Winning a David-and-Goliath legal battle against an international pharmaceutical giant has secured a local generic cancer drug manufacturer the right to continue making affordable cancer treatment for South Africans.
Johannesburg-based Eurolab became embroiled in a court battle with Astellas, a Japanese multinational pharmaceutical company, for their use of enzalutamide, an androgen receptor inhibitor used in the treatment of prostate cancer patients in South Africa.
The lifetime risk for prostate cancer in men in South Africa, is 1 in 15, according to the 2022 National Cancer Registry.
Eurolab identified the potential of enzalutamide for prostate cancer treatment, but the compound was patented, which posed a challenge with its use.
The patentee was the Regents of the University of California (UC), and Astellas Pharma, which sells the enzalutamide product, Xtandi, in South Africa.
Eurolab CEO Lynne du Toit said when Astellas became aware of their registration of Enzutix, which contained enzalutamide, with the South African Health Products Regulatory Authority, the pharmaceutical giant along with UC, threatened legal action on the basis that Enzutix is identical to Xtandi and would infringe on the patent if launched.
Since the launch of Enzutix, Eurolab has noted a substantial increase in the number of patients receiving enzalutamide that may not have received this treatment in the past due to financial constraints
— Lynne du Toit, Eurolab CEO
Enzutix helps to slow disease progression by blocking androgens from stimulating cancer cell growth, making it an essential treatment option for prostate cancer patients. Most patients are on this type of treatment long term.
Despite the threat of litigation, Eurolab launched Enzutix early last year, prompting Astellas to sue for patent infringement and seek a temporary interdict to stop them and distributors “holding stock of Enzutix, from marketing and selling Enzutix before the patent infringement case had been heard in court”.
The court eventually ruled that UC was not entitled to apply for the patent, and therefore it was not valid.
“The only issue to be considered was whether UC, as the patentee, was entitled to apply for the patent, as it had. They were not, the judge ruled, because the inventors of the medicine had not signed over their rights to UC, which means the intellectual property did not belong to them.
“As a result, the patent was revoked. UC and Astellas were also prohibited from directing any further threats of patent infringement to Eurolab or any wholesaler or distributor dealing with Enzutix,” said Du Toit.
Astellas didn't respond to queries from TimesLIVE Premium.
Du Toit told TimesLIVE Premium the court victory “is a major breakthrough for prostate cancer patients in South Africa, ensuring continued access to affordable oncology treatment”.
“Access to prostate cancer treatment in South Africa has been limited for many patients due to the high cost of certain oncology medications. Eurolab’s victory is a crucial step in breaking these barriers.”
Du Toit said the savings for prostate cancer patients “will be substantial” — the calculation is estimated to be a saving of about R50,000 a year.
“Since the launch of Enzutix, Eurolab has noted a substantial increase in the number of patients receiving enzalutamide that may not have received this treatment in the past due to financial constraints,” said Du Toit.
According to the Cancer Association of South Africa (Cansa) international and local research indicates that the risk for aggressive prostate cancer is higher in black men.
“It tends to run in families so it is important for men to know their family cancer history, especially where there is prostate or breast cancer in a first degree family relative.”
In the early stages, men may have no symptoms.
Later, symptoms can include frequent passing of urine, especially at night; difficulty starting or stopping urination; weak or interrupted urinary stream; painful or burning sensation during urination or ejaculation; and blood in the urine or semen. Advanced cancer can cause deep pain in the lower back, hips, or upper thighs.
Risk factors for prostate cancer include age, ethnicity, family history, being obese or overweight and some dietary factors appear to increase risk.
Men can lower their risk of prostate cancer by eating a healthy diet, maintaining a healthy weight and limiting red meat and high-fat dairy products.
Prof Riana Bornman, senior research professor at the University of Pretoria’s School of Health Systems and Public Health, and Prof Vanessa Hayes, a genomicist from the Garvan Medical Institute of Medical Research in Sydney, focused their research on men of black and Khoisan descent in Southern Africa to better understand the possible links between prostate cancer and African ancestry.
“The most common risk factors include African ancestry, increasing age (from 50s onwards) and a family history of prostate cancer — on either the mother or father’s side. It might be that prostate cancer grows more rapidly in black than in white men and that transformation from latent to aggressive prostate cancer might occur earlier in black men,” said Bornman.
“Rural men especially may present late and with advanced disease.
“Men who were biopsied for prostate cancer will be registered in the National Cancer Registry database in South Africa, however, there’s currently no registry for prostate cancer cases that were diagnosed without a biopsy. Therefore, the numbers reported for prostate cancer in South Africa are likely an underestimate of the real numbers occurring.
“Annual prostate specific antigen testing is essential to help detect prostate cancer early, through a simple blood test and this is currently not routinely measured in men presenting at public hospitals.”
Cansa is investing in research in the high incidence of prostate cancer and is funding the Southern African Prostate Cancer study conducted at the University of Pretoria. This study will contribute to understanding of prostate cancer risk, disease progression and outcomes specifically in the South African population.
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.