UNITED
STATES
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
Date
of
Report (Date of Earliest Event Reported):
January
3, 2007
Commission
File No. 000-16929
DOR
BIOPHARMA, INC.
(Exact
name of small business issuer as specified in its charter)
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DELAWARE
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41-1505029
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(State
or other jurisdiction of incorporation or organization)
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(I.R.S.
Employer Identification Number)
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1101
Brickell Ave., Suite 701 S
Miami,
FL
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33131
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(Address
of principal executive offices)
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(Zip
Code)
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(305)
534-3383
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(Issuer’s
telephone number, including area code)
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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):
[
]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[
]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act
(17 CFR 240.14d-2(b))
[
]
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act
(17 CFR 240.13e-4(c))
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Item
1.01
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Entry
into a Material Definitive
Agreement.
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On
January 3, 2007, DOR BioPharma, Inc. (the “Company”) entered into a non-binding
letter of intent (the “Letter of Intent”) with Sigma-Tau Pharmaceuticals, Inc.
(“Sigma-Tau”), which grants Sigma-Tau an exclusive right to negotiate terms and
conditions for a possible business transaction or strategic alliance regarding
the Company’s lead product, orBec® (oral beclomethasone dipropionate), and
potentially other Company pipeline compounds until March 1, 2007. In
consideration for entering into the Letter of Intent, Sigma-Tau has agreed
to
purchase $1 million of the Company’s common stock, par value $0.001 per share
(“Common Stock”), at the market price of $0.246 per share, representing
4,065,041 shares of common stock, and has contributed an additional $2 million
in cash. The $2 million contribution will be considered an advance payment
to be
deducted from future payments due to the Company by Sigma-Tau pursuant to any
future orBec® commercialization arrangement reached between the two parties.
If
the
parties do not execute definitive agreements relating to a business transaction
or strategic alliance regarding the Company’s lead product, orBec® (oral
beclomethasone dipropionate), and potentially other Company pipeline compounds
by March 1, 2007 or if Sigma-Tau terminates the Letter of Intent at an earlier
date, the Company will be required to return the $2 million to Sigma-Tau within
60 days. If the Company does not return the $2 million to Sigma-Tau in cash
by
May 31, 2007, interest will accrue at a rate of 6% compounded annually, and
Sigma-Tau will have the option, in its sole discretion, to convert the accrued
amount into Common Stock at a price per share equal to 80% of the average
closing price of Common Stock for the five business days immediately preceding
the date such election is made.
The
closing of the transaction relating to a business transaction or strategic
alliance regarding the Company’s lead product, orBec® (oral beclomethasone
dipropionate), and potentially other Company pipeline compounds is subject
to
execution of definitive agreements between the parties, containing such
representations, warranties, covenants, conditions, indemnities and limitations
as are customary in a transaction of this kind. The Company has granted
Sigma-Tau demand and piggy-back registration rights with regard to the shares
issued, and to be issued upon election, to Sigma-Tau.
A
copy of
the Letter of Intent is filed as Exhibit 10.1 to this Current Report on Form
8-K.
Item
3.02
Unregistered
Sales of Equity Securities.
Under
the
terms of Letter of Intent described in Item 1.01 above, the Company has agreed
to issue 4,065,041 shares of Common Stock, to Sigma-Tau, for gross proceeds
of
$1 million. Such securities were issued pursuant to an exemption provided by
Section 4(2) of the Securities Act of 1933, as amended, and Rule 506 of
Regulation D promulgated thereunder.
The
net
proceeds from the sale of the securities will be used for working capital and
general corporate purposes.
Item
9.01
Financial
Statements and Exhibits
(c)
Exhibits:
10.1
Letter
of
Intent dated January 3, 2007 by and between DOR BioPharma, Inc. and Sigma-Tau
Pharmaceuticals, Inc.
99.1
Press
release issued by DOR BioPharma, Inc. on January 4, 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 hereunto
duly authorized.
