3 Japan Allergan Employees Jailed in Bribery Probe

An Allergan Inc. executive in Japan and two other employees have been arrested and held in custody as authorities investigate bribery allegations over the company’s effort to get a drug approved for sale there.

The Irvine eye-care company said Wednesday that the three are still being detained a week after their arrest. A university doctor responsible for testing the drug for the government also was arrested.

The bribery case comes at a time when the company expects sales to soar past last year’s record $1 billion, but is fighting to remain competitive in an industry in which it is overshadowed by pharmaceutical behemoths.

Allergan has long relied on international sales to boost its bottom line. The company picked up 59% of its $835.2 million in revenue from overseas sales during the first nine months this year.

In Japan, authorities said that Allergan K.K., the company’s Japanese unit, gave $13,900 to Ryuji Kaji, the doctor in charge of testing the drug, and provided an additional $43,580 to Kaji’s private research organization in 1993 and 1994, according to Japanese news reports.

At the time, Kaji and another doctor at Kyoto University Hospital were conducting tests on Allergan’s drug, Botox, to determine if it should be recommended for government approval for treating eye muscle disorders. Kaji was quoted in a Tokyo newspaper as saying that the payments didn’t sway test results, but details of the results weren’t available.

Under Japan’s drug-testing system, a pharmaceutical company asks a university or research institution to conduct tests on a drug. The testing institution then reports the results to the government, which decides whether to approve the drug.

Though reports in Japan stated that Botox was approved last month, Allergan spokesman Jeffrey D’Eliscu said that Botox has not yet been approved in Japan. He refused to discuss the arrests or the company’s efforts to get the drug approved.

The Allergan executive arrested was Hideo Tajima. The two employees were identified as Masami Hakane and Hiromi Maezono. The three worked in the research and development area, D’Eliscu said, but he would not reveal their titles or jobs.

The company, he said, is cooperating fully with Japanese officials.

Botox, which accounted for $49 million in sales last year, reaped nearly that much--$48 million--in the first nine months this year. It is sold in the United States and nearly a dozen other countries.

Earlier this year, Allergan disclosed that the U.S. Commerce Department was investigating the company’s apparent failure to obtain the correct export license to sell Botox overseas. For 15 months after it began selling Botox in 1991, Allergan used a general export license instead of a special license.

The federal government requires a special license because Botox is made from a lethal toxin, botulinum, that can be used in biological warfare. Allergan said, though, that no one could turn the powdery substance it exports into biological weapons.

D’Eliscu said the Commerce Department investigation, revealed publicly last April, is still pending.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

A Toxin That Heals

Allergan’s Botox was the first bacterial toxin approved for use as a medicine. It is a purified form of botulinum type A, a variety of the same toxin that in larger doses causes food poisoning. Details on the toxin and Botox:

BOTULINUM

* What it is: Toxic byproduct from the growth of clostridium botulinum bacteria and spores

* Where found: Contaminated food, soil, marine sediment

* Distribution: Worldwide

* Toxic effects: Attacks central nervous system; severe nausea and vomiting are first symptoms. Left untreated, it will cause muscle paralysis and respiratory failure. Antitoxin serum does not cure it, but lessens severity. No vaccine exists.

* Export: Requires special license because it is one of the most toxic substances known and has potential use as a biological weapon.

*

BOTOX

* What it is: Botulinum toxin type A purified and vacuum dried into a powder

* Medicinal use: Relaxes severely contracted eye muscles

* How administered: Small doses mixed with saline solution and injected into affected eye muscles; repeat doses required to maintain effect

* How it works: Blocks transmission of a chemical that causes eye muscles to contract severely.

* FDA approval: 1989

* 1995 sales: $48.9 million

Source: U.S. Food and Drug Administration; Allergan Inc.; Researched by JANICE L. JONES / Los Angeles Times