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 – 10 December 2021 – 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.

 

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs.1 Globally, it is the third most common cancer among women and has the highest mortality rate2,3. 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 significantly4,5. 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 prognosis6.

 

About Apealea® (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel that can be given without premedication such as steroids and with a shorter infusion time. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and oesophageal cancer, as well as other types of solid tumour cancers. Cremophor-EL, is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor-EL formulation of paclitaxel approved for use in ovarian cancer. 

 

About Inceptua Group

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

 

About Elevar Therapeutics

Elevar Therapeutics is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidates include rivoceranib (apatinib) and Apealea® (paclitaxel micellar). Rivoceranib, under the name apatinib in China, was developed by Hengrui in China and approved in China as a single agent for treatment of gastric cancer in 2014 and second-line advanced HCC in 2020. It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide in numerous cancer indications. Apealea® (paclitaxel micellar) is a non-Cremophor EL based formulation of paclitaxel that received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has offices in Utah, California, Ireland, and South Korea. Additional information is available at: elevartherapeutics.com

 

About Oasmia Pharmaceutical AB

Oasmia 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. Oasmia’s most advanced program is Apealea (paclitaxel micellar), which is being made available to ovarian cancer patients through a partnership with Elevar Therapeutics, Inc. Other development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Oasmia’s proprietary drug delivery platform XR-17™ is designed to improve drug solubility, efficacy and safety. Oasmia’s shares are traded on Nasdaq Stockholm (OASM). To find out more about Oasmia please visit: oasmia.com

 

For further information, please contact:

 

Inceptua Media Contact:

Morten Grøn, Vice President,  Corporate Communication

Mobile: +45 2556 4781

E-mail: morten.gron@inceptua.com

 

Elevar Media Contact:

Elixir Health Public Relations

Lindsay Rocco

(862) 596-1304

E-mail: lrocco@elixirhealthpr.com

 

Oasmia Pharmaceutical Media Contact:

Consilium Strategic Communications

Jonathan Birt, Chris Welsh, Ashley Tapp

+44 (0)20 3709 5700

E-mail: oasmia@consilium-comms.com

 

 

  1. American Cancer Society “About Ovarian Cancer.” https://www.cancer.org/cancer/ovarian-cancer/about/what-is-ovarian-cancer.html Accessed November 24, 2020
  2. 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.
  3. 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.
  4. 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.
  5. 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.

6. 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.

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