By ANDREW POLLACK
Published: June 19, 2012
Two of the front-runners in the race to develop drugs to treat mental retardation and autism are joining forces, hoping to save money and get to the market sooner.
A deal, expected to be announced on Tuesday, will pool the resources of Roche, the Swiss pharmaceutical giant, and Seaside Therapeutics, a private 30-employee company based in Cambridge, Mass.
“This deal will establish the biggest effort to date” in autism drugs,
Luca Santarelli, head of neuroscience for Roche, said before the
announcement. Financial terms are not being disclosed.
There is rising excitement that drugs might be able to relieve some of
the behavioral problems associated with autism and in particular a cause
of autism and mental retardation known as fragile X syndrome. About 100,000 Americans have fragile X syndrome.
Some parents of children being treated with new drugs in clinical trials
have said they see positive changes in behavior.
Becky Zorovic of Sharon, Mass., said that when she used to take her son
Anders, who has fragile X, to the dentist, she would have to lie in the
chair and hold him on top of her as he screamed.
But after Anders starting taking Seaside’s drug, arbaclofen, in a
clinical trial, she said, “He sat in the chair by himself and he opened
his mouth and let the dentist polish his teeth and even scrape his
teeth.” Anders has also has gone to birthday parties, which he once
refused to do, she said.
Still, Ms. Zorovic said that until the clinical trial comparing the drug
to placebo was completed, it was difficult to say whether the effects
were from the drugs or merely a result of parents’ perceptions.
The mechanism that has perhaps shown the most promise, at least in mice,
is to damp signaling in the brain by blocking a receptor called mGluR5.
Novartis is considered ahead in developing such a drug. Roche is next,
having entered the midstage of clinical trials. Seaside is further back
but has patents covering the use of mGluR5 antagonists to treat
neurodevelopmental disorders.
Under the deal, Roche will get exclusive rights to those patents from
Seaside. That might provide some leverage that Roche can use against
Novartis, although Dr. Santarelli said Roche had no intention of keeping
a rival’s drug off the market.
Roche also gets the option to license commercial rights to Seaside’s
arbaclofen. That drug, which works somewhat differently, is in
late-stage testing for fragile X and in midstage testing for autism.
Roche will provide money to help Seaside complete its clinical trials of
arbaclofen. Seaside will halt development of its own mGluR5 antagonist,
which it licensed from Merck, and will instead receive royalties on
sales of Roche’s drug.
The alliance could pose a challenge to Novartis. “This is No. 2 and No. 3
ganging up on No. 1,” said Dr. Michael Tranfaglia, medical director of
the Fraxa Research Foundation, which sponsors research into treatments
for fragile X syndrome.
Dr. Randall L. Carpenter, chief executive of Seaside, said the money
from Roche was a needed diversification of the company’s funding.
Virtually all of the $90 million Seaside has raised has come from the
Barony Trust, which is run by Peter Whipp, a British investment manager.
“They would like to see new treatments,” Dr. Carpenter said, referring
to Mr. Whipp and his family. “I think they carried us a long way, longer
than they wanted to.”
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