On December 11, 2018 PharmaMar (MSE:PHM) reported the Australian Regulatory Agency (TGA) has informed STA that Aplidin (plitidepsin) has been approved for the treatment of multiple myeloma in combination with dexamethasone (Press release, PharmaMar, DEC 11, 2018, View Source [SID1234532007]).

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Aplidin will be available to patients who have failed or are resistant to other therapies, after the TGA decision to approve Aplidin before any other country.

The indication has been approved for the treatment of patients that relapse after three lines of treatment, including proteasome inhibitors or immunomodulators. It can also be administered as 3rd line treatment, when the patient has already received two prior lines and is refractory or intolerant to proteasome inhibitors or immunomodulators.

This approval opens the door to many other markets in South America, Mexico, Canada, Asia Pacific, Middle East and North Africa, among others, that will review Aplidin after TGA’s decision, and where PharmaMar has partners for this product.

PharmaMar signed a licensing agreement with Specialised Therapeutics Asia Pte, Ltd (STA), established in Singapore, to market Aplidin in Australia and New Zealand in August 2015, along with a new agreement for 12 other Asian countries in February 2016.

Professor Andrew Spencer, Head of the Malignant Haematology and Stem Cell Transplantation Service at The Alfred Hospital, 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."

Professor Jeff Szer, Peter MacCallum Cancer Centre and Royal Melbourne Hospital haematologist, 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."

Carlo Montagner, Chief Executive Officer of Specialised Therapeutics Asia, 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 recognizing the great need that exists in multiple myeloma. This disease remains incurable and patients eventually run out of treatment options."

José María Fernández Sousa-Faro, President of PharmaMar, 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."

Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, 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."
In Europe, as already announced, the decision of the European Medicines Agency (EMA) is being appealed to the Luxembourg Court.

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