Clinigen Group Plc extends agreement to supply three medicines to Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval and registration

CLINIGEN Group Plc  the global pharmaceutical and services company, has extended its exclusive agreement with Eisai Europe Ltd. to obtain the marketing authorisation and subsequently launch Halaven® (eribulin), Fycompa® (perampanel) and Lenvima® (lenvatinib) into 10 African countries.

The new agreement follows the successful launch of Halaven and Fycompa in South Africa in February and July 2017, respectively. All three medicines will be submitted for registration in Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval.

Eribulin is currently licensed in South Africa only for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their disease. These would usually include an anthracycline and taxane, unless not suitable. In 2012, breast cancer was the leading cancer among the female population in the majority of countries in Africa and is responsible for one in four diagnosed cancers and one in five cancer deaths in women worldwide.

Perampanel is currently licensed in South Africa only for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Across Africa, the prevalence of epilepsy varies between 2.2 to 58 cases per 1000 people, with an average prevalence of 15.8 per 1000. The World Health Organisation estimates that in Africa, epilepsy directly affects 10 million people.

Lenvatinib is not currently registered in any of the 10 countries. In Europe, lenvatinib is licensed for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine. DTC is the most common form of thyroid cancer. Overall annual incidence globally is about 1/10,000, and the incidence appears to be increasing.

Benjamin Miny, managing director, South Africa, Clinigen, said: “This agreement builds on the strong partnership we have with Eisai in providing access to medicines.”

“We are able to leverage our extensive distribution network in the region and local expertise to enable access to these important medicines, helping to address the unmet medical needs of patients and their families across southern Africa.”