-----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, DBeDEXp84cIKtdZ+U76DyDbwCqoOILym+spjWOHyJ0ojxm5V/o6lFbg0E2F+MA8j UF3v/Fjyz1AKEcbA1snKJQ== 0000812796-05-000021.txt : 20051102 0000812796-05-000021.hdr.sgml : 20051102 20051102141241 ACCESSION NUMBER: 0000812796-05-000021 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20051028 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051102 DATE AS OF CHANGE: 20051102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DOR BIOPHARMA INC CENTRAL INDEX KEY: 0000812796 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 411505029 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16929 FILM NUMBER: 051172700 BUSINESS ADDRESS: STREET 1: 1691 MICHIGAN AVE. STREET 2: SUITE 435 CITY: MIAMI STATE: FL ZIP: 33139 BUSINESS PHONE: 305-534-3383 MAIL ADDRESS: STREET 1: 1691 MICHIGAN AVE. STREET 2: SUITE 435 CITY: MIAMI STATE: FL ZIP: 33139 FORMER COMPANY: FORMER CONFORMED NAME: ENDOREX CORP DATE OF NAME CHANGE: 19960916 FORMER COMPANY: FORMER CONFORMED NAME: IMMUNOTHERAPEUTICS INC DATE OF NAME CHANGE: 19920703 8-K 1 gastrotechacq.htm GASTROTECH ACQUISITION 110205 Gastrotech Acquisition 110205

 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934


Date of Report (Date of Earliest Event Reported):    October 28, 2005    

Commission File No. 1-14778


DOR BIOPHARMA, INC.
(Exact name of small business issuer as specified in its charter)


DELAWARE
 
41-1505029
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification Number)
     
1691 Michigan Ave., Suite 435
Miami, FL
 
33139
(Address of principal executive offices)
 
(Zip Code)
 
(305) 534-3383
 
 
(Issuer’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))
 
Item 1.01. Entry into a Material Definitive Agreement.

On October 28, 2005, DOR BioPharma, Inc. (the “Company”) entered into a Binding Letter of Intent to acquire Gastrotech Pharma, a private Danish biotechnology company developing therapeutics based on gastrointestinal peptide hormones to treat gastrointestinal and cancer diseases and conditions. In connection with the closing of the acquisition, the Company will issue the stockholders of Gastrotech $9 million in Company common stock priced at the 10-day volume weighted average price immediately prior to the closing. In no event will the Company issue less than 20 million or more than 30 million shares of its common stock to Gastrotech’s shareholders. This corresponds to a price collar on the transaction of between $0.30 and $0.45 per share of Company common stock. In addition, the Company will pay Gastrotech shareholders another $30 million upon the occurrence of the following milestones: $4 million in stock priced at the time of initiation of a pivotal Phase 3 study of any of Gastrotech’s compounds, $6 million in stock priced at the time of filing of an NDA for any of Gastrotech’s compounds, $10 million payable in cash or stock when either of Gastrotech’s compounds achieves $50 million in sales in any calendar year, and $10 million payable in cash or stock when either of Gastrotech’s compounds achieves $200 million in sales in any calendar year. The parties intend that the acquisition would include the transfer of Gastrotech’s ongoing clinical programs to the Company as well as all intellectual property and facilities.

The closing of the acquisition is subject to execution of definitive agreements between the parties, containing such representations, warranties, covenants, conditions, indemnities and limitations on the Gastrotech stockholders' liability as are customary in a transaction of this kind. The Company has agreed to register the shares issued to the Gastrotech stockholders for resale under the Securities Act of 1933. The largest Gastrotech stockholder has agreed to limit its sales of the Company's common stock to 20% of its holdings per quarter. The Company has agreed to expand its Board of Directors to nine members, with three positions being appointed by the Gastrotech stockholders. There is a breakup fee of $1.0 million if either party breaches the terms of the Binding Letter of Intent.

A copy of the Binding Letter of Intent is filed as Exhibit 10.1 to this Current Report on Form 8-K.

Item 9.01.  Financial Statements and Exhibits.
 
(c) Exhibits.

Exhibit No. Title
 
10.1  
Binding Letter of Intent Dated October 28, 2005 between the Company and Gastrotech.
 
10.2  
Press Release issued by the Company dated November 2, 2005.


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.

