Innovator in the antibiotic arena Xellia

INNOVATOR IN THE

ANTIBIOTIC ARENA

Xellia is a speciality pharmaceutical company and a global leader in the development and manufacture of active pharmaceutical ingredients (APIs) and finished dosage form products (FDFs), mainly in the antiinfective segment. Philip Yorke talked to Carl Aake Carlsson, the company’s president and CEO, about its latest pipeline products and new delivery system platforms.

Xellia can trace its roots back more than 100 years to a small, apothecary business that was founded by a group of pharmacists in Oslo, Norway in 1903. After initial success with traditional remedies, the company experienced a financial downturn in the 1930s. Under new, visionary management, the company was invigorated and took up production of the new ‘miracle drug’, penicillin and a few other, selected antibiotics, in the late 40s and early 50s. This landmark achievement heralded the beginning of a long and propitious journey for Xellia into manufacturing and sales of a range of fermentation-based and semi-synthetic antibiotics. Xellia is currently a world leading supplier of vancomycin, bacitracin, polymyxin B, colistimethate sodium (CMS) and amphotericin B, in addition to several other antibacterial and antifungal substances and a few corticosteroids.

Xellia is a privately owned company that operates five highly automated, state-ofthe-art manufacturing facilities. These are located in Denmark, Norway, Hungary and China, and work under strict regulatory control with long-standing approvals from all relevant authorities, including the US FDA. The company is also present with sales offices and labs in Chicago, Singapore, Tokyo and Zagreb.

Xellia sales are continuing to grow in the 70 or more countries where it is operational and it currently serves over 700 pharmaceutical and healthcare customers. In order to meet the increasing global demands for new formulations and treatments, the company is developing advanced dosage forms using its own active pharmaceutical ingredients. These comprise innovative, proprietary delivery systems and formulations designed for use in topical, inhaled and injectable applications. Most of the company’s APIs are available both in bulk and as selected FDFs.

Xellia is seeing consistent growth in all areas of its operations, both in its highquality fermented and semi-synthetic APIs as well as in its FDFs and delivery system products. Today, Xellia employs more than 850 people worldwide and in 2012 recorded sales of approximately $ 220m.

Improving antibiotic productivity and quality

In order to provide customers with highquality products at a competitive price, Xellia continuously strives to enhance its processes and to optimise productivity. Key technologies include advanced methods for microbial strain development such as metabolic engineering, as well as fully automated, state-of-the art fermentation and purification processes.

Furthermore, Xellia is developing semisynthetic APIs involving complex, strictly controlled chemical reactions, utilising innovative, route-of-synthesis procedures. The company has particular focus on injectable antibiotics and has established lyophilisation facilities that can handle high product volumes and most vial sizes. This capability has positioned Xellia as one of few ‘one-stop’ providers of injectable FDFs for industrial customers. Expanding product range and market reach

Mr Carlsson said, “In addition to improving our production processes and product qualities, we are continuously expanding our generic API pipeline as well as our FDF offering. As part of our long-term strategy, we are also developing new chemical entities (NCEs) that are related to our current antibiotics. Some of these have proven to be less prone to resistance development than most other, newer drugs and are thus in increasing demand for treatment of life-threatening, multi-resistant infections. As part of our approach we are doing basic research on our production strains and fermentation broths, for which we are receiving governmental research grants.

“We are also developing new delivery systems and have recently entered into a 50/50 joint venture (Pharmaero) with Scandinavian Health Ltd in Sweden, in order to develop products based on a new aqueous droplet inhaler (ADI). This is technically the most advanced proprietary platform system for administration of inhaled FDFs on the market today. The ADI device delivers a slow aqueous aerosol mist as opposed to the traditional dry powder formula, and requires only a fraction of the dosage and very short administration time compared to conventional nebulisers.”

Xellia is furthermore developing a novel proprietary, ready-to-use (RTU) infusion delivery system comprising a multi-department infusion bag that is easy to use and contains both drug and diluents in one dual-chamber presentation. This considerably eases the administration process and reduces medication error within every day hospital environments.

Carlsson added, “We are a truly global operator and are expanding our business by moving into evolving pharmaceutical mar-

SAI

To make a partnership truly deliver, it takes commitment on both sides. At SAI we have been both surprised and delighted with the significant support and effort Xellia has put into the tech transfer which has been a critical factor in completing the validation of one of the most complex small molecules in many years as stated by Xellia themselves.

Also in terms of handling unexpected deviations they have shown maturity and a long term view which has cemented the partnership further.

SAI is proud to part of Xellia’s supply base and considers the collaboration a great example of how an Indian and Western can partner for mutual success.

kets such as Asia and eastern Europe. Until recently these markets were less regulated and considered to be un economical for an operation such as our own; however, today they are catching up to western European standards in many respects, and especially in the field of pharmaceuticals and healthcare.

“With demand for our anti-infective products and treatments increasing year on year we have invested considerable resources in our new, highly automated production facility in Taizhou, China. This adds significantly to our overall global production capabilities and will also provide a stepping stone for our entry into the growing Chinese market itself.”

Global technical support programme

Xellia has its own global technical support team to provide answers on a range of technical issues. These include questions relating to analytical methods, product specifications, production processes and stability data, as well as storage conditions and packaging materials.

Xellia’s Global Technical Support team also accompanies its regional managers to various markets where more complex issues may be discussed on the customer’s premises at their request. n

For further information on Xellia products and services, visit: www.xellia.com