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Karyopharm and Promedico, a Member of the Neopharm Group, Enter into an Exclusive Distribution Agreement to Commercialize XPOVIO (Selinexor) in Israel
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NEWTON, Mass. and PETAH TIKVA, Israel, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, and Promedico, a member of the
Neopharm Group, today announced their entry into an exclusive distribution agreement for the commercialization of XPOVIO (selinexor), Karyopharm’s lead SINE compound, in Israel and the Palestinian
Authority.
Under the terms of the agreement, Karyopharm will receive certain prespecified payments and is eligible to receive additional payments if prespecified regulatory and commercial milestones are achieved by Promedico, a fully-owned Neopharm LTD company. Karyopharm is also eligible to receive double-digit royalties on future net sales of XPOVIO in the covered territory. In exchange, Promedico will receive exclusive rights to commercialize XPOVIO in the covered territory and is responsible for all regulatory filings and obligations required for registering XPOVIO. Karyopharm has retained exclusive production rights and will supply finished product for commercial use in the covered territory.
“The addition of XPOVIO fits our portfolio of innovative oncology products designed to treat diseases with significant unmet need,” said Avishay Zlotnik, Chief Executive Officer of Promedico Ltd. “We share Karyopharm’s commitment to cancer patients and believe our deep expertise as one of the largest healthcare distributor groups in Israeli will allow us to effectively bring XPOVIO to the Israeli market.”
“Neopharm companies have a proven track record of successfully commercializing new therapeutics in Israel, making them an ideal partner to further expand the global reach of XPOVIO,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “We look forward to working with their world-class team to bring XPOVIO to cancer patients in need of novel therapies.”
About XPOVIO (selinexor)
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XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. In addition to receiving accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor. A New Drug Application was recently submitted to the FDA seeking accelerated approval for selinexor as a new treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Selinexor has received Fast Track and Orphan designation from the FDA for the patient population evaluated in the SADAL study. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), as a potential backbone therapy in combination with approved therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.
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