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H Lundbeck A/S : Lundbeck Acquires Chelsea Therapeutics

06/29/2014 | 12:48am US/Eastern

H. Lundbeck A/S said that it has completed its acquisition of Chelsea Therapeutics International for USD 6.44 per share in cash and non-transferable contingent value rights that may pay up to an additional USD 1.50 per share upon achievement of certain sales milestones, in each case without interest and subject to any required withholding of taxes.

According to a release from the company, as a result of the acquisition, Chelsea became an indirect subsidiary of Lundbeck, and shares of Chelsea common stock will no longer be listed on the NASDAQ Capital Market.

"The acquisition of Chelsea and its lead therapy NORTHERA is a perfect fit for Lundbeck in the U.S., given our track record supporting people living with central nervous system (CNS) disorders that are often overlooked or misunderstood," said Staffan Schuberg, president of Lundbeck in the U.S. "Over the past five years, we've brought three therapies to the U.S. for people living with rare neurological disorders where there is a significant unmet need - not only for therapies - but for education and resources. Similarly, with today's announcement, we're ready to partner with healthcare professionals, advocacy groups and families to support adults living with symptomatic neurogenic orthostatic hypotension."

Lundbeck expects to make NORTHERA available in the U.S. through specialty pharmacies in the fall of 2014. NORTHERA was approved by the U.S. Food and Drug Administration (FDA) in February 2014 and is indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta- hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond two weeks of treatment has not been demonstrated. The continued effectiveness of NORTHERA should be assessed periodically.1 Please see below for Important Safety Information including NORTHERA's boxed warning for supine hypertension. Click here for NORTHERA Prescribing Information on the FDA's DailyMed website.

"Our passion to bring NORTHERA to the U.S. has been fueled by the unmet need among patients, pressing our sense of urgency throughout the clinical development process," said Joseph G. Oliveto, president & chief executive officer of Chelsea Therapeutics. "We are thrilled that Lundbeck will carry this passion forward, given the company's track record of bringing therapies to people with rare diseases, supporting patient communities and investing in research, development and education."

The NORTHERA approval was granted under the FDA's accelerated approval program, which allows for conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted.

H. Lundbeck A/S is a global pharmaceutical company specialized in brain diseases.

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