Australian Students Synthesize Daraprim for Just $2

In the wake of a Zika epidemic, the world seems to have forgotten that other infectious diseases, such as toxoplasmosis, can also cause life-changing sequelae in pregnant women and their developing fetuses. Treatment for this infection (Daraprim) is quite costly in the United States—$750 per pill—however, students from an Australian high school have found a way to manufacture it for under $5. Whether or not this discovery will lead to a cheaper treatment option for those who are suffering with the infection remains to be seen.

According to the Centers for Disease Control and Prevention (CDC), toxoplasmosis has among the highest rates of death related to food-borne illnesses. This disease is caused by Toxoplasma gondii. Although infection with this parasite does not always cause serious symptoms, infection can be detrimental in the immunocompromised, elderly, newborns, infants, and pregnant individuals.

What Complications Are Caused by Toxoplasmosis?

Infection during pregnancy can affect fetal development, causing abnormally large or abnormally small head size; toxoplasmosis can also result in miscarriage or stillbirth. Furthermore, 20% to 80% of infants congenitally infected with toxoplasmosis develop eye lesions, which may lead to “an acute inflammatory lesion of the retina, which resolves leaving retinochoroidal scarring." Acute eye disease can lead to serious eye pain, photophobia, eye tearing, and blurry vision. Immunocompromised individuals, such as those with HIV-positive infections, are reported to experience the most serious symptoms, including fever, confusion, headache, seizures, nausea, and poor coordination, according to the CDC.

What is the Incidence of Toxoplasmosis?

The World Health Organization reported on the global burden of congenital toxoplasmosis in a study published in the 2013 issue of the Bulletin of the World Health Organization. According to this study, “Toxoplasmosis is present in every country and seropositivity rates range from less than 10% to over 90%.” The CDC also reported that 22.5% of the US population above the age of 12 years was infected with the parasite.

Daraprim to Treat Toxoplasmosis

Treatment options for toxoplasmosis include pyrimethamine and sulfadiazine plus folinic acid. Pyrimethamine and sulfadiazine are both included in WHO’s List of Essential Medicines. As such, it came as no surprise that when the cost of Daraprim, the brand name for the generic pyrimethamine, skyrocketed from $13.50 a pill to $750 a pill, people were infuriated, and Martin Shkreli, CEO of Turing Pharmaceuticals (the drug company that acquired Daraprim and raised its price) was dubbed “the most hated man in America,” by BBC.

Nonetheless, in February, a group of students from Sydney Grammar, a high school in Sydney, Australia, were given the opportunity to work with University of Sydney’s Alice Williamson, a postdoctoral teaching fellow in the School of Chemistry, and with Open Source Malaria to develop a more economic-friendly generic for Daraprim. The students purchased 17 grams of materials for only $15. Using the patent recipe, the students worked with their science teachers on the drug. According to a Washington Post article, the group “posted all of their work online periodically through Open Source Malaria, which allowed scientists to provide them with guidance and feedback.”

The group completed their work on the drug in November, and it was taken to be tested at the university. The molecular fingerprint and the crystal’s melting point were found to be complementary to those of Daraprim. According to Dr. Williamson, the drug the students created was a “very pure sample of the medicine… which is a challenge.” The materials the students bought were able to come up with 3.7 grams of Daraprim, which, in the US market, would sell for a little over $100,000.

Outside of the United States, Daraprim is quite inexpensive. In Australia, for example, 50 pills cost $12.99. According to the Sydney Morning Herald, although the drug is currently not protected by the patent, a loophole called the “closed distribution model” allows Turing Pharmaceuticals to control Daraprim drug sales in the United States. Meaning, if Shkreli does not allow the drug the students created to be tested against Daraprim in order to validate it as a generic, the drug must be tested in new clinical trials, which requires funding.

Shkreli released a video statement on Monday, December 1, in response to this news. In it, he said, “I’m delighted to hear about more and more students entering the STEM field. These Australian students are proof that the 21st century economy will solve problems of human suffering through science and technology… Medical science has brought tremendous advances in cancer, mental health, autoimmune disorders, and many others. Technology has lowered the costs of a myriad of goods and services dramatically. We should congratulate these students for their interest in chemistry, and I’ll be excited for what is to come in the STEM-focused 21st century.”

The students were able to present their work at the annual Royal Australian Chemical Institute’s NSW Organic Chemistry Symposium. This is quite an achievement considering the typical presenters at the Symposium are usually postgraduate and postdoctoral researchers. So far, there has been no word on what the next project will be for the student researchers.