Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Files An 8-K Entry into a Material Definitive Agreement
Item 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 Companys
lead, novel, oral Selective Inhibitor of Nuclear Export (SINE)
compound, as well as KPT-8602, the Companys 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 Onos 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 Onos Manufacturing
Election, the Company will furnish clinical supplies of drug
substance to Ono for use in Onos 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 Companys 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 Companys 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. |
(d) |
Exhibits |
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| 99.1 |
Press release issued by Karyopharm Therapeutics Inc. on October12, 2017 |
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.