DOR
BIOPHARMA, INC.
By:
/s/
Christopher J. Schaber
Name:
Christopher J. Schaber
Title:
Chief Executive Officer
Date:
January 4, 2007
EXHIBIT
INDEX
Exhibit
No.
Description
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10.1
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Letter
of Intent dated January 3, 2007 by and between DOR BioPharma, Inc.
and
Sigma-Tau Pharmaceuticals, Inc.
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99.1
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Press
release issued by DOR BioPharma, Inc. on January 4,
2007.
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Exhibit
10.1
LETTER
OF INTENT
Sigma-Tau
Pharmaceuticals Inc.,
a New
Jersey corporation having its principal office at 800 South Frederick Ave,
Suite
300 Gaithersburg, MD 20877 (hereinafter referred to as "STPI")
And
DOR
BioPharma Inc.,
a
Florida corporation having its principal office at 1101 Brickell Avenue, Suite
701-S, Miami, FL 33131 (hereinafter referred to as “DOR”)
WHEREAS
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a)
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DOR
has developed and owns intellectual property rights and data relating
to
Beclomethasone Dipropionate orBec® (the “Product”);
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b)
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STPI
wants to complete its evaluations of the Product, to understand if
it is
interested or not in pursuing development and commercialization of
such
Product; and
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c)
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DOR
is willing to enter into exclusive negotiations with STPI for a limited
period of time to allow both parties to determine whether and if
both
parties can negotiate and execute definitive written agreements
(“Definitive Agreements”) relating to a possible business transaction or
strategic alliance involving the Product and/or any DOR biotherapeutic
products other than the biodefense products (RiVax™ and BT-VACC), the
terms of which are mutually acceptable to both parties as determined
in
each party’s sole discretion.
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NOW,
THEREFORE, in consideration of such preambles and the mutual promises and
covenants hereinafter set forth, the parties hereby agree as
follows:
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1.
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a.
DOR hereby grants STPI an exclusive right (except with respect to
paragraph 1(a)(iii) which shall be non-exclusive) until March 1, 2007
to
negotiate with DOR with regard to terms and conditions of a possible
business transaction or strategic alliance between DOR and STPI regarding
any or all of the following:
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(i)
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Acquire
European exclusive rights in respect of the development and
commercialization of the Product,
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(ii)
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Execute
a Co-Promotion agreement for the Product with DOR in the United
States,
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(iii)
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Invest
and become a shareholder of DOR,
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(iv)
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Participate
in the development and commercialization of the Product with DOR,
and/or
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(v)
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Acquire
rights and/or participate in the development and commercialization
of any
DOR products other than the Product.
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b.
During
the No-Shop Period (as defined below), DOR will discontinue any and all
discussions and will not engage in negotiations with any other party in respect
to the items outlined in Paragraph 1(a) with the exception of paragraph
1(a)(iii). STPI acknowledges that DOR is scheduled to attend the BioAsia
conference in Japan during the last week of January, 2007. Accordingly, nothing
contained in this Agreement shall prohibit DOR from discussing a transaction
with respect to the Product outside of Europe and the United States.
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2.
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The
No-Shop Period shall last until March 1
st
,
2007 (the “No-Shop Period”).
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3.
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In
consideration for entering into this Agreement, STPI will pay DOR the
following amount within two (2) business days upon signature of this
Agreement:
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(i)
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A
reimbursable amount of Two-Million U.S. Dollars (US$2,000,000.00) (the
“Reimbursable Amount”) to be paid in cash by wire transfer;
and
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(ii)
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An
amount of One-Million U.S. Dollars (US$1,000,000.00) to be immediately
converted into unregistered newly issued shares of DOR Common Stock,
$0.001 par value, (the “DOR Common Shares”) at a price per share equal to
the average closing market price of DOR Common Shares as quoted on
the OTC
Bulletin Board during the five (5) business days immediately preceding
the
date of this Agreement, rounded up to the third decimal.
