If the conditions are relatively minor and easily resolved, the company is generally all too eager to make that clear straight away.
But up to this point, Sanofi- Aventis (which only two weeks ago was telling financial analysts and selected journalists it was "very, very confident" that FDA approval was imminent) has decided not to shed any light on the issues the FDA has raised.
They said only that they "will continue to work in close collaboration with the FDA."
This fuels suspicion that the issues might be quite serious.
In addition, the fact that Sanofi chose to put out news of the FDA delay in approving Acomplia late in the day on a Friday, after most U.S. financial markets had closed for the weekend and most of Europe was asleep was also "whiffy".
This is a real PR "sign" of bad news!
So, let's speculate a little:
Just this week investigators for the RIO-North America trial reported in the Journal of the American Medical Association that a year of treatment with 20 mg of Acomplia was associated with an average weight loss of almost 14 pounds and a waist reduction of 2.4 inches, versus just under four pounds and less than an inch in the placebo group.
Moreover, patients treated with 20 mg of Acomplia and calorie reduction for a year increased HDL cholesterol by 12.6% versus a 5.4% increase in the placebo arm (P<0.001).
In year two, 40% of patients maintained on 20 mg achieved "a weight loss of 5% or greater" compared with 19% of patients in the placebo arm (P<0.001).
Moreover, after two years, patients taking 20 mg of Acomplia were able to maintain a waist measurement that was about two inches smaller than baseline measurements, compared with a reduction of just 0.87 inches for those in the placebo arm (P<0.001).
Nonetheless, a high dropout rate (51% dropped out after a year) led F. Xavier Pi-Sunyer, M.D., of the obesity center at St. Luke's-Roosevelt Hospital in New York and colleagues to conclude that more study is needed to finally confirm a long-term benefit for Acomplia, which is the first cannabinoid-1 receptor blocker.
The FDA may have asked why did so many of the participants getting the full dose of Acomplia stop taking it? What happened that turned them off from taking Acomplia? What do we know about the weight and overall health of those who started on Acomplia, and then quit?
The Acomplia Report looks at the dropout figures in more detail.
Some patients reported depression and anxiety, which is a reason some doctors have urged caution.
In a recent research paper, Goldman Sachs predicted that, because of those CNS side effects, Acomplia would be approved only on the condition the company conducted a rigorous postmarketing surveillance program.
Looking at the ongoing trials, that are still recruiting, is interesting. These would be the earliest possible sources of new data.
Insiders' view: There are recent cases of bad news "approvable" letters: Crestor (their letter caused a delay of well over a year, asking for more safety data) and Pargluva (in reality, now a dead duck) spring immediately to Insiders' mind.
Sources: Diet Drug Report, Acomplia Report, New York Times
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PARIS (AFX) - Shares were lower in late afternoon trade, taking their cue from declines on Wall Street Friday and with no US trading today to direct trade, heavyweight Sanofi-Aventis dragged the index lower after news of a delay in the US approval process for its Rimonabant weight-loss drug, dealers said.
At 4.00 pm the CAC-40 was down 22.90 at 4,977.10.
Volume was 1.9 bln eur.
On the Matif, March CAC-40 futures were down 16.5 at 4,988.
The index closed Friday at over 5,000 points for the first time since summer 2001, but losses Friday on Wall Street meant "the market hit the 5,000 threshold without being able to stay over it," a dealers said.
The US market is closed for Presidents' Day.
Sanofi led shares lower, dropping 1.90 eur or 2.57 pct to 72.00 in heavy volume after its would-be wonder-drug Rimonabant suffered a double blow at the hands of US drugs regulator the FDA.
Late on Friday, the company announced that the FDA had only issued an 'approvable' letter regarding anti-obesity treatment for rimonabant, also known as Acomplia.
At the same time, the FDA issued a non-approvable letter for using rimonabant as an anti-smoking treatment. Although this potential use is minor when compared to the anti-obesity treatment, analysts said the regulatory setback could damage the company's management credibility.
"This response from the FDA resembles a repudiation for the French laboratory, which until just recently said it was confident of its chances for a launch of the product in the second quarter," said analysts at Raymond James in Paris, who cut their rating on the stock to 'fair value' from 'buy.'
Several analysts said the launch delay for anti-obesity treatment could be six months or more, but the FDA has not specifically identified its concerns with the drug, and so investors are hoping the company can provide further information on Friday, when Sanofi will hold an analyst meeting alongside its release of 2005 earnings. Morgan Stanley said that in a worst-case scenario, the FDA could require "prolonged efficacy or safety trials that would delay launch until after 2009" but kept its 'overweight' rating on the stock.
The shares were cut to 'sell' from 'hold' at Citigroup.
Sanofi-Aventis trial confirm Acomplia 20 mg tablet taken every day significantly decreased weight and waist circumference.
But Acomplia should not be initiated in patients with hepatic or renal impairment or patients with uncontrolled serious psychiatric illnesses.
Read more here: acomplia
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