February 1, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Tokyo, Japan-based Eisai Co., Ltd. announced today that it had inked an exclusive license agreement with HUYA Bioscience International for HBI-8000. The deal covers rights to the compound in Japan, South Korea, Thailand, Malaysia, Indonesia, Philippines, Vietnam and Singapore.
HYUA had headquarters in China, with offices in the U.S., Japan, South Korea and eight locations in China.
HBI-8000 is an oral class I-selective histone deacetylase (HDAC) inhibitor being developed for Non-Hodgkin’s Lymphoma (NHL) and solid tumors. Japan’s Ministry of Health, Labour and Welfare granted the compound orphan drug status.
“This collaboration aligns with Eisai’s drive to contribute to patients in our focused field of oncology,” said Terushige Like, chief product creation officer of Eisai Product Creation Systems, in a statement. “Eisai and HUYA will cooperate to develop and commercialize this HDAC inhibitor which we hope to deliver to the market as a treatment that will fulfill the diverse needs of, and bring about benefits for, patients with cancer and their families.”
The U.S. Food and Drug Administration (FDA) also indicated today that it has approved Eisai’s drug, Halaven, for a rare type of soft tissue cancer, liposarcoma. The drug, which is derived from a marine sponge called Halichondria okadai, was approved in 2010 for advanced breast cancer.
In March 2015, Eisai announced that it had received approval to manufacture and market its drug Lenvima in Japan for unresectable thyroid cancer. The drug was launched in the U.S. in February 2015 for the treatment of thyroid cancer. Eisai projects Lenvima can hit more than $1 billion in annual sales.
The new deal for HBI-8000 has an undisclosed upfront payment, and various milestones payments that could hit $280 million to be paid to HUYA, as well as royalties on net sales. HUYA will handle manufacturing and Eisai will hand commercialization and future development.
“We are delighted to enter into this partnership with Eisai,” said Mireille Gillings, president, chief executive officer, and executive chairman of HUYA, in a statement. “Our excitement about HBI-8000 increases almost daily, particularly as we are also demonstrating important immunological properties for this oral product with exemplary safety. Patients with both liquid and solid tumors will benefit as our precision medicine team develops 8000 to its full potential. The license reinforces our vision of leveraging clinical data generated within Asia using the Tripartite Cooperation Treaty to expand into other countries such as Japan and Korea. Eisai’s global strength in oncology will help ensure the drug’s path to regulatory approval.”
Eisai has been battered recently, primarily due to the lost of patent protection for its Alzheimer’s drug, Aricept, on November 2010. It also lost patent protection for its acid reflux drug, AcipHex.
Eisai has been moderately volatile, although it appears to currently be on an upswing. On Mar. 24, 2015, shares traded for 7,570 Japanese Yen (JPY) or $62.53 US, dropped to 6,684 JPY ($55.21 US) on Oct. 8, rose back to 8,111 JPY ($67 US) on Dec. 29, then dropped to 6,791 JPY ($56.09 US) on Jan. 21. Shares are currently trading for 7,251 JPN ($59.89). Currently 1 Japanese Yen is equal to 0.0083 U.S. dollars.
