InDex Pharmaceuticals | August 23, 2021
InDex Pharmaceuticals Holding AB today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod.
Anders Bröijersén is joining InDex as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations.
Anders Bröijersén is a medical doctor and PhD with 15 years of experience in Clinical Development, Medical Affairs and Drug Safety at leading pharmaceutical companies such as Boehringer Ingelheim and MSD. Anders joins InDex from Sobi where he currently serves as Medical Director, Global Pharmacovigilance & Patient Safety.
Johan Levin is a trained nurse and has more than 20 years of experience in Clinical Development at leading pharmaceutical companies and clinical research organizations (CROs) such as MSD and Covance. He currently works as senior Clinical Research Associate (CRA) at PRA Health Sciences.
"I am pleased that InDex has been able to attract two highly qualified new employees and welcome Anders and Johan to the team," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "We are expanding the organisation in preparation of the start of our global phase III study CONCLUDE with cobitolimod to be able to be active towards the study sites in collaboration with our CRO. This was a successful model for patient recruitment in our previous study CONDUCT."
The phase III study CONCLUDE with cobitolimod will include 440 patients and be conducted at several hundred clinics in over 30 countries. It is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company's lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.
Vivera Pharmaceuticals, Inc. | May 26, 2022
Vivera is pleased to announce the allowance of its third U.S. patent for ZICOH™, the Company's high-tech, electronic dose-controlled portfolio of drug delivery devices. The patent allowance from the U.S. Patent and Trademark Office secures ZICOH's rights as a smart dosing system with automated delivery, measurement, and management for oral format medications, including pills, capsules, and tablets.
ZICOH is an electronic dose-controlled delivery device and technology designed to enable real-time communication through the drug supply chain, from drug manufacturers, distributors, and wholesalers to pharmacists, providers, physicians, caregivers, and patients. The device can be programmed to dispense the medication dosage type, amount, and frequency according to the health care provider's orders to ensure compliance with dispensed prescriptions while also implementing controls to help prevent medication misuse and abuse. Later versions of the device will also implement user authentication features, such as fingerprint authorization and facial recognition, to help prevent prescription drugs from being diverted.
Medication reminders are another core feature of ZICOH. These reminders can be programmed into the device by the pharmacist per the physician's orders to alert the patient when it's time to take their medication. This feature can be particularly beneficial for patients who forget to take medications on time or for patients and caregivers who manage multiple medications.
"ZICOH is a major innovation in the medical device and technology sectors. This device is going to make it easier than ever for patients to comply with their medication regimens, regardless of how complex they are."
Mehdi Hatamian, Ph.D., Chief Scientific Advisor for Vivera
This third patent differs from the device's two previously issued patents in that it specifically pertains to the dispensing of tablets, capsules, and pills. The device has already secured its patent rights as a secure, smart liquid and inhaler delivery device with automated dose delivery, measurement, and management.
"We are proud of the progress we have made on the development of ZICOH's multiplatform uses and technology," said Paul Edalat, CEO and Chairman of Vivera. "The way that Tesla revolutionized the automotive industry, and the way Apple created a category for smart devices, is what Vivera is doing to the prescription dispensing industry. ZICOH will forever change the way that medications are prescribed and dispensed, and Vivera is reaching the milestones to get there in a fraction of the time projected."
Vivera is looking forward to bringing ZICOH to market. The Company has already initiated the device's design and is looking forward to having a working prototype by late summer 2022.
About Vivera Pharmaceuticals
Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH™, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.
Pfizer | July 22, 2021
Pfizer Inc. and BioNTech SE today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, also known as "Biovac," a South African biopharmaceutical business headquartered in Cape Town, to produce the Pfizer-BioNTech COVID-19 Vaccine for sale inside the African Union.
Biovac will manufacture and distribute COVID-19 vaccines as part of Pfizer and BioNTech's worldwide COVID-19 vaccine supply chain and production network, which currently spans three continents and includes more than 20 facilities. Technical transfer, on-site development, and equipment installation operations will begin immediately to enable Biovac's participation in the process.
Biovac's Cape Town plant is expected to be integrated into the vaccine supply chain by the end of 2021, according to Pfizer and BioNTech. Biovac will acquire drug substances from European facilities, and final dosage manufacturing will begin in 2022. Annual production will reach 100 million finished dosages at full operating capacity. All dosages will be delivered solely inside the African Union's 55 member states.
Quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program are all factors that Pfizer and BioNTech consider when selecting contract manufacturers. Since 2015, Pfizer and Biovac have collaborated on the Prevenar 13 vaccine's sterile formulation, fill, finish, and distribution.
Pfizer and BioNTech have delivered more than 1 billion doses of COVID-19 vaccine to more than 100 nations and territories across the globe. The companies are firmly committed to ensuring that all people around the world have equitable and affordable access to COVID-19 vaccines, actively working with global governments and global health partners to provide 2 billion doses to low and middle-income countries in 2021 and 2022 – 1 billion each year. This comprises a non-profit arrangement to provide 500 million doses to the US government, which the government will then give to the African Union and the COVAX 92 Advanced Market Commitment (AMC) nations, as well as a 40 million dose direct supply deal with the COVAX facility.
Both BioNTech and Pfizer worked together to create the Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's unique mRNA technology. In addition to the European Union, BioNTech has emergency use authorizations or equivalent in the United States (jointly with Pfizer), Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but it has been approved for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19), which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 12 and up. Unless the declaration is ended or the permission withdrawn sooner, the emergency use of this product is only allowed for the duration of the declaration that conditions exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act.