The stomach medication that became the biggest blockbuster of the 1990s
Av The gastric ulcer medication Losec became one of Astra’s greatest successes ever, although it was not a given triumph from the beginning, far from it. Behind the drug lay decades of work, and several times it seemed nothing would come of the so called gastrin project.
The substance omeprazole was first produced in the late 1970s. It was a milestone for researchers at Astra Hässle and the University of Gothenburg, who had long researched the connection between acid secretion and stomach ulcers.
However, a substance is far from a finished drug and must pass many tests and studies before it can even begin to be tested on humans.
In the mid-1980s, the decades old research project, had nevertheless begun to take off. The situation looked bright, and perhaps approval was within reach.
Then came a setback that no one at Astra had anticipated. Animal experiments in the USA showed that Losec caused cell changes in the stomach of rats. All clinical trials on humans had to be halted. The atmosphere at Astra was tense, to say the least.
He saved the development of Losec from being shut down
That’s when one of the many people who have been crucial to Losec’s success came into the picture. Niilo Havu, a Docent in Pathology recruited to Astra from Umeå University, entered the scene. He boarded a plane to the United States to visit the contract laboratory that conducted the studies. Once there, he could ascertain that the cell changes were benign and could not affect humans.
“He saved the development of Losec from being shut down,” says Staffan Ternby, Communications Director at the Swedish pharmaceutical giant at the time.
In 1988, Losec was approved in Sweden and several other countries. The drug became increasingly established, and now success seemed secured.
However, the development took a new headache-inducing turn at Astra. On the other side of the world, in Australia, scientists had discovered that stomach ulcers are caused by the bacterium Helicobacter pylori, and this discovery led to the conclusion that peptic ulcers should be treated with antibiotics.
Lars Fändriks, Professor at the Department of Surgery at the University of Gothenburg, describes it as a battle between two phalanxes. He remembers attending a large convention in Australia where both sides were represented with roughly equal numbers of participants. On one side, physiologists, internal medicine doctors and surgeons spoke warmly of Losec. On the other side, bacteriologists and immunologists supported the theory of Helicobacter.
“These two groups were unable to communicate,” says Lars Fändriks, and he tells us that he and the other Losec followers called the researchers who supported the new findings “helicomaniacs”.
By this time, Losec had already been established as a treatment, while research into bacteria’s link to ulcers was still in its infancy.
The rivalry between the two phalanxes did not last long. Soon both sides emerged victorious and could be more than satisfied. The understanding that both omeprazole and antibiotics are important in helping patients with stomach problems was established. The researchers behind the discovery that Helicobacter causes stomach ulcers received the Nobel Prize in 2005, and Losec became a Swedish billion-dollar success. In 1996 it became the world’s best-selling drug and retained that position for many years to come.
“In the early 1980s, we at Astra hoped that Losec would become a “billion dollar brand”, but it exceeded our expectations by far,” notes Staffan Ternby.
Losec came to be known as a “stomach ulcer medicine”, but actually, it was used more often against reflux oesophagitis, i.e. heartburn and acid regurgitation, than against stomach ulcers.
20 years after its launch, the drug had sales of approximately SEK 440 billion. In financial terms, it is undoubtedly the biggest Swedish export success ever in life science. But above all, omeprazole has helped millions of people improve their health and completely changed the treatment of patients with stomach or oesophagus problems.
“When I started my career as a surgeon, we surgically removed parts of the stomach or the vagus nerves to reduce acid production, and it was one of our most common procedures. All that surgery is history now, except just a few operations a year on people who suffer from acute stomach bleeding,” says Lars Fändriks.
The development of Losec took a long time, and many researchers were involved in different ways. Surgeon Lars Olbe at Sahlgrenska hospital, Pharmacist Ivan Östholm, Veterinarian Sven-Erik Sjöstrand and Research Director Enar Carlsson at Astra are some of the researchers who are frequently mentioned.
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