FDA OKs epilepsy drug by Md. firm Shire Laboratories' Carbatrol requires fewer daily dosages

March 28, 1997|By Mark Guidera | Mark Guidera,SUN STAFF

A Maryland biotechnology company said yesterday that the Food and Drug Administration has given it tacit approval to market its new drug to treat epilepsy in the United States, one of the first new drugs to be approved for the disease in 15 years.

Final regulatory approval for the drug known as Carbatrol rests on Rockville-based Shire Laboratories Inc.'s meeting certain manufacturing requirements for the drug.

Krystyna Belendiuk, senior vice president for business development at Shire Laboratories -- known as Pharmavene, Inc. until it was bought recently by Shire Pharmaceuticals of Andover, England -- said the company "fully expects to meet the FDA's requests."

The company, she said, anticipates Carbatrol to be on the market by the end of the year or early next year.

Final FDA approval would position the drug for a share of the sizable epilepsy drug market in the United States, estimated at more than $140 million annually.

Carbatrol will be marketed in the United States, where 2.5 million people suffer from epilepsy, by Athena Neurosciences, Inc., of South San Francisco, a subsidiary of Elan PLC of Ireland.

Athena licensed the right to market the drug from Pharmavene in July 1996. Under the agreement, its parent, Elan PLC, retains the hTC right to seek regulatory approvals to market Carbatrol overseas.

Pharmavene's shareholders of record at the time of the merger with Shire are due an $8 million payment from Athena at the time of final FDA approval for Carbatrol. Athena will also pay Shire sales royalties on Carbatrol, said Belendiuk.

"We think this validates our ability to take a drug from concept to the lab and to the market," she said.

Final FDA approval for the drug will also trigger a $2 million payment to the shareholders under the merger deal with Shire Pharmaceuticals, which bought Pharmavene for an estimated $160 million.

Carbatrol was developed by taking the most widely prescribed medicine for epileptic seizures, known as carbamazepine, and reformulating it with several coatings of Pharmavene, which assures that the medicine releases into the body slowly over 12 hours.

As a result, patients will only need to take the capsules twice a day, as opposed to three to four times daily for the most common epilepsy drugs currently prescribed, said Belendiuk.

A common problem in treating epilepsy is getting patients to take their medicine regularly and on schedule because of the frequent dosing requirements.

Advantage with doses

The reduced dosing is an advantage Athena hopes to exploit in marketing Carbatrol, said Michael D. Coffe, president and chief operating officer at Athena, which specializes in marketing neurology products.

The leading products for Athena, which rang up $60 million in sales last year, are two treatments for Parkinson's Disease.

"We think [Carbatrol] will do pretty nicely on the market," said Coffe. "We have no market share or sales dollar projections. But there are some other unique aspects to the formulation that make it sufficiently different from anything else on the market which we think will make it attractive to neurologists."

Historically, there have been three other major drugs prescribed to control and treat the seizures associated with epilepsy.

The largest selling of these, 15-year-old Tegretol, marketed by Novartis, generated an estimated $340 million in sales worldwide in 1994.

Tegretol, according to industry analysts, holds an 80 percent market share in the United States, where sales of all carbamazepine products hit an estimated $142 million in 1993, the most recent sales figure available.

Tegretol-XR rival

But the drug that Carbatrol will be its chief rival is Tegretol-XR, made by Novartis, the world's No. 1 pharmaceutical company. It was approved for sale by the FDA last year.

Tegretol-XR is a reformulated version of Tegretol, and is designed for slow, or "extended," release. It is also marketed by Novartis.

Like Carbatrol, it is to be prescribed to be taken twice daily.

Pub Date: 3/28/97

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