Biogen Asked in Suit to Return ALS Biosamples to Knopp

Knopp Neurosciences Inc. asked a federal judge to order Biogen Idec Inc., its partner in a failed attempt to develop a drug for Lou Gehrig’s disease, to turn over to Knopp biosamples from patient tests.

U.S. District Judge Nathaniel Gorton scheduled an expedited trial without a jury in June on closely held Knopp’s breach of contract lawsuit against Biogen, according to a filing today in federal court in Boston.

Knopp, based in Pittsburgh, sued Biogen Feb. 25 claiming it breached a licensing agreement the companies had to develop and market a drug to treat amyotrophic lateral sclerosis, known as ALS or Lou Gehrig’s disease. Knopp wants Biogen to return the biosamples from its ALS trial, called Empower, and Biogen says it isn’t obligated to do so, according to the complaint.

“The failure to preserve the Empower biosamples, and ultimately to investigate them using the right tools in the right hands, will represent a research setback during which time thousands of patients will have died of ALS,” Knopp said in its complaint.

Gorton, at a hearing in Boston today, set four days for a bench trial beginning June 17. At the trial, he will also hear arguments on Knopp’s request for an injunction to prevent Biogen from destroying or studying any of the samples.

Clinical Trial

Biogen, based in Weston, Massachusetts, said in January that the drug, dexpramipexole, failed to show any efficacy in a large clinical trial, in the third and final phase of studies generally required for regulatory approval. The drug had been thought to potentially slow the progression of ALS after promising signs in earlier studies.

ALS affects about 30,000 people at any time in the U.S., causing nerve damage that leads muscles to shut down progressively over three to five years until most patients die from respiratory failure. There’s just one drug on the market for the disease, Sanofi’s Rilutek, which provides only a modest benefit.

Biogen paid $80 million in cash and stock for a licensing deal in August 2010 with Knopp, which first developed the drug. The trial reported in January showed no efficacy in improving patients’ ability to function or extending their lives, Biogen said in a statement at the time.

Development Halt

Based on the results, Biogen said it would stop development of dexpramipexole. That would also lead to a termination of the agreement with Knopp.

Biogen fell 98 cents to $171.47 at 5:20 p.m. in Nasdaq Stock Market trading. The shares have gained 47 percent in the past year.

Knopp’s own analyses of the trial results found “subgroups of the total study population that exhibited slower disease progression and reduced mortality when treated with dexpramipexole,” according to the complaint. Knopp said it wants the patients’ samples from the trial to help it continue to try to develop the medicine itself.

Biogen is planning ways to use the biosamples in its own ALS research, said Dan McIntyre, a spokesman for the company. Biogen agreed not to use the samples through June 21, when the trial is expected to conclude, he said.

Study Results

“While we’re deeply disappointed in the negative results of the Empower trial, we’re confident in the validity of the study results,” McIntyre said in a telephone interview. “We did additional analyses of multiple sub-populations and they failed to demonstrate any efficacy. If we had found any hope ourselves, we would have pursued it.”

Knopp claims Biogen is required to return the samples under the terms of the companies’ license agreement. Biogen told Knopp it doesn’t believe it has such an obligation, and that patient consent forms prohibit Biogen from transferring them, according to the complaint.

Redi Kasollja, a lawyer for Knopp, didn’t immediately respond to messages seeking comment on the suit.

The case is Knopp Neurosciences Inc. v. Biogen Idec International Holding Ltd., 13-cv-10386, U.S. District Court, District of Massachusetts (Boston).