- Source : Press Release
- Date : 2021-02-15
- Event type : Marketed
- Companies : Clinigen Group plc
Clinigen Partners with Karyopharm to Distribute Xpovio (Selinexor) to Patients Outside of the United States as Part of a Named Patient Program
Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical Products and Services company, has partnered with Karyopharm Therapeutics Inc. (NASDAQ: KPTI, ‘Karyopharm’), to provide XPOVIO® (selinexor) on an unlicensed basis as part of a Named Patient Program, to patients outside the US with multiple myeloma and diffuse large B-cell lymphoma.
Named Patient Programs, also known as Managed Access Programs, provide patients and physicians with access to important medicines that are approved and commercially available in one country but not approved and available in the patient’s own country.
As part of the agreement, Clinigen will manage and facilitate pre-launch, charged-for access to XPOVIO® for 49 in-scope countries across Africa, Asia, Europe, and Central and South America.
XPOVIO® is an oral Selective Inhibitor of Nuclear Export (SINE) medicine. It is approved in the US in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of patients with heavily pretreated multiple myeloma, and as a monotherapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
Healthcare professionals can obtain details about the XPOVIO® Named Patient Program by calling the Clinigen customer service team at 44 1932 824 123 (RoW) or 44 1932 824 100 (UK) or emailing [email protected].
This program is specifically limited to patients with either multiple myeloma or diffuse large B-cell lymphoma.
Patients seeking medical information should contact their physician.
Clinigen Group plc
Peter Belden, Executive Vice President, Services
44 (0) 1283 495 010
Melanie Toyne-Sewell / Phillip Marriage / Nathan Billis
44 (0) 20 7457 2020
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical Products and Services company focused on providing ethical access to medicines with a mission to deliver the right medicine to the right patient at the right time. The Group operates from sites in North America, Europe, Africa and Asia Pacific.
Clinigen now has over 1,150 employees across five continents in 16 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 21 of the top 25 pharmaceutical companies; interacting with over 18,000 registered users across over 115 countries, shipping approximately 6.5 million units in the year.
For more information on Clinigen, please visit www.clinigengroup.com
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for selinexor for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
About XPOVIO® (selinexor)
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. Karyopharm received 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 in this same RRMM indication. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma 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.