Novartis, the $17 billion in sales pharmaceutical giant forged four years ago by the merger of Sandoz and Ciba-Geigy, is moving at a frenetic pace to introduce, what it considers, a block buster drug that will provide immense relief to people suffering from chronic myelogenous leukemia (CML).
CML is an insidious cancer that starts out as a genetic flaw, which causes overproduction of platelets and white blood cells. Once set in, the disease over four to six years the genetically defective cells slowly accumulate more mutations, eventually crowding out the good cells as a result of which the body can no longer fight infection.
Traditionally, the only cure for CML has been a bone marrow transplant. With patients being unable to find a suitable donor the procedure, which costs $150,000, is generally out of reach for most of the suffering patients.
It is in this background that Novartis' new find, Glivec, is seen as a ray of hope not only for the suffering patients, but also for Novartis, which has long been considered a slumbering laggard in the global pharmaceuticals sweepstakes.
The first breakthrough for the drug designed to attack the molecular machinery that drives CML was made in a Ciba-Geigy research lab in Switzerland. Like most pharma research products, which are based on serendipity, researchers were not focusing on leukemia. But one of the compounds produced at the lab was discovered useful in disabling the defective protein made by the CML gene.
Novartis, which began testing Glivec on patients in the summer of 1998, was surprised by the spectacular results the drug produced. At the first test, all 31 patients who were given high doses, reported normal blood cell counts after only a few weeks after taking the drug. In another trial over 290 patients who were given Glivec for at least six months, 56 per cent saw the drug destroying most or all of the marrow cells with the defective gene.
Faced with such a startling discovery, the giant was suddenly scrambling to scale up production. It was then that Novartis chief executive, Mr. Daniel Vassella, decided to take a big gamble. Even as additional tirals were continuing and formal approval from regulatory authorities for the mass introduction of the drug were to come, he authorised the scaling up of production of the drug, which would normally take two years given its complex nature, in as short a time as possible.
Workers at the company's factory in Ringaskiddy, Ireland, have been working 12-hour shifts round the clock for last one year to successfully produce its first batch of 10-tons of the drug – a plain looking white powder with extraordinary qualities. While this quantity is enough to treat about 30,000 patients a year, the company is already thinking of its second batch of a similar size.
Novartis' plans to apply for formal approval from regulatory authorities in March this year, will make Glivec the fastest track drug in pharmaceutical history. Typically, a drug takes at least five years of clinical testing to win regulatory approval and Glivec will achieve this in barely two and a half years after the first trials began.
Novartis is clearly looking at Glivec as the remedy to boost its sagging image. In the current euphoria of the drug no one is even thinking of the possible lethal side effects such a drug may have after a few years of use. Patients are not pausing to think that Glivec, like most anti-cancer drugs may not rid them of their disease but only postpone the inevitable.
In addition to Glivec, Novartis is planning a slew of new product introductions to take on the pharmaceutical world. The company reportedly has 24 new drugs in various stages of clinical testing aimed at other forms of deadly diseases like asthma, diabetes, schizophrenia, organ failure, arthritis and skin disorders.
Of the possible new drugs, two are potential blockbusters. The first is Zelmac (yet another drug discovered serendipitously at Sandoz labs) which is targeted at patients with the "irritable bowel syndrome" marked by indigestion, constipation and stomach pain. The second is Xolair, which promises to be one of the first anti-allergy drugs aimed directly at the molecular causes of allergies.