UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2008
Sucampo Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-33609 | 13-3929237 | ||
| (State or Other Juris- diction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
||
| 4520 East-West Highway, Suite 300 | 20814 | |
| Bethesda, Maryland | ||
| (Address of Principal Executive Offices) | (Zip Code) | |
Registrant’s telephone number, including area code: (301) 961-3400
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 1.01 | Entry into a Material Definitive Agreement. |
Under the Collaboration and License Agreement between Takeda Pharmaceutical Company Limited
(Takeda) and Sucampo Pharmaceuticals, Inc. (Sucampo), dated October 29, 2004, if Sucampo wishes to
use data or information developed under the collaboration with Takeda outside the United States or
Canada, for example in support of a regulatory filing in Europe or Asia, Sucampo is obligated to
pay to Takeda a one-time fee the first time such data or information is used in specified
territories. The amount of the fee for each territory is to be agreed between Sucampo and Takeda.
In connection with the filing of a Marketing Authorization Application in the United Kingdom
by Sucampo’s wholly-owned European subsidiary, as described in item 7.01 below, Sucampo agreed with
Takeda to make a one-time payment of $1.8 million, which will permit Sucampo and its subsidiaries
to use certain data and information developed under the Collaboration and License agreement in
Europe, the Middle East and Africa.
| Item 7.01. | Regulation FD Disclosure. |
On February 27, 2007, Sucampo Pharmaceuticals, Inc. announced that its wholly-owned European
subsidiary, Sucampo Pharma Europe, Ltd., has filed a Marketing Authorization Application for
lubiprostone, 24 mcg, for the indication of chronic idiopathic constipation in adults in United
Kingdom. The full text of the press release issued in connection with the announcement is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
Under the license agreement between Sucampo and Sucampo AG, dated June 30, 2006, Sucampo is
required to make a $1.0 million payment to Sucampo AG, which is a related party, for its first new
drug application filing or comparable foreign regulatory filing in each of the three following
territories covered by the license agreement: North, Central and South America, including the
Caribbean; Asia; and the rest of the world. The filing of the Marketing Authorization Application
described above by Sucampo Pharma Europe, Ltd. triggered the obligation on the part of Sucampo to
make a $1.0 million payment to Sucampo AG for the rest-of-world territory.
The information in Item 7.01 of this Form 8-K (including Exhibit 99.1) shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or
otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly
set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits | ||
| The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed: |
| 99.1 | Press Release issued by the registrant on February 27, 2008. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SUCAMPO PHARMACEUTICALS, INC. |
||||
| Date: February 29, 2008 | /s/ MARIAM E. MORRIS | |||
| Name: | Mariam E. Morris | |||
| Title: | Chief Financial Officer | |||
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press release issued by the registrant on February 27, 2008 |
Exhibit 99.1
For
Immediate Release
Contact:
P. Curtis Schenck
Director, Investor Relations/Public Relations
Phone: +01-301-961-3400
Fax: +01-301-961-3440
cschenck@sucampo.com
Director, Investor Relations/Public Relations
Phone: +01-301-961-3400
Fax: +01-301-961-3440
cschenck@sucampo.com
Sucampo Pharmaceuticals Announces the Initiation of Filings of
Marketing Authorization Applications for AMITIZA® in Europe
BETHESDA, Md., February 27, 2008 — Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced
that its wholly-owned European subsidiary, Sucampo Pharma Europe, Ltd. (SPE), has filed a Marketing
Authorization Application (MAA) for lubiprostone, 24 mcg, for the indication of Chronic Idiopathic
Constipation in adults in the United Kingdom.
The application has been filed using the decentralized procedure with the Medicines and Healthcare
Products Regulatory Agency of the United Kingdom serving as the reference member state with
additional applications to be filed with the member states of Belgium, Denmark, France, Germany,
Ireland, the Netherlands, Spain and Sweden.
Under the decentralized procedure, authorization is applied for in several European countries
simultaneously. The reference member state is responsible for the scientific assessment of the
application on behalf of the other states.
The countries in these filings represent many of the primary markets within Europe and represent a
significant percentage of the pharmaceutical sales in the European Union. “Sucampo is expanding to
Europe. Our filing in the United Kingdom represents a major event in our plans for international
expansion,” said Sucampo Pharmaceuticals Dr. Ryuji Ueno, Chairman and Chief Executive Officer. “We
see great opportunities because AMITIZA® is the only approved U.S. prescription drug for
the treatment of Chronic Idiopathic Constipation in adults. In Europe, there are no approved drugs
for this indication.”
Other than the United States and Canada, Sucampo Pharmaceuticals retains all commercial rights for
AMITIZA® (lubiprostone) for Europe and the rest of the world. Sucampo Pharmaceuticals’
drug AMITIZA® (lubiprostone) was a 2006 Scrip Awards finalist for the “Best New
Small-Molecule Drug” category.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, MD, focuses
on the development and commercialization of medicines based on prostones. The therapeutic
potential of prostones, which are bio-lipids that occur naturally in the human body, was first
identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ chairman and
chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno,
Ph.D., founding chief executive officer and advisor, international business development.
Sucampo Pharmaceuticals is marketing AMITIZA® (lubiprostone) in the U.S. for chronic
idiopathic constipation in adults and is developing the drug for additional gastrointestinal
disorders with large potential markets. In addition, the company has a robust pipeline of
compounds with the potential to target underserved diseases affecting millions of patients
worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma Europe, Ltd.
headquartered in Oxford, UK with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd.
located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its products,
visit www.sucampo.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals, Inc. are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” “may” or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the results of clinical trials with respect to Sucampo Pharmaceuticals’ products under development; the timing and success of submission, acceptance and approval of regulatory filings; Sucampo Pharmaceuticals’ dependence on the commercial success of AMITIZA; Sucampo Pharmaceuticals’ ability to obtain additional funding required to conduct its discovery, development and commercialization programs; Sucampo Pharmaceuticals’ dependence on its co-marketing North America alliance with Takeda Pharmaceutical Company Limited; and Sucampo Pharmaceuticals’ ability to obtain, maintain and enforce patent and other intellectual property protection for its discoveries. These and other risks are described in greater detail in the “Risk Factors” section of Sucampo Pharmaceuticals’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the quarter ended September 30, 2007. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals’ views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals, Inc. are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” “may” or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the results of clinical trials with respect to Sucampo Pharmaceuticals’ products under development; the timing and success of submission, acceptance and approval of regulatory filings; Sucampo Pharmaceuticals’ dependence on the commercial success of AMITIZA; Sucampo Pharmaceuticals’ ability to obtain additional funding required to conduct its discovery, development and commercialization programs; Sucampo Pharmaceuticals’ dependence on its co-marketing North America alliance with Takeda Pharmaceutical Company Limited; and Sucampo Pharmaceuticals’ ability to obtain, maintain and enforce patent and other intellectual property protection for its discoveries. These and other risks are described in greater detail in the “Risk Factors” section of Sucampo Pharmaceuticals’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the quarter ended September 30, 2007. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals’ views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
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