Organon launches as a new women’s health focused company

Drugs

Organon begins trading on the New York Stock Exchange (NYSE) under the ticker symbol, OGN, today.

It is also starting out with a large commercial footprint consisting of a direct sales presence in 58 markets, and supply of products to over 140 countries.

It outlined how it will be exploring new opportunities and partnerships across three main pillars. While women’s health will be a core part of the company, it will also be developing the biosimilars and established brands businesses:

  • Women’s Health: Organon has a dedicated team focusing on improving access to contraceptive and fertility products, and a comprehensive education and training program to help women and healthcare professionals understand the choices available to them. It says there is a continued shift toward long-acting reversible contraceptives (LARCs) and a large fertility market with untapped potential driven by changing social demographics.

  • Biosimilars: It says the biosimilars market is dynamic with multiple launch opportunities in the coming years.
  • Established Brands: This portfolio will be reinvigorated to maximize market-leading, well-known brands that span key therapy areas such as cardiovascular, respiratory, pain, bone and dermatology.

Already expanding its footprint in the sphere of women’s health, March this year saw Organon announce its proposed acquisition of Alydia Health, a medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding.

In developing a new R&D approach with women at the center, Simon Nicholson, managing director of Organon UK&ENI cluster [UK, Ireland, Israel, Sweden, Denmark, Norway, Finland, Latvia, Lithuania, Estonia & Iceland], told us the company, in the initial phase, will be “actively listening”​ to healthcare professionals, to women generally about their unmet medical needs to inform its R&D work in this respect.

In terms of those unmet medical needs, Nicholson said they can manifest differently around the world, given the variance in cultures and health systems globally:

There are conditions that affect women specifically – within reproductive health, contraception and menopause – but there are also diseases that disproportionately impact women, and in our work over the past few years, we have learned that women don’t receive the care they deserve, often not through malicious intent. In some cases, women put themselves and their health last in the queue. There are also challenges in terms of access to healthcare for women in certain countries.

“Women are also, though, at a higher risk of developing a stroke than men, they are significantly more likely to develop a UTI than men, and women are going to have to visit their doctor more times to get an initial diagnosis than men. And while there are a wide variety of treatments, of medicines in the menopause space, for example, this is an area where there has been, perhaps, not enough focus, and where there is more opportunity to support women with pre, peri and postmenopausal symptoms. It is an area of real interest for us.

“We believe a women’s health focused company can make a meaningful difference in all of these areas. We will bring to bear solutions that are more holistic and will provide support in other ways. It is not all about the medicines.”

The business will look across academic centers, as well as early and established companies, to find promising drugs, diagnostics and devices to develop its global capabilities in clinical development and patient safety, regulatory and medical affairs.

“We will undoubtedly grow through an R&D focus but also through business development,”​ said Nicholson.

Biosimilars

Females make up 49.5% of the world population; however, they form a larger proportion of the population​ over 60 years, among whom cancer occurs most frequently, and they have a higher incidence and prevalence of autoimmune diseases​ than men, and those are conditions that can be treated by biosimilars.

“Biosimilars are a really important part of our growth strategy; Both that pillar and our established brands business will have a focus on women’s health as well,”​ continued Nicholson.

Growth drivers in Organon’s biosimilars portfolio are expected to include the continued success of RENFLEXIS (infliximab) in the US, the launch of AYBINTIO (bevacizumab) in the EU and HADLIMA (adalimumab) in Canada, as well as the anticipated launch of HADLIMA in the US in 2023.

It will sell these biosimilars and two others in partnership with Korea’s Samsung Bioepis.  

Additionally, Organon said it will partner with more biosimilar manufacturers and it aims to launch new products every one to two years “to enable sustained portfolio growth”, ​according to an MSD hosted presentation early last month.

Currently focused on the immunology and oncology markets for biosimilars, MSD said that Organon will consider other therapy areas “opportunistically”.

  

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