Generex Biotechnology announced its Oral-lyn, the first non-injectable form of recombinant human insulin available for commercial distribution anywhere in the world is being launched in Ecuador to soon become available through physician referrals.
A bulletin of the World Health Organisation issued in connection with the measurement of the economic burden associated with diabetes in Latin America and the Caribbean in the year 2000 reported that permanent disability caused a loss of more than $50 billion (€42 billion) and temporary disability caused a loss of more than $763 million.
Additonally, the International Diabetes Federation said there were more than 3.2 million patients with diabetes in the Andean Community, almost 700,000 of which were insulin users.
Oral-lyn is designed to improve patient compliance delaying the progression of diabetes and the onset of complications associated with diabetes (such as amputation, retinopathy, cardiovascular disease, nephropathy, neuropathy, and peripheral vascular disease).
Under the terms of the agreement, Oral-lyn will be produced for commercial distribution at the manufacturing facilities of PharmaBRAND, S.A, the Company's South American joint venture partner, in Quito, Ecuador.
The Company and PharmaBRAND expect the product to be widely available in Ecuador in the first quarter of 2006 having been approved for commercial marketing and sale for patient treatment in May 2005 by the Ecuadorian Ministry of Public Health.
Oral-lyn offers an alternative to prandial insulin injections and is delivered by the Company's proprietary RapidMist device into the mouth of the patient where it is absorbed with no lung deposition.
The RapidMist device resembles an asthma inhaler and unlike certain other alternative insulin delivery products presently under development, Oral-lyn does not enter the lungs. The formulation is absorbed in the buccal cavity with insignificant residual deposition in the gastrointestinal tract
Generex 's decision to enter the South American market comes as an analysis of the market revealed that costs associated with insulin and oral medications were $4.72 billion, hospitalisations $1.01 billion, consultations $2.51 billion and care for complications $2.48 billion. The total annual cost associated with diabetes was estimated at $65.22 billion.