FOR IMMEDIATE RELEASE
Pressnews.biz (Press Release) Dec 2, 2014
-- The company Seeks a Joint Venture US partner to finalize the development of a new low dose HIV/AIDS treatment through to Mexican Health department registration.
San Francisco, CA - John W. Majewski, Founder & CEO of Narhex Australia's Skin Treatment Products, paid for the discovery of Australia's first and only, small-molecule, and boosted protease inhibitor treatment for people living with HIV/AIDS.
For the next step Narhex Seeks a US Partner to finalize the development of a new low dose HIV/AIDS treatment to ready this new drug for Mexican Health Department Registration.
John's clear objective is one of transferring Narhex Discovery by creating a New Company, Four Guardians Life Sciences (4G) to be incorporated in the US that is dedicated to save human life, while at the same time be profitable for the future share holder investors on an IPO listing.
The Mexican HIV population of 200,000 is growing; in the US, one in every 52 Hispanics/Latinos, out 48.4 million, will be diagnosed with HIV in their lifetime.
The company's strategy is to introduce a new-generation, boosted, small-molecule protease inhibitor combination treatment, for Mexico first and the USA. Until now Mexico has, received older-generation antiviral treatments that are no longer the physician's choice in more lucrative Western markets.
This approach will be a game-changer for the emerging counties like Mexico, who require first world antiviral treatments but cannot afford Western pricing.
Under John's direction, Narhex Australia undertook ongoing research programs for the development of this New Dose Protease Inhibitor which successfully completed Phase I in healthy volunteers and Phase IIa clinical trials in HIV Infected people.
The reason he has persisted because of two significant milestone advances subsequently made DG 17 Prodrug protease inhibitor and the significant support he has received from his Mexican CRO partner and the Mexican Ministry of Health (MoH).
1. The costly complex scale-up solutions required to move from laboratory bench chemistry syntheses to producing clinical trial drug in large commercial batch GMP manufacturing has been completed.
2. Proving in second Phase I clinical trials a significant reduced pill burden as a result of a possible 70% reduction in daily dosage amount.
By implementing the same path used by the big pharmaceutical companies (*1), Narhex Australia plan is to complete the remaining Phase IIb/III clinical trials with its appointed Mexican CRO drug registration partner, in order to register a new-generation, "boosted" protease inhibitor requiring dosage only once or twice a day with the Mexican Health Department (MoH).
This reduces pill burden and lessens side effects, including lipid and metabolic disturbances.
The Mexican Ministry of Health reviewed the earlier Phase I clinical trial results for an improved enteric coating dosage formulation and Phase I/IIa clinical trial results.
The Clinical Research Organization (CRO) has, with involvement from the Mexican health department, submitted a Phase IIb & III clinical trial program and budget plan that will combine both clinical trials into one, thus shortening the time to market to an estimated two and a half years.
On achieving registration in Mexico, the company's objective is to grow to service around 60,000 patients across the Mexican and cross-border US markets, achieving an estimated annual income in excess of $150 million USD within the first few years of commencing operations.
The company's strategy was to attempt to secure the same drug registration with the US FDA. Mexican and US Hispanics/Latinos HIV population - Datamonitor (US) estimates that the current generation of Protease Inhibitors ("PI") account for 25% or $1.5 billion USD of all HIV antiviral sales.
The current available large pill burden, however, of the older first-generation PI, has been an outstanding issue affecting the PI class. The frequency of dosage prescribed in emerging countries not only affects patient quality of life and ability to adhere to their recommended regimen, but it also continually reminds them of their condition.
For more information and to download (4G) business plan and scientific publications documents go to http://www.narhexhivaids.com
email Narhex Australia info ( @ ) narhexmax dot com.au Tel + 61 2 9979 9666.