                        DOR BIOPHARMA, INC.
                    By: /s/ Michael T. Sember  
            Name: Michael T. Sember   
                            Title: President and Chief Executive Officer

 
Dated: November 2, 2005




Exhibit Index


Exhibit
Number  Description of Exhibits

 
10.1  
Binding Letter of Intent Dated October 28, 2005 between the Company and Gastrotech.
 
10.2  
Press Release issued by the Company dated November 2, 2005.

EX-10.1 2 bindloi.htm BINDING LETTER OF INTENT Binding Letter of Intent

 
Exhibit 10.1

October 28, 2005
Confidential

Kind Attn: Hans T. Schambye, PhD
Chief Executive Officer

Gastrotech Pharma A/S
Nyhavn 43B
Copenhagen 1051
Denmark

Dear Hans:

I am pleased to submit this binding letter of intent (the “Binding LOI”) to Gastrotech Pharma A/S (“Gastrotech”) to acquire 100% of the fully diluted shares outstanding1  of Gastrotech (the "Shares"). This Transaction, as defined hereunder, has been approved by the board of directors of both companies, the shareholders of Gastrotech, and is subject to the approval of the shareholders of DOR. Subject to fiduciary duty principles, the board of directors of DOR will unequivocally recommend this Transaction to its shareholders.

This letter and all the information contained herein are confidential and may not be disclosed to any third party for any purpose, and are subject to the terms of the confidentiality agreement entered into between DOR and Gastrotech (separately the “Party” or collectively the “Parties”).

The following sets forth the principal terms and conditions of the Transaction consisting of DOR’s acquisition of 100% of the Shares.

Transaction. Subject to mutual satisfaction with the terms and conditions of the Definitive Agreement and other conditions described herein and customary for similar transactions, Gastrotech will become a wholly-owned subsidiary of DOR.
 
Consideration. In connection with the closing of the Transaction, DOR shall issue to the stockholders of Gastrotech $9 million in DOR common stock priced at the 10-day VWAP2  immediately prior to the close of the Transaction ("Closing"). In no event shall DOR issue less than 20 million or more than 30 million shares of DOR common stock to Gastrotech’s shareholders.
 
Gastrotech stockholders will also be eligible for the following one-time contingent payments:
 

i.  
US$4.0 million3 of DOR common stock due upon either of the lead product candidates (GTP-010 or GTP-200/ GTP 3XX) commencing a Phase III clinical trial;
 
ii.  
US$6.0 million3 of DOR common stock due upon either of the lead product candidates (GTP-010 or GTP-200/ GTP 3XX) filing an NDA;
 
iii.  
US$10.0 million, payable at the election of DOR in cash or shares of DOR common stock3, due upon either of the lead product candidates (GTP-010 or GTP-200/ GTP 3XX) reaching $50.0 million in sales in a full calendar year; and
 
iv.  
US$10.0 million, payable at the election of DOR in cash or shares of DOR common stock3, due upon either of the lead product candidates (GTP-010 or GTP-200/ GTP 3XX) reaching $200.0 million in sales in a full calendar year.
 
Warrants in Gastrotech. At Closing, all of the issued and outstanding Gastrotech warrants shall be exercised or exchanged for new DOR warrants. The exercise price and number of new DOR warrants shall be determined in accordance with the terms of the merger consideration at the close of the Transaction. Warrants held by Nordic Biotech will be cancelled or exercised prior to Closing. The new DOR warrants shall comply with all applicable Danish laws. Appendix A represents all outstanding warrants as per the date of this Binding LOI.
 
Nordic Biotech Registration Rights. Within 30 days after DOR shareholders approve the issuance of DOR common stock to the shareholders of Gastrotech and/or of DOR issuing shares under sections i.-iv. of “Consideration”, DOR will file a registration statement with the U.S. Securities and Exchange Commission (“SEC”) covering all of the DOR shares of common stock issued to all of the shareholders of Gastrotech pursuant to the terms of the Definitive Agreement. DOR will cover the expenses associated with filing the registration statement other than broker or similar commissions of the shareholders and legal fees of counsel to the Gastrotech shareholders. The shares issued to Nordic Biotech, however, will be subject to a lock-up arrangement pursuant to which Nordic Biotech will limit its public sale of such shares to twenty percent (20%) per quarter of the aggregate amount registered on all registration statements declared effective by the SEC.
 
