CAMBRIDGE, Mass., Dec. 21 /PRNewswire-FirstCall/ -- Genzyme Corporation announced today that it has completed its acquisition of ILEX Oncology, Inc., a cancer drug development company with a growing marketed product, a second product nearing approval and a third well into Phase 2 development. The stock-for-stock transaction is valued at approximately $1 billion.
The acquisition of ILEX creates a solid foundation for Genzyme's growing oncology business by adding an emerging commercial presence, a robust pipeline and highly-regarded clinical development organization to the company. These assets significantly augment Genzyme's existing research and development programs in oncology and will leverage Genzyme's expertise in biologics manufacturing and targeted therapeutics. In addition, there are great synergies with Genzyme's expanded oncology testing business.
"Genzyme has conducted important research in oncology for several years," said Duke Collier, executive vice president, Genzyme Corporation. "It is a challenging disease, but one where biotechnology can make a significant difference to patients and their families. With our acquisition of the cancer diagnostics business of Impath, Inc. earlier this year, and now with this exciting acquisition of the therapeutics products and development experience of ILEX, Genzyme is taking major steps to build its presence in oncology."
The acquisition fits well with Genzyme's strategy. Cancer is a significant unmet medical need that includes well-defined groups of addressable patient populations. Each product in the company's portfolio is intended to make a major positive impact on the lives of patients with serious, complex diseases.
"The strength of the ILEX team in successfully building one of the best emerging cancer therapeutics companies, combined with Genzyme's oncology pipeline, scientific resources and worldwide infrastructure, provide the foundation for a sustainable and competitive commercial oncology business," added Mark Enyedy, senior vice president and general manager of Genzyme's oncology business unit. "Our immediate focus will be to advance clinical trials already well underway, to expand our sales and marketing capabilities to support the expected launch of clofarabine, and to build upon relationships with partners and customers."
"We are very pleased that the oncology franchise that we envisioned has continued to progress nicely this year," said Jeff Buchalter, outgoing president and CEO of ILEX. "Genzyme will now have the ability to advance this franchise to the next level and create value for all of the stakeholders who have made this business successful."
ILEX shares have ceased trading and been delisted from Nasdaq. Under the terms of the transaction, holders of ILEX stock received 0.4682 of a share of Genzyme stock for each share of their stock. Cash will be paid for fractional shares. In the next few weeks, former ILEX stockholders will receive instructional materials regarding the exchange of stock certificates. Genzyme will provide guidance for 2005 in its fourth quarter earnings press release on February 17.
Genzyme will continue to maintain operations in San Antonio and has retained a large majority of ILEX employees.
Campath: The Product Leader in A Growing Commercial Business
Genzyme gains a strong and growing oncology product through its acquisition of ILEX. CAMPATH(R) (alemtuzumab for injection) is indicated in the United States for the treatment of B-cell chronic lymphocytic leukemia (B- CLL) in patients who have been treated with alkylating agents and have failed fludarabine therapy. CAMPATH is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces directing the body's immune system to destroy malignant cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL, and is already having a significant impact less than three years after earning U.S. marketing approval. CAMPATH is being evaluated in a number of clinical trials to potentially expand its use in cancer and in other disease areas, including a randomized Phase II trial versus Rebif(R) in treating multiple sclerosis.
Schering AG holds exclusive worldwide marketing and distribution rights, plus additional exclusive rights in Japan and the Pacific Rim to CAMPATH (MABCAMPATH(R) in Europe). In the United States, the product is marketed by Berlex Laboratories, a U.S. affiliate of Schering AG. As part of its settlement with the FTC prior to the closing of the transaction, Genzyme has transferred to Schering exclusive responsibility for the development and commercialization of CAMPATH in solid organ transplantation, and Genzyme will no longer receive a share of U.S. profits from the use of the product in this area. The agreement with Schering remains unchanged in all other respects. Genzyme remains committed to the solid organ transplantation market and will continue to support the development of Thymoglobulin(R) (anti-thymocyte globulin rabbit) and its pipeline of other products and product candidates in the field.
