EUSA Pharma discusses its innovative approach to sourcing multi-use oncology therapeutics, enabling patients to embrace life and proving a clear competitor in the therapeutics market.
EUSA Pharma is a rapidly growing commercial stage oncology company, focused on bringing innovative drugs to market in defined, therapeutic oncology niches. Since its formation in March 2015, the company has quadrupled its head count, signed a string of deals and won European approvals for two oncology therapeutic products. The focus for the company now is to continue expanding its portfolio, as well as extending its capabilities into clinical development.
EUSA Pharma was founded by a private equity-led management buyout, which gave the independent pharmaceutical company 30 full-time employees and Jazz Pharmaceuticals’ critical care portfolio. This pipeline of commercialised products includes Caphosol, Xenazine, Collatamp, Custodiol and Fomepizole.
Continuing its success, EUSA Pharma’s business development team then made three striking oncology deals within a 12-month period, which included the acquisition of Fotivda (tivozanib) and Qarziba (dinutuximab beta), both of which were approved by the European Medicines Agency (EMA) in 2017. These approvals have driven a dramatic expansion of the company at its UK headquarters and through affiliates in the USA, as well as across Europe.
This rapid transformation is testament to EUSA Pharma’s ability to compete against other mid- to large-sized pharmaceutical companies and pharmaceutical giants. Oncology drugs that are close to approval, or are already marketed, are the most attractive and the most sought after assets in the industry. Many companies are willing to pay large sums of money to acquire assets, such as those observed with the recent trend in checkpoint inhibitors and CAR-T cell therapies. As a result, EUSA Pharma was able to strike three transformational deals in quick succession.
The company pulled off the series of coups by leveraging its key advantages over competitive rivals – speed and flexibility. EUSA’s application of a lean, biotech-style approach to business development activities has allowed it to make the best use of its resources and move quickly to assess and, subsequently, seize opportunities, proven by one of the quickest deals they have made yet; their global rights deal with Qarziba saw the agreement signed in just 76 days.
The ability of the company to size up, negotiate and sign deals rapidly is reliant upon the importance of co-operation between internal teams, especially in the run up to the deals, which also meant that EUSA Pharma maintained momentum once it acquired rights to the assets. This was clearly a positive for Fotivda, allowing a smooth transition from acquisition to filing for approval in the European Union. EUSA Pharma’s manufacturing, commercial and medical staff was ready to support the launch of the drug, once approved.
The success of this strategy is evident in the list of companies that have won approvals for new cancer drugs in Europe in 2017. The EMA approved ten oncology 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 appear.
Green light to run trials
The acquisitions and approvals of these novel therapeutics played to EUSA Pharma’s established strengths in 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 have largely refrained from clinical development activities. However, the potential of the oncology drugs acquired by EUSA Pharma has led them to reconsider this approach. The known mechanisms of action in relation to Qarziba and Fotivda suggest that these drugs will help patients suffering from a number of indications, thus EUSA Pharma is initiating clinical trials to increase the clinical applications of these drugs.
A targeted approach
Qarziba is an anti-GD2 chimeric monoclonal antibody that was originally developed for the treatment of paediatric neuroblastoma. Its approval gives physicians across Europe access to an essential tool that can enable more children to successfully defeat this disease. GD2, the target antigen of Qarziba, is highly expressed by tumour cells and makes an attractive target for immunotherapy. The preferential expression of GD2 on tumour cells – compared with healthy cells and tissues – means that neuroblastoma cells are sensitive to antibody-mediated destruction by the patient’s immune system, whilst the negative effects of off-tumour targeting are minimised. GD2 is also expressed on a multitude of neuroectodermal solid tumours, including many with low availability of treatment options and poor therapeutic outcomes. Therefore, Qarziba could potentially be used to treat other cancers that also express GD2, such as:
- Glioblastoma; and
EUSA Pharma is now initiating clinical development of Qarziba in further selected indications.
A strategy for R&D
EUSA Pharma has an equally compelling mechanistic rationale for the development of Fotivda for additional indications. Fotivda is an oral selective vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor (TKI) that blocks the signalling activity of VEGFs. By doing this, Fotivda cuts off the blood supply that promotes angiogenesis, thereby starving cancer cells of the blood and nutrients which they need to survive.
Kidney cancer is the seventh most common cancer in Europe, where renal cell carcinoma was the most common form of kidney cancer, accounting for 80% of all kidney cancers. Fotivda has demonstrated a good efficacy and safety profile in renal cell carcinoma, but the drug’s mechanism suggests that it could be used to treat a range of other 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.
Investing for the future of clinical development
Encouraged by the strong scientific rationale for the use of Fotivda and Qarziba to treat a range of oncology indications, 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 indications; and
- Oncology indications that are underserved by existing treatment options.
In branching out to 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 organisation capable of competition with larger rivals in the R&D, business development and commercial spheres, with goals of making its products globally available, thus enabling patients to embrace life.
Head of Business Development
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