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Ascendis以7000万美元的预付款出售Skytrofa和其他两种激素药物的日本版权

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

Biotech Today | 2024-02-28 | 翻译由动脉网AI生成,点击反馈

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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.

Ascendis Pharma已将7000万美元收入囊中,以换取日本获得FDA批准的长效生长激素Skytrofa和另外两种激素药物的权利。

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..

除了预付款之外,帝人制药还承诺提供高达1.75亿美元的开发和监管里程碑,以及额外的商业里程碑和版税,可能高达20年代中期。作为交换,这家总部位于东京的公司已获得使用Skytrofa(也称为TransCon hGH)以及TransCon PTH和TransCon CNP治疗日本内分泌罕见疾病的权利。。

“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.

帝人首席执行官内川秋本(Akimoto Uchikawa)在11月29日的发布中表示:“Ascendis利用其创新的TransCon技术平台,创建了一套高度分化的候选产品,这些候选产品具有同类最佳的潜力,可以补充我们现有的药物组合。”。

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.

Skytrofa于2021年获得FDA批准,用于一岁及以上体重至少25.4磅的生长激素缺乏症儿童。它标志着第一个被批准的儿科治疗方法,可以每周服用一次,而不是每天服用标准的生长激素。

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.

该药物也获得了欧盟的批准,但尚未在日本提交。这意味着帝人现在有权与TransCon PTH和TransCon CNP一起在国内商业化该药物。

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).

Skytrofa为Ascendis带来了4700万欧元(5200万美元)的第三季度收入,使这家丹麦制药商将其对激素治疗的全年预期从1.65-1.7亿欧元(1.81-1.87亿美元)提高到1.7-1.75亿欧元(1.87-1.92亿美元)。

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..

TransCon PTH与监管机构的合作并不轻松。尽管Ascendis在本月早些时候与FDA举行会议后重新提交了这一请求,但FDA在5月份就公司的成人甲状旁腺功能减退症批准申请发布了与制造业相关的完整回复信。该药上周在欧盟获得批准,将在那里以Yorvipath的名义销售。。

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