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

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.

 

Stefan Fraenkel, Chief Executive Officer, Inceptua Group, says:

“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.”

 

Clive Whitcher, Head of Inceptua Pharma, says:

“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.”

 

About Ovarian Cancer

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.

  

About Apealea® (paclitaxel micellar)

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 relapse.8

 

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 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 www.elevartherapeutics.com.

 

About Vivesto AB
Vivesto 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

 

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:

Rosemary Ostmann

Mobile +1 (201) 615-7751

E-mail: Rostmann@rosecomm.com

 

Vivesto Pharmaceutical Media Contact:

Consilium Strategic Communications

Jonathan Birt, Ashley Tapp

+44 (0)20 3709 5700

E-mail: vivesto@consilium-comms.com

 

  1. Apealea Summary of Product Characteristics
  2. American Cancer Society “About Ovarian Cancer.” https://www.cancer.org/cancer/ovarian-cancer/about/what-is-ovarian-cancer.html Accessed November 24, 2020
  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.
  8. Vergote I et al. Gynecol Oncol 2020; 156: 293-300.

0120_NPM_08/22

August 2022

Latest News and Insights

BIO

CEO and Board Member

Stefan Fraenkel

Stefan Fraenkel is the CEO of the Inceptua Group and is also on the Inceptua Board. He has extensive experience in the pharmaceutical industry. Before joining Inceptua, he held senior management positions at Sobi (Swedish Orphan Biovitrum), Sweden’s largest publicly listed specialty pharmaceutical company, leading Marketing & Sales and serving as Head of Corporate Development and Strategy.

Previously, Stefan worked at Pfizer and Wyeth in international commercial leadership roles across Europe and the USA, gaining deep insights into global pharmaceutical markets and strategies. Stefan has also spent part of his career in management consulting. Stefan holds a PhD in International Economics, an MBA, and a BSc in Engineering.

BIO

Member of the Board

Chris Hasslinger

Chris Hasslinger is a Partner of Vesey Street Capital Partners and serves as a member of the Firm’s Investment Committee. He joined VSCP in 2023 and is responsible for sourcing and evaluating new investment opportunities and general portfolio company management. Mr. Hasslinger has nearly three decades of experience in healthcare and technology strategy and deal-making within the industry as well as in investment banking and private equity. He has extensive M&A experience, having closed over $20 billion in transaction value, and has established and structured a number of large commercial partnerships.

BIO

Executive Vice Chairman

Alan Raffensperger

Alan Raffensperger has a robust leadership background in the pharmaceutical industry, having served as CEO of Inceptua and COO of Sobi (Swedish Orphan Biovitrum), along with significant international executive roles at Amgen, Roche, and Pharmacia.

He has also been CEO for venture capital-owned medical device companies, showcasing his versatility in healthcare leadership. Alan’s early career as an advanced life support paramedic provided a strong foundation in emergency healthcare.

He holds an MBA and a BA in Emergency Health Care Management.

BIO

Member of the Board

Blake Goodner

Blake Goodner is a founder member of the investment firm Bridger Capital. He previously worked as a healthcare analyst at Tiger Management and a healthcare investment banker at Morgan Stanley. He currently serves as an advisor and board member for a range of healthcare companies. Mr. Goodner has been a member of the Trinity College Board of Visitors and the Duke Annual Fund Executive Committee. He is a current advisory board member with The Duke Margolis-Center for Health Policy.

BIO

Member of the Board

Adam Feinstein

Adam Feinstein is the Managing Partner of Vesey Street Capital Partners. Mr. Feinstein has 30 years of investment experience exclusively in the healthcare services sector. Prior to founding Vesey Street Capital Partners in 2014, he was a Managing Director on Wall Street and a healthcare industry executive. He held the position of Senior Vice President of Corporate Development, Strategic Investments, and Office of the Chief Executive Officer at LabCorp. Before his tenure at LabCorp, he spent 14 years as the Managing Director in Equity Research at Lehman Brothers/Barclays Capital. Mr. Feinstein is the Chairman of VSCP’s investment committee. He is also actively involved in working with portfolio company executives and sourcing new investment opportunities. At the same time, he oversees all of the firm’s investment activities and employees.

BIO

Member of the Board

Larry Marsh

Larry is a General Partner of Vesey Street Capital Partners and serves as a member of the Firm’s Investment Committee. He joined VSCP in 2016, and currently sits on the Board of QualityMetric, Safecor Health, and HRGi. He is responsible for portfolio company management and for evaluating new investment opportunities. Prior to VSCP, Larry was EVP, New Market Development & Chief Strategy Officer at Fortune 10 AmerisourceBergen. Prior to that, Larry was the #1 ranked Healthcare Technology & Distribution analyst on Wall Street for over a decade, at Barclays, Lehman Brothers, Salomon Smith Barney, and Wheat First Butcher & Singer. Larry worked with Adam, Bryan, Dan, and Joe at Barclays and Lehman. Larry received a B.S. in Economics & Management as well as an M.B.A. from the University of Richmond, and an M.P.H. from Columbia University.

BIO

Member of the Board

Heyward Donigan

Heyward Donigan is a seasoned healthcare CEO, Board Member, and Private Equity Advisor with broad industry experience and a track record of profitable growth. From 2019 to 2023, Ms. Donigan served as Rite Aid’s president and chief executive officer, making her one of the few women CEOs of a Fortune 500 company. While at Rite Aid, Ms. Donigan led the company to through a major brand, merchandise and technology transformation, debt reduction/refinancing, while also leading the company through a pandemic. Ms.Donigan is currently a strategic advisor to Vesey Street Capital Partners, Arima Health, and a board member of OnMed.

BIO

Executive Chairman

Doug Cook

Doug Cook is the Executive Chairman at Inceptua. Mr. Cook began his career driving the early success of Livingston Healthcare, leading to the purchase by UPS to become what is today UPS’s Global Healthcare business. After Livingston Healthcare, Mr. Cook moved to AmerisourceBergen (now called Cencora/COR) in 1998 and had an impressive career overseeing most of Cencora’s high growth, manufacturer-facing business. Mr. Cook ultimately served as the Executive Vice President, President Commercialization and Animal Health for COR.

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