Berlex Laboratories Adds CAMPATH to Its Oncology Portfolio.

MONTVILLE, N.J.--(BUSINESS WIRE)--Aug. 24, 1999--

Berlex Laboratories, Inc. today announced that the company has obtained exclusive U.S. distribution and marketing rights for CAMPATH(R) (campath-1H), from LeukoSite Inc. and ILEX Oncology, Inc.

CAMPATH(R) is a humanized monoclonal antibody in late-stage development for the treatment of patients with refractory chronic lymphocytic leukemia (CLL). In addition to CLL, Berlex has the option to also jointly develop CAMPATH(R) for other oncology indications and for use in multiple sclerosis (MS) and solid organ transplantation.

Data from a recently completed pivotal Phase II trial, which have not yet been reviewed by the FDA, demonstrated that certain refractory CLL patients treated with CAMPATH(R) experienced either complete or partial remissions. Since no therapy is currently approved to treat these patients, CAMPATH(R) has received "fast track" designation from the FDA and is expected to undergo a six-month priority review under the Prescription Drug User Fee Act. The review period begins with the submission of a completed Biologics Licensing Application (BLA) which is expected to occur later this year. In addition, given its potential to address unmet medical needs for serious or life-threatening conditions, the FDA has made CAMPATH(R) eligible for "rolling" submission, which means the FDA will accept and process sections of the BLA as they are completed. To date, both the Chemistry, Manufacturing and Controls, and the Pharmacology and Toxicology sections of the BLA have been submitted.

"No other company has Berlex's track record for commitment and technical expertise in CLL," stated Dr. Kanti Rai, M.D., Chief, Division of Hematology/Oncology, Long Island Jewish Medical Center, New Hyde Park, N.Y. "Adding CAMPATH(R) to their product line will make Berlex the major player in managing this disease. Berlex's FLUDARA(R) is the worldwide market leader for CLL treatment. Once CAMPATH(R) is approved, Oncologists will have a second effective treatment option for patients who become refractory. The sequential use of these two drugs may move us beyond palliative treatments and into a new era of long-term control of CLL."

"Berlex is a recognized authority on CLL and MS treatments. We are very excited about expanding the uses of CAMPATH(R) through further development and look forward to bringing it to the U.S. market with LeukoSite and ILEX," said Howard Robin, Vice President and General Manger-Berlex Laboratories. "In 1991, we introduced FLUDARA(R) as a breakthrough treatment for CLL, and we will use our expertise in this area to successfully position CAMPATH(R) as a leading treatment for refractory CLL. We believe the clinical data will show that there is now a second therapy for CLL which may help to alter the natural course of the disease, thus providing optimal long-term management of patients. We hope to provide Oncologists with a comprehensive new treatment regimen -- FLUDARA(R) and CAMPATH(R) -- in the fight against CLL."

Please see important prescribing information below.

Chronic Lymphocytic Leukemia is characterized by an accumulation of malignant lymphocytes, a subclass of white blood cells, in the bone marrow and other tissues, causing bone marrow dysfunction and enlargement of the lymph nodes, liver, and spleen. Affecting approximately 50,000 patients in the U.S., CLL is the most prevalent form of adult leukemia. As there is currently no cure for this disease, most patients eventually become refractory to therapy.

Berlex has a strong commitment to becoming a leader in Oncology. In addition to FLUDARA(R) (fludarabine phosphate), Berlex also markets QUADRAMET(R) (Samarium Sm 153 Lexidronam Injection), a therapeutic advancement that rapidly relieves bone pain due to cancer and reduces the patient's need for opioids. Berlex's oncology development pipeline includes ONCOLYM(R) for the treatment of intermediate- and high-grade non-Hodgkin's B-cell Lymphoma, and two pre-clinical compounds, HEPACID(R) and MELANOCID(R), which are potential treatments for hepatoma and metastatic melanoma.

Committed to developing novel therapeutics that address unmet medical needs, Berlex Laboratories, Inc. researches, manufactures, and markets ethical pharmaceuticals in three strategic areas: Female Healthcare, Diagnostic Imaging, and Therapeutics for life-threatening and disabling diseases. Berlex Laboratories, Inc. has business divisions in Montville and Wayne, N.J. and in Richmond, Calif.

Please visit our website at www.berlex.com for full-prescribing information for currently marketed products.

Data on the recently completed CAMPATH(R) Phase II trial is available at www.ilexonc.com/news/pr/index.phtml?pr id=53 or www.leukosite.com/ci/cl.html

IMPORTANT PRESCRIBING INFORMATION:

-- FLUDARA(R) FOR INJECTION should be administered by a qualified

physician experienced in the use of antineoplastic therapy.

FLUDARA(R) can severely suppress bone marrow function. When used

at high doses in dose-ranging studies in patients with acute

leukemia, FLUDARA(R) was associated with severe neurologic

effects, including blindness, coma, and death. This severe

central nervous system toxicity occurred in 36% of patients

treated with doses approximately four times greater (96 mg/m2/day

for 5-7 days) than the recommended dose. Similar severe central

nervous system toxicity has been rarely (less than or equal to

0.2%) reported in patients treated at doses in the range of the

dose recommended for CLL.

Life-threatening and sometimes fatal autoimmune hemolytic anemia 

have occurred after one or more cycles of treatment. Patients

undergoing treatment should be evaluated and closely monitored

for hemolysis. In a study using FLUDARA(R) in combination with

pentostatin (deoxycoformycin) for the treatment of refractory

CLL, there was an unacceptably high incidence of fatal pulmonary

toxicity. Therefore, FLUDARA(R) in combination with pentostatin

is not recommended.

-- QUADRAMET(R) causes bone marrow suppression. Prior to

administration, clinical benefit should be judged to outweigh the

risk in patients having compromised bone marrow reserves or

undergoing therapy that causes myelosuppression.