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Date Posted: 20:34:32 04/18/02 Thu
Author: Anna
Author Host/IP: ip68-1-115-246.pn.at.cox.net / 68.1.115.246
Subject: Schering vs Three Rivers, may be old news but I thought it was interesting.



Schering-Plough's Lawsuit Against Three Rivers Is a David vs Goliath
Story
with Hundreds of Millions of Dollars in Sales of Ribavirin at Stake

By Pamela Gaynor, Pittsburgh Post-Gazetter
Three Rivers Pharmaceuticals is a small, new pharmaceutical company,
just
trying to break into the business. At this point, it has no sales, not
even
a pill that it's permitted to sell.

All it really has is an application with the Food and Drug
Administration to
produce ribavirin, a generic form of Rebetol, which is used in
combination
with interferon to treat hepatitis C, a liver disease that could reach
epidemic scale because it is transmitted most commonly by blood through
intravenous drug use and other uses of unsterilized needles [such as
tattooing].

Still, Three Rivers already is embroiled in the kind of lawsuit that has
become almost a core business activity among generic drug makers.

The tiny Cranberry-based company filed for FDA approval in August. In
October, drug giant Schering-Plough filed suit to block Three Rivers'
application. Schering holds exclusive marketing rights for ribavirin
from
ICN Pharmaceuticals.

Like all such suits, those involving ribavirin (there are two others)
are
complex, involving not just the drug itself but also the manufacturing
processes and potentially other issues including how the drug is used.

The stakes in the battle are high. For Schering -- a third of whose
revenue
already is jeopardized as it faces patent expiration for its blockbuster
allergy drug, Claritin -- the possible loss of Rebetol sales could erode
potentially vast opportunities in a fast-growing market.

For Three Rivers, the issue is survival.

Whether or not it prevails, how the company got to this point is a tale
in
itself.

Three Rivers roots are in a Pittsburgh North Side drugstore, Fisher's
Pharmacy and a sister company, Fisher's SPS that the owners established
to
compound -- or hand make -- prescription drugs.

The pharmacy actually started making and selling ribavirin in 1999.
According to Three Rivers, that was the year ICN's patent expired, but
three
years before any generic competition could begin because of the
post-expiration exclusivity the FDA allows brand-name drug developers to
retain to compensate them for the time it took to obtain their initial
marketing approvals.

Fisher's, however, availed itself of an exception the FDA provides for
pharmacies to "compound" drugs that are not commercially available.

Although Schering was selling its brand version for the treatment of
Hepatitis C at the time, it was marketing it in a package with a form of
interferon on which it holds a patent.

The Rebetol pills were in a bottle, boxed along with a form of
interferon
that could be injected.

Because of the packaging, physicians sometimes couldn't prescribe doses
they
wanted to try on patients without causing them to waste portions of one
of
the drugs. Physicians who wanted to try their patients on the ribavirin
but
use another manufacturer's interferon also couldn't do so without waste.

The drug package, priced at about $1,400 for a month's supply, was too
precious to allow for the discarding of any part of it, said Donald
Kerrish,
a former Fisher's pharmacist and now chief executive officer of Three
Rivers, which he founded with Fisher's owners. Of course, at that price,
there also were patients who couldn't afford the therapy at all.

It was because the ribavirin wasn't available by itself that Fisher's
was
able to compound it, said Paul Fagan, Three Rivers' attorney and one of
its
investors.

Schering made no attempt to block the compounding, though a spokesman,
Robert Consalvo, said Fisher's was stretching rules under which FDA
usually
finds there to be a lack of commercial availability. The exception, he
said,
is typically one permitted to help patients obtain medication in a form
that
doesn't exist -- such as a liquid formulation for someone who can't
swallow
a pill.

Schering, which declined to discuss its lawsuit against Three Rivers,
said
it packaged the two drugs in one box to protect patients against uses
with
other forms of interferon, which physicians are permitted to recommend
but
which might not have been subjected to enough study. It has since begun
marketing the two separately because sufficient studies have since been
done, Consalvo said.

Three Rivers' attorney, however, said he suspected the packaging was
designed to give Schering a lock on treatment of Hepatitis C, protecting
its
hold with a "bundled" product. Moreover, Fagan contended Schering didn't
sue
Fisher's because it didn't want to chance an earlier challenge to its
patent.

Whichever is the case, Fisher's found plenty of takers for its
compounded
ribavirin. Kerrish wouldn't disclose actual sales but acknowledged there
was
enough demand -- considering Fisher's version cost $1.25 per tablet vs.
$10
for Schering's -- to make it worth the pharmacy's while.

With no factories, Three Rivers expects to purchase its production from
a
large contract manufacturer, assuming it wins its legal battle and gets
FDA
approval. It also would attempt to develop additional generics, possibly
investigating some of the compounds used in treating HIV infections,
Kerrish
said.

Kerrish also wouldn't say how much Three Rivers would charge for
ribavirin
if it gets approval. But he said he believed that the company's pricing
would be such that it would significantly widen the market by making the
drug affordable to more people.

The number of people in need of the drug is rising, particularly in
prison
populations where the incidence is deemed to be around 40 percent, said
Fagan.

Fagan said he was optimistic about Three Rivers' chances because it's
much
like the companies that started the generic industry but have since
become
large pharmaceutical concerns themselves, sometimes making brand name
products along with generics.

"There's no one like us. We're small and nimble," he said. 4/15/02

Source
P Gaynor. Outcome of fight with giant Schering-Plough to determine tiny
Cranberry drug maker's fate. Pittsburgh Post Gazette. April 11, 2002.

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Replies:

[> It's news to me Anna...frustrating news... -- terry, 20:59:18 04/18/02 Thu (NoHost/66.84.232.176)

It irritates the hell outa me when I hear of progress being held up by lawsuits. The chance to come up with a cheaper version is what a free-market system is all about. I know there's more to this than that, with the patent issue and all...just irks me to see a chance for more people to be able to afford tx go by the wayside.


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[> [> if i am correct i have three rivers which they call medplus??? anyone have a clue if there connected -- Donna, 21:11:54 04/18/02 Thu (pawilk-apx1-112-84.du.uplink.net/209.173.112.85)


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[> [> [> Not sure Donna........? Maybe something can be found doing a search on the web??? -- terry, 21:43:11 04/18/02 Thu (sg61.merr.com/209.83.14.192)


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[> [> [> [> p.s. ....... -- terry, 21:47:30 04/18/02 Thu (sg64.merr.com/209.83.14.195)

How are ya? I hope you take my post to you below to heart. I know too well how tough it can be to change life style. I think it made it a little easier for me since I'd gone through so much sh*t because of drinking & drugging...finally just got sick of all the hastle and head aches. I do wish you well. Try really hard to find alternative things to do, things you enjoy....take care.


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[> [> [> I doubt it Donna. The article says the Co. was started by a small pharmacy. -- Anna, 09:03:25 04/19/02 Fri (ip68-1-115-246.pn.at.cox.net/68.1.115.246)


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[> [> Re: ..frustrating news...Its big fish eats little fish and big $$$. -- sg, 21:55:59 04/18/02 Thu (Toronto-HSE-ppp3663134.sympatico.ca/65.95.154.237)


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