Mateon Therapeutics & Windlas Biotech Enter Commercialization Agreement for Covid-19 Drug

Mateon Therapeutics recently announced an agreement with Windlas Biotech Pvt. Ltd. of India (Windlas) to commercialize ARTIVeda, Mateon’s lead ethnobiology drug against COVID-19.

With clinical data supporting anti-viral activity in-vitro and in-vivo, and with its high safety index, the commercial path has been accelerated both as an Ayurvedic therapy and Nutraceutical in India that can be prescribed by physicians. We, with and through our commercialization partners Windlas, are in active discussion with large distributors, marketers, and manufacturers to establish a consortium for distribution of this drug product in an equitable manner across all territories.

Early data from ARTI-19 suggests efficacy trend and safety, which is further supported by an independent recently completed study published in Int J Antimicrob Agents. 2020 Nov 2. In this study, time to undetectable SARS-CoV-2 RNA in the treatment group was significantly less than the control group (Treatment: 10.6±1.1 days), Control: 19.3±2.1 days) and Length of hospital stay for Treatment group was 13.3±4.8 days, and Control was 21.3±9.1 days.

Windlas is a leading CDMO since last 20 years. It promotes more than 120 chronic and acute care branded products (allopathic, nutraceutical and Ayush formulations) through its “affordable generics platform” spanning over 950 wholesalers across India. Windlas branded medicines and wellness products are sold in several markets across the globe like Sri Lanka, Vietnam, Thailand, Myanmar etc.

In order to maximize the accessibility and the reach of “ARTIVeda”, Mateon and Windlas intend to launch it through its distribution network as well as through strong co-marketing partners who are existing clients of Windlas.

“We are very excited by the early data of our Phase 4 Clinical trial in Indian COVID-19 patients, and confirmatory data of other global researchers. Given the well-established safety profile of this product, with hundreds of years of usage against viral fever and associated symptoms, ARTIVeda has the potential for use even beyond the pandemic as a safe and effective anti-viral therapy,” said Hitesh Windlass, Managing Director of Windlas. “Windlas has the capability to manufacture and supply several hundred million doses of ARTIVeda a month to address the dire patient needs.”

Saran Saund, Chief Business Officer and GM of AI division of Mateon, commented “Signing the definitive agreement with Windlas is a significant milestone for the companies to come together to address this epidemic in India and rest of world. We look forward to this partnership having an impact that can make slow down or even stopping this pandemic. Windlas, with its world-class manufacturing and commercialization operations and Mateon’s innovative science team create a formidable partnership.”

“We are very excited to have signed this milestone agreement and look forward to a long and successful partnership with Windlas. We believe that ARTIVeda can be a potent solution to the pandemic and the potential revenues from the sale of ARTIVeda could be significant,” said Amit Shah, CFO for Mateon. “We anticipate launching ARTIVeda, initially in India through our commercialization partner Windlas, and then globally, reaching out to as many people as possible in need of a drug for COVID-19, which is close to becoming the most widespread virus in the history of mankind.”

Windlas Biotech Private Limited is a 20-year-old company with a strong track record of research, development, manufacturing and distribution of pharmaceutical products in India, the US, and several other emerging markets. It has four large-scale manufacturing facilities employing more than 1500 employees and is the fifth largest Contract Development and Manufacturing Organization (CDMO) serving top innovator as well as generic pharma companies across the world. It has developed more than 500 different formulations (> 2 billion doses annually) of anti-viral, cardiovascular, anti-diabetic, anti-infective, CNS and dermatology products.

ARTIVeda is Ayurveda – Dvipaantara Damanaka- and is labeled as capsule containing Artemisia Powder 500mg. Ayurveda is a natural system of medicine, originated in India more than 3,000 years ago. Its use in this trial to treat COVID-19 is per Ayurvedic text: fever and inflammation. Artemisinin is an active component of ARTIVeda. Artemisinin is able to inhibit TGF-β activity and is able to neutralize SARS-CoV-2 (COVID-19) in vitro at an EC50 of 0.45 µg/ml (based on Mateon’s test result at Utah State University), and a Safety Index of 140, which is superior to remdesivir and chloroquine. The unpurified herb extract has no anti-viral activity. ARTIVeda is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. A Phase 4 trial looking at ARTIVeda in COVID-19 is ongoing in India and globally. The US name for this drug product is ArtiShield. We are looking to leverage ex-US data for the commercialization of ArtiShield in the US. We are expecting ArtiShield to be cost effective prophylactic suitable for global deployment.

Mateon was created by the recent reverse merger with Oncotelic, which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Mateon/Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, visit www.oncotelic.com and www.mateon.com.