Gastrotech Financing. Between the signing of this Binding LOI and the Closing, Gastrotech may raise equity financing up to $2.0 million. Such financing shall be subject to the approval of DOR, which approval shall not be unreasonably withheld. In the event of such fund raising, DOR will issue additional shares of its common stock to Gastrotech Shareholders in an aggregate amount equal to the amount of such equity financing divided by the 10-day VWAP immediately prior to the close of the Transaction;
 
 
Definitive Agreement. The terms of the proposed Transaction shall be memorialized in the final definitive agreement (the "Definitive Agreement"), which shall be negotiated in good faith between the Parties, and will contain such representations, warranties, covenants, conditions, indemnities and limitations on the sellers' liability as are customary in a transaction of this kind. Both Parties will work in good faith to ensure that relevant Danish tax authorization for a tax-free share swap pertaining to this transaction is obtained. In addition to the approval of the shareholders of DOR, Closing shall be subject to, without limitation, all relevant governmental and regulatory agency approvals and other necessary consents and permits.
 
 
Key Management. 
 
·  
Michael T. Sember will be the CEO of the combined entity;
 
·  
Evan Myrianthopoulos will be the CFO of the combined entity;
 
·  
Hans T. Schambye will be the COO of the combined entity; and
 
·  
Prior to the execution of a definitive agreement, DOR will offer Gastrotech employees relevant positions within DOR’s operations.
 
 
Name Change. DOR intends to change the name of the combined entity to a newly selected name.
 
 
Corporate Offices. 
 
·  
Corporate headquarters will be located in Miami, Florida
 
·  
European subsidiary will be located in Copenhagen, Denmark
 
 
Board of Directors. DOR intends to expand the board of directors of the post merger entity to nine members, with three positions being offered to nominees appointed by the sellers of the Shares. At least one of these nominees should qualify as an independent board member. The DOR representatives are listed below:
 
1.  
Alexander P. Haig, Chairman of the Board of Directors
2.  
Steve Kanzer, Vice Chairman of the Board of Directors
3.  
Michael T. Sember
4.  
Evan Myrianthopoulos
5.  
James S. Kuo
6.  
T. Jerome Madison
 
Acquisition Agreement. Drafting of the Definitive Agreement will commence following the execution of this Binding LOI.
 
 
Schedule. Both Parties shall cooperate fully and use their best efforts to complete the due diligence and sign the Definitive Agreement within forty-five (45) days following the date of this Binding LOI or such later date as provided in clause (i) of the Termination paragraph. The proxy or consent solicitation statement to obtain approval of DOR's shareholders of the Definitive Agreement shall be filed with the Securities and Exchange Commission as soon as reasonably practicable after signing the Definitive Agreement and, in any event, within thirty (30) days of signing the Definitive Agreement.
 
 

 
 
Termination. This Binding LOI will terminate on the earlier to occur of:
 
(i) the date which is forty-five (45) days after the date of this Binding LOI, it being understood by the Parties that they will agree to extend the termination date to a new date acceptable to both Parties if an unforeseen event prevents either one or both of the Parties from signing the Definitive Agreement within such forty-five (45) day period;
 
(ii) the date the Definitive Agreement is executed by the Parties;
 
(iii) the date both parties mutually agree to not proceed with the Transaction; or
 
(iv) the date on which a Party (the “Notifying Party”) notifies the other Party (the “Breaching Party”) that the Notifying Party will not go ahead with the Transaction based on the Breaching Party’s breach of a material term contained herein.
 
Expenses. DOR and Gastrotech shall each be responsible for their own respective legal, accounting, and other fees and expenses related to the Transaction. Gastrotech's expenses incurred in connection with the negotiation and consummation of the Transaction will be Gastrotech's responsibility and not a liability of DOR after the closing of the Transaction, and such expenses will not exceed $200,000.
 
Covenants.
 
