EUSA Pharma has grown rapidly over the past three years. Since spinning out of Jazz Pharmaceuticals in 2015, the company has tripled its head count, signed a string of deals, and won approvals for two cancer drugs. Now, EUSA Pharma is expanding into clinical development to bring its drugs to more patients in more indications.
EUSA Pharma was founded by a private equity-led management buyout, which gave the independent speciality pharma company 30 full-time employees and Jazz Pharmaceuticals’ commercial critical-care portfolio. EUSA Pharma’s business development team then focused on striking transformational deals for oncology assets, and the company went on to acquire three cancer products within a 12-month period.
This rapid transformation is testament to EUSA Pharma’s ability to compete against far larger companies. The types of products targeted by the company’s business development team—cancer drugs that are on the market or close to approval—are the most sought-after assets in the industry. Many huge, global companies want to acquire such assets and are willing to pay large sums of money to do so. Yet, EUSA Pharma was able to strike three deals in quick succession.
EUSA Pharma pulled off the series of coups by leveraging its key advantages over big rivals: speed and flexibility. In applying a lean, biotech-style approach to its business development activities, EUSA Pharma made the best use of its resources and moved quickly to assess and seize opportunities. In practice, this meant EUSA Pharma was able to size up, negotiate, and sign a global deal for Qarziba (dinutuximab beta) in 76 days.
Importantly, cooperation between the business development, regulatory, pricing, and manufacturing teams in the run-up to the deals meant EUSA Pharma maintained momentum once it acquired rights to the assets. In the case of Fotivda (tivozanib), this cooperation ensured that the file for approval in the European Union proceeded smoothly and that EUSA Pharma’s manufacturing, commercial, and medical staff and capabilities were ready to support the launch of the drug once it was approved.
The success of this strategy is evident in the list of companies that won approval for new cancer drugs in Europe in 2017. The European Medicines Agency approved ten such drugs. EUSA Pharma accounted for two of the approvals, making it one of the most prolific cancer drug developers in Europe. Big companies such as Roche and Pfizer trail EUSA Pharma on the list, while other household names do not even appear on it.
Running trials to expand access
The acquisitions and approvals of the cancer drugs played to EUSA Pharma’s established strengths in the regulatory and commercial environments. These are the capabilities that have underpinned the company’s success.
Historically, EUSA Pharma and its investors have focused on these core strengths and largely kept away from clinical development. However, the potential of the cancer drugs acquired by EUSA Pharma has led it to reconsider this approach. The known mechanisms of action of Fotivda and Qarziba suggest that these drugs will help patients in a number of indications, and thus EUSA Pharma is initiating clinical trials to expand patient access..
Qarziba is an anti-GD2 chimeric monoclonal antibody that was originally developed for use in neuroblastoma patients. The antibody attaches to GD2 expressed by tumor cells and orchestrates an immune attack on the cancer. This makes Qarziba an effective treatment for neuroblastoma and potentially other cancers that express GD2, such as sarcomas, glioblastoma, and melanoma.
EUSA Pharma has an equally compelling mechanistic rationale for the development of Fotivda for additional indications. Fotivda is an oral tyrosine kinase inhibitor that blocks the activity of vascular endothelial growth factor (VEGF) proteins and thereby cuts off the blood supply that cancers need to grow. Fotivda has demonstrated efficacy in renal cell carcinoma but the drug’s mechanism suggests it can treat a range of cancers. The development of a treatment for soft tissue sarcoma, a cancer in which VEGF is a validated target, is part of EUSA Pharma’s research and development (R&D) strategy.
Encouraged by the strong scientific rationale for the use of Fotivda and Qarziba to treat a range of cancers, EUSA Pharma is now investing in clinical development. In doing so, EUSA Pharma aims to get its drugs to as many patients in as many indications as possible. The list of indications targeted by EUSA Pharma includes rare pediatric cancers and cancers that are underserved by existing treatment options.
In branching out into clinical development, EUSA Pharma is applying the lean, flexible approach that has served it so well in the commercial and regulatory sectors. The result is the evolution of EUSA Pharma into a unique organization capable of competition with larger rivals in the R&D, business development, and commercial spheres, and with goals of making its products globally available and enabling patients to live and embrace life.