Novasep, a leading supplier of services and technologies for the life sciences industry, expands its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities in Le Mans, France. The step is based on customers’ confidence in Novasep’s expertise in the development and production of HPAPIs and antibody-drug conjugates (ADC) and reinforces the company’s position as a leading Contract Development and Manufacturing Organisation (CDMO) for the production of innovative and targeted anti-cancer agents.

We are pleased to continue our development in strategic markets such as HPAPIs and ADCs, and to participate in the fight against cancer for the benefit of patients. Specifically, this expansion allows us to create more than 30 full-time jobs in Le Mans,” noted Michel Spagnol, Ph.D., Chairman, and Chief Executive Officer of Novasep.

Michel Spagnol, Chairman and Chief Executive Officer of Novasep. Photo courtesy: © 2018 – 2021 Novasep. used with permission.

Partnerships
According to Novasep, activities at the facility in Le Mans, which has already benefitted from significant investment, continues to exhibit strong growth as a result of longstanding collaborations with major pharmaceutical companies and new partnerships with biotechnology innovators.

To support this growth and sustain the increase in both clinical and commercial production capacity, Novasep is recruiting more than 30 people on this site, combined with an investment of more than €4 million (US $ 4.83 million).

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Antibody-drug conjugates
For more than 15 years Novasep has been a key partner in developing and enhancing innovators in the ADC. With a strong pipeline of novel clinical drug candidates being developed with and for their clients, Novasep has contributed to a number of recent ADC drug approvals.

Novasep’s strategy of offering integrated development and manufacturing services for both payloads and bioconjugation is bearing fruit. The state-of-the-art bioconjugation facility, launched in 2017 with an investment of € 12 million, delivers cGMP ADC batches to customers. And earlier this year the facility was successfully inspected by the Agence nationale de sécurité du médicament et des produits de santé (ANSM), the French regulatory drug authorities, demonstrating the company’s ability to offer flexible and reliable manufacturing solutions to oncology drug innovators, leveraging specialist technologies and expertise.

Exceptional growth
Earlier this year Novasep presented its 2020 financial performance and the completion of its Rise-2 strategic plan, which is designed to help the company focused on prioritizing its core business, two years ahead of schedule. The company’s sales revenue amounted to € 394 million (US $ 476 million), while EBITDA reached € 63 million (US $ 76.11).

“These results are exceptional, especially in the context of the health and economic crisis that the world is going through. They reflect the trust and commitment of our customers, the level of confidence our shareholders have placed in us over many years, the relevance of our strategic model, and the remarkable commitment of our employees under extraordinary circumstances, to whom I would like to express my special thanks,” Spagnol noted.

“[Our] operating performance, combined with the business divestments announced in January, [which included] the sale of the Gene Therapy and Viral Vectors* business and the planned sale of our Equipment service line **, will enable the Group to fully deleverage by the end of July.”

Novasep’s new financial situation closes the Rise-2 strategic cycle, which aimed to double the group’s profitability, a full two years ahead of plan. Group management is currently working on the next chapter of Novasep’s strategic development, which will build on new opportunities for growth through acquisitions.

“We are currently finalizing this new strategic growth plan, with the aim of consolidating the Group’s international positions on the pharmaceutical market”, said.

“This new chapter will be strongly consistent with our areas of expertise and technological strength, motivated by the desire to offer innovative therapeutic solutions to our customers and to patients,” he concluded.

* Thermo Fisher has completed the acquisition of Henogen S.A., Novasep’s viral vector manufacturing business based in Seneffe and Gosselies, Belgium, for approximately € 725 million (US $ 876) in cash.
** Acquired by Sartorius Stedim Biotech, a subgroup of the life science company Sartorius.

Featured image: Novasep/fill finish. Photo courtesy: © 2018 – 2021 Novasep. used with permission.

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