Genzyme also gains an exciting product candidate in clofarabine, a next generation purine nucleoside analog that is believed to inhibit DNA production necessary for cancer cell growth. Clolar(TM)(clofarabine) has been granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory acute leukemias in children. Clolar was reviewed by the Oncologic Drug Advisory Committee (ODAC) earlier this month and was recommended for accelerated approval in children with relapsed/refractory acute lymphocytic leukemia. The FDA is expected to respond to the marketing application on, or before, December 30. If approved by the FDA, Clolar will be the first drug to be labeled initially for a pediatric leukemia in more than a decade. Clolar also is being investigated for use in pediatric acute myelogenous leukemia and adult acute leukemias, as well as advanced solid tumors.
Genzyme holds the exclusive rights to develop and market Clolar for cancer applications in the United States and Canada. Bioenvision is responsible for developing clofarabine in the rest of the world and will pay royalties to Genzyme on sales of clofarabine outside of the United States and Canada.
A second pipeline candidate, now in Phase 2 clinical development, is ILX- 651, a synthetic analog of the natural substance dolastatin that has a unique mechanism of action targeting tubulin. ILX-651 complements CAMPATH and Clolar in that it is directed at solid tumors rather than cancers of the blood. Genzyme has exclusive worldwide rights to ILX-651 in cancer.
Genzyme Corporation is a global biotechnology company dedicated to making a major positive impact on the lives of people with serious diseases. The company's broad product portfolio is focused on rare genetic disorders, renal disease, osteoarthritis, cancer and immune-mediated diseases, and includes an industry-leading array of diagnostic products and services and sophisticated biomaterials. Genzyme's commitment to innovation continues today with expanded research into novel approaches to treat cancer, heart disease, and other areas of unmet medical need. More than 7,000 Genzyme employees in offices around the globe serve patients in over 80 countries.
This press release contains forward-looking statements, including statements about: the impact of the anticipated transaction on Genzyme's operations and the potential benefits of the anticipated transaction; plans for expanding the indications of, and uses for, Campath and Clolar; receipt of marketing approval for Clolar from the FDA; and expectations regarding the advancement of clinical studies, the expansion of oncology sales and marketing capabilities, and the management of relationships with partners and customers. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward- looking statements. These risks and uncertainties include, among others: the ability to successfully integrate ILEX's operations and programs with Genzyme's and the time and resources required to do so; enrollment rates for clinical trials; the timing and content of decisions made by regulatory authorities regarding the company's products and product candidates, including the receipt of marketing approval in the United States for Clolar; the ability to manufacture sufficient quantities of products for development and commercialization activities and to do so in a timely and cost-efficient manner; the ability to attract and retain qualified sales forces; the ability to manage key collaborative relationships successfully, the availability and extent of reimbursement from third party payers for Campath and Clolar; the scope, validity and enforceability of patents directed to, and the effect of any third party proprietary rights on, the company's products and product candidates; the accuracy of information concerning the markets for Campath and Clolar, including growth projections; and the risks and uncertainties described in reports filed by ILEX and Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the registration statement on Form S-4 filed by Genzyme with respect to the transaction and under the heading "Additional Business Risks" in ILEX's Annual Report on Form 10-K for the year ending December 31, 2003. We caution investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements, risks or reasons. All forward looking statements are expressly qualified in their entirety by this cautionary statement.
Genzyme(R) is a registered trademark of Genzyme Corporation. CAMPATH(R) and MABCAMPATH(R) are registered trademarks, and Clolar(TM) is a trademark, of ILEX Oncology, Inc. or its subsidiaries. Rebif(R) is a registered trademark of Ares Trading S.A. Thymoglobulin(R) is a registered trademark of SangStat Medical Corporation. All rights reserved.
Genzyme's press releases and other company information are available at http://www.genzyme.com/ and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.
Maria Foley (media) Sally Curley (investors)
(617) 768-6690 (617) 768-6140