Talecris medicine on brink

Patients suffering from a rare disease that damages the nerves' protective sheathing could find out today whether a medicine made in the Triangle will become a more accessible and affordable treatment for their condition.

Gamunex, which Research Triangle Park-based Talecris Biotherapeutics makes at its Clayton plant, is one of three medicines already used by physicians to treat chronic inflammatory demyelinating polyneuropathy, or CIDP.

But lacking regulatory approval for the indication, all three drugs are prescribed according to doctors' discretion. That makes them medicines of last resort and forces many CIDP patients to pay for their prescriptions out-of-pocket.

A full treatment of Gamunex costs up to $40,000 per year. Baxter's Gamaguard and CSL Behring's Privigen cost about the same. That's too much for some patients suffering from CIDP, said Ed Gdura, a Talecris retiree and the patient advocate of a foundation that helps people with the disease.

Food and Drug Administration approval would prompt health insurers to help cover patients' costs, giving Gamunex a competitive boost. Talecris expects to hear as early as today whether the medicine is the first FDA-approved treatment for CIPD.

"That would be a godsend for patients who have had a difficult time," Gdura said. Regulatory approval "clears the path for doctors to use [Gamunex] unincumbered."

According to Gdura's foundation, about 8,000 Americans suffer from CIPD, which causes progressive weakness in patients' arms and legs.

Talecris -- which is being bought by larger, Australian rival CSL for $3.1 billion -- is known for making blood-based medicines for rare diseases. Until now, the company has focused on diseases that affect the immune system.

As the first approved CIPD treatment, Gamunex would be the only promoted CIPD medicine for seven years. Gamunex would also be the first Talecris drug approved for a neurogenerative disease.

Talecris received regulatory approval to sell Gamunex as a treatment for primary immune deficiency in 2003, and the drug has become Talecris' best seller.