H. Lundbeck A/S (Lundbeck) today announces that the European Commission has issued a Statement of Objections to Lundbeck. The Statement of Objections is regarding agreements concluded with four generic competitors concerning citalopram.
A Statement of Objections does not represent the European Commission's final decision. Any final decision by the Commission is appealable to the European Courts (General Court and then the European Court of Justice). The whole process could take several years to reach a conclusion.
It is Lundbeck's view that the Group's business practices are consistent with all relevant national and EU competition legislation.
"Lundbeck's policy is to comply with all applicable laws, including Competition Laws, and this policy is taken very seriously by the company and its employees", says Mette Carlstedt, Senior Vice President, Corporate Legal at Lundbeck.
Lundbeck will now carefully review the Statement of Objections and the European Commission's preliminary findings, and will then submit a reply to the Statement of Objections in order to address the concerns that have been raised. Lundbeck is cooperating fully in the Commission's investigation.
At this time, Lundbeck has nothing further to add; except that it is confident the allegations made by the Commission should be rejected as groundless.
In 2008, the European Commission initiated a wide-ranging sector inquiry of the pharmaceutical industry to review possible anti-competitive conduct. In 2010, the European Commission opened a formal investigation against Lundbeck to investigate possible infringement of European competition law relating to restrictive business practices and abuse of a dominant market position. Specifically, the Commission has investigated whether Lundbeck's agreements with generic manufacturers have delayed the entry of generic citalopram into markets in the EEA.
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2012 which was provided on 8 February 2012 in connection with the release of the financial results for 2011.
|Palle Holm Olesen||Mads Kronborg|
|Chief Specialist, Head of Investor Relations||Media Relations Manager|
|+45 36 43 24 26||+45 36 43 28 51|
|Magnus Thorstholm Jensen||Simon Mehl Augustesen|
|Investor Relations Officer||International Media Specialist|
|+45 36 43 38 16||+45 36 43 49 80|
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.1 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.
Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.
Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.