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How a South African pharma company is making prostate cancer treatment cheaper

How a South African pharma company is making prostate cancer treatment cheaper
South African consumers will continue to have access to an affordable, life-saving prostate cancer treatment after a court ruling allowed local manufacturer Eurolab to keep producing its generic version. This is a big win for patients, ensuring more people can get vital treatment at lower costs despite opposition from multinational drug companies

In a landmark decision, the Gauteng Division of the High Court in Pretoria handed a significant victory to Eurolab in its battle against the University of California and Astellas Pharma, a multinational pharmaceutical company, over the production and distribution of a generic version of enzalutamide, a prostate cancer treatment.

A growing threat


According to a Frontier research report, prostate cancer is the most frequently diagnosed cancer among men worldwide. Africa’s incidence rate is 23.2 per 100,000, with southern Africa having the highest rate at 64.1. Prostate cancer cases in Africa are projected to rise to 70% by 2030.

Prostate cancer is the most commonly diagnosed cancer among men in South Africa, accounting for 26.14% of all male cancers, according to the 2022 National Cancer Registry.

The lifetime risk for South African men developing prostate cancer is about one in 15.

The incidence of prostate cancer varies across different population groups.

  • Black males: 5,636 cases (38.30% of all male cancers), with a lifetime risk of one in 17.

  • White males: 3,804 cases (17.49% of all male cancers), with a lifetime risk of one in 10.

  • Coloured males: 1,220 cases (24.82% of all male cancers), with a lifetime risk of one in 15.

  • Asian males: 284 cases (26.11% of all male cancers), with a lifetime risk of one in 25.


What the ruling means for you


Eurolab’s victory will provide financial relief to patients in South Africa, ensuring that Enzutix, a crucial treatment for prostate cancer, will remain accessible to South African patients at an affordable price. Eurolab told Daily Maverick that this decision is expected to bring estimated patient savings of R50,896.84 over 12 treatment cycles.

For Eurolab’s CEO, Lynne Du Toit: “It’s a win not only for Eurolab, but also for all the South African patients who are desperately in need of the product at an affordable price.”

To put this into perspective, Daily Maverick went to the pharmacy to get the numbers for you. A box of Xtandi 40mg (112 capsules) costs R25,578.15 at Dis-Chem. In contrast, a box of Enzutix 40mg (112 capsules) will cost you R21,244.37 - so you save R4,329.78. 

But that’s not all. A quick glance at online medical platform OpenUp reveals a similar pricing trend. Enzutix is listed at R26,613.41, while Xtandi costs a hefty R32,017.62 - a whopping R5,404.21 more.

As significant as these initial savings are, they only scratch the surface. When looking at the bigger picture, the financial implications of Enzutix are significant. According to Eurolab, patients can expect to save about R250,000 over a five-year treatment course. This translates to R100-million in total cost savings for the South African private market.

The pharmaceutical company plans to register Enzutix in other African countries, expanding into the broader African markets to address the need for high-quality, affordable oncology treatments.

Daily Maverick contacted several oncologists, who, although unwilling to comment publicly due to their close ties with both Eurolab and Astellas, privately expressed their welcome for affordable treatment options, acknowledging the benefits of low-cost medications for their patients. Others did not respond by the time of publication.

Background


The matter emerged after Eurolab identified the potential of enzalutamide, an androgen receptor inhibitor, used in the treatment of prostate cancer patients in South Africa.

Eurolab undertook a thorough analysis of any patents that could pose a bar to the launch of an enzalutamide product. This research identified South African Patent No. 2007/10870, owned by the University of California and licensed to Astellas, as posing a potential problem.

Astellas, a multibillion-dollar company, sells the enzalutamide product Xtandi in South Africa, and the patent was seen as a major obstacle to Eurolab’s plans.

Eurolab and its attorneys, Von Seidels, established that the patent was invalid. As a result, Eurolab stuck to its vision of making oncology treatments more widely accessible and affordable, and put into process plans to launch its enzalutamide product, Enzutix.

Dis-Chem was involved as the distributor of Enzutix. When Astellas became aware of Eurolab’s registration of Enzutix with the South African Health Products Regulatory Authority (Sahpra), Astellas, along with the University of California, threatened Eurolab with legal action, claiming Enzutix would infringe on the patent if launched. Dis-Chem, as a distributor, was also implicated in these threats. Despite these threats, Eurolab proceeded with the launch of Enzutix in early 2024, leading to litigation.

The court ultimately ruled in favour of Eurolab, invalidating the patent held by the University of California. The ruling found that the University of California was not entitled to apply for the patent because the inventors had not assigned their rights to the University of California, meaning it did not legally own the intellectual property. Consequently, the patent was revoked, and the University of California and Astellas were prohibited from directing any further threats of patent infringement to Eurolab or any wholesaler or distributor dealing with Enzutix, including Dis-Chem.

Astellas’ selective strike


According to Rui Morais, chief executive officer at Dis-Chem: “As a respondent in this case, our role was to defend our ability to procure and sell Enzutix while adhering to all legal and regulatory frameworks.

“We are not the only company selling Enzutix and were therefore surprised to be included in the court case by Astellas, as we are not the sole distributors of Enzutix. Dis-Chem Oncology participation was necessary to uphold our commitment to sell only Sahpra-registered products in full compliance with regulatory requirements. Any enquiries regarding the product should be directed to the South African licence holder, Eurolab, which is responsible for all regulatory and product-related matters. Our commitment remains to ensuring patients have access to legally registered, high-quality oncology treatments in alignment with Sahpra guidelines.” 

Morais concluded by saying the pharmacy is delighted with the outcome, and respects the legal processes that govern medicine registration and distribution in South Africa, adding that DisChem recognises that this decision may have positive implications for the accessibility and affordability of prostate cancer treatments. DM