The need for an integrated European developer and manufacturer of complex, differentiated and highly potent products is clearer than ever. Expirations on the patents and/or regulatory exclusivities of highly potent molecules are creating great opportunities, in terms of savings, patient accessibility, and market opportunities for pharmaceutical companies operating in therapeutic areas such as oncology, rheumatoid arthritis, multiple sclerosis, and antivirals.
However, at a time of soaring logistics costs and supply disruption, companies cannot rely on distant partners to help them capture the market. Rather, the industry needs a reliable, flexible, and high-quality European partner capable of serving global markets. Enter ONConcept, an integrated European hub for delivering highly potent complex products, mainly in the oncology field.
"The feedback we are obtaining is extremely positive," Sérgio Simões, Bluepharma Vice-President, said. "People are happy to know there is a project in Europe capable of handling development, supply, and providing a full package of specialized services, particularly concerning the IP landscape, and delivering regulatory and clinical support. We understand the needed flexibility for such low volume products and we offer expertise, reputation, and reliability in an integrated package."
Meeting the Need For Highly Potent Capabilities
The need for an integrated European hub for delivering highly potent complex products is underpinned by recent and upcoming changes in the intellectual property landscape. Between 2020 and 2024, more than 25 highly potent, anticancer molecules could face loss of exclusivity (LoE) in at least one major worldwide market.1 Those products have annual sales of more than $26 billion. Many more products are set to go off patent in the second half of the decade.
Each LoE provides an opportunity to increase savings for patients and governments, namely in cancer treatment. The barriers to realizing those opportunities are high. Dedicated infrastructure is needed to develop and commercially manufacture highly potent drugs.
Bluepharma, Helm, and Welding saw the pressing need for highly potent products, leading them to partner and pool their expertise to create ONConcept. This collaboration potentiates the synergies and strengths of each partner.
Lars Hallmayer, Welding Managing Director, explained. "The benefit achieved by ONConcept's strategy for the care of patients with highly potent complex products is enormous. The cooperative collaboration of this joint venture allows us to pool knowledge and expertise. We are proud to play such an important role in this collaboration to improve health".
Portugal-based Bluepharma operates as a CDMO with all the capabilities needed to develop a medicine from scratch. Together with the German partners Helm and Welding, the collaboration bundles its scientific and regulatory knowledge, enlarges the API sourcing network, offers its own intellectual property service, strengthens the individual market knowledge and access to realize a strong highly potent products’ portfolio made in Europe.
Bluepharma has a new, state-of-the-art, flexible, sustainable, specialized highly potent oral solid production plant in Portugal. This site gives ONConcept a short, closely controlled European supply chain to mitigate risk and insulate its customers from the impact of fast-rising logistic costs. Supply chain costs jumped in 2021 as the world recovered from the pandemic, and continued climbing as energy costs increased this year.2
Why ONConcept Is Set For Success
As of April 2022, less than three years after its formation, ONConcept had built a basket of almost 20 products. The basket includes products such as the blood cancer medicine ibrutinib (Imbruvica®) and breast cancer treatment palbociclib (Ibrance®) that are among the top 20 selling drugs globally.4,5 Like ibrutinib and palbociclib, most of the molecules in the basket are solid dosage forms for oncological indications, with other blockbusters available for licensing including cabozantinib (Cabometyx®), nilotinib (Tasigna®) and olaparib (Lynparza®).
ONConcept has also added a few molecules approved in other indications to the portfolio. Namely, the portfolio features thrombocytopenia and anemia treatment eltrombopag (Revolade®/Promacta®), multiple sclerosis therapy fingolimod (Gilenya®), and standard and extended-release versions of the rheumatoid and psoriatic arthritis medication tofacitinib (Xeljanz®/Xeljanz XR®).
The composition of the portfolio positions ONConcept to provide a steady stream of new opportunities to its partners, with some of the molecules open to off-patent competition today and others having LoE dates for later in the decade. Establishing the stream of opportunities supports ONConcept’s intent to go beyond the license and supply model and explore new business models with various stakeholders with a view to establishing strategic business relationships.
ONConcept's plan is supported by the progress of a state-of-the-art manufacturing facility fully dedicated to highly potent products. The site will be operational in 2022 and produce its first commercial batches by the end of year.
Bernd Stoiber, Member of the Executive Board of Helm: ONConcept is a European partnership by three well established European Companies. Especially for high containment products, typically low volume, you want to be reassured by a reliable supply chain managed by a partner who is easily accessible and approachable. ONConcept stands for European Standards in all aspects.
The range and standard of the equipment installed at the facility is another significant point of difference for ONConcept. Securing a very well-equipped facility with differentiated technologies and advanced analytics, ONConcept can ensure the high quality of the complex products it produces while adopting the best environmental practices and keeping a reduced CO2 footprint.
Forming Strategic Alliances
Worldwide pharmaceutical corporations can now benefit from ONConcept’s integrated offer. ONConcept is working on strategic alliances with multinationals and local companies for a basket of products. Rather than licensing one product at a time, the company will form long-term, multi-molecule alliances. ONConcept will provide the full spectrum of its expertise and capabilities, oriented to serve the needs of its marketing partner, and work with the agility and flexibility to adjust to market or territory dynamics, for example with regard to time to market.
Forming the alliances will move ONConcept toward its goal of being the partner of choice for oncology, supplied from Europe. In the coming years, the strategic alliance wants to become known as a reputable European supplier of highly potent drugs with the capabilities needed to develop, register, and supply complex products, ensuring competitiveness across the product lifecycle. In achieving that goal, ONConcept will unlock major markets for its allies and help to expand access to life-changing medicines in Europe and beyond.
REFERENCES
1. Boyd, B. Inside the market for high-potency APIs - www.dcatvci.org/6145-inside-the-market-for-high-potency-apis
2. Jennifer Smith, P. B. & O’Neal, L. Shipping and Logistics Costs Are Expected to Keep Rising in 2022. The Wall Street Journal (2021)
3. CL.1. MarketWatch - www.marketwatch.com/investing/future/crude%20oil%20-%20electronic
4. Urquhart, L. Top companies by sales in 2021. Nature - www.nature.com/articles/d41573-022-00047-9
5. Shimmings, A. Five Late-Breaking Studies To Look Out For At ASCO. In Vivo - https://invivo.pharmaintelligence.informa.com/IV125094/Five-Late-Breaking-Studies-To-Look-Out-For-At-ASCO.