A.  Exclusivity. For a period of forty-five (45) days from and after the date of this Binding LOI, Gastrotech shall not directly or indirectly, and shall not authorize or permit any of its subsidiaries or any of its or their       directors, officers, employees, agents or representatives to, directly or indirectly:
 
(i) solicit, initiate, facilitate or encourage any inquiries or the making of any proposal or offer with respect to any merger, reorganization, consolidation, share exchange, business combination, recapitalization, liquidation, dissolution or similar transaction involving it or any of its subsidiaries, or any purchase or sale of its assets or any purchase or sale of (with the exception of ongoing financing discussions with potential investors), or tender or exchange offer for its equity securities that, in each case, if consummated, would result in it terminating this Binding LOI or abandoning or failing to consummate the Transaction (an “Alternative Transaction”),
 
(ii) negotiate with any person or entity with respect to any Alternative Transaction,
 
(iii) enter into any agreement, arrangement or understanding requiring it to consummate an Alternative Transaction, terminate this Binding LOI or abandon or fail to consummate the Transaction, or
 
(iv) accept an Alternative Transaction,
 
This Binding LOI may only be terminated as set forth in the paragraph entitled “Termination” above. The exclusivity period and the terms of this Binding LOI may be extended by the mutual consent of the Parties.
 
Break-up Fee. Upon the termination of this Binding LOI pursuant to clause (iv) of the “Termination” paragraph, a Breaching Party will make a payment to the Notifying Party to cover the Notifying Party's fees, expenses and other costs in connection with the Transaction in the amount of one million U.S. dollars ($1,000,000) within thirty (30) days of such termination. The payment of such one million U.S. dollars ($1,000,000) shall constitute full and complete satisfaction of the Breaching Party’s liability to the Notifying Party and the Breaching Party shall have no further liability whatsoever to the Notifying Party.
 
Indemnification. 20% of the upfront payment of $9.0 million of DOR common stock (as defined hereunder in the “Consideration” section of this letter) will be held in escrow for eighteen (18) months to serve as appropriate reserves against any potential claims or losses regarding breaches of covenants, representations, and warranties of Gastrotech.
 
Conduct of Business. During the term of this Binding LOI, with the exception of ongoing financing discussions with potential investors, Gastrotech shall conduct its business in the ordinary course, carry on its business and activities diligently and shall not make or institute any unusual or novel methods of purchase, sale, accounting, or operation that vary materially from the methods currently used by Gastrotech. Gastrotech shall not engage in any major expansion, make any material investment, or incur any material liability without the prior consent of DOR.
 
Product Development. Post closing, DOR will use commercially reasonable efforts to advance development of the Gastrotech product portfolio, as provided in the Definitive Agreement.
 
Entire Agreement. This Binding LOI represents the entire agreement between the Parties hereto concerning the subject matter hereof and supersedes all prior and contemporaneous oral and written agreements, representations, and understandings concerning the subject matter hereof with the exception of the previously executed confidentiality and joint privilege agreements.
 
Confidentiality; Publicity. Except as required by law, the existence and terms of this Binding LOI and the negotiations between the Parties relating to the Transaction shall be treated as confidential by the Parties. The terms of any public announcements of the proposed Transaction shall be agreed among the Parties; provided that DOR shall be permitted to make such disclosure as required by applicable law, it being understood and agreed by Gastrotech that upon the execution of this Binding LOI by all of the Parties, DOR shall be required under applicable United States securities laws to publicly disclose the terms of this LOI, including the identity of Gastrotech as a contracting party. Gastrotech shall be permitted to show the Binding LOI to potential investors provided such investors have entered into appropriate Confidentiality Disclosure Agreements with Gastrotech. Such investors shall be previously approved by DOR. Gastrotech is allowed to show the Binding LOI to Bioscience Managers Ltd.
 
Governing Law. This Binding LOI and the Definitive Agreement will be governed by and construed in accordance with English law. 
 
Remedies. In the event of a breach by any Party of this Binding LOI, the other Party will be entitled to injunctive and other equitable relief in addition to all other remedies available under law.
 
Assignment. This Binding LOI may not be assigned by either Party except with the prior written consent of the other Party.
 
Counterparts. This Binding LOI may be executed in counterparts.
 
