NoBlood

Jan B. Wade · #1 (**permalink**) 11-19-2003, 08:36 AM

Saturday, November 8, 2003

Anemia medicine Cera shows promise in study

Roche Holding AG's experimental Cera drug showed promise in boosting red blood cell counts for as long as three weeks in a study of anemic kidney patients, longer than currently available treatments.

Cera appeared to help when injected at varying doses every one, two or three weeks, according to the research on 61 subjects that will be presented at an American Society of Nephrology meeting Nov. 15 in San Diego. The drug is in the second of three phases of testing generally required by regulators for approval.

Roche's medicine would compete with Amgen Inc.'s Aranesp, a longer-lasting version of that company's Epogen medicine that's approved for use in kidney patients every two weeks. Aranesp, together with older forms of the medicine, is expected to generate $4 billion in sales this year.

"This study will put Cera on the radar screen," said Ivan Kugener, who manages $700 million in health-care stocks, including Roche shares, at Lombard Odier Darier Hentsch & Cie. "It confirms that Roche has a rich pipeline and a biotech pipeline."

Shares of Roche, based in Basel, Switzerland, rose 1.75 Swiss francs to 113.25 francs in Zurich. Shares of Thousand Oaks, California-based Amgen fell $1.18 to $59.95 as of 4 p.m., New York time, in Nasdaq Stock Market composite trading.

Cera is one of a class of treatments known as erythropoietins or EPOS, which are copies of a human protein that prompts the body to make red blood cells. The group includes Johnson & Johnson's Procrit, the No. 1 anemia drug for cancer patients, and Epogen.

NeoRecormon

Roche is developing Cera to replace NeoRecormon, which will lose European patent protection in 2005 and is not sold in the U.S. The drug was Roche's second-best-selling medicine during the first nine months of the year with 1.5 billion francs ($1.1 billion) in sales. Cera may pose a bigger threat to Amgen than Roche's older drug, if it enters the U.S. market, analysts said.

"If Cera can truly offer the opportunity for dosing intervals of up to three to four weeks, Roche's product would represent an innovation over both Amgen's Aranesp as well as its own NeoRecormon," analysts at UBS wrote in a note to investors.

Analysts at Pictet & Cie. estimate Cera may generate peak sales of 1 billion Swiss francs by 2008.

Amgen, the world's biggest biotechnology company, is testing less-frequent dosing of Aranesp and will present the results of a study that examined the efficacy of the medicine given just once a month in kidney patients at the meeting next week in San Diego.

Preliminary data from that study presented this year appeared to show that Aranesp was as effective when given monthly as it was when dosed every two weeks, said Amgen spokeswoman Kelly Stoddard.

While many people with failing kidneys develop anemia, the larger market has been treating people with cancer who develop the condition as a result of chemotherapy. UBS analysts estimate the current EPO market is worth $8.1 billion.

Anemia can be caused by a deficiency in iron or from cancer or cancer treatments. Severe anemia is most common in patients suffering from lung cancer, genitourinary cancer and lymphoma.