Dynavax Announces Termination of Partnership With Merck for Heplisav Hepatitis B Vaccine

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Dynavax Announces Termination of Partnership With Merck for Heplisav Hepatitis B

Vaccine

From the PharmaLive.com News Archive - Dec. 19, 2008

All Rights Revert to Dynavax

BERKELEY, Calif.--(BUSINESS WIRE)--Dec 19, 2008 - Dynavax Technologies

Corporation (Nasdaq:DVAX) today announced the termination of a global license

and development collaboration agreement with Merck & Co., Inc. for HEPLISAVTM, a

Phase 3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize

HEPLISAV revert to Dynavax.

Dynavax will continue to evaluate regulatory options for the development of

HEPLISAV indicated for adults outside of the United States and for the global

end-stage renal disease markets, which the Company estimates represent

approximately 70% of the total market opportunity for this vaccine. If the

regulatory feedback is favorable, Dynavax plans to pursue a new partner or

financing arrangement to support the completion of HEPLISAV's development for

these markets.

“We believe the economics for HEPLISAV, which has been shown to be clinically

superior in our trials, favor identifying an appropriate regulatory path in the

U.S. and Europe,” commented Dino Dina, M.D., President and Chief Executive

Officer of Dynavax. “In the first quarter of 2009, we expect to gain additional

insight into the regulatory path for HEPLISAV that will enable us to evaluate

further development and pursue partnering agreements with potential

collaborators or investors. Independently of HEPLISAV, with our current cash

position and strong pharmaceutical partnerships, we have the ability to continue

to advance our diversified, well-funded pipeline of products to position Dynavax

for future success.”

Update to 2008 Cash Outlook

Dynavax's consolidated cash, cash equivalents, marketable securities and

investments held by Symphony Dynamo, Inc., or total cash, is projected to be

over $65 million at December 31, 2008, an increase from the previous guidance of

over $50 million. This increase is due to the $10 million initial payment under

Dynavax's worldwide strategic alliance with GlaxoKline as well as the

Company's conservatively managed cash burn rate. Due to the termination of the

Merck partnership, Dynavax anticipates that it will accelerate the recognition

of approximately $31 million of non-cash revenue previously reported as deferred

revenue.

About HEPLISAV

HEPLISAV is a Phase 3 hepatitis B vaccine that combines HBV surface antigen

(HBsAg) with Dynavax's proprietary immunostimulatory sequences (ISS), which

specifically target Toll-Like Receptor 9 (TLR9) to stimulate an innate immune

response. Clinical data demonstrate HEPLISAV's highly effective protection

against HBV with a more rapid onset of protection, superior 2-dose regimen, and

longer lasting seroprotection compared to current vaccines. In a recent Phase 3

trial, 95% of subjects receiving 2 doses of HEPLISAV were seroprotected compared

to 81% of subjects receiving 3 doses of Engerix-B. In 9 clinical trials

conducted over a period of nearly 10 years, a total of approximately 2,500

individuals have been vaccinated with more than 5,000 doses of HEPLISAV.

In October 2008, the U.S. Food and Drug Administration (FDA) requested

additional information prior to considering further development of HEPLISAV in

end-stage renal disease patients but advised that the balance of risk versus

potential benefit no longer favors continued clinical evaluation of HEPLISAV in

healthy adults and children. The clinical hold on the two U.S. IND Applications

for HEPLISAV has been in effect since March 2008 following the FDA's request for

a complete review of safety data, including all available information about a

single case of Wegener's granulomatosis reported in a Phase 3 clinical trial.

HEPLISAV is not on clinical hold in any market outside of the U.S.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,

discovers and develops a diversified, well-funded pipeline of novel Toll-like

Receptor (TLR) product candidates. Based on Dynavax's proprietary technology

platform, these products specifically modify the innate immune response to

infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax's

product programs are supported by global partnerships with leading

pharmaceutical companies such as GlaxoKline, AstraZeneca AB, and Novartis

as well as funding from Symphony Dynamo, Inc. and the National Institutes of

Health. For more information visit www.dynavax.com.

Dynavax Forward-Looking Statement

This press release contains “forward-looking statements,” including statements

related to our plans to evaluate regulatory options for HEPLISAV and the timing

of that evaluation, the prospects for HEPLISAV and the determination of whether

further clinical development of HEPLISAV will be undertaken, and if undertaken,

whether further development can be partnered or financed; and our projected year

end cash position. Actual results may differ materially from those set forth in

this press release due to the risks and uncertainties inherent in our business,

including difficulties or delays in development, initiation and completion of

clinical trials, the results of clinical trials and the impact of those results

on the initiation and completion of subsequent trials and issues arising in the

regulatory process; the scope and validity of patent protection and the

possibility of claims against us based on the patent rights of others; our

ability to obtain additional financing to support our operations; and other

risks detailed in the “Risk Factors” section of our Quarterly Report on Form

10-Q. We undertake no obligation to revise or update information herein to

reflect events or circumstances in the future, even if new information becomes

available.

Contact: Dynavax Technologies Corporation

Dino Dina, M.D., 510-665-4601

President & Chief Executive Officer

ddina@...

