Capricor Therapeutics与日本制药公司签订了欧洲扩张和领先资产商业化协议-动脉网

EXCLUSIVE: Capricor Therapeutics Inks European Expansion, Commercialization Pact For Lead Asset With Japanese Pharma Firm

benzinga 等信源发布 2024-09-17 09:07

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Tuesday, Capricor Therapeutics Inc CAPR entered into a binding term sheet with Nippon Shinyaku Co., Ltd., a Japanese pharmaceutical company, for the commercialization and distribution in Europe of Capricor's lead asset, deramiocel, for Duchenne muscular dystrophy (DMD).

星期二，Capricor Therapeutics Inc CAPR与日本制药公司日本新屋谷株式会社（Nippon Shinyaku Co.，Ltd.）签订了一份具有约束力的条款清单，用于Capricor的主要资产deramiocel在欧洲的商业化和分销，用于治疗杜兴氏肌营养不良症（DMD）。

DMD is a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles.

DMD是一种遗传性疾病，其特征是骨骼肌，心脏和呼吸肌进行性无力和慢性炎症。

In June, Capricor Therapeutics released three-year results from the ongoing HOPE-2 open-label extension study with CAP-1002 in boys and young men with DMD.

6月，Capricor Therapeutics发布了正在进行的HOPE-2开放标签扩展研究CAP-1002对患有DMD的男孩和年轻男性的三年结果。

According to the results, patients treated with CAP-1002 continued to show benefits after three years of treatment compared to an external comparator dataset of similar DMD patients.

根据结果，与类似DMD患者的外部比较数据集相比，接受CAP-1002治疗的患者在治疗三年后继续显示出益处。

The company also announced the long-term benefits of deramiocel, showing increased cardiac function based on several different measures.

该公司还宣布了deramiocel的长期益处，显示基于几种不同措施的心脏功能增强。

The potential transaction covered by the term sheet is similar to the existing Commercialization and Distribution Agreements with Nippon Shinyaku in the United States and Japan, with an opportunity for global product reach.

条款清单涵盖的潜在交易类似于与日本新亚库在美国和日本的现有商业化和分销协议，有机会实现全球产品覆盖。

In addition, Nippon Shinyaku has agreed to purchase approximately $15 million of Capricor common stock at a 20% premium to the 60-day VWAP.

此外，日本新屋谷已同意以比60天VWAP溢价20%的价格购买约1500万美元的Capricor普通股。

Nippon Shinyaku will purchase around 2.79 million common shares at $5.36 per share.

日本新亚谷将以每股5.36美元的价格购买约279万股普通股。

Capricor will be responsible for developing and manufacturing deramiocel for potential approval in the European Union, the U.K., and several other countries in the region.

Capricor将负责开发和制造deramiocel，以获得欧盟、英国和该地区其他几个国家的潜在批准。

Nippon Shinyaku will be responsible for the sales and distribution of deramiocel in those territories.

Nippon Shinyaku将负责deramiocel在这些地区的销售和分销。

Capricor will also receive an upfront payment of $20 million, additional development and sales-based milestone payments of up to $715 million, and a double-digit share of product revenue.

Capricor还将获得2000万美元的预付款，高达7.15亿美元的额外开发和销售里程碑付款，以及两位数的产品收入份额。

The potential milestones from the combined agreements now total approximately $1.5 billion.

合并协议的潜在里程碑现在总计约15亿美元。

'With the addition of the upfront payment and equity investment, we will be able to extend our runway into 2026 and be well-positioned to advance toward potential approval of deramiocel in the United States and beyond. Furthermore, these funds will provide necessary capital for commercial launch preparations, manufacturing scale-up, and product development for Europe,' said Linda Marbán, Capricor's CEO..

“随着预付款和股权投资的增加，我们将能够将跑道延长到2026年，并处于有利地位，有望在美国及其他地区获得德拉米奥塞尔的批准。Capricor首席执行官琳达·马尔班（LindaMarbán）说，此外，这些资金将为欧洲的商业上市准备、制造规模扩大和产品开发提供必要的资金。。

The company plans to start FDA rolling submission in the 2024 third quarter.

该公司计划在2024年第三季度开始FDA滚动提交。

Price Action: CAPR stock is trading higher by 6.55% to $4.69 premarket at the last check on Tuesday.

价格行动：在周二的最后一次检查中，CAPR股价上涨6.55%，至4.69美元。