Positive progress in anti-infectives

Xellia Pharmaceuticals specialises in the development and manufacture of advanced, anti-infective treatments, which are used against serious and often life-threatening bacterial infections. The company’s major investment programme in new facilities in Europe and North America underscores its growing success and innovative product pipeline, which is set to significantly enhance global patient care and convenience. Philip Yorke reports.

With more than 100 years of experience, Xellia is an international, trusted supplier of advanced anti-infective drugs. These are comprised of active pharmaceutical ingredients as well as injectable products. Continuing the company’s on-going success, Xellia is generating a growing pipeline of innovative, value-added, anti-infective medicines that enhance patient care, while providing convenience and ease-of-use for healthcare professionals.

Headquartered in Copenhagen, Denmark, Xellia has a broad global reach with R&D, manufacturing and commercial operations spread throughout Europe, Asia and North America. It is currently investing heavily to expand its sales and manufacturing capabilities in the United States and Europe. Today the company operates five state-of-the-art manufacturing facilities, which are located in Denmark, Hungary, China and the USA. Its Finished Dosage Form facilities are located in Denmark and the US. Xellia Pharmaceuticals is wholly owned by Novo Holdings AS and employs over 1500 professionals worldwide.

New boost to capabilities

Recently Xellia formally opened its new US$ 25 million manufacturing facility at its extensive HQ site in Copenhagen, Denmark, making it the company’s largest global production facility. The latest state-of-the-art facility houses the most advanced sterile manufacturing equipment and containment solutions in a modern, purpose-built environment.

Xellia’s impressive Copenhagen site is responsible for manufacturing, stability testing and packaging of both sterile active pharmaceutical ingredients (APIs) and the finished dosage forms (FDFs) for anti-infectives such as vancomycin and colistmethate sodium. Today anti-microbial resistance is one of the world’s most serious threats to human health and Xellia’s speciality anti-infective medicines are often used as the last line of defence, in situations where all other medicines have failed.

This new upgraded facility will ensure that Xellia is able to continue to provide a reliable supply of injectable and anti-infective critical care medicines and keep at the forefront of manufacturing excellence.

In addition, expanding production capacity for its sterile injectable products in the US in Cleveland and Ohio has added yet further to its global manufacturing capabilities. In Europe, completion of the company’s 3000 square metre multi-storey Centralised Laboratory Service building in Budapest provides additional product stability and further release-testing expertise.

Xellia is also significantly expanding its product and innovation R&D teams with more than 15 new scientists recently joining its new, purpose-built Centre of Excellence in Zagreb, Croatia. This centre is providing exciting new solutions for improving efficacy, safety

and the delivery of existing anti-infectives, as well as focusing on the reduction of any toxic side effects. The company’s new site in Zagreb is developing a range of novel drug-device combinations for its anti-microbial therapies.

Pioneering innovative formulations

In September 2018, Xellia Pharmaceuticals and Leukocare AG entered into a global strategic partnership, in which both companies plan to collaborate closely to develop innovative and superior formulations. This will support the further development of Xellia’s pipeline of value-added antibiotic and anti-fungal products, all of which are designed to enhance patient care and provide positive outcomes.

Under the new agreement, Leukocare will work closely with Xellia’s team of new product development experts and apply its propriety SPS (stabilising and protective solutions) formation technology platform to discover novel liquid formulations for multiple anti-infective products that will expand Xellia’s antibiotic and antifungal product portfolio. Leukocare on the other hand will receive licence fees, formulation development funding, plus royalties on future product sales.

Aleksandar Danilovski, CSO and Senior VP Global R&D and Regulatory Affairs at Xellia said, “Having access to Leukocare’s SPS® technologies and formulation development expertise strongly compliments our own in-house product innovation and development skills and capabilities. The partnership supports our long-term product development strategy of transitioning lyophilised products into liquid formulations. In addition to extending our product offering, liquid formulations will provide improved convenience and ease of use for healthcare professionals and extend improved patient care. Based upon our previous working relationship with Leukocare, we are convinced that our strategic partnership will achieve the desired outcome.”

Michael Scholl, CEO at Leukocare, commented, “We are very pleased to enter this strategic partnership with Xellia, a world-leading developer and supplier of numerous important anti-infective products. We are looking forward to supporting our strategic partner in its product development, thereby facilitating Xellia to develop and launch its new pipeline of value-added anti-infective products for global markets.”