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 May, 2006.
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 May 31, 2006, attached hereto as Exhibit Number 1 and
incorporated by reference herein in its entirety.
Exhibit Description
1 Press
release, dated May 31, 2006.
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. |
|
|
|
| Date:
May
31, 2006 |
By: |
/s/
Cary
Grossman
|
| |
Name: Cary
Grossman |
| |
Title:
Executive
Vice President and Chief Financial
Officer |
INDEX
TO EXHIBITS
Exhibit Description
1 Press
release, dated May 31, 2006.
FOR
IMMEDIATE RELEASE
Company
Contact:
Cary
Grossman
Chief
Financial Officer
713-827-2104
cgrossman@gentium.it
Investor
Relations Contacts:
U.S.
Lippert/Heilshorn
& Assoc.
Kim
Sutton Golodetz
Kgolodetz@lhai.com
Anne
Marie Fields
afields@lhai.com
212-838-3777
Italy:
Burson-Marsteller
Luca
Ricci Maccarini
luca_maccarini@it.bm.com
+39
02.721431
GENTIUM
RAISES $22.1 MILLION IN PRIVATE OFFERING
Funding
to Support Continued Development of Pipeline
Villa
Guardia (Como), Italy, May 31, 2006 - Gentium S.p.A. (NASDAQ NMS: GENT)
(the
“Company”) announced today that it has entered into definitive agreements for a
$22.1 million private placement of 1,943,525 of its American Depository Shares
(ADSs) at a price of $11.39 per ADS.
Investors in the financing will also receive warrants to purchase 388,705 ADSs
at an exercise price of $14.50 per ADS. Investors participating in the financing
are large U.S. and Italian institutional investors. ThinkEquity Partners LLC
acted as the lead placement agent for the offering, and Rodman & Renshaw LLC
and I-Bankers Securities Incorporated were the co-agents.
The
net
proceeds from the offering will be used to fund the continued development of
the
Company’s product candidates and for general corporate purposes.
Dr.
Laura
Ferro, Gentium’s Chairman and Chief Executive Officer, said, “This financing
strengthens our balance sheet and allows us continue development of Defibrotide
to prevent veno-occlusive disease (VOD) and to treat multiple myeloma. In
addition, it gives us the capital to negotiate new drug development and
licensing agreements from a position of strength. We are pleased with the
support shown by some of our existing shareholders as well as by the enthusiasm
of a number of new, recognized biotech investors who participated in this
financing”.
The
ADSs
sold in the private placement and the ADSs issuable upon exercise of the related
warrants 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 and issuable upon exercise of the warrants.
About
VOD
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
multiple organ failure (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
E.U.
About
Gentium
Gentium
S.p.A. is a biopharmaceutical company located in Villa Guardia (Como), Italy
that is 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. FDA to treat veno-occlusive disease (VOD) with multiple organ
failure (Severe VOD) in recipients of stem cell transplants 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.”
#
#
#