• 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) …

Outcome of re-examination

London, United Kingdom (Announcement) – On 14 December 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the market­ing authori­sa­tion for the medicinal prod­uct Aplidin, intended for the treat­ment of multiple myeloma. The com­pany that applied for author­i­sa­tion is PharmaMar.

The com­pany requested a re-examination of the initial opinion. After con­sidering the grounds for this request, the CHMP re-examined the opinion, and con­firmed the refusal of the market­ing author­i­sa­tion on 22 March 2018.

What is Aplidin?

Aplidin is a cancer …

Madrid, Spain (Press Release) – PharmaMar (MCE: PHM) has announced the initiation of the re-examination process by the European Medicines Agency (EMA) for Aplidin® (plitidepsin) for the indi­ca­tion of re­lapsed and refractory multiple myeloma.

PharmaMar believes that this novel molecule could become part of the thera­peutic arsenal avail­able for the treat­ment of multiple myeloma in Europe.

It is worth noting that the re-examination procedure is handled by the EMA´s CHMP and usually lasts around 4 months. It concludes with either the con­firmation of the negative opinion or with the issuing of a new …

As ex­pec­ted after the Company announcement of the 8th of November, the Committee for Medicinal Products for Human Use (CHMP), belonging to the EMA, has emitted an opinion against the approval of Aplidin® for the treat­ment of multiple myeloma.

Madrid, Spain (Press Release) – As ex­pec­ted in the announcement made by PharmaMar on November 8th, the Committee for Medicinal Products for Human Use (CHMP) has finally emitted its opinion against the approval of the Marketing Authorization Application (MAA) of Aplidin® (plitidepsin), for the treat­ment of patients with re­lapsed multiple myeloma, in com­bi­na­tion with …

Madrid, Spain (Press Release) – Pursuant to article 228 of the restated text of the Securities Market Law, we hereby inform you of the fol­low­ing SIGNIFICANT EVENT:

Pharma Mar, S.A. announces that based on the pre­lim­i­nary feed-back (“trend vote”) from the European Medicines Agency (EMA) Com­mittee for Medicinal Products for Human Use (CHMP), the Company ex­pec­ts an Opinion recommending against approval of the Marketing Authorization Application (MAA) for Aplidin for the treat­ment of multiple myeloma submitted in October 2016. The formal written de­ci­sion from the CHMP is ex­pec­ted fol­low­ing its December 2017 meeting …

Madrid, Spain (Press Release) – PharmaMar (MSE: PHM) has announced today that the European Med­i­cines Agency (EMA) has accepted to assess the Marketing Authorization Application (MAA) for Aplidin® (pliti­depsin) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of re­lapsed / refractory multiple myeloma (MM).

PharmaMar submitted the above mentioned appli­ca­tion for the antitumor drug of marine origin, Aplidin®, in com­bi­na­tion with dexa­meth­a­sone given the positive results obtained from the ADMYRE study. Plitidepsin could be a thera­peutic alter­na­tive for patients suffering from re­lapsed and/or refractory multiple myeloma.

After this acceptance, the EMA is going to …

Madrid, Spain (Press Release) – PharmaMar (MSE:PHM) has announced today the sub­mission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Aplidin® (pliti­depsin) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of re­lapsed/refractory multiple myeloma (MM). This is a type of blood cancer which rep­re­sents 10% of all hema­to­logical malig­nan­cies.

PharmaMar has gone through with this appli­ca­tion given the positive data obtained from the ran­domized, Phase III ADMYRE clin­i­cal trial, where the efficacy and safety of Aplidin® with dexa­meth­a­sone versus dexa­meth­a­sone alone in patients with re­lapsed/refractory MM after at …