Genencor International, Inc. announced that it has agreed to sell its therapeutic vaccine program to Belgian biotechnology company Innogenetics N.V. Innogenetics will develop and commercialize current product candidates in Genencor's vaccine product portfolio as well as future products based on intellectual property and technology held by Genencor.
Genencor will recognize license fees in the first year totaling $10 million, and will receive further payments of up to $87 million as development milestones are achieved. Genencor will also receive royalty payments on product sales. Genencor plans to apply the funds from this transaction towards building and advancing its Targeted Biotherapeutics pipeline focused initially in cancer.
Genencor launched its research initiative in therapeutic vaccines in 2001 and announced its plan to create innovative immunotherapeutic products for chronic diseases caused by hepatitis B, human papillomavirus and hepatitis C.
The portfolio today consists of a clinical product candidate for hepatitis B, a preclinical boost candidate for hepatitis B, a research-stage lead compound for human papillomavirus, and a discovery platform for future hepatitis C product candidates. Genencor filed an Investigational New Drug application (IND) for its hepatitis B product candidate in 2003, and recently began Phase I safety and immunogenicity testing.
Under the agreement, this product portfolio and discovery platform will be assumed by Innogenetics for additional research, development and commercialization. Genencor's research agreement and technology license from Epimmune Inc. will also be transferred as part of this transaction. After a short transition period with Genencor's assistance, Innogenetics will fully manage the current Phase I clinical study of the HBV vaccine candidate. Genencor may provide additional research or development services to Innogenetics on a funded basis.
"This agreement underscores our ability to deliver on our promise of creating significant value in our health care business in a relatively short period of time," said Genencor chairman, chief executive officer and president, Jean-Jacques Bienaimé. "We're pleased to put this valuable program in the hands of a solid company like Innogenetics with commercial experience in viral disease markets."
"This success is a result of a clear vision and superb execution by the experienced team we now have in place at Genencor," he added. "We are looking forward to applying that insight and expertise as we accelerate our efforts in therapeutics."
"Our ambition is to build a successful business based on innovative therapeutic products that serve medically and commercially important needs," said Mark A. Goldsmith, M.D., Ph.D., senior vice president, Health Care. "This transaction demonstrates that we have the capabilities needed to fulfill that ambition. Going forward, we are focusing our core competencies on delivering selective and potent Targeted Biotherapeutics engineered to provide effective and safe solutions to serious medical problems."
Goldsmith added, "We're particularly pleased with research progress in our primary focus area, oncology, and we expect to advance a Genencor lead compound for cancer into IND-enabling development during the first half of this year. In addition, we continue to pursue in-licensing of development-stage product candidates that complement our own discovery efforts."
Genencor also announced that as a result of this agreement and other events, it is increasing its annual guidance for the 2004 fiscal year. Total revenue for FY 2004 is expected to range from $398 million to $413 million. R&D expenses are expected to run from $77 million to $80 million. Operating income is expected to be $38 to $40 million, with net income available ranging from $21 to $23 million. The diluted earnings per share is expected to range from $0.34 to $0.37, compared to $0.26 to $0.30 previously announced.