dm+d

67735003

Lactation Safety Information

No
No published evidence of safety
Serious adverse effects reported in adults
21 September 2020

New Medicines

ApealeaOvarian cancer - second- or third-line combination therapy

Information

Apealea
New formulation
Inceptua
Elevar Therapeutics

Development and Regulatory status

Launched
Licensed but not launched
None
May 2022
Yes
May 22Available in UK. Price for one 60mg vial = £147.60 [21].
Dec 21European Commission (EC) and the MHRA approve the transfer of the marketing authorization for Apealea from Oasmia to Inceptua. Inceptua have the exclusive right to distribute and commercialise Apealea in the EU, Norway, Iceland, Liechtenstein, Switzerland and the UK [20].
Nov 21Elevar licensed the commercialisation rights of Apealea in Europe to Inceptua Group in Dec 20 [19].
Nov 21Oasmia has a license agreement with the FarmaMondo Group for the commercialisation of Apealea in Russia and the Commonwealth of Independent States (where it is known under the brand name Paclical). This agreement marks the completion of the out-licensing of Apealea globally and Oasmia anticipate the first royalties from partnerships during 2022. Elevar has informed Oasmia that it is reviewing the clinical and regulatory pathway for Apealea in the US in order to maximize the product ’s commercial potential. This may impact the clinical development timelines for Apealea in the US [18].
Nov 21This product is no longer an orphan medicine for this indication in the EU. It was originally designated an orphan medicine on 18 December 2006. Apealea was withdrawn from the Community register of orphan medicinal products in July 2018 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation [17].
Dec 20Oasmia partner, Elevar Therapeutics, enters a licensing agreement with Inceptua Group for commercialisation of Apealea (paclitaxel micellar) in Europe. Elevar has also announced the signing and subsequent launch of a global named patient program with Tanner Pharma, enabling access to Apealea outside the US for eligible patients at the request of a treating physician. Following a series of interactions with the FDA, it has been agreed that the US commercialisation pathway for Apealea will includes two additional studies which will be initiated in 2021, before filing a new drug application (NDA) [16].
Sep 19Company anticipates EU launch in 2020 [15].
Dec 18EC has granted approval of Apealea for treatment of adult patients [14].
Sep 18Recommended for EU approval by CHMP - the full indication is "in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (see section 5.1)." It is proposed that Apealea be prescribed by physicians experienced in the use of anticancer therapies [13].
May 17Oasmia expects list of outstanding questions from EMA after submitting response to first questions in Mar 17 [12].
Jun 16Oasmia included the final PIII study report in the EU filing. Overall survival data from the study will be added to the EU-application and will form the basis for an application for market approval to the US FDA [11].
Feb 16Filed in EU via centralised procedure for treatment of epithelial ovarian cancer in combination with carboplatin [10].
Apr 15Data from the OAS-07OVA (NCT00989131) study will form the basis of an application for market approval to the EMA [9].
Apr 15Oasmia Pharmaceutical announce that the Russian Ministry of Health has approved Paclical for treatment of epithelial ovarian cancer in combination with carboplatin. Launch is expected H2 2015. Russia is Oasmia´s first market for Paclical [8].
Feb 14A licence application has yet to be filed [6].
Feb 14Scientific advice regarding the possibility of submitting an interim report to support licencing was negative. The submission will be made when the study is completed, via the EU centralised procedure [6].
Sep 11Since completing enrollment in the PIII trial, Oasmia has been working on compiling documentation for applications of market authorizations to authorities in Russia, EU, Israel & Turkey [5].
Mar 11Oasmia signs a commercial manufacturing agreement with Baxter Oncology to ensure the large-scale production of encapsulated paclitaxel for the global market [3].
Apr 09Orphan drug status granted by FDA [2].
Nov 07Oasmia enters a licensing & distribution agreement with Orion Corporation for the marketing and sales of encapsulated paclitaxel in the Nordic region (Sweden, Denmark, Norway, Finland & Iceland) [3].
Sep 07PIII trial started in Sep 07 in EU [1].

Category

Tubulin inhibitor
The annual incidence of new diagnosed cases of ovarian cancer is approximately 125 000 women in EU. It is most often diagnosed in women over 50 (2)
Ovarian cancer - second- or third-line combination therapy
Intravenous

Trial or other data

Feb 14PIII NCT00989131 study is complete [7].
Jun 12Interim PIII results meet the EMA clinical criteria for submission of a licence application [5].
Sep 11The PIII study with Paclical reaches enrolment of 650 pts [5].
Aug 11Interim analysis of the ongoing Phase III study in ovarian cancer based on data from ~400 patients. The results pointed towards a favorable efficacy for Paclical® compared to Taxol® [4].
May 11PIII study (NCT00989131) is expected to complete & has enrolled pts from Belarus, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Romania, Russian Federation, Serbia, Slovakia, Sweden & Ukraine [4].
Aug 10Two-thirds of pts had been recruited to the EU PIII study (NCT00989131). Results obtained from this trial will form the basis for regulatory filings in the US & EU in ovarian cancer & the company expects to launch the product in 2012 [3].
Apr 09An EU PIII study is comparing Paclical vs Taxol (paclitaxel) in 650 women with ovarian cancer. A safety objective is to show the superiority of hypersensitivity reactions. Both treatments are being administered in combination with carboplatin. Treatment is being administered in six cycles, with a six-month follow-up. Enrolment will be completed in 2009 [1,2].
Apr 09Paclical is paclitaxel encapsulted in a retinoid compound called XR-17, making it water soluble. It does not require premedication and lacks Cremophor associated side effects. The main indication is ovarian cancer. Other planned indications are malignant melanoma and NSCLC [2].

Evidence based evaluations