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DOR
hereby grants STPI free of charge two demand registration rights
the
first
of which exercisable anytime after March 31, 2007, and the second of which
exercisable 3 months after issuance of shares pursuant to Section 5 below,
and
unlimited piggyback registration rights and agrees to promptly execute and
deliver to STPI an agreement setting forth such rights.
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4.
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Should
the parties execute Definitive Agreements during the No-Shop Period
(or
any other later date mutually agreed upon in writing between the parties);
the amounts set forth in Paragraph 3 above will be considered as advanced
payments to be deducted from future payments due by
STPI.
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5.
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Should
the parties not execute Definitive Agreements during the No-Shop Period
(or any other later date mutually agreed upon in writing between the
parties), or should STPI send written notice to DOR terminating the
No-Shop Period at an earlier date (the first of which to occur, the
"Termination Date"), the Reimbursable Amount received by DOR hereunder
will be paid back to STPI in cash by DOR within sixty (60) days of
the
Termination Date plus six percent (6%) interest compounded annually
with
accrual beginning May 31, 2007. In the event that DOR does not repay
the
full Reimbursable Amount together with interest thereon when due under
this Agreement, then as a nonexclusive remedy to STPI, until such time
as
such amount is repaid by DOR STPI may in its sole discretion elect
in
writing to alternatively be issued unregistered newly issued DOR Common
Shares at a price per share equal to eighty percent (80%) of the average
closing market price of DOR Common Shares as quoted on the OTC Bulletin
Board for the five (5) business days immediately preceding the date
such
election by STPI is received in writing by
DOR.
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6.
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DOR
warrants and represents that it has the authority necessary to enter
into
this Agreement and perform its obligations hereunder. DOR further warrants
and represents that by entering into this Agreement and the transactions
contemplated hereunder, DOR will not be in conflict with or in breach
of
any agreements to which it is a party.
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7.
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STPI
warrants and represents that it has the authority necessary to enter
into
this Agreement and perform its obligations hereunder. STPI further
warrants and represents that by entering into this Agreement and the
transactions contemplated hereunder, STPI will not be in conflict with
or
in breach of any agreements to which it is a party.
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8.
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This
Agreement shall be non-binding with respect to both parties with the
exception of paragraphs 1(b), 2, 3, 4 5, 6, 7, 8, 9 and 10. This Agreement
shall not constitute an Agreement with respect to the subject matter
of
paragraph 1(a). No agreements shall be valid unless made in writing
signed
by both parties and this agreement may only be amended in writing signed
by both parties. No party hereto may assign its rights or obligations
under this Agreement without the express prior written consent of the
other party hereto, which consent may be withheld at the sole discretion
of such party.
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9.
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Neither
party shall under any circumstances be liable for any additional payments
or reimbursement, special, incidental or consequential damages of any
nature whatsoever arising under or relating to this
Agreement.
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10.
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This
Agreement shall be interpreted under and governed by the laws of the
State
of New Jersey.
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IN
WITNESS WHEREOF
,
the
parties hereto have executed this Agreement by their duly authorized
representatives in duplicate, as of the date below written.
DOR
BioPharma, Inc.
SIGMA-TAU
Pharmaceuticals, Inc.
/s/
Christopher J. Schaber , PhD
/s/
Gregg A. Lapointe
Christopher
J. Schaber, PhD
Gregg
A.
Lapointe
President
& CEO
Chief
Operating
Officer
Date:
January 3, 2007
Date:
January 2, 2007
Exhibit
99.1
DOR
BioPharma, Inc.
1101
Brickell Avenue
Miami,
Florida 33131
www.dorbiopharma.com
DOR
BioPharma Receives $3 Million from Sigma-Tau Pharmaceuticals for Exclusive
Right
to Negotiate orBec
®
Strategic Alliance
MIAMI
- January 4, 2007
- DOR
BioPharma, Inc. (OTCBB: DORB) (“DOR” or the “Company”) announced today that it
has received $3 million under a non-binding letter of intent with Sigma-Tau
Pharmaceuticals, Inc.
