When Orphan Medical won U.S. regulatory approval for Busuflex in 1999, it found itself with an unexpected problem. The drug, an injectable form of busulfan, was developed to prepare blood cancer patients for bone marrow and stem-cell transplants in combination with chemotherapy. But though the drug was approved only in the United States, the small Minnetonka, Minneapolis pharmaceutical company started getting calls from physicians overseas who wanted to get a hold of it for patients.

“We were getting inundated with these requests and didn’t have ways to respond,” says John Lagus, who at the time was managing the international business for the company, which has since been acquired. And it wasn’t just calls for Busuflex that Orphan Medical was wrestling to satisfy, but requests for a series of drugs for which the company had won approval in the U.S. between 1996 and 2002. Many addressed rare and unmet medical needs ranging from an antidote for antifreeze poisoning, to a treatment for an enzyme deficiency that prevents children from metabolizing sugar.

 

As the company struggled to respond, a prospective marketing partner in Europe suggested it look into what’s called “named-patient programs,” a special fast-track process sanctioned by regulatory agencies that allows patients to acquire drugs not yet approved in their own countries for unmet medical needs. Though such programs aren’t generally well known by doctors, or even most seasoned pharmaceutical executives, they’ve long existed. In some cases, sought-after drugs have been approved in a major market or are in late-stage clinical trials. As Lagus searched for information about these programs, it was then that he found IDIS Pharmaceuticals.

 

Founded in 1987 to source and supply medicines on a named-patient basis to hospitals and pharmacies in the United Kingdom, IDIS has since expanded its services to meet demand throughout the world. Named-patient programs provide pre-approval access to innovative drugs in response to a physician request made on behalf of a specific patient. As the word gets out, the business is growing. The privately held company said it does not disclose financial data, but managing director Natalie Douglas told The Daily Telegraph revenues could reach £78 million ($154 million) in 2008.

 

With a staff of 130 people who are fluent in more than 20 languages, IDIS ships some 400 different medications each month. In the past 12 months, the Weybridge, England-based firm has filled a total 500,000 orders to pharmacists and physicians in more than 100 countries in Europe, the Americas, Asia, Africa, Australia, and the Middle East. Though there are some smaller wholesalers that provide similar services in certain countries, IDIS officials say they don’t know of anyone else offering the same scope of services on a global scale.

 

Lagus was impressed with what he saw. About two years ago, he joined IDIS as its vice president of business and corporate development. Now he’s leading the company’s expansion into the United States. Seeking to raise its visibility among pharmaceutical companies, IDIS opened an office in Iselin, New Jersey—the heart of big pharma country—in August 2007. IDIS helps pharmacists or doctors seeking access to a drug with navigating the regulatory process and sourcing the drug. “Most physicians in the United States have no idea what the process is for how to get a drug from outside the U.S. into the U.S.,” says Lagus. “We help them step through that process providing them with information on ‘this is who you need to contact’ and ‘these are the things that need to be in place.’ If we don’t have that particular product, we will go out and source that product.”