Dynavax Gains Ownership of GMP Vaccine Manufacturing Facility, Vaccine Pipeline and HEPLISAV Commercialization Rights
BERKELEY, Calif., March 27, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) announced its plan to acquire biopharmaceutical and vaccine manufacturer Rhein Biotech GmbH in a cash transaction of approximately $12 million. Rhein Biotech GmbH is part of Rhein Biotech NV (Frankfurt, Geregelter Markt:RBO), a company 93%-owned by Berna Biotech AG. Berna was recently acquired by the Dutch biotechnology company Crucell NV. (Euronext, Nasdaq: CRXL; Swiss Exchange: SW CRX). Dynavax has had an agreement with Berna for supply of hepatitis B surface antigen for use with HEPLISAV™, its hepatitis B vaccine.
The transaction is designed to accomplish key strategic goals for both Dynavax and Crucell. Through this acquisition, Dynavax gains ownership of a European Union (EU) GMP-certified vaccine manufacturing facility, control over the production of hepatitis B surface antigen and potentially other antigens to support clinical and commercial programs, management and personnel with proven expertise in biopharmaceutical product development and production, and a complementary pipeline of vaccine and antiviral products. The transaction enables Crucell to continue to focus on core competencies by divesting a non-strategic asset.
"The acquisition of Rhein Biotech GmbH is designed to accelerate Dynavax's strategy of building a diversified vaccine franchise, to provide independent ownership of antigen supply and product manufacturing for hepatitis B and other programs, and to generate a significant return on investment," said Dino Dina, MD, president and chief executive officer. "Rhein Biotech GmbH represents a timely, near-term opportunity to broaden our hepatitis B vaccine program and to expand our earlier-stage vaccine and antiviral pipeline with promising product candidates in commercially attractive markets. We believe that this transaction reflects the parties' views that the assets of Rhein Biotech GmbH can be better leveraged as part of Dynavax's operations."
Continued Dr. Dina: "I am especially excited to welcome the management and employees of Rhein Biotech GmbH to Dynavax. Their development and regulatory expertise, their high quality manufacturing capabilities and their excellent reputation among customers, collaborators and investors in Europe will be valuable assets as we build our combined business. Given the shared enthusiasm for the acquisition and alignment of priorities within Dynavax and Rhein Biotech GmbH, we anticipate that the integration of our businesses should proceed smoothly."
Financial Terms of the Transaction
Under the terms of the planned acquisition, Dynavax will pay to Rhein Biotech NV approximately $12 million, excluding expenses and based on current exchange rates. The payment includes the purchase of 100% of the outstanding capital stock of Rhein Biotech GmbH. The assets of Rhein Biotech GmbH include manufacturing facilities, research and development stage products, an industrial R&D services business and personnel.
Upon closing of the transaction, Dynavax's hepatitis B surface antigen license and supply agreement with Berna will terminate and Berna will no longer have an option to commercialize HEPLISAV.
Dynavax expects ongoing revenue from the industrial services business of Rhein Biotech GmbH, cost synergies from the combined operations, and the elimination of Dynavax's costs to Berna related to the development of HEPLISAV, to offset the additional operating expenses associated with the business of Rhein Biotech GmbH in the near term. Dynavax expects that the acquisition costs of the transaction will be recovered in the long term by reductions in cost of goods for HEPLISAV and the elimination of financial obligations to Berna under the prior licensing and supply agreement. Rhein Biotech NV will retain an option to certain co-development and commercialization rights for Rhein Biotech GmbH's hepatitis B vaccine, Supervax, in Europe and Asia.
The transaction is anticipated to close in the second quarter of 2006.
Pacific Growth Equities LLC served as advisor to Dynavax in this transaction.
About Rhein Biotech GmbH
Headquartered in Dusseldorf, Germany, Rhein Biotech GmbH is an integrated biopharmaceutical company with established businesses in hepatitis B and other vaccine product development, manufacturing and industrial services. The key products of Rhein Biotech GmbH include Supervax, a two-dose hepatitis B vaccine, Theravax, a preclinical-stage therapeutic vaccine for treatment of chronic hepatitis B, and a preclinical-stage vaccine to prevent cytomegalovirus infection. Other products Rhein Biotech GmbH has developed and licensed-out include a three-dose hepatitis B vaccine, alpha-interferon, and hirudin, an anticoagulant. Rhein Biotech GmbH has approximately 45 employees.
Conference Call Today
Dynavax will hold a conference call to discuss the acquisition of Rhein Biotech GmbH today at 5:00 pm Eastern /2:00 pm Pacific. To access the live call, please dial 866-362-4820 (US) or 617-597-5345 (international), passcode 80272008. Interested parties may listen to the webcast live at http://www.dynavax.com by clicking on the "Events" tab under the heading, "Investors." The webcast is also being distributed over CCBN's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN's individual investor center at http://www.fulldisclosure.com or by visiting any of the investor sites in CCBN's Individual Investor Network. Institutional investors can access the call via CCBN's password-protected event management site, StreetEvents, at http://www.streetevents.com . A telephonic replay will be available through April 3, 2006 by dialing 888-286-8010, access code 56832147. International callers can dial 617-801-6888, access code 56832147.
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: TOLAMBA™, a ragweed allergy immunotherapeutic, that has completed a large-scale Phase 2/3 clinical trial, and is in a supportive clinical trial in ragweed allergic children; HEPLISAV™, a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacologic activity in a Phase 2a clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation plans to acquire Rhein Biotech GmbH; Dynavax's ability to meet key strategic goals through this planned acquisition; plans to accelerate Dynavax's strategy of building a diversified vaccine franchise and to generate a significant return on investment; anticipation that the integration of the business should proceed smoothly; our view that Rhein Biotech's assets can be better leveraged as part of Dynavax's operations, our expectation that ongoing revenue from Rhein Biotech's industrial services business, cost synergies from the combined operations, and the elimination of Dynavax's costs to Berna related to the development of HEPLISAV, will offset the additional operating expenses associated with Rhein Biotech's operations; our expectation that that the acquisition costs of the transaction will be recovered in the long term by reductions in cost of goods for HEPLISAV and the elimination of financial obligations to Berna under the prior licensing and supply agreement, and statements related to plans to advance its clinical programs in ragweed allergy, hepatitis B and cancer and the commercial opportunities for those programs. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to the progress and timing of its anticipated Phase 3 clinical trials in ragweed allergy and hepatitis B; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the "Risk Factors" section of Dynavax's Annual Report on Form 10-K filed on March 16, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
SOURCE Dynavax Technologies Corporation
Jane M. Green, PhD, Vice President, Corporate Communications of Dynavax Technologies Corporation, +1-510-665-4630, or firstname.lastname@example.org