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Millennium In-Licenses Novel Oncology Program From Xenova

- Addition of Three Novel Molecules Complement Company`s Portfolio of
Cancer Product Candidates -

CAMBRIDGE, Mass., and SLOUGH, U.K., Dec. 17 /PRNewswire/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) and Xenova Group, plc (Nasdaq: XNVA; London Stock Exchange: XEN), today announced that the companies have signed a license agreement for the development and North American commercialization of Xenova`s novel compounds, which have a unique mechanism of action including dual inhibition of topoisomerases I and II, for the treatment of solid tumors in cancer. The program includes three molecules; XR11576, XR5944, and XR11612. XR11576 is an oral agent that has entered Phase I clinical development with the first patients screened for study entry. The two additional compounds are in preclinical development. (Photo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )

Under the terms of the agreement, Millennium will acquire development and exclusive marketing rights to the topoisomerase program in North America in exchange for an upfront payment of US$11.5m (7.8m pounds) as well as future milestone payments and royalties following the achievement of specific development and sales goals. Xenova retains commercialization rights for all products arising from this topoisomerase collaboration outside the United States, Canada and Mexico, including marketing in Europe and the rest of the world. Xenova will retain responsibility for performing development activities associated with the program, which will be funded by Millennium commencing in 2003, to the end of Phase II clinical trials. Thereafter, Millennium will assume responsibility for subsequent development activities in North America and Xenova will retain development activity responsibility for the rest of the world. Additionally, Millennium has the right to market in North America any improvements or additional products based on the same topoisomerase inhibitor technology, in which case Xenova will receive further milestones and royalties on the sales of such products. Additional terms of the agreement were not disclosed.

"We have been impressed by the potential of Xenova`s compounds and believe this is a novel and exciting mechanism of action that falls into a proven class of therapies, but more importantly, as suggested by the dramatic activity in in vivo models, may have additional undiscovered mechanisms that are synergistic with cellular pathways that are part of Millennium`s ongoing research effort," said John Maraganore, Ph.D., senior vice president, strategic product development at Millennium. "Millennium continues to build a significant portfolio of cutting-edge cancer therapeutics through a combination of internally-derived, in-licensed and acquired products and capabilities. We believe this latest collaboration has the potential to complement our lead oncology program, LDP-341, and we plan to move these molecules forward aggressively."

"We are delighted to announce this collaboration with Millennium, a strong North American partner with both a commitment to pursuing oncology as a core franchise area and a deep existing oncology pipeline," said David Oxlade, Chief Executive Officer of Xenova. "Today`s agreement gives us an excellent development and marketing partner, potentially provides us with future milestone payments and royalties which are significant for our business and allows us to retain substantial rights to the program outside North America."

Topoisomerases are enzymes that are critically involved in the replication of DNA during the process of cell division and that play a key role in the proliferation of cancer cells. Topoisomerase inhibitors comprise a major and established class of cytotoxic anti-cancer agent that is widely used to treat cancer patients. Topoisomerase inhibitors that inhibit either topoisomerase I or II are used to treat a number of different tumor types: camptothecins (topoisomerase I inhibitors) for colorectal cancer; anthracyclines (topoisomerase II inhibitors) for breast, ovarian, bladder cancer and Non Hodgkin`s Lymphoma; etoposide (topoisomerase II inhibitor) for lung cancer. Given the differing roles and expression of the two types of enzymes within the cell cycle, inhibitors of both topoisomerase I and topoisomerase II (dual inhibitors) are expected to have potentially significant therapeutic advantage over agents targeting one type of topoisomerase alone. In addition, dual inhibitors may circumvent mechanisms of drug resistance and may also have a broader spectrum of activity as expression levels of the two enzymes are variable between different types of cancers, as suggested by Xenova`s preclinical data of the three molecules. Dual Inhibitor of Topoisomerase I and II

Topoisomerases I and II are well-characterized enzymes that are responsible for DNA topology and are essential for DNA replication. Inhibition of these enzymes blocks cell division and leads to apoptosis, or cell death. Several widely used anticancer agents target topoisomerases, including irinotecan, topotecan, doxorubicin, and etoposide.

