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New Generic Lung Cancer Drug
June 29, 2015   
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A new generic drug for non-small cell lung cancer is being developed by the Pharmaceutical Research Institute in Warsaw. Once available, the new drug will be put on the market by Polish pharmaceutical company Polfa Production.

Lung cancer is the most commonly diagnosed type of cancer among men worldwide and the most frequent cause of death due to cancer. The risk of developing lung cancer among men is roughly three times as high as among women. The disease most often strikes patients over 50 years of age. On average Polish men suffer from it more often than men in other countries in the European Union.

“We are working on a cure for non-small cell lung cancer,” says Rafał Bednarczyk, CEO of Polfa Production. “This will be a Polish equivalent to an original drug containing erlotinib, a substance from the group of kinase inhibitors, which is also used in patients with non-small cell metastatic lung cancer and sometimes metastatic pancreatic cancer.”

In the case of the original drug, the average dose is 150 mg per day. A pack contains 30 tablets, and each tablet contains about 25 mg of active substance. One pack is enough for five days and costs zl.2,000, an expense reimbursed by the health ministry. If the patent on the original drug has expired, and a generic drug (or an equally good equivalent) is brought to market, its price falls by 30-40 percent.

Few cancer drugs are produced in Poland. Most are imported. That’s why the National Center for Research and Development (NCBR) says it has decided to co-finance work on developing a Polish equivalent of the lung cancer drug. Thanks to this, patients will have better access to cheaper medical treatment.

The total cost of the project is nearly zl.13 million, co-financed to the tune of zl.10 million by the NCBR under its Innomed program.

“Non-small cell cancer is particularly malignant and most patients lose the battle against it,” says Bednarczyk. “Chemotherapy, including kinase treatment, requires the selection of the right combination of drugs that will produce a satisfactory result,” says Bednarczyk.

The researchers aim to modify the active pharmaceutical ingredient (API), or erlotinib, while maintaining Good Manufacturing Practice (GMP) and the highest manufacturing standards in force in the European Union.

The project started in May 2014 and will be completed in 2019.

The Pharmaceutical Research Institute is looking for the best way of synthesizing the active substance and placing it in a tablet or capsule. Polfa Production is responsible for the commercial part of the project and for putting the drug on the market.
Karolina Olszewska


Factfile

The National Center for Research and Development’s Innomed program seeks to financially support the most innovative projects in medicine in Poland. Innomed is one of a range of NCBR programs targeted at various sectors of the Polish economy. In the fall, the NCBR will announce another call for proposals involving innovative projects in medicine for a new round of co-financing.
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