View:
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
August 2, 2007
Date of Report (Date of earliest event reported)
-----------------
PRO-PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
-----------------
NEVADA 000-32877 04-3562325
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
7 WELLS AVENUE
NEWTON, MASSACHUSETTS
02459
(Address of Principal Executive Offices) (Zip Code)
(617) 559-0033
(Registrant's telephone number, including area code)
-----------------
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))
Other Events
Item 8.01 Other Events.
On August 3, 2007, Pro-Pharmaceuticals, Inc. announced it has retained Camargo
Pharmaceutical Services, LLC to provide strategic regulatory support for the
Company's 505(b)(2) filings. A copy of the news release is furnished as Exhibit
99.1 to this report and is incorporated herein by reference. This information
shall not be deemed to be "filed" for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, and shall not be deemed to be
incorporated by reference in any filing under the Securities Act of 1933, as
amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibit is furnished with this report:
Exhibit Number 99.1
Description
News release dated August 3, 2007 announcing Pro-Pharmaceuticals, Inc. has
retained Camargo Pharmaceutical Services, LLC to provide strategic regulatory
support for the Company's 505(b)(2) filings.
SIGNATURES
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.
PRO-PHARMACEUTICALS, INC.
By: /s/ David Platt
-------------------------------
David Platt
Chief Executive Officer
Date: August 3, 2007
EXHIBIT INDEX
Exhibit
Number Exhibit
- ------- ---------------------------------------------------------------------
99.1 News release dated August 3, 2007, reporting a consulting agreement.
Exhibit 99.1
Pro-Pharmaceuticals Retains Camargo Pharmaceutical to Provide Strategic
Regulatory Support for 505(b)(2) Submissions
Camargo has Consulted on 24 Successful 505(b)(2) Drug Development
Programs
NEWTON, Mass.--(BUSINESS WIRE)--Aug. 3, 2007--Pro-Pharmaceuticals,
Inc. (AMEX: PRW), a company "Advancing Drugs Through Glycoscience(R)",
today announced it has retained Camargo Pharmaceutical Services, LLC
to provide strategic regulatory support for the Company's 505(b)(2)
submissions with the U.S. Food and Drug Administration (FDA).
Camargo's expertise in regulatory affairs and submissions includes
the preparation and submission of New Drug Applications, Abbreviated
NDAs, and 505(b)(2) NDAs. Camargo's capabilities can expedite the
regulatory submission and approval process, resulting in time and cost
savings for its clients.
"Our goal is to get DAVANAT(R) to market in a timely manner with
multiple chemotherapy drugs," stated David Platt, Ph.D., Chief
Executive Officer, Pro-Pharmaceuticals, Inc. "We submitted
pre-clinical and clinical data to the FDA that demonstrates DAVANAT(R)
improves 5-FU. In other pre-clinical studies, DAVANAT(R) also improved
activity of FDA-approved chemotherapeutics, such as Irinotecan,
Oxaliplatin, Cisplatin, Avastin(R), Taxol and Doxorubicin."
"Our regulatory track record speaks for itself, with more than 150
FDA approvals completed by Camargo members and an outstanding history
of first-cycle FDA approvals," said Kenneth V. Phelps, President,
Camargo Pharmaceutical Services, LLC. "Based on our success with
505(b)(2) submissions, our distinctive process for these applications
is one of the most efficient and effective in the industry. Camargo's
proven success with 505(b)(2) applications results from our detailed
knowledge of FDA filing requirements, and use of established and
well-accepted methodologies."
DAVANAT(R) Submissions for 505 (b)(2) Filings as a Functional
Excipient
The Company has submitted data to begin 505(b)(2) filings for
DAVANAT(R), as a functional excipient, to be co-administered
intravenously with 5-FU to treat cancer. In previous news releases,
the Company noted that the FDA stated that DAVANAT(R) does not require
additional toxicity or clinical trial data for 505(b)(2) filings. With
the addition of Camargo to its regulatory team, the Company will
reassess, based on prior and future correspondence with the FDA,
whether additional studies may be required for the 505(b)(2)
submissions and the Company will subsequently collect and submit any
additional data required. This reassessment is now ongoing, and the
Company plans to finalize its 505(b)(2) filing strategy by the end of
2007. Though subject to change based on this reassessment, the Company
now intends to submit a 505(b)(2) application in support of DAVANAT(R)
as a functional excipient to be co-administered with 5-FU to treat
cancer by the fourth quarter of 2007 or first quarter of 2008.
Additional 505(b)(2) filings for DAVANAT(R)/5-FU/leucovorin and
DAVANAT(R)/5FU/irinotecan will follow.
DAVANAT(R) as a Functional Excipient
The Company is using Section 505(b)(2) to obtain more timely and
efficient marketing approval of new formulations of previously
approved therapeutics that incorporate DAVANAT(R), the Company's drug
target delivery compound. The Company is seeking approval for
DAVANAT(R), a galactomannan, to be co-administered intravenously with
5-FU and to be co-administered with Irinotecan for the treatment of
cancer. In complex products such as chemotherapeutics, the functional
role of an excipient is important when used as a drug target delivery
to reduce toxicity and/or increase efficacy. Galactomannans have been
approved by the FDA for applications, such as oral, topical and
vaginal delivery of drugs. DAVANAT(R) extends the use of
galactomannans to the delivery of chemotherapeutic drugs.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services, LLC increases speed-to-market for
its pharmaceutical clients in the U.S. and abroad. As their strategic
outsourcing partner, Camargo provides efficient, cost-effective
comprehensive drug product development, clinical program development
and regulatory services for Phases I-IV. Team Camargo members have
realized over 150 FDA approvals for ANDAs and NDAs, 505(b)(1)s and
505(b)(2)s, in a wide range of therapeutic areas. Additional
information is available at www.camargopharma.com.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals, Inc. is engaged in the discovery,
development, and commercialization of therapeutic compounds for
advanced treatment of cancer, liver, microbial, cardiovascular, and
inflammatory diseases. The Company's initial focus is the development
of carbohydrate polymers to enhance the safety and efficacy of
chemotherapy agents. The Company's technology also is directed at
"rescuing" drugs that were shelved for toxicity or "half-life" issues,
increasing the solubility of existing drugs, and developing polymers
as new chemical entities. The need to improve drug therapies,
particularly anti-cancer agents, is significant and represents a large
market opportunity. Founded in 2000, the Company is headquartered in
Newton, Mass. Additional information is available at
www.pro-pharmaceuticals.com.
FORWARD-LOOKING STATEMENTS: Any statements in this news release
about future expectations, plans and prospects for the Company,
including without limitation statements containing the words
"believes," "anticipates," "plans," "expects," and similar
expressions, constitute forward-looking statements as defined in the
"safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are based on
management's current expectations and are subject to a number of
factors and uncertainties, which could cause actual results to differ
materially from those described in such statements. We caution
investors that actual results or business conditions may differ
materially from those projected or suggested in forward-looking
statements as a result of various factors including, but not limited
to, the following: uncertainties as to the utility and market for our
potential products; uncertainties associated with pre-clinical and
clinical trials of our product candidates, and uncertainties related
to regulatory review and approval of our product candidates. More
information about those risks and uncertainties is contained in the
Company's most recent quarterly or annual report and in the Company's
other reports filed with the Securities and Exchange Commission. While
the Company anticipates that subsequent events may cause the Company's
views to change, the Company disclaims any obligation to update such
forward-looking statements.
DAVANAT and Advancing Drugs Through Glycoscience are registered
trademarks of Pro-Pharmaceuticals. AVASTIN is a registered trademark
of Genentech, Inc.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com