By Kim Coghill

Washington Editor

ILEX Oncology Inc. and Millennium Pharmaceuticals Inc. received FDA approval to market Campath, a leukemia drug expected to generate upwards of $68 million in its first full year of worldwide sales.

Campath (alemtuzumab) will be marketed in the U.S. by Berlex Laboratories Inc., a U.S. affiliate of Germany-based Schering AG. Berlex, ILEX and Millennium will equally divide the U.S. profits and expenses related to Campath, company officials said. The drug is approved as a treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy.

The drug has orphan status. Campath has no competition with the exception of off-label use of Rituxan. Thus, Shalini Cornelio, an analyst with CIBC World Markets in New York, said if the product is launched in June as expected, its first six months of worldwide sales should top $32.7 million and about $68.4 million in 2002.

Millennium and ILEX will receive royalties from Schering for European sales, expected to begin in the second half of this year.

Campath was developed in a 50-50 joint venture between San Antonio, Texas-based ILEX and Cambridge, Mass.-based Millennium, which acquired its rights to the product through its December 1999 acquisition of LeukoSite Inc., also of Cambridge.

¿This approval signifies a lot of hard work and it is a real milestone for any biotech to get approval of a drug,¿ said Richard Love, ILEX¿s CEO. ¿This is very important to us economically, but it also validates our basic business plan of focusing on the development of oncology drugs. That¿s where our expertise is and I think we have demonstrated that.¿

John Maraganore, Millennium¿s senior vice president of strategic product development, said, ¿This is what Millennium is all about ¿ first and foremost ¿ bringing a new drug that has an important benefit to patients who don¿t have therapies.¿

Chronic lymphocytic leukemia is the most prevalent form of adult leukemia, affecting about 120,000 patients in the U.S. and Europe. B-CLL is characterized by an accumulation of leukemic (malignant) lymphocytes that often bear the CD52+ antigen in the bone marrow, blood and other tissues. As a result of the accumulation of malignant lymphocytes, bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen may occur. Patients with B-CLL may suffer from disease-related symptoms such as fatigue, bone pain, night sweats and decreased appetite and weight loss.

Campath binds to CD52+ and induces antibody-dependent lysis following binding. This results in the removal of the malignant lymphocytes from the blood, bone marrow and other affected organs. In responders, treatment with Campath may improve blood counts and decrease the size of the liver and spleen. The CD52+ antigens also are found on nonmalignant lymphocytes, monocytes, macrophages, NK cells, some granulocytes and some normal bone marrow cells.

In evaluating Campath, the FDA reviewed efficacy data from a single-arm clinical trial involving 93 patients with B-CLL as well as two earlier supporting trials involving 32 B-CLL patients and 24 B-CLL patients, respectively.

The Campath biologics license application was submitted to the FDA in December 1999, and a year later, on Dec. 14, 2000, the Oncologic Drugs Advisory Committee voted 14 to 1 to recommend accelerated approval to the FDA. (See BioWorld Today, Dec. 15, 2000.)

The marketing authorization application for Campath in Europe was submitted in March 2000 to the European Agency for the Evaluation of Medicinal Products and remains under review.

ILEX¿s stock (NASDAQ:ILXO) closed Monday at $20, down 10 cents. Millennium¿s stock (NASDAQ:MLNM) closed at $38.57, up $1.52.

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