Eli Lilly and United Therapeutics extend licence agreement
Pharmaceutical company United Therapeutics and Eli Lilly have extended and amended a nearly decade-long licence agreement covering Adcirca (tadalafil).
Adcirca is a treatment for pulmonary arterial hypertension.
According to a Securities and Exchange Commission filing on May 17, one of the purposes of the amendment was to change its economic terms following a patent expiry in November 2017.
Under the agreement, Eli Lilly had granted the company an exclusive licence for the right to develop, market, promote and commercialise Adcirca.
The agreement originally provided that it would be terminated upon either the expiration, lapse, cancellation, abandonment or invalidation of the last claim to expire within an Eli Lilly patent or the expiration of any government-conferred exclusivity rights, whichever was later.
Eli Lilly has two additional patents expiring in 2020 that cover the drug, however the Patent Trial and Appeal Board (PTAB) has issued a final decision finding these patents invalid after instituting inter partes review proceedings initiated by Actelion Pharmaceuticals.
Eli Lilly’s appeal of the PTAB decision is pending at the US Court of Appeals for the Federal Circuit.
The company has previously said that it is likely to face competition from generic companies after the expiration of the patent in November.
According to the filing, the Food and Drug Administration has approved Abbreviated New Drug Applications filed by at least two generic companies that intend to market Adcirca generics.
The licence agreement has been extended until 2020, meaning that United will continue to market and sell branded Adcirca, even if generic competition enters the market.
The amendment will become active in December 2017, and United will pay Eli Lilly a 10% royalty on net product sales of the drug.
United will also pay a milestone amount of $325,000 for each $1 million made in net product sales.
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