We’re meeting at a coffee shop not far from 57th and Lex. She’s just about to see a company that promises to help her get in touch with American investors. As this is October 2008, it sounds like a waste of time, but Elisabeth Lindner thinks Diamyd Medical is different. They are not selling LCD-TV’s, but a diabetes vaccine.
Unlike diabetes type 2, which is linked to lifestyle and obesity, type 1 can strike an other-ways perfectly healthy person. There is no cure yet, but Diamyd Medical claims to be able to do just that. “54-58 percent of pharmaceuticals tested in Phase III succeed, but I strongly believe that our vaccine against diabetes type 1 will be approved,” says Elisabeth Lindner, a chemist and civil engineer who became CEO a year ago after 25 years in the pharmaceutical industry.
Diabetes type 1 – sometimes called Childhood or Juvenile diabetes – can be a deadly disease if left untreated. It’s an autoimmune disease that destroys the very beta cells of the pancreas, which are necessary for insulin production. Without the insulin hormone, the body can’t break down glucose and turn it into energy, which over time can have devastating effects. There is no cure for diabetes type 1, but the diabetes patient can be treated by regular insulin injections.
Little is known about why people get diabetes type 1, but for some reason Finland has the highest rate in the world of the disease, followed by Sweden. “We don’t know what causes the disease, and only five percent can be explained genetically,” says Elisabeth Lindner, adding that there are intriguing correlations between flare-ups of a certain type of rat pest (sorkpest) in Sweden and spikes in diabetes type 1. This could indicate that a virus can cause the disease. It is also possible that high levels of milk and gluten consumption are factors.
Diamyd has developed a vaccine with a potential to not only treat, but also cure the disease. It is currently in a phase III test, and an article about the phase II study of the vaccine was recently published in the New England Journal of Medicine, the foremost medical journal in the world. The article showed that children who took part in the phase II study regained their ability to generate their own insulin.
The story behind Diamyd goes back to the mid-1990’s, when the Swedish medical entrepreneur Anders Essen-Möller, after selling his company Synectics Medical to Medtronic, launched a new project focusing on diabetes type 1, a disease his daughter had come contracted. He located and licensed the GAD-genome from University of California at Los Angeles (UCLA) as well as a method for using GAD in diabetes therapy from the University of Florida. The new company – Diamyd Medical – has developed a vaccine that has successfully passed two phases of testing.
Elisabeth Lindner is convinced that Diamyd has a huge potential, and the potential market for Diamyd’s vaccine is a billion dollar market. The company is still a small virtual operation with ten employees, doing research and development in Sweden and a three in Pittsburgh, PA, who are designing the production process, which is done in the Netherlands with drug substance from Connecticut. When needed the company contracts with outside experts and consultants to do work. Elisabeth actually started out as a consultant herself before she was recruited to be its leader.
Diamyd Medical is listed at the OMX Stockholm Nordic Exchange, but Elisabeth Lindner wants to take the company to on OMX Nasdaq, instead of just having its shares mirrored there. “We plan to file for FDA approval in 2010 and to introduce the product by 2011.” Next step will be to set up a marketing and sales organization in the U.S., something that will cost a lot of money, but also open up a path to a market that is measured in billions, and is relatively recession proof.