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Analysis: Analysts split on Amylin
WASHINGTON, Feb. 22 (UPI) -- The U.S. Food and Drug Administration removed the requirement that Amylin's Byetta be refrigerated, but analysts are split on whether this will lead to a boost in sales of the diabetes medication.
The FDA's decision means the Byetta pen, which still has to be refrigerated until first use, can now be kept at room temperature after that.
"It will have a minimal impact on growing the number of patients," Matthew Osborne, an analyst with Lazard, told United Press International.
Osborne's reasoning is that it will ease convenience for patients who already use the medication since they will no longer have to carry it around in cold packs when traveling, but this probably won't do much to draw new patients.
"We think it's more convenient for current users than a way to incentivize new patients to come on to therapy," he said.
He also was concerned that the reacceleration in growth of Byetta prescriptions that Amylin hoped to generate by giving away free samples of the low dose starting last quarter had not yet materialized.
"We haven't seen that reacceleration happen yet," Osborne said.
The drug showed a growth of 8 percent, but he said he was looking for something on the order of 20, 30 or 40 percent.
The reason for the lack of reacceleration could be two-fold, Osborne said. On one hand, it could be that Byetta has reached a plateau, but some of it could also be stemming from Merck's launch of Januvia, the first in a new class of diabetes agents called DPP-IV inhibitors.
Januvia is off to a great start, and it offers the advantage of being an oral compound, so it could be providing significant competition to Byetta, which is given by injection but offers the advantage of weight loss, Osborne said.
Sanofi aventis' Acomplia -- if it wins FDA approval -- could also impact Byetta. Sanofi is seeking an obesity indication for the drug, but if it gets approved for type 2 diabetes, it could steal some share from Byetta because it too offers the advantage of weight loss.
A lingering question, however, is Acomplia's association with depressed mood in some patients, Osborne said. "So we'll see how that plays out once it's on the market," he added.
Sanofi said last week the FDA pushed back its timeframe for making a decision on Acomplia from April 26 to July 27. The company did not divulge the reasons for the delay. Acomplia, which has been launched in 12 countries so far, generated 31 million euros in sales last year.
Friedman, Billings & Ramsey analyst Jim Reddoch saw the removal of the Byetta refrigeration requirement as a positive and anticipates an increase in sales of the drug.
"Our recent diabetes survey showed a majority of doctors would prescribe more Byetta once the storage requirement is removed," Reddoch stated in a research report.
"Additionally, with the recent approval in combination with a (thiazolidinedione) and the strong sampling effort which began late last quarter, investors should expect to see continued growth," he added.
In the diabetes survey, Reddoch found that 65 percent of doctors they talked to said the refrigeration requirement was an issue, and 70 percent of those said they would prescribe the drug more often once it was removed.
In that same survey, 40 percent of doctors said they would increase use of Byetta upon its approval to be used in conjunction with a TZD diabetes medication.
The TZD combination means an additional 1.5 million potential patients for Byetta, Reddoch stated.
He's also confident the effects of Amylin's program of doling out free samples will begin to pay off in the second quarter of this year. Amylin gave out almost 221,000 units, and he anticipates a majority of those will turn into prescriptions.
Overall, Reddoch thinks Amylin has a bright future that will be driven by Byetta LAR -- a once-weekly version of the drug.
"Amylin is still one of the best growth stories in biotech, expecting to average 28 percent revenue growth between 2007 and 2011," he stated.
Upcoming catalysts include Byetta LAR phase 3 data in the fall. Reddoch noted that most investors view Byetta LAR as the real growth driver for the company, adding that the Byetta/LAR franchise could exceed his $3 billion peak forecast.
Another potential catalyst is the phase 2 obesity data on pramlintide plus leptin, which is expected to be released in the second half of the year. "This could be another blockbuster franchise," Reddoch stated.
Friedman, Billings & Ramsey told UPI Reddoch could not be reached for comment.
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