Keywords
Annual report
In 2003, Octapharma obtained approval from the US FDA for intravenous human normal immunoglobulin (IVIg) to treat PID in the USA and began to explore growing its presence in the world’s largest market.
The following year, as part of its expansion strategy, the company launched Octapharma USA Inc. Shortly afterwards, Tobias Marguerre, then responsible for establishing an American subsidiary, sent Flemming Nielsen to the USA to set up operations, finance and logistics functions. Within six months, he was promoted to General Manager and later became President Octapharma USA Inc. and a member of the Octapharma Board. Under his leadership and through the steadfast commitment of the US team, the subsidiary now contributes roughly half of Octapharma’s global sales and continues to experience robust growth.
“My father and I had no hesitation in promoting Flemming to General Manager in April 2005,” says Tobias Marguerre. “His leadership has helped Octapharma become an important and influential player in the US market. We continue to work very closely together, and I look forward to continuing to do so in the future.”
“We were virtually unknown in the USA and our early partners showed significant trust in Octapharma and our team. We were determined to prioritise their needs and worked hard to nurture these early relationships through solid communication and delivery.”
Flemming Nielsen
President, Octapharma USA Inc.
With only one FDA-approved product and negligible brand recognition, the company faced many challenges in those early days. “To say that we faced an uphill climb was an understatement,” explains Tanya Keller, Octapharma USA Senior Key Account Manager. “Back then, we had a skeleton crew out in the field and in the office, nobody knew who we were and sales were really slow. Thankfully, times have changed.”
Octapharma USA’s fortunes began to change when, in 2005, the team secured its first major contract to distribute Octapharma's intravenous immunoglobulin with US Oncology, which has been a key customer ever since.
“We were virtually unknown in the USA and our early partners showed significant trust in Octapharma and our team,” says Flemming. “We were determined to prioritise their needs and worked hard to nurture these early relationships through solid communication and delivery.”
This focus built the solid foundations for Octapharma USA’s growth and underpinned a strong reputation for reliability and integrity. Since then, the business has expanded its portfolio of treatments and continues to build strategic partnerships with patient and professional organisations.
“Back then, we had a skeleton crew out in the field and in the office, nobody knew who we were and sales were really slow. Thankfully, times have changed.”
Tanya Keller
Senior Key Account Manager, Octapharma USA
In the last 20 years, Octapharma USA has achieved many milestones, securing multiple FDA approvals and successfully passing inspections of all Octapharma production sites. Today, Octapharma offers a portfolio of 10 FDA-registered products in the USA.
Octapharma USA is actively pursuing ambitious growth strategies to increase demand for our current portfolio of FDAapproved products and further grow our pipeline through R&D investments in our three therapeutic areas: haematology, immunotherapy and critical care.
A recent notable example is the July 2023 approval for Octapharma’s four-factor prothrombin complex concentrate for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy.
The company’s commitment to patientcentred care has earned Octapharma USA broad industry recognition – notably the R&D Award for Outstanding Innovation in Myositis Research at The Myositis Association 2023 Annual Patient Conference, which acknowledges its remarkable achievement of being the only pharmaceutical company to obtain FDA approval in adult dermatomyositis.
At the heart of these strategies is a strong focus on providing patient-centred care through close collaborations with patient advocacy organisations such as the Immune Deficiency Foundation, The Myositis Association, Hemophilia Federation of America and Hope Charities to ensure patients get access to needed treatments and support throughout their health journey.
Factor My Way® and IgCares® showcase Octapharma USA’s dedication to comprehensive care for patients and caregivers living with bleeding disorders such as haemophilia A and von Willebrand disease as well as PID. These dynamic, complementary, multi-dimensional programmes aim to enhance their healthcare journey by providing tailored resources, a supportive online community, virtual events, and personalised support that focuses on their unique needs and challenges.
Octapharma USA envisions a future not only marked by market growth but also by a broader impact on patients. R&D remain central to these aspirations, with numerous clinical studies under way for FDA approval of ground-breaking therapies in haematology, immunology and critical care.
The Special Projects team drives innovation at Octapharma USA by exploring new business development opportunities through strategic partnerships. The team is responsible for supplying and supporting the use of Octapharma’s plasma proteins in the manufacturing of next-generation biotech and diagnostic products. The team also identifies business development opportunities through strategic research partnerships. One result of these efforts is the partnership with Akron, Inc., which has led to a growing opportunity to supply plasma-based serum for cell and gene therapy manufacturing derived from Octapharma's pooled S/D treated human plasma.
“Our focus on strategic partnerships has allowed us to explore new horizons in the pharmaceutical industry, ensuring Octapharma USA’s position as a trailblazer,” says Vijay Nair, Octapharma USA Senior Director, Special Projects.
Annual report