(“Sigma-Tau”), which grants Sigma-Tau an exclusive right to negotiate terms and
conditions for a possible business transaction or strategic alliance regarding
orBec
®
(oral
beclomethasone dipropionate)
and
potentially other DOR pipeline compounds until March 1, 2007.
Under
the
terms of the agreement, Sigma-Tau has purchased $1 million of DOR’s Common Stock
at the market price of $0.246 per share, representing approximately four million
shares. An additional $2 million was paid in cash, and will be considered an
advance payment to be deducted from upfront monies due to DOR by Sigma-Tau
pursuant to any future orBec commercialization arrangement reached between
the
two parties. If no agreement is reached by March 1, 2007, DOR will return the
$2
million to Sigma-Tau within 60 days. If DOR does not pay Sigma Tau back in
cash
by May 31, 2007, interest will accrue at a rate of 6% compounded annually and
Sigma Tau will have the option in its sole discretion of converting the accrued
amount into Common Stock at a price per share equal to 80% of the market price
at the time the payment is made.
“We
are
exceptionally pleased with Sigma-Tau’s interest in orBec
®
and in
DOR’s pipeline products,” said Christopher J. Schaber, Ph.D., President and CEO
of DOR. “We view Sigma-Tau as an excellent potential partner for
orBec
®
especially with regard to the EU territory. We look forward to productive
discussions with Sigma-Tau to reach a mutually beneficial
arrangement.”
The
Common Stock sold to Sigma-Tau has not been registered under the Securities
Act
or any state securities laws, and the securities may not be offered or sold
absent registration or an applicable exemption from the registration
requirements of the Securities Act and applicable state securities laws.
About
orBec
®
orBec®
represents a first-of-its-kind oral, locally acting therapy tailored to treat
the gastrointestinal manifestation of Graft-versus-Host Disease (“GVHD”), the
organ system where GVHD is most frequently encountered and is highly
problematic. orBec®, if approved by the EMEA and the FDA, would be the first
approved treatment for GI GVHD and the first oral formulation of beclomethasone
dipropionate ("BDP") available in the European Union and the United States,
respectively. orBec® is intended to reduce the need for systemic
immunosuppressive drugs to treat GI GVHD. BDP is a highly potent, topically
active corticosteroid that has a local effect on inflamed tissue. BDP has been
marketed in the U.S. and worldwide since the early 1970s as the active
pharmaceutical ingredient in a nasal spray and in a metered dose inhaler for
the
treatment of patients with allergic rhinitis and asthma. orBec® is formulated
for oral administration as a single product consisting of two tablets; one
tablet is intended to release BDP in the proximal portions of the GI tract,
and
the other tablet is intended to release BDP in the more distal portions of
the
GI tract.
About
Sigma-Tau Pharmaceuticals, Inc.
Sigma-Tau
Pharmaceuticals, Inc. is a U.S. based, wholly-owned subsidiary of the Sigma-Tau
Group, and is dedicated solely to the global development and commercialization
of medicines for patients with rare (“Orphan”) diseases. Sigma-Tau
Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.
The
Sigma-Tau Group is a privately held, research focused pharmaceutical company
headquartered in Pomezia (Rome), Italy, with subsidiaries in France,
Switzerland, the Netherlands, Portugal, Germany, Spain, and the U.S. Employing
2,400 people worldwide (400 in R&D), the Sigma-Tau Group focuses on several
therapeutic areas, including cardiovascular, metabolism, central and peripheral
nervous system, immunology and oncology, with a portfolio comprising 48 projects
and clinical trials currently being conducted in 32 different
indications.
About
DOR BioPharma, Inc.
