By Donna Kardos
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Shares of Dyax Corp. (DYAX) reversed their double-digit losses Friday afternoon as investors began focusing on the silver lining to a U.S. Food and Drug Administration decision to decline approval for a treatment for a rare swelling disorder: No further trials will be necessary to gain approval.
Nevertheless, shares of ViroPharma Inc. (VPHM) - whose Cinryze drug is already approved for attacks of hereditary angioedema and is under FDA review to be approved for acute attacks - rose.
The FDA's decision on Cinryze is expected to be rendered as early as June, and investors are now hopeful it will have a first-to-market advantage over Dyax's drug. There is currently no approved treatment for acute attacks of hereditary angioedema.
Among the requirements that the FDA outlined for Dyax to gain approval for ecallantide, its treatment for acute attacks, is submission of a risk-evaluation and mitigation strategy and additional information regarding the chemistry, manufacturing and controls section of the application.
"Importantly, FDA is not requiring them to run any additional studies," Wedbush Morgan analyst Kimberly Lee told Dow Jones Newswires. "I've been going out to clients saying I thought this was positive for Dyax, in that it gives them a clear path for approval. FDA has told the company what questions they answered, and I think they're manageable."
Shares of Dyax were down 3.3% recently to $2.66. Earlier, they sunk 12% to an intraday low of $2.42. The shares are now up 41% on the month, though down 27% year to date.
Meanwhile, shares of ViroPharma Inc. (VPHM) were up 13% to $4.92 in recent trading Friday.
Late Thursday, Dyax said it received a so-called complete response letter from the FDA outlining what it needs to do to have ecallantide approved. The company said it intends to fully address the requests "in a timely manner."
Lee said she expects the drug, if approved, could hit the market as early as 2010. If the company got the approval now, it would have been expected to hit the market as early as June, she said.
She noted that the consensus expectation prior to Dyax's late-Thursday announcement was that the FDA would indicate ecallantide had no shot at approval or would need additional trials. "Neither of those scenarios occurred," Lee said. "I viewed what happened as the best scenario after outright approval."
Lee added that potential partners may start taking a closer look at the drug, now that the FDA has signaled what Dyax has to do to get an approval. She expects Dyax's shares may now be "rangebound for a while until either of two things happen - a partnership or when they respond to the FDA."
Lee said Dyax's shares likely fell so much earlier because of initial fears about the competitive landscape, as Cinryze now has a better chance at being first to market for acute hereditary angioedema.
However, Lee said that while Cinryze will initially have an advantage of it is approved for acute attacks, she expects that advantage will be erased if and when Dyax's drug is approved, largely due to the different ways the drugs are administered. Ecallantide is administered subcutaneously, which Lee believes is the preferred method, while Cinryze is given intravenously.
Still, ViroPharma Chief Executive Vincent Milano told Dow Jones Newswires "from a competitive standpoint, one of the things we've always felt very strongly about is the ability to deliver what's deficient in the best way."
He noted that Cinryze acts as a replacement for the protein inhibitor that is deficient in people with hereditary angioedema, while ecallantide inhibits an enzyme that produces the swelling and pain associated with the disease.
Milano said Cinryze has a strong safety and tolerability profile. "We're looking forward to trying to deliver that in an acute setting in June," Milano said.
-By Donna Kardos, Dow Jones Newswires; 201-938-5963; donna.kardos@dowjones.com
No comments:
Post a Comment