* Zerenex meets goals of Phase III study
* 6 gram dose reduces serum phosphorus 25 percent
* 8 gram dose demonstrates 28.8 percent reduction
* Shares up more than 5 pct after initial 10 pct rise
(Adds analyst comment, background, share price)
By Bill Berkrot
NEW YORK, Nov 30 An experimental drug being
developed by Keryx Biopharmaceuticals Inc (KERX.O) to lower
abnormally high levels of phosphate in the blood of patients
with advanced kidney disease met its goals in a late-stage
clinical trial, the company said.
Keryx released the positive top-line data from a
146-patient, short-term Phase III study of its Zerenex
phosphate binder on Tuesday, saying the drug produced highly
statistically significant results at the two highest doses
tested. Its shares rose as much as 10 percent after the news.
End-stage kidney patients on dialysis who received 6 grams
of Zerenex per day saw their serum phosphorus levels drop 25
percent after 28 days to 5.7 milligrams per deciliter from 7.6
mg/dl. Patients who received 8 grams per day of Zerenex
experienced a nearly 29 percent drop to 5.3 mg/dl from 7.5
A dose of 1 gram per day failed to reduce serum phosphorus
levels, according to the data.
"We are excited by the Zerenex efficacy data and believe
that the product's profile continues to strengthen in its
potential ability to take market share from the market leading
products," Genzyme Corp's GENZ.O Renagel and Renvela, Roth
Capital Partners analyst Joseph Pantginis said in a research
Phosphate binder sales exceeded $1 billion worldwide in
2009 with more than $700 million coming from U.S. sales.
Pantginis raised his price target on Keryx shares to $10
from $7 and, based on the data, increased his view on the
likelihood of Zerenex approval to 65 percent from 35 percent.
The drug, an oral ferric iron-based phosphate binder, was
given via a one gram caplet formulation, so 6 gram patients
took six pills a day and 8 gram patients took 8 pills a day,
the company said.
"Based on the results of this Phase 3 study, it appears
that the Zerenex efficacy and safety profile is emerging in a
way that could make it the phosphate binder of choice for
dialysis patients," Dr. Julia Lewis, chairwoman of the Zerenex
Phase III study program, said in a statement.
"We are very excited to have taken this big step forward
towards bringing Zerenex to the patients who are in need of
additional alternatives to the existing phosphate binders,"
added Lewis, professor of medicine, Department of Nephrology,
at Vanderbilt University School of Medicine.
The drug appeared to be safe and well tolerated, with nine
patients -- 6 percent -- dropping out of the study, the company
No clinically meaningful change in serum calcium was seen,
but a dose-related reduction in calcium-phosphorus was observed
in the study, the company said.
Elevated levels of serum calcium and high levels of
calcium-phosphorus product, both of which are believed to be
drawbacks associated with some currently marketed phosphate
binders, increase the risk of soft tissue calcification and may
contribute to serious health problems and death in patients
with end-stage kidney disease.
Keryx is currently enrolling patients in a longer-term,
58-week Phase III study of the safety and efficacy of Zerenex
that will be used in seeking U.S. approval to sell the drug,
the company said. Keryx expects to be able file to seek U.S.
approval in the first half of 2012.
Keryx shares were up 29 cents, or 5.4 percent, at $5.65 in
afternoon trading on Nasdaq after rising as high as $5.91
earlier in the day.
(Editing by Steve Orlofsky; editing by Andre Grenon)