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Many Drugs in One
August 28, 2015   
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Polish scientists are working on a drug that will combine in one capsule the positive effects of several medicines used by those who suffer from an abnormal level of lipids—chiefly cholesterol—in the blood.

Polish scientists are working on a drug that will combine in one capsule the positive effects of several medicines used by those who suffer from an abnormal level of lipids—chiefly cholesterol—in the blood.

The condition, called dyslipidemia, can lead to the development of arteriosclerosis and circulatory problems. To treat it, most sufferers must take a variety of pills every day.

Many people develop dyslipidemia because they have a poor diet, exercise too little, and smoke cigarettes. However, remedying these faults is not enough to ward off dyslipidemia. The condition may also have a genetic origin or may be a side effect of various diseases or drugs taken by patients.

This complicated disorder leads to an elevated level of cholesterol in the body. The lipid cholesterol is found in foods such as eggs, meat and dairy products, but the body also produces its own cholesterol via the liver. When there is too much “bad” cholesterol, a person’s arteries become narrower—a symptom of atheromatous plaque, a buildup of deposits within artery walls that produces a condition known as atherosclerosis. The walls of the arteries harden, and the clinging deposits reduce their width. The person’s blood pressure rises as a result, often leading to problems with the heart, the circulatory system as a whole and the kidneys. Veins become obstructed and supply less blood and oxygen to the brain, with negative consequences. As brain cells die, various neurological and mental disorders develop, including memory problems.

That nasty cholesterol

Dyslipidemia takes different forms. One variety is hypercholesterolemia, or excessive cholesterol concentration. Treatment involves taking many pills that are often similar in appearance, which carries the risk of making a mistake. This is why the Polish scientists are looking for a drug that will combine a number of active substances in one capsule.

The research is part of a project entitled “Development and implementation of modern pharmaceuticals for the treatment of dyslipidemia,” which is being conducted by Polish biotechnology and pharmaceutical company Adamed Group, a provider of what are described as new-generation drugs. The project is financially supported by the National Center for Research and Development (NCBR), which has provided zl.3 million as part of its Innomed program. The project’s total R&D budget is zl.11 million, including zl.1 million to finance preparations for putting the drug on the market.
The main class of drugs used to treat lipid disorders is statins. Although effective, these have certain clinical limitations and are often used in combination with other types of drug, says Jarosław Marchewka, head of the project management department at Adamed Group.

Modern strategies for the treatment of dyslipidemia include the use of fixed-dose combination (FDC) drugs. These combine several medicinal substances that are complementary in terms of their overall effect.

“Patients will no longer have to remember to take a number of different pills that often look similar,” says Marchewka. “This will reduce the probability of swallowing the wrong pill or failing to take some of them.”

Development of such a drug could particularly benefit elderly people who take handfuls of pharmaceuticals for various ailments. Reducing the number of required pills will make it easier to take the right dosage, which would increase their effectiveness, according to Marchewka. In the case of chronic diseases, strict adherence to medical recommendations is a key factor of therapeutic success. Moreover, patients will be consuming fewer of the additive substances that are contained in the pills.

Brand-name, generic, FDC

Original brand-name drugs are protected by patents. They often take years and substantial spending to develop. A generic drug is a substitute that contains the same active ingredient. Its production can begin after patent protection for the original drug expires. Before a generic drug hits the market, it must pass a battery of pharmacological, biological and toxicological tests.

Developing an FDC drug requires much more intense R&D than generic drugs, says Marchewka, who manages an 11-person team of researchers working on the new dyslipidemia drug. “Often additional clinical tests are needed to demonstrate that the active ingredients involved are effective when they are combined, that there are no adverse interactions between them, and that their use is safe.”

The researchers’ goal is to create an FDC drug that will have the same effect as all the separate drugs used in treating dyslipidemia. This is not easy, because otherwise stable drugs may change their form or effectiveness when combined. This is an additional challenge for the pharmaceutical company and requires a more complicated production process.

“Registering products that contain more than one chemical substance is much more difficult than the registration of standard generic drugs,” says Marchewka. “Consequently, few pharmaceutical companies actually decide to develop such products.”

After 3 1/2 years of work, the project is due to wind up with the registration of the drug in the fourth quarter of 2017. According to the researchers, the new medicine will be much cheaper than the corresponding combination of original drugs available on the market, making treatment more affordable for patients.

Karolina Olszewska

The National Center for Research and Development’s Innomed program seeks to financially support the most innovative projects in medicine in Poland. In late July, the center announced another call for proposals as part of the program for a new round of co-financing. The NCBR will allocate zl.95 million to support research, development and implementation efforts designed to yield innovative medicines, modern treatment methods and new technology for the production of generic drugs.
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