FDA APPROVES GENERIC OXYCONTIN

Teva, Endo Get Clearance After Agreeing To Implement Abuse-Reduction Programs

In a closely watched test case for how regulators will handle the risks
posed by potent opioid painkillers, the Food and Drug Administration
approved the first generic versions of the controversial drug OxyContin.

The approval came with an agreement by the two generic-drug makers to
create programs to reduce the risk of abuse and diversion onto the "street"
market. The FDA said those "risk-management plans" would be consistent with
measures taken by Purdue Pharma LP, the maker of branded OxyContin, which
put additional safeguards into place after widespread abuse of the drug
opened the company up to criticism as well as lawsuits.

Peter J. Pitts, the FDA's associate commissioner for external relations,
said the agency didn't believe that the availability of generic versions
would increase demand for the drug, based on the pattern with past generic
introductions. Mr. Pitts said the generic versions may cut the cost for
legitimate patients. "FDA's job is to maximize potential benefits patients
receive and minimize risks due to the products," he said.

Law-enforcement officials have long been concerned about the potential for
a bigger, cheaper, less well-controlled supply once versions of OxyContin
are marketed by multiple companies. OxyContin has become a high-profile
example of the risks posed by powerful painkillers. Originally approved in
1995, it had a special mechanism that allowed the painkiller, chemically
known as extended-release oxycodone hydrochloride, to be released gradually
over many hours for management of severe pain. But by crushing the pill and
snorting or injecting the powder, abusers found they could get all the
effects of the drug at once, for a potent high.

Teva Pharmaceutical Industries Ltd. and Endo Pharmaceuticals Holdings Inc.,
the two generic companies that got FDA go-ahead, declined to immediately
comment on their abuse-prevention safeguards. Because both companies are
still locked in a legal battle over patents with closely held Purdue
Pharma, it isn't clear when they might actually begin selling their cheaper
versions. The generic companies said it was too early to talk about pricing.

OxyContin's sales rose to $1.9 billion last year, from $1.6 billion in
2002, according to data from IMS Health. Including OxyContin, sales of
narcotic painkillers were $5.6 billion last year, up 20% from the year
before, and 127% from 1999, according to IMS Health, a market research company.

The debate over control of such powerful drugs is ramping up because of an
expected flood of new painkiller products. Among those in the pipeline are
asthma-style inhalers that could administer morphine and fentanyl, a
synthetic opioid. Johnson & Johnson, which makes the Duragesic fentanyl
patch, has said it hopes to sell other painkilling patches.

The FDA is already moving to push companies to create proactive anti-abuse
plans for all new potent painkillers. But as it moves forward, the agency
is trying to strike a delicate balance. Many researchers and pain doctors
argue that patients with severe pain often don't get the drugs they need.
One major 1998 study of 13,625 nursing-home cancer patients found that more
than a quarter of those who suffered daily pain got no analgesic at all.
Moreover, pain doctors have complained that aggressive law-enforcement
efforts may discourage legitimate prescriptions for patients who need
potent opioids, which are narcotic drugs with effects similar to those of
drugs derived from opium.

On the other side, law-enforcement officials have said they need tough
measures to avoid abuse and addiction and trafficking.

About 1.9 million people had at some point used OxyContin without a medical
need, according to a 2002 federal study on abuse of prescription
painkillers, which also found that an estimated 29.6 million people had at
some point used painkillers without a medical need.

The Bush administration recently announced a major crackdown on abuse of
prescription drugs, particularly highly addictive painkillers. The Drug
Enforcement Administration in the past has called for limits on the
distribution of potent and easily abused drugs to certain pharmacies or
physicians. But the FDA has never limited any opioid to certain pharmacies,
and agency officials say they don't have the authority to block certain
physicians from prescribing a drug.

As the problems of OxyContin abuse became more evident, Purdue several
years ago began putting in place a number of measures designed to reduce
abuse of OxyContin. The program's measures include a national system that
is supposed to help track diversion with the goal of informing law
enforcement officials of signs of problems. The company also conducts
education efforts among doctors and community officials, and offers tools
to limit diversion such as special prescription pads for doctors.

Still, it can be hard to accurately gauge the effects of such programs,
partly because it is difficult to measure the extent of abuse.

Purdue has said it believes its program to be effective. In fact, the
company filed a petition with the FDA asking the agency to ensure that
generic makers have abuse-reduction programs similar to its effort.

"If you don't have a risk management program and you flood the market with
generic oxycodone formulations, that seems to us like asking for trouble,"
said a Purdue spokesman. "It seems to us it should be an even playing
field, and all companies should be held to the same standard."

Purdue is now seeking FDA approval for a new time-release painkiller,
Palladone, but it has fought hard in court to retain the exclusivity of its
major product. Endo won its first round of litigation in January when a
judge in the Southern District of New York invalidated Purdue's patent
because, the court found, the company misled federal patent regulators in
obtaining it.

Purdue has filed an appeal in that case, which could take a year or more.
Endo could decide to launch its generic product before then, but would face
paying steep damages if the higher court overturned the ruling. Bill
Newbould, a spokesman for Endo, said the company hasn't yet decided when it
plans to launch its generic.

Teva has a patent litigation case pending in the same court and before the
same judge for a different dosage. That trial hasn't yet begun, but Teva
could choose to launch its product before the other appeal is settled. A
spokesman for Teva said no such decision has yet been made.