Oseltamivir chemical structuresynthesis of tamiflu
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Tamiflu

Oseltamivir (pronounced ah sell TAH mih veer) is an antiviral drug used in the treatment and prophylaxis of both influenza A and influenza B. Like zanamivir, oseltamivir is a neuraminidase inhibitor, acting as a transition-state analogue inhibitor of influenza neuraminidase and thereby preventing new viruses from emerging from infected cells. Oseltamivir was the first orally active neuraminidase inhibitor commercially developed. more...

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Oseltamivir is a prodrug (usually administered as phosphate); it is hydrolysed hepatically to the active metabolite, the free carboxylate of oseltamivir (GS4071).

Oseltamivir was developed by Gilead Sciences and is currently marketed by Hoffmann-La Roche (Roche) under the trade name TamifluĀ®.

With increasing fears about the potential for a new influenza pandemic, oseltamivir has received substantial media attention. Production capacity is limited, and governments are stockpiling the drug.

Technical information

Indications and dosage

Roche recommendations in the United States

Tamiflu is available from Roche in 75mg capsules and as a powder for aqueous suspension of 12 mg/mL. According to prescription information by Roche for the United States, Tamiflu usage is indicated for both the treatment and prophylaxis of influenza at the following dosages.

  • Tamiflu is indicated for the treatment of influenza in patients 1 year and older who have had symptoms for no more than two days. For influenza treatment, the standard dosage for patients 13 years and older is 75 mg twice daily for five days. Dosage for children is by weight.
  • Tamiflu is indicated for prophylaxis of influenza either during a community outbreak or following close contact with an infected individual. Standard dosage is 75 mg once daily for patients aged 13 and older, which has been shown to be safe and effective for up to six weeks. Safety and efficacy for prophylaxis has not been established for patients under 13 years old.

The above treatment regimes are based upon studies of normal human influenza.

Dosage for avian flu

Peter Hobby (of the World Health Organization) has suggested that Vietnam should investigate and test a higher dosage and longer treatment with Tamiflu for patients with avian influenza. Doctors in Vietnam concur, noting that

t least in some patients with influenza A (H5N1) virus infection, treatment with the recommended dose of oseltamivir incompletely suppresses viral replication. Besides allowing the infection to proceed, such incomplete suppression provides opportunities for drug resistance to develop. (de Jong et al. 2005)

Co-administration with probenecid

It has been suggested that co-administration of oseltamivir with another drug called probenecid could dramatically extend the world's limited supply of oseltamivir. Probenecid reduces excretion of oseltamivir's active metabolite. 500 mg of probenecid given every six hours doubles oseltamivir's maximum blood concentration and also doubles the time that oseltamivir stays in the blood, multiplying a patient's overall exposure to the drug 2.5-fold. Probenecid was used in similar fashion during World War II to extend limited supplies of penicillin. The evidence for this interaction comes from a 2002 study by Roche (Hill et al. 2002), but was publicized only in October 2005 by a doctor who had reviewed the data (Butler 2005).

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Tamiflu's Road Remedy - Brief Article
From Brandweek, 3/12/01 by Christine Bittar

For marketers of seasonal products in a category as competitive and unpredictable as cold and flu remedies, it's crucial to be first. Just ask the folks at Hoffman-La Roche Pharmaceuticals, Nutley N.J, manufacturers of the prescription anti-viral flu medication Tamiflu.

At the start of last year's flu season, Tamiflu's chief competitor, Glaxo-Weilcome's Relenza, had received approval from the Food & Drug Administration and was building consumer awareness via a TV campaign featuring Wayne Knight, a.k.a. Newman from Seinfeld. While Tamiflu is a pill and Relenza is an inhaler, both had been approved to ease influenza symptoms if taken within the first 48 hours.

To make up for lost time, Roche teamed with Momentum Worldwide, New York, in a promotional tour to bolster its own ad campaign. Tour organizers hit the streets in heavy flu markets, armed not only with informational brochures but a plan to give passersby a live demonstration of flu prevention.

Well, sort of. Call it a day-in-the-life of a healthy person. An actor on display in a 9-by 20-foot, glass-enclosed, fully-furnished apartment mounted on the back of a flat-bed truck. The subject rose from bed in his pajamas, brushed his teeth, read the newspaper and ate breakfast. Later he watched TV, snacked, played videogames and worked on his hobbies, never acknowledging the hordes of people staring inward.

Besides attracting attention, the demonstration conveyed the message that while this man living in an enclosed, germ-free environment was therefore safe from the flu bug, the rest of us were at risk of getting sick. "We were looking for ideas that would resonate with people and [contrast with] how miserable they feel when they're sick," said Dan Stevenson, creative director at Momentum.

To ensure that even onlookers peering out from building windows had a clear view of the demonstration, Momentum hired Broadway set designer David Gallow to create the model apartment. Signage on top of the studio read, "One person in this town who can probably feel safe from the flu ... For the rest of us flu sufferers, there's Tamiflu."

Rather than the usual perky young volunteers, kindly grandma types stood outside distributing the Tamiflu brochures and specially packaged envelopes of "Granny's" chicken soup, complete with a picture of a white-haired Granny on the packet.

The tour ran from Jan. 1 through March 15, weaving its way into the country's 71 heaviest flu markets using eight mobile apartments. Meanwhile, in-store collateral buttressed the effort with an interactive moveable "symptom wheel" display to address whether or not one was suffering from the flu or just a cold.

With last year's severe flu outbreaks making national news, the Tamiflu tour accounted for more than 100 million brand impressions. In a fortuitous twist for Roche, Glaxo skipped a direct-to-consumer Relenza campaign this year when those Newman spots came under scrutiny by the FDA. Glaxo had altered the spots in 1999 when officials deemed the campaign "misleading" in its suggested effectiveness, and the company was forced to revise its labeling to reflect reports of serious respiratory problems in people using the inhaler.

From an unknown, late-market entry just three months prior to the tour, Tamiflu went on to dominate the anti-viral flu category with a 58% market share. The drug manufacturer rang up $41 million in U.S. sales from Nov. 1999 through April 2000, versus Relenza at $20 million, per IMS Health. Marketers are considering whether to export the Tamiflu promotion to cities outside the U.S.

CATEGORY: National Consumer Promotion (Between $3,000,000 and $6,000,000 )

PROGRAM: Launch of Tamiflu

MARKETER: Hoffman-La Roche Pharmaceuticals, Nutley, N.J.

AGENCY: Momentum Worldwide, New York

KEY PLAYERS:

Roche:

Momentum:

Nancy Serkow, consumer products director

Sean O'Malley, ass't creative director

Dan Stevenson, creative director

COPYRIGHT 2001 BPI Communications, Inc.
COPYRIGHT 2001 Gale Group

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