Do-it-yourself blood drug a threat to Baxter

Sara Ahrens pinches her thigh, pushes a half-inch needle into her skin and turns on a pump. Then she sits back to watch “Grey's Anatomy” at her Long Beach, California home as life-saving liquid flows into her body.

Ahrens is one of about 10 million people worldwide whose bodies don't produce enough antibodies, leaving them vulnerable to infections healthy people fend off without help. Last month, the 36-year-old teacher began home injections of the Hizentra immune-system booster from CSL Ltd., ending a seven-year ritual of monthly trips to a clinic to have rival products pumped into a vein.

“I like the fact that I can do it at home and I don't have to worry about taking time off work,” Ahrens said in a telephone interview while infusing Hizentra. “Sometimes I grade papers and sometimes I watch TV. I've cooked before.”

Doctors and analysts predict a surge in the number of U.S. patients switching to Hizentra in search of a more convenient option. Hizentra, the most advanced in the fastest-growing class of treatment for such ailments, may help CSL overtake Baxter International Inc.'s lead in the $5 billion global market for antibody-boosting drugs, or immunoglobulins, said Shane Storey, an analyst at Wilson HTM Ltd. in Brisbane.

“The dominance they might have there is really under- appreciated,” Storey, who rates Melbourne-based CSL “buy,” said in a telephone interview. He is the top-ranked analyst among 16 covering the company in the past year, according to data compiled by Bloomberg.

Market Lead

CSL, whose U.S. immunoglobulin market share of 29 percent trails Baxter's 33 percent, rose 1.2 percent to A$35.16 at the 4:10 p.m. close in Australian trading, the most since Nov. 11. The stock has advanced 8.2 percent this year, compared with a 12 percent drop for Deerfield-based Baxter.

Hizentra lets patients treat themselves at home with simple injections that take as little as 90 minutes once or twice a week, after basic training by a nurse. The shots don't require refrigeration, unlike rival products, and are given subcutaneously or just under the skin, typically in the stomach, thighs, upper arms or hips.

The medicine, which builds on research by Nobel Prize winner Emil von Behring more than a century ago, was approved in March in the U.S. for people such as Ahrens with primary immunodeficiency, a family of 150 mostly inherited disorders.

The Australian company became the first to sell subcutaneous immunoglobulins in the U.S., the world's largest drug market, when its Vivaglobin product was approved in 2006.

Severe Infection Risk

Without immunoglobulin, patients are at risk of severe recurrent infections, which can be fatal or cause complications such as chronic lung disease, meningitis or arthritis, said Hans Ochs, a professor of pediatrics at Seattle Children's Hospital, who has used such drugs since 1973.

Hizentra is designed to replace intravenous infusions such as Talecris Therapeutics Holdings Corp.'s Gamunex and Baxter's Gammagard that usually require patients to go to a clinic or hospital once a month for several hours each time. Ahrens said that process meant taking time off work and caused side effects she doesn't get with CSL's treatment.

“I was getting nauseous and light-headed, my veins were starting to hurt, and they were having a hard time finding a vein,” she said.

Each gram of Hizentra packs a higher concentration of antibodies than competing medicines, potentially reducing treatment times and costs. That will appeal to patients, doctors and insurers, said David Low, a health-care analyst at Deutsche Bank AG in Sydney.

Rival Products

Baxter awaits approval from the U.S. Food and Drug Administration for its subcutaneous immunoglobulin and is concluding a late-stage trial of another product that may let patients administer a monthly dose with one injection at home, Deborah Spak, a company spokeswoman, said in an e-mail.

Talecris, based in Research Triangle Park, North Carolina, received approval Oct. 13 for its subcutaneous product, Gamunex- C, which contains half the antibody concentration of Hizentra. It's the only immunoglobulin that offers both an intravenous and subcutaneous mode of administration so patients don't have to switch products if they want to change the way they receive it, Becky Levine, a Talecris spokeswoman, said in an e-mail.

Its lower concentration means it will take patients twice as long to infuse as Hizentra, said Lisa Kobrynski, an associate professor of pediatrics at Emory University in Atlanta, who has used immunoglobulin products to treat patients for 16 years.

‘Superior Product'

“Even as the competition is now arriving, CSL has a superior product,” Low said. “CSL's product superiority and recognition among patients that this is a more convenient treatment form means it will continue to grow.”

Hizentra sells for $74.12 a gram, according to FFF Enterprises Inc., a Temecula, California-based distributor. Ahrens said she uses 26 grams a week, translating to a cost of about $100,000 a year, according to Bloomberg calculations.

Prices of intravenous treatments range from $64.70 a gram for Carimune, a CSL product, to $90.35 a gram for Baxter's Gammagard, according to FFF.

Revenue from Hizentra and Vivaglobin, a less concentrated subcutaneous treatment, will expand about 20 percent annually for the next three to five years as volumes rise, Paul Perreault, executive vice president of worldwide commercial operations, said in a telephone interview.

Sales of both drugs jumped 35 percent to about $200 million in the year ended June, making them CSL's fastest growing product group, said Sharon McHale, a spokeswoman for the company. Total revenue fell 3.6 percent to A$4.46 billion ($4.4 billion) last fiscal year. Baxter's 2009 revenue was $12.6 billion.

Full Capacity

CSL currently makes Hizentra at a factory in Bern, Switzerland, that's running at full capacity, Perreault said. The company expects FDA approval by “mid to late summer” next year for Hizentra produced at a neighboring plant, based on a conservative timeline, he said.

The second plant will allow CSL to quadruple capacity for Hizentra and help boost earnings before interest, taxes, depreciation and amortization from blood therapies by 15 percent in five years, Wilson HTM's Storey said.

Even Levels

Weekly subcutaneous injections have fewer serious side effects and maintain antibodies at a more even level in the blood than the peaks and troughs associated with monthly intravenous infusions, Emory's Kobrynski said.

“Patients who've switched to subcutaneous infusions by and large love it,” she said in a telephone interview. The doctor said almost half her patients already use Vivaglobin and she plans on switching them to Hizentra.

Children and their parents usually prefer subcutaneous to intravenous treatment because it avoids the need to go to a hospital or clinic, which can be a “very traumatic experience,” according to Seattle Children's Hospital's Ochs.

Some people may prefer to stay on intravenous immunoglobulins, such as elderly patients who like having a nurse present, or those who are squeamish about injecting themselves, Kobrynski said.

Patients who moved to subcutaneous from intravenous treatments increased their antibody levels by an average of 5.4 percent after a year and used 28 percent less medicine, according to a study published in July in the Journal of Clinical Immunology.

“The difference I have seen in satisfaction is to be in charge and do it yourself at home, rather than have to dance to someone else's music,” Ochs said. “I'm a great supporter.”