Apealea® (paclitaxel micellar) is now available in Germany for the treatment of ovarian cancer

LUXEMBOURG – 15 August 2022 – Inceptua Group – pharmaceutical company and service partner – today announced that Apealea® (paclitaxel micellar) has a published national price listing and is now available in Germany for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer in combination with carboplatin.

Apealea is the first Cremophor-free formulation of paclitaxel approved in combination with carboplatin for ovarian cancer1. Inceptua has the exclusive right to distribute and commercialize Apealea in the EU, Norway, Iceland, Liechtenstein, Switzerland, and the UK.

“We look forward to bringing this treatment to patients as we continue our launch of Apealea throughout Europe. We believe there is great potential for Apealea, and the launch in Germany is an important milestone for Inceptua.”

“With the launch of Apealea in Germany, first relapse ovarian cancer patients now have a treatment option that provides a Cremophor-free formulation, reducing the need for mandatory premedication and offering a shorter infusion time.”

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs.2 Globally, it is the third most common cancer among women and has the highest mortality rate3,4. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly5,6. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis7.

Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first Cremophor-free formulation of paclitaxel approved in combination with carboplatin for use in first relapse ovarian cancer1. Apealea is a patented, water-soluble, intravenously injectable formulation that can be given with reduced premedication such as steroids and with a shorter infusion time1. In the pivotal trial OAS-07OVA, Apealea was shown to be non-inferior to Cremophor-based paclitaxel for Progresion Free Suival (PFS) and Overall Survival8. An ad-hoc subgroup analysis suggests a significant benefit of Apealea for PFS in patients with first relapse but not in the small subpopulation with second relapse8.

Inceptua Group is a specialty pharmaceutical company and global service partner. Inceptua Pharma commercializes and markets orphan and specialty care products and have the expertise and capabilities to supply unlicensed medicines globally. The service business units, Inceptua Clinical Trial Supply and Inceptua Early Access, support pharma and biotech companies with global clinical trial comparator sourcing, packaging, labelling, and distribution solutions and strategy, design and implementation of global early access programs (pre-approval, managed access, compassionate use). Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience, and has global operations with local offices across Europe, North America, and Asia. Additional information is available at: www.inceptua.com

Elevar Therapeutics is a rapidly growing, fully integrated biopharmaceutical company whose mission is to elevate treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. With offices in Utah, California, Ireland and South Korea, Elevar has multiple drug candidates in clinical development in multiple oncology therapy areas. In 2020, it licensed European distribution and commercialization of Apealea to Inceptua. Additional information is available at is a specialty pharmaceutical company focused on the development of new therapeutic options for patients suffering from hard-to-treat cancers. It has a growing pipeline of clinical-stage assets targeting late-stage cancers. Vivesto has proprietary drug delivery technology designed to improve solubility, efficacy and safety. Vivesto’s shares are traded on Nasdaq Stockholm (VIVE). To find out more about Vivesto please visit www.vivesto.com

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3. Bray F, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov; 68(6):394-424.

4. Coburn SB, et al. International patterns and trends in ovarian cancer incidence, overall and by histologic subtype. Int J Cancer. 2017 Jun 1; 140(11):2451-2460.

5. Yoneda A, et al. Breast and ovarian cancers: a survey and possible roles for the cell surface heparan sulfate proteoglycans. J Histochem Cytochem. 2012 Jan; 60(1):9-21.

6. Bray F, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov; 68(6):394-424.

7. Minlikeeva, Albina N., et al. “History of hypertension, heart disease, and diabetes and ovarian cancer patient survival: evidence from the ovarian cancer association consortium.” Cancer Causes & Control 28.5 (2017): 469-486.