Broker/ Finder Fees. Any Party or any shareholder of Gastrotech who engages or have engaged any person as broker or agent shall be responsible for the fees of such person (including broker's or finder's fees) in connection with the Transaction and shall indemnify and hold harmless the other Party or shareholder of Gastrotech, as applicable, from any claim arising out of such engagement.
 

 
 

 

 

 
 

 
 
Agreed and Accepted on October 28, 2005:
 
Agreed and Accepted on October 28, 2005:
 
DOR BIO PHARMA, INC.
By: /s/Mike Sember____________________
Mike Sember
Chief Executive Officer
 
GASTROTECH PHARMA A/S
By: /s/Hans T. Schambye, PhD ___________
Hans T. Schambye, PhD
Chief Executive Officer
 
By: /s/Olle Isaksson_____________________
Olle Isaksson
Chairman of the Board of Directors
   
   
   
 

 
 

 
 
 


1 Fully diluted shares outstanding is calculated as the number of basic common shares currently outstanding plus any shares resulting from the conversion of any outstanding convertible debt, convertible preferred shares, or any other convertible securities and the exercise of any outstanding options, warrants, or any other financial instruments that may further affect dilution.
2 VWAP - volume weighted average price
3 Based on the 10-day VWAP of DOR common stock immediately prior to the announcement of the corresponding milestone

 
 

 


 

 
 

 
       
Gastrotech Pharma A/S
       
           
 
SHAREHOLDER:
Present
Share of ownership
Diluted and
Diluted and
 
 
converted
converted
 
 
Shares
(%)
Shares
(%)
 
John-Olov Jansson (A-Shares)
53,752
5.21%
53,752
1.46%
 
Johan Svensson (A-Shares)
21,504
2.08%
21,504
0.58%
 
Sahltech i Göteborg AB (A-Shares)
209,690
20.31%
209,690
5.69%
 
Nordic Biotech K/S (B-Shares)
745,566
72.21%
2,967,665
80.48%
 
Zinc Invest ApS (A-Shares)
1,966
0.19%
1,966
0.05%
 
 
 
 
 
 
 
 
 
 
 
 
 
Total Shares
1,032,478
100.00%
3,254,577
 
 
 
 
 
 
 
 
Convertible Bonds
 
 
 
 
 
Nordic Biotech K/S (price 26.6544)
187,586
 
included under shares
 
 
Nordic Biotech K/S (price 26.6544)
187,586
 
included under shares
 
 
Nordic Biotech K/S (price 26.6544)
187,586
 
included under shares
 
 
 
 
 
 
 
 
Total (present and converted)
1,595,236
 
 
 
 
 
 
 
 
 
 
Warrants
 
 
 
 
 
Nordic Biotech K/S (25% B-Warrants)
921,856
25.00%
included under shares
 
 
Nordic Biotech K/S (20% B-Warrants)
737,485
20.00%
included under shares
 
 
Olof G. P. Isaksson (A-Warrants) (*)
60,087
 
60,087
1.63%
 
Claes Post (A-Warrants) (**) (***)
32,794
 
32,794
0.89%
 
Birgitte Holst (A-Warrants) (**) (***)
19,446
 
19,446
0.53%
 
Henning Lie (A-Warrants) (*)(***)
2,000
 
2,000
0.05%
 
Lise A. Rygaard (A-Warrants) (*) (***)
51,696
 
51,696
1.40%
 
Hans Schambye (A-Warrants) (*) (***)
145,173
 
145,173
3.94%
 
David Cummings (A-Warrants) (*) (***) (¤¤)
5,000
 
5,000
0.14%
 
Kent Lundholm (A-Warrants) (*) (***) (¤¤)
5,000
 
5,000
0.14%
 
Josef E. Fischer (A-Warrants) (*) (***) (¤¤)
5,000
 
5,000
0.14%
 
Jens Juul Holst (A-Warrants) (*) (***) (¤¤)
5,000
 
5,000
0.14%
 
Tina Nielsen (A-Warrants) (*)(***)
15,000
 
15,000
0.41%
 
Hiro Saito (A-Warrants) (*) (***) (¤¤¤)
5,000
 
5,000
0.14%
 
Tamas Bartfai (*) (1 year vesting period)
3,287
 
3,287
0.09%
 
Unused Company A-Warrants
78,365
 
78,365
2.13%
 
Total
2,092,189
 
432,848
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Grand Total
3,687,425
 
