Novartis Gets EU Approval For Promising Exjade

Swiss pharmaceutical company Novartis AG (NVS) Wednesday said it received European Union approval to sell Exjade, a treatment for people with excess iron in their bloodstream.

Novartis, based in Basel, Switzerland, expects the medicine to eventually become a cornerstone therapy for the removal of excess iron, a condition that often arises in patients who require frequent blood transfusions to treat some types of anemia. Analysts' view on the drug's potential are divided, but some expect it to become a blockbuster with more than $1 billion in annual sales.

The U.S. Food and Drug Administration approved the drug last November. ( drug pipeline database )

Exjade, a tablet that is dissolved in a glass of juice or water, provides similar benefits to patients as Desferal, another Novartis drug that is today's standard therapy, but which has the drawback of requiring lengthy infusions.

Analysts expect Exjade not only to replace Desferal, but also to be much more widely used because it's so much easier to take.

Desferal is pumped slowly into the bloodstream over the course of eight to 12 hours a day, for five to seven days a week. Patients usually wear a pump at night while they sleep to receive the treatment, known as iron chelation therapy. Both Desferal and Exjade contain agents that bind to the excess iron and remove it from the system, a process that is called iron chelation.

"The approval of Exjade is fantastic news for people like me who need regular blood transfusions," Anand Ghattaura, who lives in London, said in a statement. "I've always found chelation with a pump and needle difficult to keep up with. I often used to worry all day about my infusion in the evening. Now I can take Exjade in the morning with a glass of juice and can forget about it until the next day."

Novartis said in July that in the U.S., sales of Exjade in the few months that it's been on the market were already twice as high as those of Desferal during its best year.

"The approval is good news for Novartis because around 80% of sales are likely to come from Europe, where diseases like Thalassemia, which requires lengthy blood transfusions, are more widespread than in the U.S," said Karl-Heinz Koch, analyst in Zurich with private bank Lombard Odier Darier Hentsch, who has a buy rating on the stock.

At 0705 GMT, Novartis was up CHF0.25, or 0.4%, at CHF70.75, in line with the broader market.

Following regulatory approval, Novartis will now start negotiations with E.U. member countries on the price of Exjade.

In the U.S., Exjade costs around $32,000 a year to treat conditions other than sickle cell anaemia, for which treatment costs are roughly a third lower. Costs vary by weight of the patient, as well as dosing. Most analysts expect Exjade to generate revenue from $500 million to $700 million in its best year, but some say it has the potential to achieve more than $1 billion if it will be much more widely used than Desferal.