DOR
BioPharma, Inc. is a biopharmaceutical company developing products to treat
life-threatening side effects of cancer treatments and serious gastrointestinal
diseases, and vaccines for certain bioterrorism agents. DOR’s lead product,
orBec
®
(oral
beclomethasone dipropionate), is a potent, locally-acting corticosteroid being
developed for the treatment of GI GVHD, a common and potentially
life-threatening complication of bone marrow transplantation. DOR has filed
an
NDA with the FDA for the treatment of GI GVHD, and has received an FDA PDUFA
date of July 21, 2007. An MAA with the EMEA for orBec
®
has also
been filed and validated. orBec
®
may also
have application in treating other gastrointestinal disorders characterized
by
severe inflammation.
Through
its Biodefense Division, DOR is developing biomedical countermeasures pursuant
to the recently enacted Project BioShield Act of 2004. DOR’s biodefense products
in development are recombinant subunit vaccines designed to protect against
the
lethal effects of exposure to ricin toxin and botulinum toxin. The ricin toxin
vaccine, RiVax
TM
,
has
been evaluated successfully in a Phase 1 clinical trial in normal volunteers.
For
further information regarding DOR BioPharma, please visit the Company's website
located at
www.dorbiopharma.com
.
This
press release contains forward-looking statements, within the meaning of Section
21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.’s
current expectations about its future results, performance, prospects and
opportunities, including statements regarding the potential use of
orBec
®
for the
treatment of gastrointestinal GVHD and the prospects for regulatory filings
for
orBec
®
.
Where
possible, DOR has tried to identify these forward-looking statements by using
words such as "anticipates", "believes", "intends", or similar expressions.
These statements are subject to a number of risks, uncertainties and other
factors that could cause actual events or results in future periods to differ
materially from what is expressed in, or implied by, these statements. DOR
cannot assure you that it will be able to successfully develop or commercialize
products based on its technology, including orBec
®
,
particularly in light of the significant uncertainty inherent in developing
vaccines against bioterror threats, manufacturing and conducting preclinical
and
clinical trials of vaccines, and obtaining regulatory approvals, that its
technologies will prove to be safe and effective, that its cash expenditures
will not exceed projected levels, that it will be able to obtain future
financing or funds when needed, that product development and commercialization
efforts will not be reduced or discontinued due to difficulties or delays in
clinical trials or due to lack of progress or positive results from research
and
development efforts, that it will be able to successfully obtain any further
grants and awards, maintain its existing grants which are subject to
performance, enter into any biodefense procurement contracts with the U.S.
Government or other countries, that the U.S. Congress may not pass any
legislation that would provide additional funding for the Project BioShield
program, that it will be able to patent, register or protect its technology
from
challenge and products from competition or maintain or expand its license
agreements with its current licensors, or that its business strategy will be
successful. Important factors which may affect the future use of
orBec
®
for
gastrointestinal GVHD include the risks that: because orBec
®
did not
achieve statistical significance in its primary endpoint in the pivotal Phase
3
clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may
not
consider orBec
®
approvable based upon existing studies, orBec
®
may not
show therapeutic effect or an acceptable safety profile in future clinical
trials, if required, or could take a significantly longer time to gain
regulatory approval than DOR expects or may never gain approval; DOR is
dependent on the expertise, effort, priorities and contractual obligations
of
third parties in the clinical trials, manufacturing, marketing, sales and
distribution of its products; or orBec
®
may not
gain market acceptance; and others may develop technologies or products superior
to orBec
®
.
These and other factors are described from time to time in filings with the
Securities and Exchange Commission, including, but not limited to, DOR's most
recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to
update or revise any forward-looking statements as a result of new information,
future events, and changes in circumstances or for any other
reason.
Company
Contact:
Investor
Contacts:
Evan
Myrianthopoulos
Lippert/Heilshorn
& Associates
Chief
Financial Officer
Anne
Marie Fields (
afields@lhai.com
)
(786)
425-3848
(212)
838-3777
www.dorbiopharma.com
Bruce
Voss (
bvoss@lhai.com
)
(310)
691-7100
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