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Vaxine Pty Ltd Announces COVID-19 Vaccine Collaboration with Leading South Korean BioPharma Company, Medytox Inc
Vaxine has entered a collaboration with Medytox Inc., a Korean biopharma company to develop COVAX-19®, Vaxine’s promising vaccine candidate against COVID-19"Vaxine is moving forward rapidly with its COVID-19 vaccine candidate which it expects to be in human clinical trials before mid-year” — Nikolai Petrovsky, Chairman and Research Director, Vaxine Pty Ltd ADELAIDE, SOUTH AUSTRALIA, AUSTRALIA, May 23, 2020 /EINPresswire.com/ -- Vaxine Pty Ltd., Adelaide, Australia announced today that it has entered into a formal collaboration with Medytox Inc., a Korean stock exchange listed biopharma and development company to accelerate development and commercialisation of COVAX-19®, Vaxine’s promising vaccine candidate against COVID-19.COVAX-19® vaccine is currently undergoing late stage animal testing and is based on Vaxine’s proprietary Advax™ adjuvant technology combined with a recombinant SARS-CoV-2 spike protein.The Memorandum of Understanding was formally signed on May 12 and both companies will work together to conduct product development, process development, clinical trial program and commercial scale-up for the Australian and Asian markets, including Korea.“It is wonderful to be working with such an experienced GMP manufacturing partner as Medytox to make our COVAX-19® vaccine available to as much of the world as possible,” said Professor Petrovsky, Research Director of Vaxine. “Korea is host to some of the most advanced pharma manufacturing companies in Asia, making this an ideal partnership.”Animal studies of COVAX-19® vaccine are already underway in Australia and the USA and Phase 1 clinical trials are scheduled to begin mid-year, with early results expected by August. Phase 2/3 clinical trials are planned for Q4 2020 with product launch early in 2021.“We are excited by the strong evidence of immunogenicity generated by Vaxine’s COVAX-19® vaccine in animal studies” said Dr. GiHyeok Yang, Sr, Executive Vice-President and Head of Research and Development at Medytox. “Vaxine is an impressive Australian company who have a track record of developing state of the art pandemic vaccines including against SARS coronavirus and pandemic influenza. Medytox did a thorough examination of the globally available COVID19 vaccine technologies and quickly reached the conclusion that Vaxine’s approach was the best and most reliable approach to protect the community against COVID-19 and help bring this pandemic to an end”.Vaxine Pty Ltd is an Australian vaccine company with deep experience in artificial intelligence and pandemic vaccine development and will provide its proprietary antigen and adjuvant platforms and clinical trial know-how to this partnership.Medytox Inc. (Korea) is an innovative BioPharma manufacturer with licensed products distributed in global markets and with extensive expertise and know-how in GMP biological product and process development through to global commercialization.For more information on this Covid-19 vaccine project, contact:Name: Nikolai Petrovsky, MBBS, FRACP, Ph.D. (Chairman and Research Director, Vaxine),Email: nikolai.petrovsky@flinders.edu.auhttp://vaxine.netDr. GiHyeok Yang, Sr, Executive Vice-President and Head of Research and Development at MedytoxEmail: hjchang@medytox.com
2020.05.26
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Medytox Public Announcement
Medytox Public Announcement We sincerely apologize to all our customers and investors for causing concerns regarding the ‘recent administrative actions by the MFDS (KFDA)’.Medytox, which was established in the year 2000 as a venture biotech company, developed ‘Meditoxin’ as the first botulinum toxin product in Korea and fourth in the word.In 2013, Medytox developed ‘Innotox’, which is the first ever liquid botulinum toxin product. In 2016, Medytox also developed ‘Coretox,’ which reduces the immune response risk by using non animal sourced media in the manufacturing process for the first time in the world. Medytox now exports these 3 products to 60 countries. In addition, Medytox achieved KRW 121.6 billion in exports, which is 60% of total sales, in 2019. We are also anticipating the approval of the license in China this year, which will result in even greater sales. There have been no reports to date of any severe adverse effects for using Meditoxin, which has manufactured 16.9 million vials (100 unit equivalent) from the date of initial launching in the market to 2019.The ‘Meditoxin issue’ was initiated of actions by MFDS based on a report in 2019 to the Korea ACRC (Anti-Corruption & Civil Right Commission) by a former Medytox employee (last name with "A"), who was working for Daewoong pharmaceutical in 2019. The issue arose from prosecution investigation based on a report that Medytox used ingredients without change of permission for some of Meditoxin products which were manufactured from December 2012 to June 2015. Following the above report, the MFDS and prosecution have investigated Medytox several times and currently related hearings are ongoing.On April 17, 2020 the MFDS suspended manufacturing and sales of Meditoxin 50 unit, 100 unit and 150 unit products, based on Article 71 of the Pharmaceutical Act.Medytox's position in regard to such decision by the MFDS is as follow1. Actions of MFDS are based on the article 71 of the Pharmaceutical Act pertains to concerns over current "public health" based on sales and manufacturing. However, the period related to the ‘Meditoxin issues’ was from the manufacturing period of December 2012 to June 2015. Meditoxin products manufactured during such period have all been used a long time ago and no longer exist. Therefore, no harm to public health can currently exist.2. The Meditoxin products that are currently being distributed were manufactured after April 2017. Medytox not only received a conformity decision on the inspection for distributed products which was undertaken in 2016 and 2018 by the MFDS, but also had no issues whatsoever during the MFDS' numerous inspections concerning special observations and random collections for distributed products in terms of efficacy and safety within the shelf life.In this connection, Medytox submitted a request for suspension of execution on the MFDS’s order and for cancellation of the MFDS’s order to the Taejon District Court at 9pm on April, 19 2020.Currently, based on the order by the MFDS, Medytox temporarily has suspended the manufacturing and sales of Meditoxin. In response to the above, Medytox plans to increase revenue by promoting 'Innotox' and 'Coretox', which are advanced new botulinum toxin type A products.As a leading global company in the botulinum toxin industry, Medytox has developed the world's first pre filled syringe botulinum toxin products for maximizing usage convenience. Also the R&D division, comprised of 20% of all employees, will soon develop innovative new bio products.Medytox again offers a sincere apology to its shareholders and customers. Taking this opportunity, Medytox will do our best to prevent this from occurring again in the future by preparing internal verification processes and strengthening a continuous monitoring system.Finally, the recent order of the MFDS is related to the production process of Meditoxin which occurred in the past. We note that this issue is a separate and unrelated issue from the legal disputes with Daewoong Pharmaceutical at the U.S International Trade Commission (ITC) and the civil and criminal cases with respect to the theft of Medytox's botulinum toxin strain and manufacturing process. The truth will start to unfold with the ITC's initial determination on June 5, 2020.
2020.04.20
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