SINGAPORE and MELBOURNE, Australia, Feb. 2, 2016 /PRNewswire/ -- International biopharmaceutical company Specialised Therapeutics Asia (ST Asia) will supply and distribute a novel oncology drug candidate throughout South East Asia, following an exclusive licensing deal with European pharmaceutical company PharmaMar.
Under the terms of the latest agreement, ST Asia will be allowed marketing and distribution rights to new multiple myeloma compound APLIDIN® (plitidepsin) in key regions including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Papua New Guinea, Philippines, Singapore, Timor-Leste, Thailand, and Vietnam, as well as in Australia and New Zealand.
APLIDIN is a first in class drug currently in development for the treatment of multiple myeloma and a type of T cell lymphoma.
Commercial terms of the agreement are not being disclosed, but PharmaMar will receive an upfront payment, royalties and additional remunerations for regulatory and sales milestones achieved by APLIDIN in these new markets.
PharmaMar will retain production rights and will supply the finished product to ST Asia for exclusive
commercial use in all agreed regions.
APLIDIN is PharmaMar's second anti-cancer drug candidate obtained from a marine organism. The company announced in June 2015 that patient recruitment of the international pivotal Phase 3 trial (ADMYRE) for APLIDIN in refractory/relapsed multiple myeloma was successfully completed.1 Data from this study is expected to be reported later this year.
Specialised Therapeutics Asia Chief Executive Officer Mr Carlo Montagner said the APLIDIN licensing deal was an important step forward as the company expanded operations to include key territories in South East Asia.
"We look forward to working with PharmaMar to ensure this valuable multiple myeloma therapy is available as soon as possible to patients in key South East Asia regions, as well as in Australia and New Zealand," he said.
"APLIDIN may be highly valuable as a new therapeutic for this difficult to treat cancer. While multiple myeloma remains relatively rare, it is an insidious disease with one of the lowest survival rates in oncology. ST Asia has been established to provide new therapeutics like this one to patients where there is a high unmet need."
"APLIDIN is the first step. We look forward to changing the lives of patients affected by a range of diseases – not only in oncology – in these new and important markets."
PharmaMar Chairman José María Fernandez Sousa-Faro said: "We are proud to enter into agreements with laboratories such as STA that enable us to ensure that all patients who need plitidepsin can avail themselves of it. We are firmly committed to advancing in the development of innovative therapies that benefit society."
The total population of South East Asian regions including Australia and New Zealand is put at 650 million, with an estimated 300,000 people living with multiple myeloma overall and between 30,000 and 40,000 new cases of the disease diagnosed annually.
Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international biopharmaceutical company established to provide pioneering healthcare solutions to patients throughout South East Asia, as well as in Australia and New Zealand. The company is a close affiliate of Specialised Therapeutics Australia (STA), which also collaborates with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life changing healthcare solutions to patients affected by a range of diseases. ST Asia is committed to making new and novel therapies available to patients around the world, with a broad therapeutic portfolio spanning oncology, hematology, urology and ophthalmology. Additional information can be found at www.specialisedtherapeutics.com.au.
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical stage programs under development for several types of solid and hematological cancers PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States. PharmaMar fully owns three other companies: GENOMICA, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAI); and two other chemical enterprises, Zelnova and Xylazel. To learn more about PharmaMar, please visit us at www.pharmamar.com
Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death). Plitidepsin is currently in clinical development for hematological cancers, including a Phase III study in relapsed or refractory multiple myeloma, a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
Multiple myeloma is a relatively uncommon type of blood cancer that accounts for 10% of all hematological malignancies and that is caused by malignant plasma cells that very rapidly multiply.2 Normal plasma cells are white blood cells found in the bone marrow that form part of the immune system and produce the antibodies necessary to fight infections.3 Abnormal cells produce a type of antibody that does not benefit the body and accumulate, thus preventing normal cells from functioning properly.
Almost all patients with multiple myeloma progress from an initial, asymptomatic pre-malignant stage to established disease. In 2015, 26,850 new cases will be diagnosed in the US, and about 11,200 people will die of this disease.4 In Europe, there will be 4.5–6.0 out of 100,000 people diagnosed per year.5 In Australia, approximately 1,200 Australians are diagnosed each year.6
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