Amy Figueroa, 510-665-7211

Investor Relations & Corporate Communications

afigueroa@...

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Dynavax Announces Termination of Partnership With Merck for Heplisav Hepatitis B

Vaccine

From the PharmaLive.com News Archive - Dec. 19, 2008

All Rights Revert to Dynavax

BERKELEY, Calif.--(BUSINESS WIRE)--Dec 19, 2008 - Dynavax Technologies

Corporation (Nasdaq:DVAX) today announced the termination of a global license

and development collaboration agreement with Merck & Co., Inc. for HEPLISAVTM, a

Phase 3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize

HEPLISAV revert to Dynavax.

Dynavax will continue to evaluate regulatory options for the development of

HEPLISAV indicated for adults outside of the United States and for the global

end-stage renal disease markets, which the Company estimates represent

approximately 70% of the total market opportunity for this vaccine. If the

regulatory feedback is favorable, Dynavax plans to pursue a new partner or

financing arrangement to support the completion of HEPLISAV's development for

these markets.

“We believe the economics for HEPLISAV, which has been shown to be clinically

superior in our trials, favor identifying an appropriate regulatory path in the

U.S. and Europe,” commented Dino Dina, M.D., President and Chief Executive

Officer of Dynavax. “In the first quarter of 2009, we expect to gain additional

insight into the regulatory path for HEPLISAV that will enable us to evaluate

further development and pursue partnering agreements with potential

collaborators or investors. Independently of HEPLISAV, with our current cash

position and strong pharmaceutical partnerships, we have the ability to continue

to advance our diversified, well-funded pipeline of products to position Dynavax

for future success.”

Update to 2008 Cash Outlook

Dynavax's consolidated cash, cash equivalents, marketable securities and

investments held by Symphony Dynamo, Inc., or total cash, is projected to be

over $65 million at December 31, 2008, an increase from the previous guidance of

over $50 million. This increase is due to the $10 million initial payment under

Dynavax's worldwide strategic alliance with GlaxoKline as well as the

Company's conservatively managed cash burn rate. Due to the termination of the

Merck partnership, Dynavax anticipates that it will accelerate the recognition

of approximately $31 million of non-cash revenue previously reported as deferred

revenue.

About HEPLISAV

HEPLISAV is a Phase 3 hepatitis B vaccine that combines HBV surface antigen

(HBsAg) with Dynavax's proprietary immunostimulatory sequences (ISS), which

specifically target Toll-Like Receptor 9 (TLR9) to stimulate an innate immune

response. Clinical data demonstrate HEPLISAV's highly effective protection

against HBV with a more rapid onset of protection, superior 2-dose regimen, and

longer lasting seroprotection compared to current vaccines. In a recent Phase 3

trial, 95% of subjects receiving 2 doses of HEPLISAV were seroprotected compared

to 81% of subjects receiving 3 doses of Engerix-B. In 9 clinical trials

conducted over a period of nearly 10 years, a total of approximately 2,500

individuals have been vaccinated with more than 5,000 doses of HEPLISAV.

In October 2008, the U.S. Food and Drug Administration (FDA) requested

additional information prior to considering further development of HEPLISAV in

end-stage renal disease patients but advised that the balance of risk versus

potential benefit no longer favors continued clinical evaluation of HEPLISAV in

healthy adults and children. The clinical hold on the two U.S. IND Applications

for HEPLISAV has been in effect since March 2008 following the FDA's request for

a complete review of safety data, including all available information about a

single case of Wegener's granulomatosis reported in a Phase 3 clinical trial.

HEPLISAV is not on clinical hold in any market outside of the U.S.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,

discovers and develops a diversified, well-funded pipeline of novel Toll-like

Receptor (TLR) product candidates. Based on Dynavax's proprietary technology

platform, these products specifically modify the innate immune response to

infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax's

product programs are supported by global partnerships with leading

pharmaceutical companies such as GlaxoKline, AstraZeneca AB, and Novartis

as well as funding from Symphony Dynamo, Inc. and the National Institutes of

Health. For more information visit www.dynavax.com.

Dynavax Forward-Looking Statement

This press release contains “forward-looking statements,” including statements

related to our plans to evaluate regulatory options for HEPLISAV and the timing

of that evaluation, the prospects for HEPLISAV and the determination of whether

further clinical development of HEPLISAV will be undertaken, and if undertaken,

whether further development can be partnered or financed; and our projected year

end cash position. Actual results may differ materially from those set forth in

this press release due to the risks and uncertainties inherent in our business,

including difficulties or delays in development, initiation and completion of

clinical trials, the results of clinical trials and the impact of those results

on the initiation and completion of subsequent trials and issues arising in the

regulatory process; the scope and validity of patent protection and the

possibility of claims against us based on the patent rights of others; our

ability to obtain additional financing to support our operations; and other

risks detailed in the “Risk Factors” section of our Quarterly Report on Form

10-Q. We undertake no obligation to revise or update information herein to

reflect events or circumstances in the future, even if new information becomes

available.

Contact: Dynavax Technologies Corporation

Dino Dina, M.D., 510-665-4601

President & Chief Executive Officer

ddina@...

Amy Figueroa, 510-665-7211

Investor Relations & Corporate Communications

afigueroa@...