OSAKA, Japan, June 24, 2019 - Shionogi & Co., Ltd. (hereafter "Shionogi" or “the Company”) announces that the Company has concluded an agreement with Eddingpharm (hereafter “Eddingpharm”) to license-out lusutrombopag, a thrombopoietin receptor agonist (brand name in Japan: MULPLETA®).
There are a large number of adult patients with chronic liver disease in China, and some patients are said to be planning to receive elective invasive therapy. On the other hand, the country faces a chronic shortage of blood for transfusions due to a growing demand for blood during advanced higher-level medical care, in addition to a lower rate of voluntary blood donation as compared to Europe, the U.S., and Japan. Additionally, it is also known that the current stored blood supply in China is at high risk of transfusion-transmitted infections. Under such circumstances, the application of lusutrombopag is a preferable mode of therapy versus platelet transfusion.
Eddingpharm is a pharmaceutical company with mature commercial platform that covers hospitals nationwide specializing in liver disease, blood disorders, and infections where prescriptions of lusutrombopag are expected. Following product approval, it is anticipated that the two parties will further contribute to clinical treatment of patients in China by leveraging Eddingpharm’s broad sales network and Shionogi’s know-how in developing and marketing lusutrombopag globally. With the execution of this agreement, Eddingpharm will be granted with exclusive license right of lusutrombopag in Mainland China, Hong Kong, and Macau while Shionogi will supply the product to Eddingpharm and receive an upfront payment as well as milestone payments according to post-launch sales periods. It is also agreed that the two companies will cooperate on the application for approval. The Company has been proceeding with preparations toward the application for approval of the product in China.
“We are very excited about this collaboration. This collaboration is an important milestone for patients in China living with chronic liver disease, bringing a well-tolerated and effective treatment option for severe thrombocytopenia that facilitates the management of invasive procedures one step closer to these patients.”, said Dr. Isao Teshirogi, President and Chief Executive Officer, Shionogi & Co., Ltd.
Ni Xin, Chief Executive Officer of Eddingpharm, said:“The relationship between Eddingpharm and Shionogi started 12 years ago and I am very pleased to establish this long-term collaboration with Shionogi on Mulpleta. As a pharmaceutical company with 140 years of history, Shionogi has a proven track record in developing innovative products. It’s an honor for Eddingpharm to bring such a high quality medicine Mulpleta to China. We will work closely with Shionogi to launch Mulpleta in China as soon as possible to help thrombopenia patients in need.”
About Lustrombopag
Lusutrombopag, which has already been approved for routine use in the US, EU, and Japan, is an orally active, small molecule agonist of the human thrombopoietin receptor that triggers the production of endogenous platelets.
About Thrombocytopenia in Chronic Liver Disease
Thrombocytopenia is a common complication of chronic liver disease (CLD) and may be caused by multiple mechanisms including splenic sequestration and decreased production of thrombopoietin3. There is evidence that the annual health care cost of a CLD patient with thrombocytopenia is more than three times that of a CLD patient without thrombocytopenia4. In addition to the potential of thrombocytopenia, especially severe thrombocytopenia, to aggravate procedural or traumatic bleeding, it may also significantly complicate routine diagnostic procedures and patient care, such as liver biopsy and medically indicated or elective procedures for cirrhotic patients, resulting in delayed or cancelled curative treatment5.
References
1. Estimated from DM Report, Global Data
2. Estimated from Chronic Diseases Statistical Data in China 2008
3. Datamonitor report
4. Poordd F, et al. J Med Econ. 2012; 15:112-124
5. Hayashi H, et al. World J Gastroenterol. 2014; 20: 2595-2605
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.