Otsuka receives complete response letter for extended-release injectable suspension of aripiprazole
H. Lundbeck A/S
Otsuka receives complete response letter for extended-release injectable
suspension of aripiprazole
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today
announced receipt of a complete response letter (CRL) from the U.S. Food and
Drug Administration (FDA) to the New Drug Application (NDA) for the
investigational intramuscular (IM) depot formulation of aripiprazole. In the
letter, the only issue FDA cited was deficiencies from a recent inspection of a
third-party supplier of sterile water.
Otsuka is working closely with the third-party supplier to resolve the issue as
quickly as possible and is planning further discussions with the agency to
determine next steps.
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, and further
specified in connection with the announcement of the restructuring plan on 14
Otsuka Pharmaceutical Co., Ltd. Contacts
Public Relations Department Otsuka
America Pharmaceutical, Inc.
Otsuka Pharmaceutical Co., Ltd.
+81 3 6361 7379
+1 609 524 6798
Investor Relations Department
Otsuka Holdings Co., Ltd.
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
About Otsuka Pharmaceutical Co. Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company
with the corporate philosophy: 'Otsuka-people creating new products for better
health worldwide.' Otsuka researches, develops, manufactures and markets
innovative and original products, with a focus on pharmaceutical products for
the treatment of diseases and consumer products for the maintenance of everyday
health. Otsuka is committed to being a corporation that creates global value,
adhering to the high ethical standards required of a company involved in human
health and life, maintaining a dynamic corporate culture, and working in
harmony with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings
Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has
business operations in 24 countries and regions around the world, with
consolidated sales of ¥1,154.6 billion for fiscal year 2011. For more
information, visit www.otsuka.co.jp/en.
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
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
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