Double whammy for AZ

It has been a tough month for AstraZeneca across the globe with the news that it is set to face a complaint from families of Japanese patients who died after taking its controversial lung cancer drug, Iressa.

On top of this, the Anglo-Swedish firm was slapped with a Ä60m fine by the European Commission for breaking antitrust laws by illegally trying to prolong patent protection for ulcer blockbuster, Losec ñ once the biggest-selling drug in the world.

Reports coming out of Japan say the Iressa complaint is based around allegations by the families that AZís advertising for the drug not only exaggerated its benefits but was run before the product was approved for marketing.

AZ said it had been notified of four civil cases related to Iressa in Japan, three in the Osaka district court and one in Tokyo. However, it is still unclear whether the focus of the suits will be on alleged fatal side effects or whether the drug failed to meet advertised claims regarding its efficacy.

ëAZ believes the [civil] claims are without merit and will vigorously defend them in court,í the company said in a statement.

In the US, the Food and Drug Administration has moved to pull the drug from the market for new patients, effecting a label change; from September 15, Iressa will only be available to patients who have already seen benefits from the drug or are enrolled in continuing studies.

In a research note, London-based investment banking firm Code Securities said the impact of the label change would be minimal, as ëitís only going to be marketed to tiny numbers of peopleí.

Hopes for the drug plummeted last December when a clinical study showed that it did not, on average, help advanced lung cancer patients to live longer.

Antitrust fine

Meanwhile, AZ has vowed to fight the European Commission antitrust fine, which is being regarded as a precedent for future similar cases.

The Commission ruled that AZ had not only provided incorrect information to several national patent offices in order to gain extended patent protection for Losec, but had also de-registered Losecís capsule formulation from several patent offices, after it switched to a tablet version, thereby thwarting entry onto the market of generic tablet  copies. 

ìBy preventing generic competition, AZ kept Losec prices artificially high,î commented EU competition commissioner, Neelie Kroes.

The company described the case as ìtechnically and legally complexî but said it ìfundamentally disagrees with DG Competitionís findingsî.

ìAZ has not made misrepresentations or behaved inappropriately,î said AZ chief executive Sir Tom McKillop. ìWe believe that a proper evaluation on appeal of all the facts and legal position will confirm that the Commissionís analysis is fundamentally flawed.î