the virus that causes COVID-19. Hyperimmune globulin is a plasma derived-therapy that has previously been shown to be effective in the treatment of severe acute viral respiratory infections and could be a treatment option for patients with COVID-19. We’re collaborating with several health and regulatory agencies and health care partners across the globe to move the research forward. To develop TAK-888, scientists need to have access to source plasma from people who have successfully recovered from COVID-19.
In parallel, we are also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients. This will take time, but we are moving as quickly as possible. In addition, Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative in Europe to leverage our collective expertise with the hope of developing diagnostics for COVID-19as well as inhibitors to help prevent future outbreaks, and consider whether the currently approved medicines might be repurposed. We are excited about the potential to address this public health crisis in both the short and long-term, but we knew from the beginning that we needed to act immediately. This is why we are doing what we can to support healthcare workers in China by sending medical protective clothing, including masks and protective jumpsuits to impacted regions. Our first donation arrived in Wuhan, China and was delivered to local hospitals in early February. The second donation consisting of 5000 jumpsuits arrived shortly afterwards, and our third donation, which included critical medicines, is being delivered now. In addition, Takeda has donated JPY 31 million to the Red Cross and various hospitals in China.
While we continue to monitor the worldwide impact very closely and ensure we have the appropriate contingency plans in place, we are confident that patients will continue to receive Takeda medicines, and that our supply chain has not been negatively impacted by the spread of COVID-19.
We are actively taking steps to help the broader patient and health care provider community, the health and safety of our employees is also a top priority. Where possible, we are strongly encouraging employees in impacted regions, including Japan, to split shifts, commute in off-peak hours, or work from home. We are also providing support for working parents who are home with children due to school closures. We are significantly limiting international travel and utilizing technology in place of face-to-face meetings, to continue to collaborate and minimize business disruption as much as possible. We are closely monitoring the outbreak and recommendations of public health authorities and will update this guidance on a regular basis.
- Anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) being developed to treat infected, high-risk individuals with COVID-19- Exploring the potential to repurpose marketed products and molecules to potentially treat COVID-19
Cambridge, Mass. and Osaka, Japan, March 4, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today will share with members of the United States Congress that it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with COVID-19, while also studying whether Takeda’s currently marketed and pipeline products may be effective treatments for infected patients. SARS-CoV-2 is the virus that causes COVID-19.
Hyperimmune globulins are plasma derived-therapies that have previously been shown to be effective in the treatment of severe acute viral respiratory infections and may be a treatment option for COVID-19. As a leader in plasma-derived therapies with more than 75 years of experience in the development of plasma-derived products, Takeda has the expertise to research, develop, and manufacture a potential anti-SARS-CoV-2 polyclonal H-IG, which Takeda is referring to as TAK-888.
“As a company dedicated to the health and well-being of people around the world, we will do all that we can to address the novel coronavirus threat,” said Dr. Rajeev Venkayya, President of Takeda’s Vaccine Business Unit and co-lead of the company’s COVID-19 response team. “We have identified relevant assets and capabilities across the company and are hopeful that we can expand the treatment options for patients with COVID-19 and the providers caring for them.”
Takeda is currently in discussions with multiple national health and regulatory agencies and health care partners in the US, Asia, and Europe to expeditiously move the research into TAK-888 forward. This requires access to source plasma from people who have successfully recovered from COVID-19 or who have been vaccinated, once a vaccine is developed. These convalescent donors have developed antibodies to the virus that could potentially mitigate severity of illness in COVID-19 patients and possibly prevent it.
H-IG works by concentrating the pathogen-specific antibodies from plasma collected from recovered patients or vaccinated donors in the future. By transferring the antibodies to a new patient, it may help that person’s immune system respond to the infection and increase their chance of recovery. Because the plasma needed for TAK-888 is unlikely to come from current plasma donors, Takeda will initially produce the therapy in a segregated area within its manufacturing facility in Georgia, and development and production of it should not negatively impact Takeda’s ability to produce its other plasma-derived therapies.
“Plasma-derived therapies are critical, life-saving medicines that thousands of people with rare and complex diseases rely on every day around the world,” said Dr. Chris Morabito, Takeda’s Head of Research and Development, Plasma-Derived Therapies Business Unit. “Our heritage, combined with our scale, expertise and capabilities, uniquely position Takeda to realize the potential of plasma-derived therapies, such as TAK-888.”
In addition, Takeda is exploring whether select marketed therapies and molecules in its drug library could be viable candidates for the effective treatment of COVID-19. These efforts are at an early stage but being given a high priority within the company.
An internal working group of in-house experts in public health, vaccines, plasma-derived therapies, and R&D will continue to seek opportunities to leverage our expertise and extensive network of global partners to address COVID-19. COVID-19 is the disease caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), which can cause pneumonia and has resulted in more than 3,000 deaths globally since its recent discovery. To date, there are no approved vaccines or therapies to prevent or treat COVID-19.
About Takeda Pharmaceutical Company LimitedTakeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
About Plasma-Derived TherapiesPlasma-derived therapies are essential for treating patients with a variety of rare, life-threatening, complex and genetic diseases for which there are few or no other treatment options. Plasma is the clear, straw-colored liquid portion of blood that remains after red blood cells, white blood cells, and platelets are removed. Plasma has multiple components with different clinical uses. Plasma products have existed for ~ 80 years, and industry-wide research is underway to assess the larger potential therapeutic value of plasma in new diseases.
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Meanwhile, the Shanghai government, China has announced its official recommendation that COVID-19 should be treated with high amounts of intravenous vitamin C.
ReplyDeleteDosage recommendations vary with severity of illness, from 50 to 200 milligrams per kilogram body weight per day to as much as 200 mg / kg / day.
These dosages are approximately 4,000 to 16,000 mg for an adult, administered by IV.
This specific method of administration is important, says intravenous therapy expert Atsuo Yanagisawa, MD, PhD, because vitamin C's effect is at least ten times more potent by IV than if taken orally.
Dr. Yanagisawa is the president of the Tokyo-based Japanese College of Intravenous Therapy. He says, "Intravenous vitamin C is a safe, effective, and broad-spectrum antiviral."
Richard Z. Cheng, MD, PhD, a Chinese-American specialist physician, has been working closely with medical and governmental authorities throughout China.