In preclinical studies XR11576 has shown a significantly improved biological profile when compared with first generation dual topoisomerase I and II inhibitors, including oral bioavailability and a marked enhancement of potency. In preclinical studies XR5944 has demonstrated exceptional activity against human and murine tumor cell lines. XR5944 has been shown to induce tumor regression in the majority of cases in a model considered to be relatively unresponsive to chemotherapy. In a further preclinical model, low doses of XR5944 induced complete tumor regression in the majority of cases and was more effective in this respect than certain currently marketed topoisomerase inhibitors. In preclinical studies XR11612 was shown to have significant antitumor efficacy against certain cancer disease models.

The three dual topoisomerase inhibitors are thought to result in DNA damage in cells, activating the pathways that lead to apoptotic cell death in tumor cells. Millennium is investigating LDP-341, which also works to interrupt the apoptotic pathways, allowing for potential synergies between the two oncology programs. Millennium`s Oncology Franchise

Millennium has committed to pursuing oncology as a core franchise area, dedicating significant resources and capabilities in the areas of technology, scientific expertise and strategic business development. To this end, Millennium has already produced a deep oncology pipeline that ranges from multiple novel targets to commercialized therapeutic and diagnostic products. Among the most advanced clinical compounds is LDP-341, a proteasome inhibitor that is currently is in phase II trials for multiple myeloma and chronic lymphocytic leukemia, and in phase I trials for a variety of solid tumors including colon, breast, pancreatic and prostate cancers. Millennium`s oncology pipeline also includes an anti-PSMA antibody currently in phase I clinical trials for advanced prostate cancer, and guanylyl cyclase C (GC-C), a protein uniquely expressed on the cell surface of colorectal tumors, and its related ST ligand. The CAMPATH(R) (alemtuzumab) monoclonal antibody, a therapeutic developed from a joint venture of Millennium, is on the market in both the United States and a number of European countries. A Millennium alliance partner and licensee is in the process of developing and commercializing Melastatin(TM), a melastatin detection product developed through our predictive medicine efforts. Millennium Pharmaceuticals, Inc.

Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Massachusetts, Millennium currently employs more than 1,500 people. Xenova Group, plc

Xenova Group plc`s product pipeline focuses principally on the therapeutic areas of cancer, infectious and autoimmune diseases. Xenova currently has a broad pipeline of eight products in clinical development. Xenova`s lead program is a P-glycoprotein antagonist for the treatment of multi-drug resistance in cancer, known as tariquidar or XR9576. Tariquidar has completed a successful series of three Phase IIa clinical trials and is expected to enter Phase III clinical development in the first half of 2002. Tariquidar was partnered for the North American market with QLT Inc in August 2001. The Group has a well-established track record in the identification, development and partnering of innovative products and technologies and has partnerships with other major pharmaceutical companies including Lilly, Pfizer and Celltech.

For Millennium: This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause Millennium`s actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For Xenova Disclaimer to take advantage of the "Safe Harbor" provisions of the US Private Securities Litigation Reform Act of 1995. This press release contains "forward-looking statements," including statements about the discovery, development and commercialization of products. Various risks may cause Xenova`s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in our drug discovery and clinical development programs; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Editor`s Note: This release is available on Millennium`s website at www.millennium.com.

For further information about Xenova please visit the Xenova website at www.xenova.co.uk

Contacts:
Gina Brazier (investor)
(617) 551-3611
Adriana Jenkins (media)
(617) 761-6996
Millennium Pharmaceuticals, Inc.

David Oxlade: Chief Executive Officer
Daniel Abrams: Finance Director
Hilary Reid-Evans: Corporate Communications
Tel: +44 (0) 1753 706600
Xenova Group plc

Brad Miles(Ext 17)/Lauren Tortorete (Ext 20)
Tel 212 477 9007
BMC Communications

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/CONTACT: Gina Brazier (investor), +1-617-551-3611, or Adriana Jenkins (media), +1-617-761-6996, both of Millennium Pharmaceuticals, Inc.; or David Oxlade, Chief Executive Officer, or Daniel Abrams, Finance Director, or Hilary Reid-Evans, Corporate Communications, all of Xenova Group plc, +44 (0) 1753 706600; or Brad Miles, +1-212-477-9007, ext 17, or Lauren Tortorete, +1-212-477-9007, ext 20, both of BMC Communications/
 
aus der Diskussion: XENOVA - DISKUSSIONS-THREAD Nr. 2 (Stand: 06.11.2000)
Autor (Datum des Eintrages): Wunram  (17.12.01 13:22:40)
Beitrag: 90 von 275 (ID:5142401)
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