-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D1tDKFKBGSH3vatc0cU45VRLxn9WS47/F9wV2S3AFr25aSQ2F1zgH3OCeUVOeJKt zfJJv/DVz4EGawtpmRTasw== 0001299933-06-004632.txt : 20060711 0001299933-06-004632.hdr.sgml : 20060711 20060711080309 ACCESSION NUMBER: 0001299933-06-004632 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060711 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060711 DATE AS OF CHANGE: 20060711 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEOSE TECHNOLOGIES INC CENTRAL INDEX KEY: 0000877902 STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833] IRS NUMBER: 133549286 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27718 FILM NUMBER: 06955141 BUSINESS ADDRESS: STREET 1: 102 WITMER RD CITY: HORSHAM STATE: PA ZIP: 19044 BUSINESS PHONE: 2154415890 MAIL ADDRESS: STREET 1: 102 WITMER ROAD CITY: HORSHAM STATE: PA ZIP: 19044 FORMER COMPANY: FORMER CONFORMED NAME: NEOSE PHARMACEUTICALS INC DATE OF NAME CHANGE: 19950817 8-K 1 htm_13601.htm LIVE FILING Neose Technologies, Inc. (Form: 8-K)  

 


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):   July 11, 2006

Neose Technologies, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 000-27718 13-3549286
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
102 Witmer Road, Horsham, Pennsylvania   19044
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   215-315-9000

Not Applicable
______________________________________________
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:

[  ]  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))


Item 8.01 Other Events.

Neose Technologies, Inc. today provided an update on its clinical development program for NE-180, the company's long-acting, GlycoPEGylated erythropoietin for the treatment of anemia.





Item 9.01 Financial Statements and Exhibits.

The attached Exhibit Index is incorporated herein by reference.





Neose “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this Current Report on Form 8-K and the attached press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties, including the risk that we will be unable to resolve clinical hold issues in the U.S., the risk that we will be unable to resolve the issues surrounding our potency assay, the risk that NE-180 fails in clinical trials, the risk that we will never receive regulatory approval of NE-180 or any of our other product candidates and the risk that we will be unable to successfully commercialize or market NE-180 or any of our other product candidates. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the section of Neose’s Annua l Report on Form 10-K for the year ended December 31, 2005, entitled “Factors Affecting the Company’s Prospects” and discussions of potential risks and uncertainties in Neose’s subsequent filings with the SEC.


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.

         
    Neose Technologies, Inc.
          
July 11, 2006   By:   A. Brian Davis
       
        Name: A. Brian Davis
        Title: Senior Vice President and Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press Release dated July 11, 2006.
EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

NEOSE PROVIDES UPDATE ON NE-180 PROGRAM

HORSHAM, PA, July 11, 2006 — Neose Technologies, Inc. (Nasdaq: NTEC) today provided an update on its clinical development program for NE-180, the Company’s long-acting, GlycoPEGylated erythropoietin for the treatment of anemia. The Company has concluded the dosing and safety follow-up for its Phase I trial in Western Europe.  Final analyses of pharmacokinetic data and other parameters are ongoing.  NE-180 was generally well-tolerated at the doses tested, and the expected increases in reticulocytes and hemoglobin were observed in both the intravenous and subcutaneous dose groups. 

In the United States, the Company continues to work with the Food and Drug Administration (FDA) on its NE-180 clinical hold. As previously announced, the initial hold items were successfully addressed. The FDA has raised additional questions with regard to the reliability of the existing potency assay as a measurement of product stability. The Company expects to address these questions during the next three quarters.

“We are pleased with the data we have seen thus far in the Phase I trial. The initial stopping criteria, based on increases in hemoglobin, were met after dosing the first two of the four planned dose groups. Although we added an option to dose additional subjects to gain more data, we have elected to end the study at this point given the issues surrounding the reliability of our potency assay. We believe we have sufficient clinical data and expect to commence Phase II in Western Europe as planned in the fourth quarter of 2006,” said George J. Vergis, Ph.D., Neose president and chief executive officer.

About Neose Technologies, Inc.
Neose Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development of next-generation therapeutic proteins that are competitive with best-in-class protein drugs currently on the market, on its own and through strategic partnerships. The lead candidates in its pipeline, NE-180 for use in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure and GlycoPEG-GCSF for neutropenia associated with myelosuppressive chemotherapy, target markets with aggregate sales in excess of $14 billion. NE-180 is expected to commence Phase II in a Western European country in the fourth quarter of 2006. Neose expects that its partner for GlycoPEG-GCSF, BioGenerix AG, will commence a Phase I trial in a Western European country in the third quarter of 2006.

CONTACTS:

 
 
Neose Technologies, Inc.
 
A. Brian Davis
Sr. Vice President and Chief Financial Officer
(215) 315-9000
 
Barbara Krauter
Manager, Investor Relations
(215) 315-9004

For more information, please visit www.neose.com.

Neose “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties, including the risk that we will be unable to resolve clinical hold issues in the U.S., the risk that we will be unable to resolve the issues surrounding our potency assay, the risk that NE-180 fails in clinical trials, the risk that we will never receive regulatory approval of NE-180 or any of our other product candidates and the risk that we will be unable to successfully commercialize or market NE-180 or any of our other product candidates. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statement, see the section of Neose’s Annual Report on Form 10-K for the year ended December 31, 2005, entitled “Factors Affecting the Company’s Prospects” and discussions of potential risks and uncertainties in Neose’s subsequent filings with the SEC.

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