Arena signs deal with United Therapeutics; Sanofi gets positive EMA opinion on rare disease drug

By PharmaCompass

2018-11-22

Impressions: 112 Article

There was lots of activity in the field of new drug development. Last week, Arena Pharmaceuticals Inc sold rights to develop and sell its pulmonary arterial hypertension (PAH) treatment — Ralinepag — to United Therapeutics Corp for US$ 1.2 billion.

The money, according to Arena Pharma, will help it prepare for the eventual launch of its bowel disorder drugs. The deal involves an upfront payment of US$ 800 million, and US$ 400 million in milestones.

United Therapeutics is a great partner for Ralinepag since it has substantial exposure to the PAH space. With its wide range of dosage options, Ralinepag could be used to treat several types of patients. It could, in fact, become a first-line treatment over some of the company’s existing treatments.

“The size and structure of the deal would put this company in a completely different trajectory as we develop etrasimod and olorinab,” Arena’s chief executive officer Amit Munshi said. Etrasimod is Arena’s experimental treatment for ulcerative colitis, while olorinab is being tested in a mid-stage trial as a treatment for pain associated with inflammatory bowel disease.

This is the second PAH agreement United Therapeutics has signed in recent months. In September, it struck a deal with Mannkind Corp to develop and sell dry powder treprostinil, an experimental treatment for the same condition.

Meanwhile, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of fexinidazole, the first all-oral treatment for sleeping sickness.

This approval is a result of clinical trials led by DNDi, a non-profit research and development organization, and an application submitted by Sanofi. The decision paves the way for the distribution of fexinidazole in endemic countries in 2019.

Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal. Transmitted by the bite of a tsetse fly, it causes neuropsychiatric symptoms; including aggression, psychosis, and a debilitating disruption of sleep patterns that have given this neglected disease its name. About 65 million people in sub-Saharan Africa are at risk.

Fexinidazole is the first all-oral treatment that works both for the early stage of the disease as well as the second stage of the disease in which the parasites have crossed the blood-brain barrier, causing patients to suffer from neuropsychiatric symptoms.

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