-----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, K9Bjvm/uqjzS+JHeO0/kFYTDlsG9xVp3j1wCJ//Ky4/Bg2Ky0LuBdnLHzLqq1rsH pt4phxD/fi9gABHVuXXuXg== 0001104659-05-061916.txt : 20051221 0001104659-05-061916.hdr.sgml : 20051221 20051221103620 ACCESSION NUMBER: 0001104659-05-061916 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051219 ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051221 DATE AS OF CHANGE: 20051221 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DYAX CORP CENTRAL INDEX KEY: 0000907562 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 043053198 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24537 FILM NUMBER: 051277171 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 MAIL ADDRESS: STREET 1: ONE KENDALL SQ BLDG 600 STREET 2: 5TH FL CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: BIOTAGE INC DATE OF NAME CHANGE: 19951117 8-K 1 a05-22130_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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):  December 19, 2005

 

DYAX CORP.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-24537

 

04-3053198

(State or Other Jurisdiction of Incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

300 Technology Square

Cambridge, MA  02139

(Address of Principal Executive Offices)  (Zip Code)

 

(617) 225-2500

(Registrant’s telephone number, including area code)

 

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:

 

o                  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 1.02                                           Termination of a Material Definitive Agreement.

 

On December 19, 2005, Dyax Corp. and Debiopharm S.A. entered into a license agreement, which supersedes and terminates the existing license agreement dated January 24, 2001 between Dyax and Debiopharm.

 

Under the prior license agreement, Debiopharm had been developing DX-890, a neutrophil elastase inhibitor, for the treatment of cystic fibrosis (CF).  Debiopharm was responsible for all preclinical and clinical trials and all costs associated with the clinical development of DX-890 under that agreement and had exclusive rights to commercialize DX-890 in Europe for cystic fibrosis, acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disease (COPD), and for these indications Dyax retained the rights to North America and the rest of the world.  Also under the prior license agreement, if Dyax wished to outlicense the commercialization of any of these indications to a third party outside of Europe, Debiopharm had a right of first refusal to obtain the outlicensing rights.  Dyax was entitled to receive a percentage of revenues generated by Debiopharm from the commercialization of the cystic fibrosis product in Europe and was obligated to pay Debiopharm a percentage of any royalties received on product sales outside of Europe under the prior license agreement.  As none of the product candidates developed under the prior license agreement were approved for sale during the term of that agreement, Dyax neither paid nor received any royalties thereunder.

 

Under the new license agreement, Debiopharm has exclusive worldwide rights for the development, manufacture and commercialization of a native form of DX-890 in CF and ARDS.  Dyax retains rights to receive milestone payments and royalties with respect to Debiopharm’s DX-890 programs if they advance in development and are ultimately commercialized.  In addition, Dyax retains the exclusive worldwide rights to extended half-life versions of DX-890 that it may develop, manufacture and commercialize in other chronic pulmonary indications such as COPD.  Dyax also received a milestone payment upon execution of the new license agreement in connection with Debiopharm’s recent initiation of Phase I clinical studies in ARDS patients.

 

Item 7.01                                             Regulation FD Disclosure.

 

A copy of the press release announcing the termination of the prior license agreement and entry into the new license agreement is furnished as Exhibit 99.1 to this report.

 

 

Item 9.01.                                          Financial Statements and Exhibits.

 

(d)                                 Exhibits.

 

99.1                           Press Release of Dyax Corp. dated December 20, 2005 reporting the restructuring of its relationship with Debiopharm S.A.

 

2



 

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.

 

 

 

DYAX CORP.

 

 

 

 

 

 

 

 

 

 

Dated:

December 20, 2005

By:

/s/ Stephen S. Galliker

 

 

 

Stephen S. Galliker

 

 

 

Executive Vice President, Finance

 

 

 

and Administration, and Chief

 

 

 

Financial Officer

 

3



 

EXHIBIT INDEX

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release of Dyax Corp. dated December 20, 2005 reporting the restructuring of its relationship with Debiopharm S.A.

 

4


EX-99.1 2 a05-22130_1ex99d1.htm EXHIBIT 99

Exhibit 99.1

 

 

 

Debiopharm S.A. Contact:

 

Dyax Contacts:

Kim Bill

 

Ivana Magovcevic-Liebisch

VP Business Development & Licensing

 

General Counsel and Executive Vice

Phone: +41 21 321 01 11

 

President, Corporate Communications

kbill@debio.com

 

Phone: +1 617-250-5759

 

 

imagovcevic@dyax.com

Additional Media Contacts:

 

 

In London

 

Nicole Jones

Maitland Noonan Russo

 

Investor Relations Manager

Brian Hudspith

 

Phone: +1 617-250-5744

Phone: +44 (0)20 7379 5151

 

njones@dyax.com

bhudspith@maitland.co.uk

 

 

 

 

 

In New York

 

 

Euro RSCG Life NRP

 

 

Emily Poe

 

 

Assistant Vice President

 

 

Phone: +1 212 845 4266

 

 

emily.poe@eurorscg.com

 

 

 

Dyax Corp. and Debiopharm S.A. Restructure Development Agreement for DX-890 (Depelestat) in Pulmonary Disorders

 

CAMBRIDGE, MA and LAUSANNE, Switzerland, December 20, 2005 - Dyax Corp. (Nasdaq: DYAX) and Debiopharm S.A. today announced the restructuring of their long-standing development agreement for DX-890 (Depelestat), a recombinant inhibitor of human neutrophil elastase (hNE) discovered by Dyax and developed by Debiopharm, for the treatment of pulmonary disorders.  Under the terms of the restructured agreement, Debiopharm will have exclusive worldwide rights for the development, manufacture and commercialization of a native form of DX-890 in cystic fibrosis (CF) and acute respiratory distress syndrome (ARDS).

