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"AstraZeneca
have raised delay tactics beyond an art form – what they
have done is unparalleled. By innuendo they have tried to
imply that there should be a problem with generic Prilosec,"
Elliott Hahn, President of Andrx Corporation, told IMS HEALTH’s
Pharmaceutical
Company Profiles .
A trial scheduled for December
5 2001 will likely set the stage for the critical court
battle over Prilosec (omeprazole). AstraZeneca's
main US patent over the chemical in Prilosec expired on
October 5 2001, but a legal minefield involving secondary
patents is set to keep rivals off Prilosec's US turf, certainly
for the immediate future. Generic drugmakers may be awaiting
the outcome of court proceedings before launching their
products - they risk incurring
significant damages if they start selling generic omeprazole
but lose the cases. Alongside Andrx, units of Dr. Reddy's
Laboratories, Schwarz Pharma AG and Merck KGaA are also
involved in the litigation.
Generic exposure
- the next five years
Source: IMS HEALTH Consulting
Final generic approval delayed
Separately to the December case,
Andrx announced on October 4 2000 that final marketing approval
of its generic omeprazole could be delayed; the FDA had
advised them that it is addressing "certain issues"
raised by AstraZeneca in a letter to the agency on July
5 2001. Andrx had anticipated receiving final marketing
approval for its ANDA on, or shortly after, October 5 2001
- the due date for Prilosec's
US patent expiration.
AstraZeneca first began communicating
with the FDA about these issues on April 10. Hahn told IMS
HEALTH that they refer in particular to the ratio of the
different crystalline forms inherent in the make up of omeprazole.
"Astra claim (more for purposes of trying to shield themselves
from further claims of violation of antitrust laws) that
they are not seeking the FDA to delay approval of a generic
Prilosec. Yet they imply by innuendo that the FDA should
investigate more carefully the generic products to ensure
that they have relatively uniform ratios," he stated.
Hahn claims that AstraZeneca
also sent the FDA details of an assessment carried out by
a Spanish company of various generics on the market in Europe.
This study indicates that if the manufacturing process is
not well controlled, the appropriate integrity of the enteric
outer coat polymer, and thus the performance characteristics
of the drug, could be affected. "Andrx has approximately
three years of room temperature stability on its 10mg and
20mg strengths and about two years of room temperature stability
on its 40mg strength. The information that Astra has provided
the FDA with is just a further tactic in the delay process.
We are confident that this latest issue will be recognised
by the FDA for what it is – smoke and mirrors."
Martin Nicklasson, Executive
Vice President and head of the gastrointestinal franchise
at AstraZeneca, told Pharmaceutical Company Profiles that
the information submitted by AstraZeneca to the FDA in April
2000, and then subsequently in July 2001, concerns "appropriate
scientific criteria for omeprazole". He stated, "AstraZeneca
told the agency that they were free to share this information
with the generics companies if they deemed it appropriate.
However, the agency decided to inform the generic companies
three days before the first possibility for approval that
they were not going to receive an approval at that date."
IMS HEALTH asked whether Nicklasson
deemed the FDA slow in their response? "I can't speculate
about how fast the FDA has handled this information, but
more than three months is a considerable time for such a
review."
A lot at stake
In 2000, Prilosec garnered $4.2
billion in sales in the US alone. In the past a 'megabrand'
such as Prilosec could be expected to lose sales at a fairly
steady rate following patent expiration, but the recent
Prozac (fluoxetine) debacle has altered the threat
posed by generic competition in an almost unprecedented
way. Eli
Lilly's iconic drug,
which lost patent exclusivity in the US on August 2 2001,
haemorrhaged over 70% of its sales in the first two months
post-patent.
"What has happened to Prozac
is a new phenomenon. Whether Prilosec will follow the Prozac
route or another model, it is absolutely impossible to tell,"
said Nicklasson.
According to a survey published
by Merrill Lynch, the launch of generic omeprazole could
put pressure on sales of all the branded proton pump inhibitors
(for example, Takeda/Abbott’s Prevacid, Protonix
from American Home Products and Altana, and Eisai/Johnson
& Johnson’s Pariet/Aciphex). Of the physicians
surveyed, 70-80% thought there were no unique features that
differentiate one PPI from another. They predicted that
up to 75% of existing patients could be switched to generic
omeprazole within the first year of launch, if priced at
a 50-75% discount. This agrees with similar findings on
generic penetration from IMS HEALTH’s Consulting group.
Price Dynamics
- Generics
|
Country
|
Average
penetration after 4 years
|
Price
differential between brand and generic
|
|
USA
|
60-70%
|
80%
|
|
UK
|
50-60%
|
80%
|
|
Germany
|
40-50%
|
30%
|
|
France/Italy/Spain
|
5-15%
|
20-30%
|
Source: IMS HEALTH Consulting
Andrx confident
Regarding the court case scheduled
for December, Hahn said, "We are confident that the Andrx
product is a non-infringing product and believe that the
patents should have no impact on our decision to launch.
The launch/no launch decision will be made by our board
of directors."
And whereas the exact patents
that may be in question on December 5 seem to be shrouded
by mystery (though it is known that they consist of four
AstraZeneca patents relating to the formulation and use
of Prilosec), Nicklasson told IMS HEALTH that AstraZeneca
has not instituted any late listing lawsuits, "Lawsuits
being managed by the courts in the USA are about patents
that Astra was awarded by the US Government ten years ago."
While the PPI class is the largest
revenue generating therapeutic class in the world, it is
also one of the biggest expense lines for those paying for
prescription drugs. "AstraZeneca received the patent on
the basic omeprazole compound 21.5 years ago. The patent
was extended twice by the Waxman-Hatch act and they subsequently
got the third extension for paediatric exclusivity. I believe
AstraZeneca’s delay tactics will cause grass roots and consumer
complaints that will have an impact on the people in Congress,"
concluded Hahn.
Review the
current sales trends of the molecules that will come off
patent in the next 12 years, and evaluate the patents that
protect them, with IMS HEALTH’s
Generic
Planning
service.
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