Healthcare Industry News:  paclitaxel 

Biopharmaceuticals Oncology Licensing

 News Release - December 28, 2020

Elevar Therapeutics Announces Licensing Agreement with Inceptua Group for Commercialization of Apealea(R) (Paclitaxel Micellar) in Europe

SALT LAKE CITY, Dec. 28, 2020 -- (Healthcare Sales & Marketing Network) -- Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that it has entered into an exclusive agreement with Inceptua Group ("Inceptua") for the distribution and commercialization of Apealea® (paclitaxel micellar) in Europe. Apealea has been authorized by European regulatory authorities for use in the European Economic Area 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.

"We are very pleased to announce our partnership with Inceptua to make Apealea® (paclitaxel micellar) available to patients with ovarian cancer in Europe," said Alex Kim, Chief Executive Officer of Elevar Therapeutics. "Apealea is the only non-Cremophor based paclitaxel treatment approved in Europe for ovarian cancer, providing a treatment option with a higher paclitaxel dose and shorter infusion time without mandatory premedication versus Cremophor-based paclitaxel. Inceptua's proven capabilities to develop and commercialize oncology and orphan treatments in Europe make them the ideal partner to accelerate access to Apealea in this important region. This agreement further propels progress for Apealea development and commercialization, an important step in Elevar's strategy to optimize the value of its portfolio in global markets."

Under the terms of the agreement, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland).

"We are delighted to enter into this agreement with Elevar to commercialize Apealea® (paclitaxel micellar) in Europe," said Stefan Fraenkel, Chief Executive Officer of Inceptua. "We believe there is great potential for Apealea to help patients with ovarian cancer who cannot tolerate paclitaxel formulated with Cremophor, and we look forward to leveraging our established sales force, distribution networks, and market access capabilities to bring this important treatment to patients and healthcare providers throughout Europe."

Apealea® (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received marketing authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in ovarian cancer and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs.i Globally, it is the third most common cancer among women and has the highest mortality rate.ii,iii 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 significantly.iv,v 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 prognosis.vi

About Apealea® (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a toxic 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 Elevar Therapeutics

Elevar Therapeutics (formerly LSK BioPharma) 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 is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). 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 and South Korea, and additional information is available at www.elevartherapeutics.com.

About Inceptua Group

Inceptua is a specialty pharmaceutical company and a premium global service partner. Inceptua Pharma commercializes and markets orphan and specialty care products and have the expertise and capabilities to supply unlicensed medicines globally. Inceptua Services supports pharma and biotech companies with global clinical trial comparator sourcing, packaging and labelling solutions, pre-approval and medicines access programs and consulting

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 Media Contact:
Elixir Health Public Relations
Lindsay Rocco
+1 862-596-1304
lrocco@elixirhealthpr.com

Inceptua Media Contact:
Morten Grøn
Vice President, Communications
+45 2556 4781
morten.gron@inceptua.com

i American Cancer Society "About Ovarian Cancer." https://www.cancer.org/cancer/ovarian-cancer/about/what-is-ovarian-cancer.html Accessed November 24, 2020

ii 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.

iii 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.

iv 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.

v 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.

vi 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.


Source: Elevar Therapeutics

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