 

Dyax will retain rights to milestones and royalties with respect to Debiopharm’s DX-890 programs, as well as the exclusive worldwide rights to extended half-life versions of DX-890 for development, manufacturing and commercialization in other chronic pulmonary indications such as chronic obstructive pulmonary disease (COPD).  Dyax will receive a milestone payment upon execution of the agreement in connection with Debiopharm’s

 



 

recent initiation of Phase I clinical studies in ARDS patients.  Other financial details were not disclosed.

 

“This new agreement with Debiopharm is beneficial for both companies, providing Dyax with the ability to seek new development partners for our extended half-life versions of DX-890 in chronic pulmonary disorders, while providing Debiopharm with control of future development activities of the native form of DX-890 for CF and ARDS,” said Henry E. Blair, Chairman and Chief Executive Officer of Dyax.

 

“I am happy to conclude this new agreement which provides the structure and facility for DX-890 to be developed and commercialized in the global marketplace,” said Rolland-Yves Mauvernay, President and Chief Executive Officer of Debiopharm.

 

About DX-890 (Depelestat)

DX-890 is a highly potent and specific inhibitor of human neutrophil elastase (hNE). hNE is an enzyme produced as part of the inflammatory response and is implicated in the loss of lung function in patients with CF and other clinical conditions.  A drug that can block hNE may control the inflammatory processes early in the course of CF disease, and may limit the damaging effects of excessive inflammation, potentially delaying the progression of pulmonary deterioration and decreasing mortality.  DX-890 is currently in a Phase IIb study in children, adolescents and adults to demonstrate clinical benefit and define dosing for a Phase III trial.  DX-890 is also in a Phase I study in ARDS patients.  DX-890 has orphan drug designations in both the United States and Europe.

 

About Dyax

Dyax Corp. is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on cancer and inflammatory indications.  Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.

 

Dyax’s lead product candidate is DX-88, a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications.  In its joint venture with Genzyme Corporation, Dyax has successfully completed two Phase II trials of DX-88 for the treatment of hereditary angioedema (HAE).  A third Phase II trial is nearing completion, and a pivotal Phase III trial has just commenced.  Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during heart surgery (CABG procedures) and is in partnering discussions for further development of DX-88 in this indication.  DX-88 has orphan drug designation in the US and EU, as well as Fast Track designation in the US for the treatment of HAE.

 



 

Dyax identified DX-88 and other compounds in its pipeline using Dyax’s patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets.  Dyax leverages its technology broadly with over 75 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.

 

About Debiopharm S.A.

Founded in 1979 in Lausanne, Switzerland, Debiopharm is an experienced and competent drug development company that in-licenses compounds with promising in-vivo results to develop for global registration and to out-license to sales and marketing pharmaceutical partners.

 

Debiopharm is part of an established group of five complementary and synergistic companies, namely Debiovision in Canada, Debioinnovation and Debio R.P. in Switzerland and Debioclinic in France.  Together, they provide drug development expertise and know-how from the evaluation of early-stage and innovative research, partnering, financing, pre-clinical and clinical trials, to manufacturing and sophisticated drug-delivery systems.

 

Debiopharm has developed and registered three products with combined sales in excess of $1.8bn in 2004: Eloxatin®, one of sanofi-aventis’ leading marketed products; Decapeptyl®, the leading product of Ipsen; and Trelstar® (1-and 3-month), marketed by Watson Pharmaceuticals, Inc.

 

For more information on Debiopharm and the Debio companies, please visit: www.debio.com.

 

Dyax Disclaimer

This press release contains forward-looking statements, including statements regarding the prospects for further clinical trials and commercialization of the native form of DX-890 compound by Debiopharm and Dyax’s research and development program for an extended half-life form of DX-890 for indications other than CF and ARDS.  Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes.  The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict.  Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements.  Important factors which may affect the further clinical trials and commercialization of the DX-890 compound by Debiopharm and Dyax’s research and development program for DX-890 include the following risks:

 



 

our dependence on the expertise, effort, priorities and contractual obligations of Debiopharm and others in the development, clinical trials, manufacture, marketing, sales and distribution of DX-890; DX-890 may not show therapeutic effect or an acceptable safety profile in clinical trials or could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; DX-890 may not gain market acceptance; Dyax’s ability to obtain and maintain intellectual property protection for DX-890; the development of technologies or products superior to DX-890; and other risk factors described or referred to in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission.  Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release.  These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.  Dyax specifically disclaims responsibility for statements made by Debiopharm and the paragraph of information describing Debiopharm that was provided by Debiopharm.

 

Dyax is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium.  For online information about Dyax Corp., please visit www.dyax.com. Dyax and the Dyax logo are the registered trademarks of Dyax Corp.

 

# # #

 


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