Amgen Inc., put off by disappointing test results for a Parkinson's disease drug licensed from Guilford Pharmaceuticals Inc., has returned the rights to that drug and an entire family of similar ones to Guilford.
Baltimore-based Guilford said yesterday that it would push forward with development of at least some of the nerve-regeneration drugs, but it will have to do so without the millions of dollars in backing the Amgen deal provided. Amgen, based in Thousand Oaks, Calif., had licensed the drugs from Guilford for 10 diseases and injuries, including Alzheimer's disease, multiple sclerosis and traumatic head injuries.
Analysts had anticipated that Amgen might drop development of the entire line of treatments after Guilford announced in July that NIL-A, the first of the family to be tested in people, had failed to reverse the motor symptoms of Parkinson's disease.
"The drug was going to be dead anyway if Amgen held onto it, so it's a positive," Brian Rye, an analyst for Raymond James & Associates in Nashville, Tenn., said of the Parkinson's drug. "Only good things can result from regaining the rights to the product."
Shares of Guilford closed at $9.09, up 94 cents, or 11.5 percent, on the Nasdaq stock market.
While Guilford said it intends to push forward with the development of the family of drugs, it has yet to reveal whether NIL-A will be among them.
The tests in people, Guilford Chief Executive Officer Craig R. Smith said in a statement, did suggest that "there may have been some benefit for the nonmotor symptoms of Parkinson's disease. However, these results are preliminary and will require additional study to confirm their significance."
Legg Mason Wood Walker analyst Stefan D. Loren said Amgen had been pursuing "a do-or-die, home run-or-strikeout type of approach" with NIL-A. The failure to achieve the goal of reversing those symptoms, he said, "doesn't mean the drug doesn't work."
Parkinson's patients who took NIL-A reported anecdotally a lessening of other symptoms not measured in the human test, such as difficulty sleeping, facial rigidity and unclear speech, Guilford spokeswoman Stacey Jurchison said.
In addition, she said, the company has "very intriguing" data from animal tests for various other uses of the nerve-regeneration drugs.
"We haven't made a determination yet what will be our first priority," she said.
Guilford likely will review its entire portfolio of drugs to decide what, if anything, to move more slowly on, given that it no longer has Amgen's financial backing, Loren and Rye said.
The company has three other treatments in clinical trials: the injectable anesthetic Aquavan; the diabetic peripheral neuropathy treatment GPI-5693; and Paclimer, being tested as a treatment for ovarian cancer.
A fourth Guilford drug, a treatment for post-surgical pain called Lidomer, could begin trials early next year.
Amgen already had paid Guilford more than $54 million as part of the deal, and Guilford stood to gain up to $392 million in additional payments as the drugs achieved certain development milestones. Guilford reported $179 million in cash and cash equivalents at the end of June and has been spending cash reserves at a rate of about $35 million to $40 million a year.
Amgen's decision comes on the heels of an unrelated setback for Guilford.
The company had hoped that a Food and Drug Administration advisory panel would vote Sept. 11 to recommend expansion of the uses for Gliadel, a brain-cancer treatment that is Guilford's only product on the market.
But the panel ended its meeting early, postponing talk of Gliadel in the wake of that day's terrorist attacks in New York and Washington.
The panel's next scheduled meeting is to be Dec. 6.