 
100.00%
           
 
20-Jun-05
       
           
 
(*): Exercise price is DKK 42 per share of nominally DKK 1
     
 
(**): Exercise price is DKK 25.82 per share of nominally DKK 1
     
 
(***): Three year vesting period
       
 
(¤): Six months cliff from the signing of employment contract
     
 
(¤¤): Six months cliff from the signing
consultancy agreement
   
 
(¤¤¤): Vesting of 1,666 warrant for agreement entered into with a Japanese third party independent of the Company
           
           

EX-10.2 3 pressreleasedorgastro.htm PRESS RELEASE GASTROTECH ACQUISITION Press Release Gastrotech Acquisition

 
DOR BioPharma, Inc.
1691 Michigan Avenue
Miami, Florida 33139
www.dorbiopharma.com


DOR BioPharma Executes Letter of Intent for
Acquisition of Gastrotech Pharma

Acquisition Bolsters Biotherapeutics Pipeline

Miami, FL. November 2, 2005 - DOR BioPharma, Inc. (AMEX: DOR) (“DOR” or the “Company”), announced today that it has signed a binding letter of intent to acquire Gastrotech Pharma A/S (“Gastrotech”), a private Danish biotechnology company based in Copenhagen, Denmark. Gastrotech develops therapeutics based on peptide hormones to treat cancer and gastrointestinal (GI) diseases and conditions. Gastrotech was founded on technology developed at the Sahlgrenska University Hospital in Sweden which is known as the development cradle of Growth Hormone and IGF-1 research.

Following the close of this acquisition, DOR’s pipeline will be bolstered by the addition of two Phase 2 programs: GTP-010, an analogue of glucagon-like peptide-1 (“GLP-1”), and GTP-200, Gastrotech’s wild type ghrelin compound, a naturally occurring peptide hormone produced in the stomach to stimulate appetite.

GTP-010 is being studied in collaboration with Eli Lilly in a Phase 2, double-blinded, placebo-controlled trial for the treatment of pain associated with irritable bowel syndrome (“IBS”). The product also has application in the treatment of functional dyspepsia. GLP-1 has been shown to reduce the gastrointestinal contractions associated with IBS and other GI disorders.

Preclinical and clinical studies have demonstrated GTP-200’s positive effect on regulation of appetite, food intake, and metabolism. Cancer cachexia is estimated to be a $4 billion market and an unmet medical need affecting 50% of all cancer patients and fatal in 40% of patients.  GTP-200 completed patient treatment in a Phase 1/2 clinical trial for the treatment of cancer cachexia in September 2005. Results from this study will be available later this quarter. GTP-200 is also being evaluated for the treatment of gastrectomized patients as well as for several other indications.

 In connection with the closing of this acquisition, DOR will issue the stockholders of Gastrotech $9 million in shares of DOR common stock priced at the 10-day volume weighted average price immediately prior to the close of the transaction. In no event will DOR issue less than 20 million or more than 30 million shares of its common stock to Gastrotech’s shareholders. This corresponds to a price collar on the transaction of between $0.30 and $0.45 per share of DOR. In addition, DOR will pay Gastrotech shareholders another $30 million in cash or stock upon the occurrence of a series of developmental, regulatory and commercial milestones, $20 million of which are payable in connection with first product sales of $50 million and $200 million in any calendar year.

The companies intend that the acquisition would include the transfer to DOR of Gastrotech’s ongoing clinical programs as well as all intellectual property and facilities. This acquisition will be concluded pursuant to the execution of definitive documents and must be approved by a majority of DOR BioPharma’s shareholders. BIO-IB LLC, a New York based healthcare investment banking boutique, acted as financial advisor to DOR BioPharma.

