Science in the Triangle

A treatment for an inherited protein deficiency that causes lung and liver disease features prominently in the Federal Trade Commission’s request to block the $3.1 billion takeover of Talecris Biotherapeutics, one of the Research Triangle’s largest drugmakers.

Alpha-1 Antitrypsin is made from blood plasma and, taken in proper doses, prevents the damage suffered when the body doesn’t produce enough of the protein. Talecris’ Prolastin is the best selling of three available treatments for Alpha-1 deficiency. CSL, the Australian rival that wants to buy Talecris, makes Zemaira, which is third in sales.

In the antitrust lawsuit the FTC filed a few days ago, the regulators argued that CSL’s takeover of Talecris would create a company that controls 80 percent of worldwide Alpha-1 sales.

The merged company would also own market shares of 42 percent or larger for three other life-saving treatments made from blood plasma - scenarios rife for supply controls aimed at raising prices, according to the lawsuit. But nowhere would CSL gain as much sway as in the Alpha-1 market.

“Ridiculous,” said John Walsh, the founder and president of the Alpha-1 Foundation, a Florida-based nonprofit that funds the search for a cure. “I don’t understand where the FTC is coming from.”

Walsh was diagnosed with Alpha-1 deficiency in 1989 and his health relies on sufficient supplies of the protein. But supply of Alpha-1 has not been an issue for patients since 2003, he argued, the year CSL brought Zemaira to market and Baxter International, the Deerfield, Ill., market leader in blood plasma-based medicines, launched Aralast.

And more options are on the way for the about 10,000 Americans diagnosed with Alpha-1 deficiency.

Three companies are testing experimental treatments for Alpha-1 deficiency in clinical trials to compete with Baxter, CSL and Talecris, according to a pipeline update that will be published in the Alpha-1 News newsletter this week. The most advanced of the three, an Alpha-1 infusion developed by Israeli biotech company Kamada, is awaiting regulatory approval for sale.

Talecris is working on two new versions of Prolastin and two other companies are considering developing treatments to enter the Alpha-1 market, Walsh said.

“We had exhaustive interviews with the FTC,” he added. Regulators were well aware of treatments in the pipeline before they decided to pursue an antitrust lawsuit to block the sale of Talecris.

While it may be debatable how much of an issue supply of Alpha-1 is - FTC spokesman Mitchell Katz countered that any new treatments still have to pass significant regulatory hurdles, which might take a while - price is clearly a concern among regulators and patients. Alpha-1 supplies can cost as much as $90,000 per patient per year, according to the FTC lawsuit.

Regulators are particularly alarmed about signs that Baxter and CSL may already control supplies to keep prices high. In 2006, the U.S. Department of Health and Human Services found supply rationing of immune globulin, one of the three other medicines made from blood plasma, after patients complained they had problems obtaining their medicine, according to the antitrust lawsuit.

The FTC stopped short of accusing any of the companies of price fixing. But the FTC lawsuit does allege signaling, which is the intentional sharing of competitive information to secure accommodating reactions.

According to Walsh, the cost of Prolastin has increased by about one-third, from 32 cents per milligram, since Zemaira and Aralast came to market at more than 50 cents per milligram six years ago.

The Alpha-1 Foundation and its patient outreach arm, the Alpha-1 Association, are very supportive of Baxter, CSL and Talecris. They help recruit for clinical trials and supported faster regulatory approval of Zemaira and Aralast.

But Alpha-1 supplies and prices and the antitrust lawsuit will likely come up at the annual Alpha-1 conference, which starts Friday in San Francisco. About 450 doctors, patients and family members are expected to attend, according to Marlene Erven, executive director of the Alpha-1 Association.