Alvogen launches Inflectra in Europe with Hospira

- Inflectra™ is the first biosimilar monoclonal antibody to be approved in Europe

- Launch represents huge step towards affordability of future biologic therapies

- Provides compelling cost saving opportunities to customers within the European Union

- Further strengthens Alvogen’s portfolio in the exciting biosimilar market, a major growth driver for our business

PINEBROOK, N.J.--()--Alvogen, the multinational pharmaceuticals company, today announced the launch of Inflectra™ (Infliximab) into Central and Eastern Europe. InflectraTM, Europe's first biosimilar monoclonal antibody (mAb) therapy that has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis. Alvogen and Hospira formed a strategic partnership in 2011 to provide the highest quality products and services for customers and patients throughout Central and Eastern Europe (CEE). This alliance enables us to provide increased access to the newest biosimilar drugs with state-of-the-art technology.

InflectraTM is a biosimilar medicine to the reference medicinal product, RemicadeTM (Infliximab), and is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. RemicadeTM recorded European sales of over USD 2 billion in 2012.1 Alvogen will market the product in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, and Romania.

Petar Vazharov, Executive Vice President at Alvogen in the CEE region, commented: "We are delighted about the launch of InflectraTM. This product represents a major milestone for our biosimilar portfolio, which has been making great progress since its launch in partnership with Hospira in 2011. Biosimilars offer a huge opportunity for our business in Eastern Europe and with InflectraTM we demonstrate the continued growth we are achieving in this important portfolio. InflectraTM offers a more affordable – but equally effective - treatment option for sufferers of inflammatory conditions, offering compelling cost saving opportunities within the European Union."

Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer of Hospira added: "The rigorous scientific review conducted by the European Medicines Agency and approval by the European Commission confirms that InflectraTM has demonstrated similar quality, efficacy and safety to RemicadeTM. For over a decade, biologic medicines have been pivotal in treating a range of inflammatory conditions, so the launch in Europe of InflectraTM as a biosimilar alternative represents a huge step towards the affordability of future biologic therapies."

The use of biologic medicines has led to vast improvements in the efficient treatment of conditions such as RA and IBD (inflammatory bowel disease), but these drugs are also responsible for some of the highest medicinal costs for many countries.2 The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to €20.4 billion by 2020.3

In partnership with Hospira, Alvogen has been marketing biosimilars in Central & Eastern Europe for a number of years, with great success. Partnering with Hospira gives Alvogen access to a well established biosimilar pipeline. Hospira’s biosimilar portfolio includes Inflectra™ as well as two other currently marketed products in the areas of nephrology and oncology. In addition, Hospira plans to launch a number of new biosimilar monoclonal antibodies, one of which is currently in late stage development. Together, Alvogen and Hospira share the commitment to deliver the highest quality products and services to its customers and patients.

Demonstrating its ongoing commitment to the exciting biosimilar market, Alvogen’s sister company, Alvotech, announced in November 2013 that it would invest $250 million in biopharmaceuticals. This investment includes the building of a state-of-the-art biopharmaceutical development and manufacturing center in Reykjavik, Iceland and a pipeline including six monoclonal antibodies.

About Alvogen

Alvogen is a multinational, privately owned pharmaceuticals company focused on developing, manufacturing and distributing generic, brand, over-the-counter brands (OTC) and biosimilar products. With more than 200 pharmaceutical projects in development and registration, the group’s product portfolio consists of a broad range of leading molecules for the treatment of conditions in the fields of: oncology, cardiology, respiratory, neurology and gastroenterology. Alvogen has commercial operations in over 30 countries with 2,000 employees. North America is Alvogen’s single largest market and other key markets include: South-Korea, Romania, Bulgaria, Hungary, Russia and China. Visit: www.alvogen.com

About Hospira

Hospira Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at www.hospira.com.

References

1 Merck and Co, 2012 Annual Report, available from: http://www.merck.com/investors/financials/annual-reports/. Accessed June 2013.

2 Bendtzen, K. Immunotherapy. 2012; 4(11): 1167-1179.

3 Haustein R. et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal. 2012; 1(3-4): 120-6.

Contacts

Alvogen
Halldor Kristmannsson, 354-522-2900
Global Communications & Media Relations
alvogenpr@alvogen.com
or
Hospira
90TEN Healthcare
Tarnia Ross, +44 (0)20 7627 0990
tarnia.ross@90ten.co.uk
or
James Osborn, +44 (0)20 7627 0990
james.osborn@90ten.co.uk

Robert Wessman is the Chairman and CEO of Alvogen. In Portugese, ''alvo'' means target or goal. It also means exceptionally good, that underlines our commitment to the outstanding quality of our products and services. The latter part of our name ''gen,'' links us to the future generation and our determination to build a top-10 global next-generation pharmaceutical company.(Photo: Business Wire)

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Release Summary

The multinational specialty pharma company Alvogen, is first to market with Inflectra™ (Remicade) in Central and Eastern Europe. Alvogen has commercial operations in 34 countries.

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Contacts

Alvogen
Halldor Kristmannsson, 354-522-2900
Global Communications & Media Relations
alvogenpr@alvogen.com
or
Hospira
90TEN Healthcare
Tarnia Ross, +44 (0)20 7627 0990
tarnia.ross@90ten.co.uk
or
James Osborn, +44 (0)20 7627 0990
james.osborn@90ten.co.uk