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GADOR R&D: A WIDE SCOPE OF ENDEAVORS – FROM TECHNOLOGICAL INNOVATION TO SOCIAL INSERTION.

- 20 April, 2015

Most pharmaceutical innovations come from a privileged group of countries, to which Latin American nations seldom belong. Yet Gador SA has led a number of scientific ventures and received several scientific awards. The company has also been granted various international patents for its inventions. Such endeavors, which are uncommon in this region, stem from the multifaceted thinking of Gador’s founders and continue to be fostered by a spirit of close, permanent cooperation with educational institutions of excellence.

Recently, a drinkable formulation of alendronate patented by Gador was launched in Europe; this is one of the first pharmaceutical products licensed from a Latin American company to be commercialized beyond its local market. Moreover, within its class, this is the bisphosphonate with the largest sales volume worldwide. Gador has been working on these compounds since the early 1970’s and has gained the knowledge and expertise required to process them into small crystals, which are appropriate for pharmaceuticals. The liquid formulation of alendronate, prepared with pharmaceutical pure water, ensures that the active principle is delivered in soluble form at concentrations that do not cause irritation and that gastrointestinal transit is rapid. All these features make it possible for a greater number of patients to benefit from the drug. Also, the low sodium content of the liquid formulation is an additional bonus for many elderly patients, for whom this product is an excellent option to help prevent osteoporotic fractures with fewer potential risks.

In the 1980’s, Gador produced the sole industrial formulation available for oral pamidronate, which was marketed only in some countries due to patent restrictions. This compound was originally prepared as an emulsion with enteric coating, and it was the first product to benefit from the advantages of such pharmaceutical form. Olpadronate (IG8801), a dimethyl derivative of pamidronate with unusual physical and chemical properties, is the only bisphosphonate that may be described as naturally soluble, a feature which allows for very flexible dosing regimens. Olpadronate has been tested in Paget’s disease of bone with ultrashort treatment schemes and used in children with Osteogenesis imperfecta, having received positive reviews from independent researchers for its effects on such pediatric patients, which testifies to the compound’s safety and efficacy. At present, olpadronate is being studied for use in osteoporosis in the context of a binational program; research is currently at phase IIa. It is expected that olpadronate will have clinical, pharmacological and economic advantages over its predecessors in the market.

The last generation of bisphosphonates synthesized by Gador includes modified products with different mechanisms of action. Among these products, lidadronate is the first bisphosphonate known not to inhibit bone resorption yet to exhibit selective binding to calcified tissue and sufficient anabolic properties to strengthen the skeleton in vivo. If one were to envision a drug as successful in the market as alendronate has been, that is to say, an agent without the risks of excessive bone resorption (i.e. osteonecrosis of the jaw, atypical fractures, hypocalcemia or arrhythmia) yet with all the potential to improve the biomechanical properties of the skeleton, such drug would be lidadronate, as shown by experimental studies conducted in the U.S. and in Europe. Today, lidadronate is ready to undergo the entire development process.

Gador has contributed to the scientific media with several publications, with topics ranging from the description of the biphasic biomechanical effect of bisphosphonates to the first use of a bisphosphonate in the treatment of multiple myeloma by local researchers. Especially noteworthy was the endeavor to elucidate the anti-fracture mechanism of bisphosphonates, given that such mechanism cannot be entirely explained by their already known antiresorptive (anti-osteoclastic) actions; rather, it may be accounted for by their positive effects on cells that are sensitive to mechanical load (pro-osteocytic effects) and on bone-forming cells (pro-osteoblastic effects). Gador’s research has consistently contributed to this line of work. Such investigations have resulted in the production of innovative models for diagnostic nuclear medicine, toothpaste, mouth wash and experiments for veterinary use and non-traditional applications, such as models for parasitic diseases.

Other early endeavors of Gador’s R&D department were the studies conducted in the 1980s to elucidate the antioxidant mechanism of lipoic acid. Lipoic acid has been successfully marketed for over 50 years, supported by a series of mechanistic studies and, at present, also by ongoing clinical research. This is a good example that the strategy of turning products into “classics” is a profitable resource for today’s industry. Similarly, alprazolam, a compound with already studied anxiolytic effects (GEMA project) and a leading product in the regional market, is currently being investigated as a modulator of the response to chronic stress. Once reprofiled, alprazolam will also compete favorably with other products that are newer in the market but for which there is undoubtedly less therapeutic experience and which have higher cost-utility ratios.

Various other current projects at Gador are geared towards manufacturing quality drugs at affordable prices, so that may have a positive pharmacological and economic impact in Latin America and contribute to improve the present technological and financial situation in the region. Technological innovation and social insertion are two indivisible goals for Gador.

Finally, Gador has signed a cooperation agreement with a European institution to launch an R&D program with the aim to produce the first anti-Trypanosoma cruzi vaccine. This would help fight one of the major neglected conditions in the region, Chagas disease, for which Gador has been working on a master research plan which is still in the experimental stages but holds great promise for innovation in this area.

This extensive product portfolio, which includes original, classical, improved, and/or reprofiled drugs adapted to the pharmacological and economic conditions of the market, renders Gador an attractive candidate for regional and multinational companies seeking a partner with renown, experience, flexibility and the ability to understand and address the needs of science, health and society as an indivisible whole.

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