[Ip-health] Cipla Ships First Generic Tamiflu Wednesday - Challenges Roche Monopoly

[Mike Palmedo]

Bill Haddad asked me to post this to the list...

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February 21, 2006

Cipla Ships First Generic Tamiflu Wednesday - Challenges Roche Monopoly

On October 14, 2005, the New York Times reported that Cipla, Ltd. of
India had cloned Roche's Tamiflu, one of the two medicines used to treat
avian flu.

At that time, Dr. Yusuf Hamied, Cipla's Chairman and Managing Director
announced the company would manufacture Antiflu (Oseltamivir), the
generic version of Tamiflu for third world countries "at a humanitarian
price."

The first shipment of 100,000 doses of Antiflu leaves the Cipla
warehouses on Wednesday (February 23). Cipla said it will manufacture
each week medicine for 100,000 treatments=85two tablets a day for five
days=85 and expects to increase production.

After Cipla's October announcement, several countries and companies
quickly announced they would use compulsory licenses to manufacture
Oseltamivir. To date, due to the complexities of TRIPS, no nation has
taken that action although several companies revealed they had cloned
Tamiflu and were prepared to manufacture the medicine.

Cipla said Roche lacks patents in many nations including India where a
near panic developed this week when it was revealed that bird flu would
cause the destruction of millions of domestic birds destined for the
market at a cost to exceed a billion dollars.

WHO/UN Response to Bird Flu Potential Crisis

Prior to October, the World Health Organization reported it would take
Roche ten years to meet minimum world demands but the agency urged
companies and countries "to respect patents." It also reported Roche's
statement that it would take years for clones to be developed and
manufactured.

UN Secretary General, Kofi Annan, disagreed. He urged drug companies to
be "helpful" by not letting their patent claims interfere with access to
medicines.

"I wouldn't want to hear the kind of debate we got into when it came to
the HIV anti-retrovirals," he said.

In response to Cipla, a Roche spokesperson drew the line in the sand:

"Roche intends to be the sole manufacturer of Tamiflu," he said.

At the time, Roche reported not only would it would require a company
several years to clone Tamiflu but eventual supply is limited by a plant
blossom, star anise, that is essential to create the Tamiflu starter,
shikimic acid. Without shikimic acid Tamiflu could not be produced. Star
Anise, Roche said, is only grown wild in four provinces of South China..

When companies sought to secure the star or spicy anise they learned
almost all of the production had been promised.

A Cipla investigation, however, revealed shikimic acid could be produced
synthetically in a process discovered by Dr. John Frost of Michigan
State University. In fact, the process had been licensed to Roche for
its production of Tamiflu confirmed by royalty payments to the
University. The Financial Times and other newspapers reported that
during the debate Roche was producing one-third of its Tamiflu using the
synthetic process and would increase that ratio to two-thirds.

In an interview with the New York Times Dr. Frost expressed skepticism
that the process would be limited by shimick acid.

"I am completely astonished about the gnashing of teeth and the wringing
of hands about shikimic acid" he said. "The bottleneck should not be
shikimic acid availability."

Later Roche said an "explosive process" was required to manufacture
Tamiflu. The Wall Street Journal and several raw material manufacturers
exploded that fiction.

The Journal reported that "Roche officials=85repeatedly said producing
Tamiflu was a dangerous process=85(it) turns out to be relatively routine
according to some pharmaceutical executives familiar with the chemistry."

In fact, many generic companies routinely use an identical process to
manufacture certain medicines.

Roche said that over a hundred companies had applied for voluntary
licenses to manufacture Tamiflu, but to date only a few have been
issued. The others, a Roche spokesperson said, were being "investigated"
for their competence to produce Tamiflu.

Dr. Hamied said that in addition to India, four Asian nations have
ordered Antiflu but they had requested their names not be revealed at
this time.

The bird flu has rapidly spread from China, Indonesia, Vietnam and
Southeast Asia to Turkey, Russia, Iraq and to Europe and Africa.
Although nations are frantically stockpiling Tamiflu, price and supply
will limit almost all nations from fulfillment of the WHO
recommendations. Third world countries are among those least prepared
for a pandemic.

Relenza, the other Avian Flu Drug

Dr. J.P. Garnier, CEO of Glaxo, manufacturer of the second avian flu
medicine, Relenza, told BBC 4 that "patents will not restrict" the
generic manufacturing of Relenza" and it was reported that he had
reached out to generic firms. Cipla has announced it is cloning and will
manufacture Relenza a medicine that is inhaled.

The Potential Pandemic

The Unites States and other western nations are being confronted by
requests for compulsory licenses to meet the demand that would be
generated if the avian flu mutates so that it can be passed from
human-to-human.

Most scientists predict that issue is not "if" bird flu or another
similar virus will develop into a human pandemic, but "when" it mutates.

During the flu pandemic after WWI, 2.5 percent of those infected died.
Bird flu has infected approximately one hundred persons, half of whom
have died. For the medicines to be effective they must be taken within
forty-eight hours of the visible onset of the flu. Those with damaged or
compromised immune systems are the most likely to fall victim to the virus.

If the virus is identified in time to use the medicines, the patient
will not die, but be desperately ill.

The Precursor for the Bird Flu Crisis: Generic AIDS Medicines

Cipla has faced multinational retaliation and barriers to competition in
the past.

In 2002, Dr. Hamied combined three of the most effective AIDS
anti-retrovirals into one tablet taken twice a day and reduced their
cost from the prohibitive $12-15,000 a year to a dollar a day replacing
a regime of twelve or more tablets taken from three companies at various
times of the day, an almost impossible regime in the third world.
Artificial barriers delayed use of the triple for several years.

Today the "triple" is recommended by WHO as first line treatment and
Cipla provides the medicine for over 400,000 patients in poor nations;
other generic companies supply approximately another 400,000 treatments
but neither the brand and generic AIDS medicines combined meet the needs
of millions who go unattended and eventually die leaving behind
generations of orphans.

Patents, Profits vs. Life Saving Medicines

In a full page advertisements placed in papers and magazines around the
world, Cipla raised this question:

"What's the use of developing life-saving medicines if you can't make
them available to the patient?"









--
Mike Palmedo
Research and Web
Consumer Project on Technology
T =96 202-332-2670
F =96 202-332-2673
mpalmedo@cptech.org