Ascendis sells Japanese rights to Skytrofa and two other hormone drugs for $70M upfront

Ascendis Pharma has pocketed $70 million in exchange for the Japanese rights to the FDA-approved long-acting growth hormone Skytrofa and two other hormone drugs.

Beyond the upfront payment, Teijin Pharma has pledged up to $175 million in development and regulatory milestones as well as additional commercial milestones and royalties that could reach up to the mid-20s per cent. In exchange, the Tokyo-based company has secured the rights to use Skytrofa—also known as TransCon hGH—along with TransCon PTH and TransCon CNP to treat endocrinology rare disease in Japan.

“Ascendis has leveraged its innovative TransCon technology platform to create a suite of highly differentiated product candidates with best-in-class potential that complement our existing pharmaceutical portfolio,” Teijin CEO Akimoto Uchikawa said in the Nov. 29 release.

Skytrofa bagged FDA approval in 2021 for children aged one year and older with growth hormone deficiency who weigh at least 25.4 pounds. It marked the first approved pediatric therapy for the condition that can be taken once weekly as opposed to the standard-of-care daily somatropin.

The drug also secured EU approval but has yet to be submitted in Japan. It means that Teijin now has the rights to commercialize the drug in the country along with TransCon PTH and TransCon CNP.

Skytrofa brought in third-quarter revenue of 47 million euros ($52 million) to Ascendis, leading the Danish drugmaker to increase its full-year expectations for the hormone therapy from the 165–170 million euros range ($181–$187 million) to 170-175 million euros ($187–$192 million).

TransCon PTH hasn’t had an easy ride with regulators. The FDA issued a manufacturing-related complete response letter for the company’s adult hypoparathyroidism approval application back in May, although Ascendis resubmitted the request earlier this month on the back of a meeting with the agency. The drug secured an approval in the EU last week, where it will be marketed as Yorvipath.