Pursuant to the acquisition, DOR intends to maintain an office in Copenhagen, Denmark which will oversee current and planned clinical development efforts of the combined company in Europe. At a later stage, DOR may apply for listing on the Copenhagen Stock Exchange and maintain a dual listing in Denmark and the United States. DOR will file a registration statement covering the new shares issued to Gastrotech after the acquisition is completed. Nordic Biotech, a venture capital firm based in Copenhagen and focused on biotechnology companies in the Nordic region, is Gastrotech’s largest investor and will be subject to a staged lockup period in connection with new DOR shares that it will own.

“We view this acquisition as synergistic with our orBec® program,” stated Michael T. Sember, President and Chief Executive Officer of DOR. “This acquisition will deepen our product pipeline and fortify DOR’s focus on cancer/GI disease research through the acquisition of two clinical-stage programs that are complementary to orBec®. This will enable us to eventually launch other GI focused cancer products as a follow-up to our anticipated orBec® launch. Gastrotech’s senior management team will assume an active role at DOR, contributing valuable clinical and regulatory expertise to the DOR team, as we advance these programs towards commercialization. With regard to GTP-200, we view appetite stimulation through supplemental ghrelin hormone therapy to be a logical approach to the treatment of cancer cachexia. We believe that the combination of DOR and Gastrotech will increase our profile in the investment community and establish us as a formidable presence in the GI/cancer arena.”

In connection with the acquisition, Hans Schambye, M.D., Ph.D., currently Chief Executive Officer of Gastrotech will become the Chief Operating Office of DOR. Dr. Schambye commented, “We are excited to be joining forces with DOR. Our pipelines complement each other well and the combined company will have drugs in every stage of clinical development. orBec® is an appealing product, which addresses a significant unmet medical need. We are impressed with the data package on orBec® and look forward to working on this and DOR’s other programs.”

Gastrotech’s Chairman, Professor Olle Isaksson, M.D., Chairman of the Endocrine Department at Gothenburg University added, “I believe Gastrotech has what it takes to develop successfully as an independent company, but being acquired by DOR is a good alternative. The combined company will be stronger than each separate entity and will have a deep, clinical stage pipeline.”

About GTP-200

GTP-200 is based on ghrelin, a naturally occurring peptide hormone with many important physiological activities, including stimulation of growth hormone secretion, induction of appetite and modification of metabolism. Ghrelin is primarily produced in the stomach and is an extremely potent inducer of appetite and food intake. We intend to take advantage of these properties and plan to develop GTP-200 for the treatment of a number of diseases, including cancer cachexia. 

About Cancer Cachexia

Cancer cachexia is a serious condition characterized by abnormal weight loss, weakness and general bodily decline that occurs in many cancer patients. The condition is a significant factor in the poor performance and high mortality rate of cancer patients. Cachectic patients have worse outcomes from surgery, chemotherapy and radiation therapy. No specific treatment is available for cancer cachexia which affects around 1 million patients in the US and Europe at any given time.

About Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a chronic, relapsing functional bowel disorder characterized by symptoms of pain or discomfort in the digestive tract or abdominal wall and abnormality of bowel habit. IBS affects more than 80 million people worldwide and pain is among the most dominant symptoms in these patients. More than three million patients are estimated to have frequent, severe pain attacks but no treatment is currently available for these attacks.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of therapeutic products and biomedical countermeasures for areas of unmet medical need. Our lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec® for the treatment of iGVHD in early 2006.

Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVaxTM, has completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design.
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For further information regarding DOR BioPharma, please visit the Company's website located at http://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's current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of iGVHD and the prospects for regulatory filings for orBec®. Where possible, DOR BioPharma 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 BioPharma 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 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, that it will be able to maintain its listing on the American Stock Exchange (“AMEX”) by completing a transaction which will provide it with shareholders’ equity of at least $6 million prior to a date set by AMEX for a hearing regarding the continued listing on AMEX of Dor BioPharma’s common stock, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for iGVHD include the risks that: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase III 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 BioPharma expects or may never gain approval; Dor BioPharma 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®. Dor BioPharma’s business strategy has been revised to include the issuance of its securities to acquire companies or assets. Dor BioPharma presently is involved in negotiations which could result in the issuance of a significant number of shares of its equity securities, thereby diluting the equity interests of present stockholders. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma 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:     
Evan Myrianthopoulos
Chief Financial Officer
(305) 534-3383     
www.dorbiopharma.com


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