-----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, HzJSGHhge57zr5epQjgT2e7fVTeM3G/7lx/jPNIhZoMb78pf1B92ZYtFVESxVZme RoL5seT0E8ex4J2GFqaj1A== 0001104659-06-035281.txt : 20060516 0001104659-06-035281.hdr.sgml : 20060516 20060516092619 ACCESSION NUMBER: 0001104659-06-035281 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060515 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060516 DATE AS OF CHANGE: 20060516 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: 06844178 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 a06-12019_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): May 15, 2006

DYAX CORP.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

000-24537

 

04-3053198

(State or Other Jurisdiction of

 

(Commission File Number)

 

(IRS Employer

Incorporation)

 

 

 

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 7.01.              Regulation FD Disclosure.

On May 15, 2006, Dyax Corp. (“Dyax”) issued a press release providing an update on the regulatory pathway for the DX-88 program in hereditary angioedema. Pursuant to Item 7.01, a copy of the press release is hereby furnished to the Commission as Exhibit 99.1 to this report.

Item 8.01.              Other Events.

On May 15, 2006, Dyax announced an update on regulatory pathway for the DX-88 program in hereditary angioedema (HAE). This program was transferred from the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) division to the Center for Drug Evaluation and Research (CDER) division as a result of the FDA’s ‘Plan for Consolidation.’  In meetings with CDER, following this reassignment, the FDA indicated that Dyax will likely need to complete some incremental clinical work, most probably a dose-ranging study on subcutaneously administered DX-88 to secure final approval.

Dyax and its partner, Genzyme Corporation, are currently evaluating options to address the FDA’s suggestion in a timely manner. While Dyax expects that the process of responding to the FDA and providing additional data will likely affect the previous guidance of an anticipated 2007 regulatory approval date, Dyax can not provide additional guidance until the overall regulatory submission package and specific new data requirement have been discussed and further reviewed by the FDA. This new request will not affect the estimated second half of 2006 timeline for completion of the ongoing EDEMA3, Phase III clinical trial.

This report contains forward-looking statements, including statements regarding plans for development of DX-88 for HAE. 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 report 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 position of DX-88 for HAE versus other products in development for HAE include the risks that: DX-88 may not show sufficient 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; others may develop technologies or products superior to DX-88 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; 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 report. These statements speak only as of the date of this report, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.

Item 9.01.              Financial Statements and Exhibits.

(d)

 

Exhibits.

 

 

 

99.1

 

Press release of Dyax Corp. dated May 15, 2006.

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: May 16, 2006

 

By:

 

/s/ IVANA MAGOVCEVIC-LIEBISCH

 

 

 

 

Ivana Magovcevic-Liebisch

 

 

 

 

General Counsel and

 

 

 

 

Executive Vice President,

 

 

 

 

Corporate Communications

3




EXHIBIT INDEX

Exhibit

 

 

No.

 

Description

99.1

 

Press release of Dyax Corp. dated May 15, 2006.

 

4



EX-99.1 2 a06-12019_1ex99d1.htm EX-99

Exhibit 99.1

Dyax Contacts:

 

Media Contact:

Ivana Magovčević-Liebisch

 

Robert Kloppenburg

General Counsel and Executive Vice President,

 

Senior Vice President

Corporate Communications

 

Fleishman-Hillard Inc.

(617) 250-5759

 

(617) 692-0504

imagovcevic@dyax.com

 

kloppenr@fleishman.com

 

Nicole Jones
Investor Relations Manager
(617) 250-5744
njones@dyax.com

Dyax Provides Update on Regulatory Pathway for DX-88

- Phase III Trial on Track to Complete 2H06 -

May 15, 2006 — Cambridge, MA — Dyax Corp. (Nasdaq:DYAX) today announced an update on regulatory pathway for the DX-88 program in hereditary angioedema (HAE). This program was transferred from the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) division to the Center for Drug Evaluation and Research (CDER) division as a result of the FDA’s ‘Plan for Consolidation.’  In meetings with CDER, following this reassignment, the FDA has indicated that Dyax will likely need to complete some incremental clinical work, most probably a dose-ranging study on subcutaneously administered DX-88 to secure final approval.

At this time, Dyax and its partner, Genzyme Corporation, are evaluating options to address the FDA’s suggestion in a timely manner. While Dyax expects that the process of responding to the FDA and providing additional data will likely affect the previous guidance of an anticipated 2007 regulatory approval date, Dyax can not provide additional guidance until the overall regulatory submission package and specific new data requirement have been discussed and further reviewed by the FDA. This new request will not affect the estimated second half of 2006 timeline for completion of the ongoing EDEMA3, Phase III clinical trial.




“The FDA wants data to ensure that the current 30 mg fixed dose of DX-88 is in fact the optimal dose for subcutaneous administration,” stated Tom Beck, President and Chief Operating Officer of Dyax. “The amount of additional data and analysis that might be necessary to address this requirement is currently being discussed with the FDA. However, it should be noted that the FDA has expressed no issues or concerns with the overall safety and activity of DX-88.”

“We, as well as our commercialization partner, Genzyme are fully committed to bringing DX-88 to HAE patients, and we are confident that the unique attributes of DX-88, including ease of administration and overall clinical profile will allow us to ultimately provide a highly appealing treatment option for HAE patients and their physicians,” said Henry Blair, Chairman and Chief Executive Officer of Dyax. “In clinical trials to date, DX-88 has demonstrated an excellent safety profile and has been shown to be well tolerated with over 470 doses administered to 215 individuals. The regulatory and clinical teams at Dyax and Genzyme are working together diligently to clarify and address the FDA’s position with regard to additional data and to finalize the regulatory timeline as quickly as possible.”

“We are supportive of continuing the work necessary to bring an urgently needed treatment to patients with hereditary angioedema and are encouraged by the progress that is being made toward this goal,” said Georges Gemayel, Executive Vice President of Genzyme Corporation.

About Dyax

Dyax 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 three Phase II trials of DX-88 for the treatment of hereditary angioedema (HAE). A Phase III trial is ongoing. 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 planning a Phase IIb trial while it continues partnering discussions for further development of DX-88 in this indication. DX-88 has orphan drug designation in the U.S. and E.U. for the treatment of angioedema, as well as Fast Track designation in the U.S.




Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this 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.

Dyax Disclaimer

This press release contains forward-looking statements, including statements regarding the potential administration, dosing, safety and therapeutic benefit of DX-88 for HAE and plans for development of DX-88 for HAE and CABG. 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 potential administration, dosing and therapeutic benefit of DX-88 for HAE and its position versus other products in development for HAE include the risks that: DX-88 may not show sufficient 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; others may develop technologies or products superior to DX-88 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacture, marketing, sales and distribution of DX-88; 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 and the Dyax logo are the registered trademarks of Dyax Corp. EDEMA3 is a service mark of Dyax Corp.

Dyax is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium. For online information about Dyax, please visit www.dyax.com.



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