Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Files An 8-K Entry into a Material Definitive AgreementItem 1.01.
Effective October11, 2017, Karyopharm Therapeutics Inc. (the “Company”) entered into a License Agreement (the “Agreement”) with Ono Pharmaceutical Co., Ltd., a corporation organized and existing under the laws of Japan (“Ono”), to which the Company granted Ono exclusive rights to develop and commercialize, at its own cost, selinexor (KPT-330), the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export (SINE™) compound, as well as KPT-8602, the Company’s second-generation oral SINE™ compound, for the diagnosis, treatment and/or prevention of all human oncology indications (the “Field”) in Japan, Republic of Korea, Republic of China (Taiwan) and Hong Kong as well as in the ten Southeast Asian countries currently comprising the Association of Southeast Asian Nations (the “Ono Territory”). In addition, upon Ono’s election and the parties’ full execution of a manufacturing technology transfer plan and satisfaction of other specified conditions (the “Manufacturing Election”), the Company will grant to Ono non-exclusive rights to manufacture selinexor, KPT-8602 and products containing such compounds in or outside of the Ono Territory solely for development and commercialization in the Field in the Ono Territory.
Under the terms of the Agreement, the Company will receive an upfront cash payment of ¥2.5billion (US$22.3 million), and the Company retains all rights to selinexor and KPT-8602 outside the Ono Territory. The Company is entitled to receive up to ¥10.15billion (US$90.5million at the current exchange rate) in milestone payments from Ono if certain development goals are achieved and up to ¥9.0billion (US$80.2million at the current exchange rate) in milestone payments from Ono if certain sales milestones are achieved. The Company is further eligible to receive royalties in the low double digits based on future net sales of selinexor and KPT-8602 in the Ono Territory, subject to certain customary adjustments.
The Company is responsible for conducting certain development activities and ongoing clinical trials involving selinexor and KPT-8602 at its own cost and expense. The Company expects to continue all ongoing clinical trials involving selinexor and KPT-8602 as they are currently being conducted. As part of the Agreement, Ono will also have the right to participate in global clinical studies of selinexor and KPT-8602, and will bear the cost and expense for patients enrolled in clinical studies in the Ono Territory. Ono is responsible for seeking regulatory and marketing approvals for selinexor and KPT-8602 in the Ono Territory, as well as any development of the products specifically necessary to obtain such approvals. Ono is also responsible for the commercialization of products containing selinexor or KPT-8602 in the Field in the Ono Territory at its own cost and expense.
Subject to Ono’s Manufacturing Election, the Company will furnish clinical supplies of drug substance to Ono for use in Ono’s development efforts to a clinical supply agreement to be entered into by the Company and Ono, and Ono may elect to have the Company provide commercial supplies of drug product to Ono to a commercial supply agreement to be entered into by the Company and Ono, in each case the costs of which will be borne by Ono.
Each party has also agreed to indemnify the other party from certain liabilities specified in the Agreement.
The Agreement will continue in effect on a product-by-product, country-by-country basis until the later of the tenth anniversary of the first commercial sale of the applicable product in such country or the expiration of specified patent protection and regulatory exclusivity periods for the applicable product in such country. However, the Agreement may be terminated earlier by (i)either party for breach of the Agreement by the other party or in the event of the insolvency or bankruptcy of the other party, (ii)Ono on a product-by-product basis for certain safety reasons or on a product-by-product, country-by-country basis for any reason with 180 days’ prior notice or (iii)the Company in the event Ono challenges or assists with a challenge to certain of the Company’s patent rights.
As previously disclosed by the Company in its Annual Report on Form 10-K for the year ended December31, 2016, the Company is a party to a research agreement with the Multiple Myeloma Research Foundation, or MMRF. Under this research agreement, the Company is obligated to make certain payments to MMRF, including if the Company out-licenses selinexor. The terms of this research agreement do not apply to KPT-8602. In connection with the transactions contemplated under the Agreement, the Company expects that it will be obligated to pay to MMRF approximately ¥225million (approximately US$2.0 million) of the upfront cash payment from Ono, as well as a percentage of any milestone payments from Ono and a mid-single-digit percentage of any royalty payments from Ono. The maximum aggregate amount the Company may be obligated to pay to MMRF under the research agreement is $6.0million.
The Company expects to file the Agreement as an exhibit to its Annual Report on Form 10-K for the year ending December31, 2017. The foregoing description of certain terms of the Agreement is intended to be a summary of the material terms and is qualified in its entirety by reference to the text of the Agreement when filed.
A copy of the Company’s press release announcing the entry into the Agreement is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 1.01. | Financial Statements and Exhibits. |
Karyopharm Therapeutics Inc. ExhibitEX-99.1 2 d458279dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Targeting Disease at the Nuclear Pore Karyopharm and Ono Pharmaceutical Co. Ltd. Sign Exclusive License Agreement to Develop and Commercialize Selinexor and KPT-8602 in Japan and Other Countries in Asia ONO Rights Include Oncology Indications for Selinexor and KPT-8602 in Japan,…To view the full exhibit click here
About Karyopharm Therapeutics Inc. (NASDAQ:KPTI)
Karyopharm Therapeutics Inc. is a clinical-stage pharmaceutical company. The Company is focused on the discovery, development and commercialization of drugs directed against nuclear transport and related targets for the treatment of cancer and other diseases. Its segment is the business of discovering, developing and commercializing drugs to treat cancer and certain other major diseases. The Company has discovered and is developing small molecule Selective Inhibitor of Nuclear Export (SINE) compounds that inhibit the nuclear export protein, XPO1. It lead drug candidate, selinexor (KPT-330), is an orally administered agent for the treatment of cancer indications with unmet clinical need, mainly hematologic malignancies. Its product pipeline includes Verdinexor (KPT-335), an oral SINE compound; KPT-9274, a dual p21-activated kinase 4 (PAK4)/Nicotinamide phosphoribosyltransferase (NAMPT) inhibitor, and KPT-350, a compound in development for the treatment of neurological disorders.