04/12/2021

Oncopeptides submits software for conditional promoting authorization of melflufen in the EU

STOCKHOLM, April 16, 2021 /PRNewswire/ — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a world wide biotech firm focused on the enhancement of therapies for difficult-to-treat hematological disorders, these days announces that the Organization has submitted an software to the European Medicines Company, EMA, for conditional internet marketing authorization of melflufen (melphalan flufenamide) in the EU, primarily based on the pivotal phase 2 HORIZON examine in relapsed refractory various myeloma. Pending a beneficial validation from the EMA, melflufen will be subject to a regulatory assessment according to the common timelines.

“Subsequent Oncopeptides´ start in the US, we are broadening our geographical footprint and distributing an application for conditional advertising authorization of melflufen in Europe forward of expectations”, states Marty J Duvall, Main Executive Officer at Oncopeptides. “This important milestone marks the commitment of our group to deliver hope to several myeloma sufferers all around the planet, by way of impressive science”.

“This is vitally important and supports the advancement of a dedicated organization across Europe“, states Andrea Passalacqua, Normal Supervisor Europe, Oncopeptides. “We believe that that melflufen may well address a developing healthcare require in people with relapsed refractory a number of myeloma in Europe. In get to aid carrying out this, we have also released an Early Access Program that delivers eligible people obtain to melflufen in advance of a prospective internet marketing authorization”.

In accordance to the European Medications Company, medicines are suitable for conditional acceptance if they are aimed at dealing with or protecting against seriously debilitating or lifetime-threatening disorders. Conditional advertising and marketing authorizations may be granted if the profit-risk balance of the item is constructive, comprehensive information can be delivered, there is an unmet health care need to have, and the gain to community health and fitness of earning the solution out there outweighs the risks because of to have to have for additional facts.

On February 26th the U.S. Foodstuff and Drug Administration, Fda, authorized PEPAXTO® (melphalan flufenamide), in mix with dexamethasone, for the therapy of grownup people with relapsed or refractory numerous myeloma, who have gained at minimum four prior lines of remedy and whose condition is refractory to at minimum a single proteasome inhibitor, a person immunomodulatory agent, and a person CD38-directed monoclonal antibody.

For far more data, you should get in touch with:

Rolf Gulliksen, World wide Head of Company Communications, Oncopeptides AB
E-mail: [email protected]
Cell cellphone: + 46 70 262 96 28

Linda Holmström, Director of Trader Relations, Oncopeptides AB
E-mail: [email protected]  
Cell cellphone: +46 70 873 40 95

The information and facts in the press release is details that Oncopeptides is obliged to make general public pursuant to the EU Industry Abuse Regulation. The details was submitted for publication, by way of the agency of the get hold of human being higher than, on April 16, 2021, at 08:00 (CET). 

About Oncopeptides

Oncopeptides is a world wide biotech firm focused on the advancement of qualified therapies for tricky-to-take care of hematological ailments. The enterprise employs its proprietary peptide-drug conjugate (PDC) system to build compounds that speedily and selectively supply cytotoxic brokers into most cancers cells. The initial drug stemming from the PDC platform, PEPAXTO® (melphalan flufenamide), has been introduced in the U.S., for the therapy of adult individuals with relapsed or refractory numerous myeloma. Melphalan flufenamide is evaluated in a comprehensive medical analyze software like the global phase 3 scientific tests OCEAN and LIGHTHOUSE. Oncopeptides is producing a number of new compounds which are centered on the PDC platform. The to start with a single is anticipated to enter into medical advancement in 2021.

Oncopeptides has somewhere around 300 coworkers. The worldwide Headquarters is centered in Stockholm, Sweden and the U.S. Headquarters is positioned in Boston, Mass. The enterprise is stated in the Mid Cap section on Nasdaq Stockholm with the ticker ONCO. Extra info is out there on www.oncopeptides.com.

About melphalan flufenamide

Melphalan flufenamide, also recognized as melflufen, is a initially-in-class peptide-drug conjugate that targets aminopeptidases and fast releases alkylating agents within cancer cells. Aminopeptidases are overexpressed in many myeloma cells and are associated with innovative disorder and tumor mutational load. Targeting aminopeptidases results in selective activity in most cancers cells, sparing balanced cells.

In the US, PEPAXTO® (melphalan flufenamide) is indicated in combination with dexamethasone for the procedure of adult clients with relapsed or refractory various myeloma, who have gained at least four prior lines of therapy and whose disease is refractory to at minimum just one proteasome inhibitor, 1 immunomodulatory agent, and one particular CD38-directed monoclonal antibody.

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https://news.cision.com/oncopeptides-ab/r/oncopeptides-submits-application-for-conditional-internet marketing-authorization-of-melflufen-in-the-eu,c3326849

The next data files are out there for obtain:

Source Oncopeptides AB