Edwards Lifesciences Corp.’s growth ambitions go beyond a new type of replacement heart valve the company is developing.
Irvine-based Edwards, the market leader in valves implanted during open-heart surgery, is looking to stents and patient monitoring devices as part of its plan to top $1 billion in yearly sales this year.
Edwards, which spun off from Deerfield, Ill.-based Baxter International Inc. about five years ago, had $931 million in sales last year.
Stuart Foster, Edwards’ corporate vice president of discovery and technology, detailed the company’s strategy late last month at Roth Capital Partners LLC’s annual stock conference at the St. Regis Monarch Beach Resort & Spa in Dana Point.
“We have a clear strategy,heart valves, peripheral vascular disease and critical care,” Foster said. “We want to leverage our core competencies.”
A key push for Edwards is a new type of heart valve that’s inserted via a catheter. The company is conducting clinical trials for its Cribier-Edwards less-invasive valve.
Edwards received approval from the Food and Drug Administration for the trial late last month.
Getting approval and launching the trial “bodes well for the commercialization of this technology in the next three to four years,” wrote Jason Kroll, Roth’s medical device analyst, in a report issued last month after Edwards released its fourth-quarter and 2004 financial results.
“We believe this is a strong win for Edwards as the company has been involved in long discussions with the FDA over the design of the trial with much debate over its control arm,” Kroll said.
In the trial, patients who receive the less-invasive valves will be working against a control group receiving balloon valvuloplasty surgery, instead of traditional open-heart valve replacement surgery.
The control group “could have been difficult to enroll,” Kroll wrote.
Besides the less-invasive valve, Edwards is looking for growth from stents to treat diseases of the body’s peripheral blood vessels, Foster said.
The stents are designed to prop open arteries in the legs and arms.
“There’s room for Edwards,” Foster said. “It’s a $600 million business that’s growing at 15% a year.”
Peripheral vascular disease is under diagnosed and under treated, according to Foster. Some 10 million people in the U.S. have the disease, he said.
Edwards’ LifeStent should be in full production by the end of the quarter, Foster said.
Edwards also plans to launch FloTrac, a critical care patient monitoring system that can be used on more patients than traditional pulmonary artery catheters, Foster said. It’s due in the second quarter.
“In particular, we believe the FloTrac offers advantages in the clinical setting by being able to be connected by a nurse, not a physician, through an already established arterial line as well as offering continuous monitoring of a patient’s output,” Roth’s Kroll said in his report.
“By being less invasive, the FloTrac monitoring system permits the clinician to monitor patients that are in less critical conditions, which we believe expands the market considerably,” Kroll wrote.
Edwards projects sales of between $980 million and $1.02 billion this year. The company expects net income to grow 13% to 15% this year, according to Foster. Edwards had net income of $1.7 million in 2004.
Eventful Week for Spectrum
The last full week of February was a busy one for Irvine-based drug maker Spectrum Pharmaceuticals Inc. on several fronts.
Spectrum, which makes drugs to treat cancer, received a $750,000 equity investment from an entity affiliated with J.B. Chemicals & Pharmaceuticals, an Indian drug maker.
Spectrum said the money was triggered by FDA approval of its abbreviated new drug application for its ciprofloxacin drug last September.
Ciprofloxacin, an antibiotic, is the generic version of Bayer Corp.’s Cipro tablets. Sales of ciprofloxacin are under way through Lannett Co., Spectrum’s Philadelphia-based marketing and distribution partner for the drug in the U.S.
Spectrum also said it filed a pair of abbreviated new drug applications with the FDA. The applications cover a pair of eye care products. The first one is for an eye care drug that was filed on behalf of India’s FDC Ltd.
Lastly, Spectrum appointed new managers and promoted others. The appointments are: William Pedranti, vice president, general counsel; Guru Reddy, director, preclinical research; Dorla Mirejovsky, director, science and technology; and Van Huynh, manager, analytical development and support.
Promotions include Dr. Gino Lenaz, to chief scientific officer from president, oncology division; Ashok Gore, to senior vice president of pharmaceutical operations and regulatory compliance; Rosemarie Rosales to associate director, medical research; and Frederik Defesche to assistant director, pharmaceutical operations and regulatory affairs.
Bits and Pieces:
Blue Shield of California, which has more than 143,000 health plan enrollees in Orange County, said it was lowering the rates for its Medicare supplement plans by an average of 10% to 15% effective April 1 Randall and Sharon Radcliff opened a Rancho Santa Margartia location of AristoCare Home Health Services, a Tucson-based franchiser of senior care facilities.
