By Frances Bishopp
La Jolla Pharmaceutical Co. and Abbott Laboratories have signed a collaboration, worth more than $50 million, for the worldwide development and marketing of La Jolla’s compound, LJP 394, for lupus nephritis.
Abbott, of Abbott Park, Ill., and La Jolla, of San Diego, will jointly develop the drug, which began Phase II/III clinical trials earlier this month.
The deal, Andrew Wiseman, director of business development at La Jolla, told BioWorld Today, includes an up-front payment of approximately $10 million. Part of this payment includes equity and, Wiseman said, "there is a possibility of some equity later on."
The remaining $40 million will be used for a combination of milestones and research funding, primarily the rest of the development of the drug, which Abbott will underwrite.
"This is a very significant relationship for our company," Wiseman said. "Abbott is extremely strong at development and marketing. They have a renal division, so they already have an access to the market."
LJP 394 is a molecule, created with La Jolla Pharmaceutical’s Tolerance Technology, designed to bind to the surface of cells and shut off their production of double-stranded DNA antibodies, which attack the kidneys.
Damage to the kidneys is the major killer of lupus patients, whose numbers are approximately 500,000 individuals in the U.S., with 16,000 new cases being diagnosed each year.
Interim data from the Phase II trial, presented in February 1996, showed the lupus drug was safe and that levels of the double-stranded DNA antibodies decreased as LJP 394 dosage increased. (See BioWorld Today, Feb. 19, 1996, p. 2.)
The additional Phase II data showed patients receiving 50 mg of the drug once a week experienced a 48 percent decrease in median levels of double-stranded DNA antibodies as well as increases in C3 proteins of 15 percent and C4 proteins of 9 percent.
The findings, said the company, demonstrated statistical significance compared to the placebo in reducing antibody levels in patients receiving 50 mg or 10 mg once a week.
The Phase II study involved 58 patients. Nine were in the placebo group and the other 49 were divided into nine treatment groups receiving either 1 mg or 50 mg of LJP 394, once a week, once every two weeks or once every four weeks.
The current trial has 300 patients divided into two groups, half receiving a placebo and the other taking 100 mg of LJP 394 once a week for 12 months. Following the treatment, the patients will be monitored for six months before data are compiled. During the trial, investigators will determine the best mix of dose and frequency to first reduce antibodies and then maintain those levels.
The main endpoint for the Phase II/III study is an evaluation of the time it takes patients to progress to renal flare, an indication the disease is getting worse.
In May, La Jolla Pharmaceutical canceled a potential $40 million deal with Danish drug maker, Leo Pharmaceuticals Ltd., over disagreements on a timetable for development of LJP 394.
At the time, Wiseman said the collaboration was ended in a friendly manner and La Jolla kept a $3 million up-front payment made by Leo, of Ballerup, Denmark, which has purchased European and Middle Eastern rights to the drug. La Jolla, which had retained ownership of the drug in the U.S. and elsewhere, reacquired those rights from Leo.
La Jolla’s stock (NASDAQ:LJPC) closed Monday at $6.026 up $0.312.