Lek, a Sandoz company, today opened a new facility for production of state-of-the-art biopharmaceutical active substances.
The new investment of USD 3.75 million at the Mengeš site represents a further strengthening of Lek within the global Sandoz biopharmaceutical development and production network. Mengeš is one of the three main biopharmaceutical development and production centers within Sandoz worldwide, and a center of excellence for cell culture and modified protein technology.
The new 430 m2 facility will serve as a global supply point for Sandoz modified proteins. Over the years, Sandoz and its parent company Novartis have invested a total of EUR 45 million in biopharmaceuticals in Slovenia – a clear demonstration of corporate confidence in our knowledge and expertise.
Dr. Violeta Gabrijelčič, Head Biopharmaceuticals at Lek, said: “Following the opening of the production for recombinant technologies ¬– PORT 1 – in 2004, and the Development centre in 2007, one of the key milestones in our history was regulatory approval to manufacture epoetin alfa drug substance in Mengeš at the end of 2009. This achievement is a further contribution to reinforcing Sandoz’s position as the global leader in biosimilars.”
Lek Biopharmaceuticals is the only industrial centre for modern, recombinant technology in Slovenia. There are 150 experts working here (pharmacists, chemists, biotechnologists, microbiologists, biochemists), of whom more than one quarter have a PhD or Masters Degree. We offer these Slovenian experts the chance to work in their home country for a major global pharmaceutical company.
“Our endeavours in biopharmaceuticals will have an important impact on health systems going forward. Biologics are an increasingly indispensable part of modern medicine, but are very expensive due to demanding research and development. Biosimilars, pioneered by Sandoz, make these vital medicines accessible to more people. We are proud that all three Sandoz biosimilars (human growth hormone somatropin, epoetin, filgrastim) are available to patients in Slovenia, “ said Zvonko Bogdanovski, member of the Lek Board of Management.
Biosimilars offer comparable quality, safety and efficacy to their reference products, at a more affordable price. The introduction of biosimilars has already led to significant savings in the EU. The European Generic Medicines Association (EGA) estimates that a 20% price reduction on five off-patent biopharmaceuticals can save the EU over EUR 1.6 billion per year.
Sandoz human growth hormone somatropin was the first biosimilar ever to be introduced in the EU (in 2006), followed in 2007 by epoetin alfa (anemia), and filgrastim in 2009 (oncology).
Sandoz is now the only company with three biosimilars on the EU market, including Slovenia –and products on three continents – Europe, North America (US and Canada), and Asia (Japan), as well as Australia.
Ameet Mallik, Head Biopharmaceuticals Sandoz, said at the opening ceremony: “The development and production of biopharmaceuticals is extremely complex and challenging. Sandoz has decades of experience in biotechnology, and this has paved the way for us to pioneer the field of biosimilars – affordable, high quality, follow-on biopharmaceuticals, which are at the vanguard of the ongoing biologics revolution, helping to meet the growing needs of governments, payers, physicians, and patients. With three biosimilars already on the market and an unrivalled pipeline, Sandoz and Novartis are determined to continue leading the way forward.”
Lek, a Sandoz company, is one of the pillars of leading world generics company Sandoz. It operates as a global development center for products and technologies, as a global manufacturing center for active pharmaceutical ingredients and medicines, as a competence center for the development of vertically integrated products, as a Sandoz competence center in the field of development and manufacturing of biosimilar products and as a supply center for the markets of CEE, SEE and CIS, sales Slovenia and sales services for Sandoz global markets. For further information please visit www.lek.si/eng/.
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in more than 130 countries. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and Eon Labs (US). In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion. For further information please visit www.sandoz.com.
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group’s continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit www.novartis.com.
This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.
For further information contact:
Katarina Klemenc Dinjaški
Lek Pharmaceuticals d.d.
Phone: + 386 1 580 22 43
Fax: + 386 1 580 24 32