Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
REPORT
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES
EXCHANGE ACT OF 1934
For
the
month of February, 2007.
Commission
File Number 000-51341
Gentium
S.p.A.
(Translation
of registrant’s name into English)
Piazza
XX Settembre 2, 22079 Villa Guardia (Como), Italy
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports
under
cover of Form 20-F or Form 40-F.
Form
20-F
S
Form
40-F □
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as
permitted
by Regulation S-T Rule 101(b)(1): ____
Note:
Regulation S-T Rule 101(b)(1) only permits the submission in paper of
a Form 6-K
if submitted solely to provide an attached annual report to security
holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as
permitted
by Regulation S-T Rule 101(b)(7): ____
Note:
Regulation
S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K
if
submitted to furnish a report or other document that the registrant foreign
private issuer must furnish and make public under the laws of the jurisdiction
in which the registrant is incorporated, domiciled or legally organized
(the
registrant’s “home country”), or under the rules of the home country exchange on
which the registrant’s securities are traded, as long as the report or other
document is not a press release, is not required
to
be and
has not been distributed to the registrant’s security holders, and, if
discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission
pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes □ No
S
If
“Yes”
is marked, indicate below the file number assigned to the registrant
in
connection with Rule 12g3-2(b):
82-_______________.
Description
of events affecting the Registrant are set forth in the Registrant's press
release, dated February 12, 2007, attached hereto as Exhibit Number 1 and
incorporated by reference herein in its entirety.
Exhibit
|
|
Description
|
1
|
|
Press
release, dated February 12,
2007.
|
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 thereunto
duly
authorized.
|
|
|
|
GENTIUM
S.P.A.
|
|
|
|
|
By: |
/s/ Gary
G. Gemignani |
|
|
|
Name: Gary
G. Gemignani Title: Executive
Vice President and Chief Financial Officer |
Date: February
12, 2007 |
|
INDEX
TO EXHIBITS
Exhibit
|
|
Description
|
1
|
|
Press
release, dated February 12,
2007.
|
Exhibit
1
FOR
IMMEDIATE RELEASE
Company
Contact:
Gary
Gemignani
Chief
Financial Officer
212-332-1666
ggemignani@gentium.com
Investor
Relations Contacts:
U.S.
Lippert/Heilshorn
& Associates
Anne
Marie Fields
afields@lhai.com
212-838-3777
Bruce
Voss
bvoss@lhai.com
310-691-7100
Italy:
Burson-Marsteller
Florian
Ciornei
florian_ciornei@it.bm.com
+39
02
72143532
GENTIUM
COMPLETES $47.5 MILLION PRIVATE PLACEMENT
Villa
Guardia (Como), Italy, February 12, 2007 - Gentium S.p.A. (NASDAQ: GENT)
(the
“Company”) announced today that it has completed its previously announced $47.5
million private placement of 2,354,000 of its American Depository Shares (ADSs)
at a price of $20.17 per ADS.
Investors participating in the financing were large U.S. and Italian
institutional investors. ThinkEquity Partners LLC acted as the exclusive
placement agent for the offering.
The
net
proceeds from the offering will be used to fund the continued development of
the
Company’s product candidates, for the repurchase of certain marketing rights to
Defibrotide from Crinos S.p.A., as previously announced, and for other general
corporate purposes.
The
ADSs
sold in the private placement have not been registered under the Securities
Act
of 1933, as amended, or state securities laws, and may not be offered or sold
in
the United States without being registered with the Securities and Exchange
Commission (SEC) or through an applicable exemption from SEC registration
requirements. The ADSs were offered only to accredited investors. The Company
has agreed to file a registration statement with the SEC covering the resale
of
the ADSs issued in the private placement.
About
VOD
Veno-occlusive
disease (VOD) is a potentially life-threatening condition. Certain high
dose chemotherapy and radiation therapies and stem cell transplantation (SCT)
can damage cells of the blood vessels and result in VOD, a blockage of the
small
veins of the liver that can lead to liver failure and the failure of other
organs (severe VOD). SCT is a frequently used treatment following high
dose chemotherapy and radiation therapy. The International Bone Marrow
Transplant Registry estimated that approximately 45,000 people received blood
and bone marrow transplants, which are types of SCT, in 2002. Based on the
Company’s review of more than 200 published papers, it believes that
approximately 20% of patients who undergo SCT develop VOD, approximately
one-third of those who develop VOD progress to severe VOD, and approximately
80%
of severe VOD patients die within 100 days of the SCT. The Company
believes that there are no approved therapies to treat or prevent VOD in the
U.S. or the EU.
About
Gentium
Gentium
S.p.A. is a biopharmaceutical company focused on the research, discovery and
development of drugs derived from DNA extracted from natural sources, and drugs
that are synthetic derivatives, to treat and prevent a variety of vascular
diseases and conditions related to cancer and cancer treatments. Defibrotide,
the Company’s lead product candidate in the U.S., is an investigational drug
that has been granted Orphan Drug status by the U.S. Food and Drug
Administration to treat severe VOD and Fast Track designation for the treatment
of severe VOD in recipients of stem cell transplants.
Cautionary
Note Regarding Forward-Looking Statements
This
press release contains “forward-looking statements.” In some cases, you can
identify these statements by forward-looking words such as “may,” “might,”
“will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,”
“predict,” “potential” or “continue,” the negative of these terms and other
comparable terminology. These statements are not historical facts but instead
represent the Company’s belief regarding future results, many of which, by their
nature, are inherently uncertain and outside the Company’s control. It is
possible that actual results may differ, possibly materially, from those
anticipated in these forward-looking statements. For a discussion of some of
the
risks and important factors that could affect future results, see the discussion
in our Form 20F filed with the Securities and Exchange Commission under the
caption “Risk Factors.”
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