HORIZON THERAPEUTICS AND NITEC PHARMA COMPLETE
MERGER AND COMBINE BUSINESSES
Combined company has one approved product in Europe (LODOTRA ®
) and two late-stage U.S. product candidates in pain management
and rheumatoid arthritis
NORTHBROOK , IL . and REINACH, Switzerland April 1, 2010 Horizon
Therapeutics, Inc. and Nitec Pharma AG, both privately held companies,
today announced a definitive agreement in which the two companies
have combined in an all-stock transaction. The combined company
also completed a concurrent preferred stock financing in conjunction
with the transaction.
The combined company will be named Horizon Pharma, Inc
., and will be led by Timothy P. Walbert, previously
president and chief executive of Horizon Therapeutics. The company
will be headquartered in Northbrook , IL , with offices in Reinach
, Switzerland (Horizon Pharma AG) and Mannheim , Germany (Horizon
This combination provides immediate strategic value by strengthening
and diversifying our potential product portfolio, as well as providing
greater access to the U.S. capital markets, said Timothy P. Walbert,
chairman, president and chief executive officer, Horizon Pharma,
Inc. With LODOTRA ® marketed in Europe and anticipated U.S.
new drug application (NDA) submissions for both DUEXA ® and
LODOTRA in 2010, we are optimistic that we will be able to provide
patients and physicians with new treatment options in pain management
and chronic inflammatory diseases.
The combined company now has two late-stage U.S. product candidates
in development. One of them, LODOTRA, has been approved and is
marketed in Europe .
LODOTRA, a novel single-pulse delayed-release (SPDR) low-dose
prednisone tablet, was first launched in Germany in April 2009,
and is currently being marketed for the reduction in morning stiffness
associated with rheumatoid arthritis (RA). A European Phase 3
trial of LODOTRA in rheumatoid arthritis (RA) was completed in
2006 and a marketing authorization application was submitted to
15 Member States of the European Union using the Decentralized
Procedure with Germany as Reference Member State . The procedure
was completed in December 2008, resulting in the recommendation
to grant a national marketing authorization of LODOTRA for the
treatment of RA and associated morning stiffness in the Reference
Member State and the other 14 Concerned Member States, namely
Austria, Belgium, Denmark, Finland, France, Italy, Luxembourg,
the Netherlands, Norway, Poland, Portugal, Spain, Sweden, and
the United Kingdom.
Merck KGaA holds marketing rights to LODOTRA in Germany and Austria
, and Mundipharma holds marketing rights to LODOTRA in the rest
of Europe .
The company has completed a Phase 3 trial for LODOTRA in the U.S.
for the treatment of the signs and symptoms of RA. In the pivotal
U.S. Phase 3 clinical study (CAPRA-2), patients treated with LODOTRA
experienced a statistically significant improvement in ACR-20
response when compared with patients in the placebo group (48.5
percent vs. 28.6 percent; p=0.0002). In addition, patients taking
LODOTRA experienced a statistically significant improvement in
ACR-50 response (22.7 percent vs. 9.2 percent; p=0.0027). Importantly,
patients treated with LODOTRA also experienced a statistically
significant reduction in morning stiffness when compared with
patients in the placebo group (44 percent vs. 21 percent; p=0.0008).
LODOTRA is also being investigated for the treatment of severe
asthma and polymyalgia rheumatica (PMR).
DUEXA, formerly HZT-501, is a novel, proprietary tablet formulation
containing a fixed-dose combination of ibuprofen, one of the world's
most prescribed non-steroidal anti-inflammatory drugs (NSAID),
with high-dose famotidine, the most potent H 2 antagonist. In
two Phase 3 clinical studies (REDUCE-1 and REDUCE-2), DUEXA was
shown to significantly reduce the incidence of NSAID-induced upper
gastrointestinal (GI) ulcers in patients with mild-to-moderate
pain and arthritis. The trials were conducted in the U.S. via
a Special Protocol Assessment (SPA) with the U.S. Food and Drug
Administration (FDA) and enrolled more than 1,500 patients.
Horizon recently submitted an NDA for DUEXA to the FDA and expects
an FDA decision on acceptance for review in the 2nd quarter of
2010. The Company also anticipates it will submit an NDA for LODOTRA
to the U.S. FDA in the second half of 2010 and anticipates submitting
a marketing authorization application (MAA) for DUEXA in the European
Union through the Decentralized Procedure in the second half of
Other product candidates in the combined companys development
pipeline include: HZN-602 (naproxen/famotidine), a combination
oral drug consisting of immediate-release naproxen with high-dose
famotidine, being investigated for the reduction of the risk of
upper gastrointestinal (GI) ulcers in patients with pain and arthritis;
and TruNoc (tarenflurbil), which is under investigation as a potential
treatment for pain-related diseases.
The combined company holds worldwide commercialization rights
for its products and product candidates, other than the distribution
rights granted for LODOTRA in Europe .
About the Transaction
In the completed transaction, Horizon Therapeutics and Nitec Pharma
exchanged shares into a new holding company, Horizon Pharma, Inc.
Horizon Therapeutics, Inc. is now a subsidiary of Horizon Pharma,
Inc. and has been renamed Horizon Pharma USA, Inc. and Nitec Pharma
AG is now a subsidiary of Horizon Pharma, Inc. and will be renamed
Horizon Pharma AG. Nitec's German subsidiary, Nitec Pharma GmbH
will be renamed Horizon Pharma GmbH. Bank of America Merrill Lynch
acted as financial advisor and Cooley Godward Kronish LLP was
legal counsel to Horizon in the transaction. JMP Securities LLC
acted as financial advisor and Mintz, Levin, Cohn, Ferris, Glovsky
and Popeo, P.C. served as legal counsel to Nitec in the transaction.
About Horizon Pharma
Horizon Pharma, Inc. is a late-stage biopharmaceutical company
focused on the development and commercialization of innovative
medicines for pain-related diseases and chronic inflammation.
Horizon Pharma's product portfolio includes innovative therapies
in early- and late-stage development that are designed to improve
the efficacy, safety and quality of life for patients with chronic
pain and inflammation. Horizons most advanced product is LODOTRA,
a circadian cytokine modulator (CCM) for the treatment of rheumatoid
arthritis (RA), which has received a recommendation for granting
of a national marketing authorization in certain Member States
of the European Union. LODOTRA is already launched in Germany
. The Company is financed by leading life-science investors Atlas
Venture, Deutsche Bank AG, London , Essex Woodlands Healthcare
Ventures, FirstMark Capital, Global Life Science Ventures, NGN
Capital, Scale Ventures, Sutter Hill Ventures and TVM Capital.
For more information about the company and its products, please
Forward Looking Statements
This press release includes forward-looking statements that are
subject to risks, uncertainties and other factors. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements, including, but not limited
to, statements regarding the ability of the combined company to
realize the anticipated benefits of the combination; any statements
regarding the future of any product or product candidate, including
the submission of such products or product candidates for approval;
and any statements of the plans, strategies and objectives of
management for future operations of the combined company. Such
statements are only predictions, and actual events or results
may differ materially from those projected in such forward-looking
statements. Factors that could cause or contribute to the differences
include, but are not limited to, risks associated with the ability
of the combined company to achieve any benefit resulting from
the combination, risks associated with operations conducted in
multiple jurisdictions, the inherent risks of product development
and approval, clinical outcomes, regulatory risks, risks related
to proprietary rights, market acceptance and competition and risks
associated with the combined companys ability to obtain additional
capital to support its planned operations.
Robert J. De Vaere
Executive Vice President, Chief Financial Officer
Horizon Pharma, Inc.
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