FDA Document Suggests Setback to Merck on Vioxx
Label
By Yi Ping Ho
Staff Reporter
2/7/01 4:19 PM ET
Updated from 1:27 p.m. ET
A Food and Drug Administration review of Merck's (MRK:NYSE - news)
blockbuster arthritis drug recommends warning Vioxx users about possible
cardiovascular side-effects.
A briefing document posted Wednesday on the agency's Web site
recommends warning Vioxx users about "cardiovascular thrombotic events,"
or blood clots. Notably, the document doesn't recommend removing from
Vioxx labels a warning that Vioxx could cause gut problems, and says
additional studies may be necessary to clarify outstanding questions. The
findings appear to set back the company's efforts to make safety claims that
could markedly expand the drug's already significant market.
The document will be considered Wednesday and Thursday, along with
remarks by company officials, by a panel of outside experts who will
recommend to the FDA whether to change the label for the bestselling drug.
Advisory panel recommendations aren't binding, though the agency tends to
follow their advice.
Merck said it was confident that the data, which will be presented tomorrow,
support "the excellent GI (gastrointestinal) and overall safety profile of Vioxx."
The company also said that "the real issue is how and where that information
is going to be included in the labeling."
"Once the advisory panel is done, there will be many discussions between us
and the FDA discussing how the labeling will be modified," a Merck
spokeswoman said.
Merck and Pharmacia (PHA:NYSE - news), maker of the competing
Celebrex arthritis treatment (and co-marketer of Celebrex with Pfizer
(PFE:NYSE - news)), contend that Vioxx and Celebrex are safer than
over-the-counter painkillers such as Aleve and Advil. The companies have
been arguing that these prescription drugs, which belong to a class known as
Cox-2 inhibitors, don't cause the ulcerlike side effects common with the
nonprescription painkillers, which are also known as nonsteroidal
anti-inflammatory drugs. If the agency accepts their argument, it could allow
them to advertise Vioxx and Celebrex as safer than the so-called NSAIDs.
If the agency permits the companies to make the expanded safety claims, the
market for Cox-2 drugs could expand significantly beyond the $5 billion or so
a year that analysts already project Vioxx and Celebrex will together bring in.
With many other blockbuster drugs on the verge of losing patent protection,
increasing the sales of current blockbuster drugs has been among the drug
companies' top priorities.
"Whatever change (in the Vioxx label) will not create market upside unless
the FDA gives them a clear label indicating a lower risk of ulcer," said
Sanford Bernstein analyst Richard Evans. "And I don't think they're going to
get a license to put that message out."
An FDA advisory panel also indicated today that studies don't show
competing drug Celebrex to be any safer than traditional painkillers. The panel
found Celebrex had "no clinically meaningful safety advantage." Yesterday,
the panel warned Pharmacia that its promotional activities for Celebrex didn't
explain the "serious risk" of bleeding when the product is used with
Coumadin, a clot-busting drug.
In a report issued this afternoon, Deutsche Banc Alex. Brown analyst
Barbara Ryan said a favorable label change for Vioxx was unlikely and
indicated that the additional cardiovascular warning is a "risk" for the
company. Ryan maintained her buy ratings on both Merck and Pharmacia,
and said the Cox-2s "will expand their share of the arthritis market, with or
without a label change in the near term."
However, Ryan added that "the market will likely be skeptical of the
companies abilities to meet their growth targets for these drugs" if they fail to
win FDA approval to change the labels.
Merck closed down $2.51, or 3%, at $81.85, while Pharmacia lost $1.52, or
2.6%, to $56.13. Pfizer fell $1.35, or 2.9%, to $44.50 during the trading
session. |
