Patients first
Using the power of science to bring down the cost of treating MDS
Myelodysplastic Syndrome (MDS) is one of a group of cancers in which immature blood cells in the bone marrow are prevented from growing into healthy blood cells. The condition can lead to bone marrow failure and severe anaemia, and eventually lead to cancer of the blood and the bone marrow.
Azacitidine is a chemotherapy drug that is used in the treatment of MDS. It is believed to work by helping bone marrow grow normal blood cells so that the patient will need fewer blood transfusions. It also kills abnormal blood cells that have grown too fast and do not work properly.
A medicine made from this drug is the most effective treatment available to patients suffering from MDS. However, Azacitidine is a chemically unstable compound. It degrades rapidly in the presence of water, even at low temperatures. This made medicines that used this drug an expensive proposition for patients battling MDS.
In early 2000s, we decided to develop a generic version of Azacitidine. Our goal was to bring to market a medicine that would use the drug but still be affordable and available for all. Our scientists conducted structured experiments to resolve the drug’s chemical instability. Once that was achieved, it was possible to produce the drug on a commercial scale at a fraction of the cost.
The next step was to prove that our version was just as effective as the innovator company’s medicine. This usually requires a complex bioequivalence study, which would assess the expected in vivo biological equivalence of the two preparations of the drug. If the products are found to be bioequivalent, it would mean that they would expected to be, for all intents and purposes, the same.
The time taken for a study of this nature was time MDS patients could ill-afford. We put together a detailed scientific report with supporting experimental data to prove the pharmaceutical equivalence between the innovator’s product and our generic version of the drug. The data was good enough to convince the authorities, and we were granted a waiver of the bioequivalence study.
Our innovative approach lead to two significant breakthroughs:
Patients suffering from MDS would receive critical medicines that were affordable, equally compliant and just as effective.
Other companies that manufacture generic drugs can follow our path, and develop and launch generics faster.
Nearly a third of MDS patients in the United States now use our version of Azacitidine. And we are still only one of three companies providing this crucial medicine at an affordable price to patients fighting MDS.
