Inceptua receives approval of marketing authorization transfer of Apealea® (paclitaxel micellar) for the treat

Dear Editorial Team,

Inceptua Group, a specialty pharmaceutical company and global service partner, has announced that the European Commission and the UK Medicines and Healthcare products Regulatory Agency has approved the transfer of the marketing authorisation for Apealea® (paclitaxel micellar) from Oasmia Pharmaceutical AB to Inceptua AB. Inceptua have the exclusive right to distribute and commercialize Apealea in the EU, Norway, Iceland, Liechtenstein, Switzerland and the UK.

Apealea is approved, in combination with carboplatin, for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Please see below for the full release. If you would like any further information or to talk to an expert from Inceptua, please do not hesitate to contact me.

With best wishes,

Nicole

Inceptua receives approval of marketing authorization transfer of Apealea®
(paclitaxel micellar) for the treatment of ovarian cancer
European Commission and MHRA approves transfer of marketing authorization from
Oasmia Pharmaceutical AB to Inceptua AB

LUXEMBOURG – 14 December 2021 – Life Science Newswire – Inceptua Group – pharmaceutical company and service partner – today announces that the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the transfer of the marketing authorization for Apealea® (paclitaxel micellar) from Oasmia Pharmaceutical AB to Inceptua AB. Apealea is approved in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Inceptua have the exclusive right to distribute and commercialize Apealea in the EU, Norway, Iceland, Liechtenstein, Switzerland and the UK.

Stefan Fraenkel, Chief Executive Officer, Inceptua Group, says:
“We are pleased that the European Commission and MHRA has granted approval for Inceptua to market Apealea, Europe’s first non-Cremophor EL formulation of paclitaxel. With our deep commercialization capabilities and expertise, Inceptua is uniquely positioned to maximize the availability of Apealea for patients with ovarian cancer in this region.”

Clive Whitcher, Head of Inceptua Pharma, says:
“With Apealea, ovarian cancer patients now have a treatment option that provides a shorter infusion time without mandatory premedication. We believe there is great potential for Apealea to help patients with ovarian cancer and we look forward to bringing this important treatment to patients in need throughout Europe.”

On 25 March 2020, Oasmia Pharmaceutical AB and US based Elevar Therapeutics Inc. signed a global strategic partnership deal to commercialise Apealea. On 28 December 2020, Inceptua signed a licence agreement with Elevar Therapeutics Inc. to commercialise Apealea in Europe.

Nicole Anscombe-Cox
nanscombe-cox@lifesciencenewswire.com