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New Osteoporosis Drug in the Making
April 30, 2014   
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Warsaw researchers have teamed up with a pharmaceutical retailer to develop a new generic drug for osteoporosis. If the project ends in success, patients with osteoporosis will have a new drug available that will be cheaper than those already on the market, the researchers say.

The new drug is being developed by a consortium established by the Pharmaceutical Research Institute in Warsaw and the Pol-Nil company, a Warsaw-based pharmaceutical retailer. The project has been financed by the National Center for Research and Development (NCBiR). The research consortium hopes to go international with the new drug and is eyeing several European markets.

The drug will contain an active substance known as risedronate sodium that the researchers say will prevent changes in the bones of people affected by osteoporosis. The disease causes a decrease in bone mass and density, thus leading to a high risk of fracture and broken bones. About 30 percent of women over the age of 50 suffer from osteoporosis, accounting for about 80 percent of all those affected. Many of these patients have problems living normal lives even though they are highly qualified and want to continue their professional careers despite their deteriorating physical condition.

Prof. Łukasz Kaczmarek, director of the Pharmaceutical Research Institute, says the new drug will be cheaper than other osteoporosis drugs and will thus help bring about a situation in which more patients will be undergoing treatment. As a result, many patients will no longer be forced to give up their careers and the burden on their family budgets as well as on the government posed by the costs of treatment will be smaller as well, Kaczmarek says.

Both in Poland and throughout the European Union risedronate sodium is used in the treatment of osteoporosis—usually patients receive a weekly dose of 35 milligrams. The Polish researchers plan to introduce a drug with a larger content of the active substance, at 75 milligrams. This will make it possible to reduce the dosage to two pills—taken on two consecutive days—a month. The producer of the original drug, the Sanofi-Avensis company, has registered a 75 mg drug, but has only introduced it on some European markets. The 75 mg drug is unavailable in Poland and several other countries.

“Our project will result in the introduction onto the Polish market of a generic osteoporosis drug that will contain 75 milligrams of risedronate sodium,” says Kaczmarek. “This will decrease the treatment costs for both the patient and the government. The lower price of generic drugs is because they do not have to undergo full clinical trials—they contain the same active substance that has already been tested in the past.”

The Warsaw researchers have teamed up with the Pol-Nil company to develop the new drug. After Pol-Nil financed the laboratory tests with its own funds, the National Center for Research and Development provided more than zl.2.2 million for further research.

The detailed concept for the project was drawn up by Pol-Nil and the Pharmaceutical Research Institute. The research team is made up of process engineers and analysts from Pol-Nil and researchers from the Pharmaceutical Research Institute—more than a dozen people in all, in addition to the CEO of Pol-Nil, Marek Rafałowski. The MTZ Clinical Research center supports the consortium.

The safety and effectiveness of a generic drug must be confirmed by numerous tests. The most important of these is a bioequivalence test. It is based on comparing two products: the original drug, which had been put on the market with full clinical documentation, and a generic drug—a counterpart with comparable performance characteristics. The Pharmaceutical Research Institute’s Department of Pharmacology has been conducting bioequivalence tests for several decades. More than 10 years ago it obtained a Good Laboratory Practice Certificate in this area.

If a generic drug passes the Pharmaceutical Research Institute test it can enter the market. Thanks to this, full clinical tests—which take a long time and cost a lot of money—are not necessary. Some tests, however, need to be conducted in order to measure factors such as the concentration of the drug in the blood.

Usually, a test group consists of about 30 healthy volunteers. However, in the case of the osteoporosis drug, more than 100 people were needed because of the fluctuating degree of assimilation of the active substance.

The costs and risk related to research are a major barrier for a drug before it can enter the market. If it wasn’t for financial support from public funds, the project could probably not be carried out. “It’s unlikely that other pharmaceutical companies are working on a similar drug. But R&D work is confidential, so we cannot rule out that large companies are in fact working on such a generic drug,” says Kaczmarek.

The application received high ratings from the National Center for Research and Development on all counts. Supporting Polish business initiatives, particularly those undertaken by small and medium-sized enterprises, is in the interests of the Polish economy in terms of increasing its international competitiveness. That was also the main aim of the European Union’s Innovative Economy 2007-2013 program, which was the source of funds for the research consortium and which were disbursed by the NCBiR.

The project is being carried out according to plan. The paperwork has been taken care of and clinical tests are under way. Soon the researchers plan to analyze the concentration of risedronate in samples of human plasma.

The process of preparing samples for analysis is complex because it involves the use of a highly toxic reagent. That is why the analysis procedure requires special protection measures for staff.

The risedronate concentration must be determined with an accuracy of less than one nanogram—one billionth of a gram—per milliliter. This can be compared to 50 drops of water in an Olympic-size swimming pool. In order to achieve the necessary level of precision, the tests require the use of a hi-tech analytical technique—mass spectrometry combined with high-performance liquid chromatography.

The project is due to end in the second half of this year. If the market entry process goes smoothly, the drug will be available in drugstores two to three years from now. The method developed by the consortium during work on the new generic drug will be submitted for patenting with the patent office.

According to experts, demand for 75-milligram risedronate is high. Several producers and distributors have voiced interest in obtaining the license and putting the drug on selected European markets.

Karolina Olszewska
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