• Australia's Therapeutic Goods Admin­istra­tion approves APLIDIN (plitidepsin) for re­lapsed / refractory multiple myeloma patients
• APLIDIN will con­tinue to be made avail­able to eli­gible patients via a Compassionate Access Program, pending reim­burse­ment
• APLIDIN is a first-in-class anti-cancer agent approved to treat multiple myeloma, which has one of the lowest survival rates in cancer

Singapore (Press Release) – Australian multiple myeloma patients will have world-first access to a new first-in-class drug developed to treat the disease, fol­low­ing approval by Australian regu­la­tory author­i­ties.

The drug, APLIDIN (plitidepsin) will be avail­able to patients who have failed or are resistant to other ther­a­pies, after the Therapeutic Goods Admin­istra­tion (TGA) de­ci­sion to approve APLIDIN before any other country.

Leading Australian myeloma clinicians are welcoming the de­ci­sion, saying APLIDIN will provide another valuable treat­ment option for patients.

Alfred Hospital Head of the Malignant Haematology and Stem Cell Transplantation Service, Professor Andrew Spencer, said: "APLIDIN provides a chance for some myeloma patients to extend their lives."

"We now have another drug to offer patients who have re­lapsed after being treated with existing ther­a­pies."

"This is important, because once patients become resistant to standard ther­a­pies, there have been very limited treat­ment options."

And Peter MacCallum Cancer Centre and Royal Melbourne Hospital haematologist, Professor Jeff Szer, who was the Australian principal investigator on the pivotal APLIDIN registration study, said APLIDIN had been shown to be effective and well tolerated.

He commented: "More Australian myeloma patients were enrolled into the pivotal inter­na­tional trial of APLIDIN than any­where else in the world.

"These patients in the Phase 3 study known as ADMYRE have now paved the way for others to have access to a new and novel ther­apy."

"This really means that some patients with ad­vanced myeloma have the possibility of im­proved out­comes, when pre­vi­ous ther­a­pies have failed."

Specialised Therapeutics will con­tinue providing APLIDIN to eli­gible Australian patients at no cost via a Compassionate Access Program, prior to national reim­burse­ment.

Chief Executive Officer of Specialised Therapeutics Asia, Carlo Montagner, said Australian regu­la­tory author­i­ties should be commended for ensuring Australian myeloma patients have the first oppor­tu­ni­ty to access this cutting-edge ther­apy.

He commented: "It is not often that Australian patients are the first in the world to access new medicines. In this case, the TGA is at the forefront, with de­ci­sion-makers recognising the great need that exists in multiple myeloma. This disease remains incurable and patients eventually run out of treat­ment options."

The com­pany is pursuing oppor­tu­ni­ties to provide APLIDIN to myeloma patients across South East Asia.

Specialised Therapeutics Asia has exclusive rights to market and distribute APLIDIN in Australia, Singapore and 12 other South East Asian countries under the terms of an exclusive arrangement with European partner, PharmaMar.

APLIDIN was the first drug licensed by Specialised Therapeutics Asia for the broader SE Asian market.

PharmaMar Pres­i­dent, Jose Maria Fernandez Sousa-Faro, said: "This approval for an incurable disease, corroborates the work that the PharmaMar team has done over the years with APLIDIN®. Patients and the medical com­munity will now have a new thera­peutic alter­na­tive with a new mech­a­nism of action, that is dif­­fer­en­t from the prod­ucts cur­rently in use."

Managing Director of PharmaMar's Oncology Business Unit, Luis Mora, added: "The approval of APLIDIN® is a very important step forward for the com­pany. This in­­creases PharmaMar's presence with a second drug on the Australian market and, together with our partners, we are initiating procedures for other markets, such as South America, Mexico, Canada, Asia and Israel."

About APLIDIN® (plitidepsin)

Plitidepsin is an 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 com­bi­na­tion studies in re­lapsed or refractory multiple myeloma, and a Phase II study in re­lapsed or refractory angioimmunoblastic T-cell lym­phoma.

About Multiple Myeloma in Australia

It is esti­mated that around 1800 Australians are diag­nosed with MM every year and 1000 people die.[1] Fewer than 50% of patients survive five-years post diag­nosis.[1]

MM accounts for between 10 and 15% of all haematological malig­nan­cies and is predominately a disease of the elderly, with median age at diag­nosis 65-70 years.[2]

This disease typically causes in­­creased bone osteolysis resulting in pathological fractures, renal failure, hypercalcaemia, immune suppression, in­­creased in­fec­tion risk and bone marrow failure.[2]

Despite sig­nif­i­cant devel­op­ments in frontline, main­te­nance and sup­port­ive ther­apy options, MM remains incurable, with treat­ment refractory relapse eventually occurring in all patients. [3]

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (ST Asia) is an inter­na­tional bio­pharma­ceu­tical com­pany estab­lish­ed to provide inno­va­tive specialist ther­a­pies and tech­nolo­gies to patients throughout South East Asia, as well as in Australia and New Zealand. ST Asia's existing prod­uct portfolio spans on­col­ogy, haematology, neurology, urology and ophthalmology. Additional in­for­ma­tion can be found at www.stbiopharma.com.

About PharmaMar

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.

References:

1. Australian Institute of Health and Welfare (AIHW) 2017. Cancer in Australia 2017. Cancer series no. 101. Cat. No. 100. Canberra: AIHW
2. Palumbo A & Anderson K. Multiple Myeloma N Engl J Med 2011; 364: 1046-1060
3. Ludwig H et al. Survival and years of life lost in different age cohorts of patients with multiple myeloma. J Clin Oncol. 2010 Mar 20; 28(9): 1599-605

Disclaimer

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the com­pany. Moreover, no reliance should be placed upon this document for any investment de­ci­sion or contract and it does not constitute a recom­men­da­tion of any type with regard to the shares of the com­pany.

Source: Specialised Therapeutics Asia.