Exclusive Distribution Agreement for Ukraine
Immunotech Laboratories, a subsidiary of Eco Petroleum Solutions, has forged an exclusive Distribution Agreement with LLC Project Development and Implementation Centre Omega for the distribution of its revolutionary HIV/AIDS treatment, ITV-1, in Ukraine. This agreement marks a significant milestone in the company’s journey towards full commercialization.
Agreement Details
The agreement spans an initial ten-year period, with an option for an additional ten-year renewal. It establishes a price of EUR 3,300 per one 8-week cycle of injections, consisting of 16 vials. The treatment protocol entails two 8-week cycles administered twice weekly, with a one-week break between cycles.
Initial Order and Validation Process
The first order placed under the agreement is for 10,000 units, which will undergo manufacturing validation before being delivered to Omega for distribution in Ukraine once the manufacturing permit is issued. This initial validation order is valued at EUR 2,062,500 ($2,116,125 USD).
The validation documentation will be completed in batches of 3,300, and the necessary documentation for registration is anticipated to be completed and submitted to the Bulgarian Drug Administration (BDA) by the end of September.
Mass Production and EU Distribution
Upon successful completion of the validation and review of the resulting documentation by the BDA, Immunotech expects to obtain the permit for mass production and sale within the EU. This permit will also be recognized in Ukraine, allowing for the distribution of ITV-1 throughout the country.
The company anticipates additional orders of similar quantities on a monthly basis after the issuance of the permit.
Addressing a Critical Need in Ukraine
Immunotec: 5 key points
- Exclusive distribution agreement for Ukraine
- Initial order and validation process
- Mass production and distribution in the EU
- Addressing a critical need in Ukraine
- Exceptional clinical trial results
Ukraine has an estimated 210,000 individuals living with HIV/AIDS, with the number reaching 2.5 million across Western and Central Europe and 1.5 million in Eastern Europe and Central Asia. The initial order of 10,000 vials of ITV-1 represents enough treatment to provide 312 individuals with both 16-week cycles.
Exceptional Clinical Trial Results
ITV-1 has successfully completed Phase I, II, and III clinical trials in Sofia, Bulgaria. The Phase III trial, conducted at the National Center of Infectious and Parasitic Diseases, demonstrated remarkable results.
The treatment showed improvements in immune indices, significant decreases in viral load, and a positive effect on opportunistic infections. It was also compatible with other antiretroviral drugs and exhibited exceptional tolerance, with no major side effects.
Approximately 80% of the test subjects reported undetectable viral loads, and 67% showed an enhanced immune system.
A Testament to Dedication and Support
Immunotec: 5 key points
- Exclusive distribution agreement for Ukraine
- Initial order and validation process
- Mass production and distribution in the EU
- Addressing a critical need in Ukraine
- Exceptional clinical trial results
CEO and Chairman Harry Zhabilov expressed gratitude for the unwavering support provided by the IMMB BG subsidiary and its Chairman and CEO Dimitar Savov. Their hard work and financial contributions have been instrumental in bringing this life-saving treatment closer to patients worldwide.
Immunotech Laboratories: A Pioneer in Drug Development
Immunotech Laboratories is dedicated to developing innovative treatments for debilitating infectious diseases. Their flagship compound, ITV-1, is a testament to their commitment to improving the health and well-being of humanity.
