Ista Pharmaceuticals Inc., an Irvine drug developer, is known for eye treatments.
Now it’s moving toward fighting nasal allergies.
Ista soon plans to start clinical trials for a nasal formulation of bepotastine, a drug candidate that’s now being looked at to fight allergic swelling and redness in the eye.
The company plans to report final third-phase results for the eye drug, called Bepreve, within the next three months and plans to have it on the market in 2009.
Ista Chief Executive Vince Anido is optimistic about expanding beyond eye drugs.
“As we look out over the next five years or more, we think that somewhere around 40% to 50% of our revenue may come outside eye care,” he said.
Ista had $59 million in revenue in 2007.
Xibrom, which treats pain after cataract surgery, accounts for more than 70% of the company’s sales.
Anido flew to Philadelphia earlier this month to introduce Ista to attendees at the American Academy of Allergy, Asthma and Immunology’s annual meeting.
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Ista researcher: company saw setback with Xibrom QD, planning new clinical trial |
During that convention, Anido met with some 20 allergists to begin working on planning a nasal clinical trial.
A challenge is making sure a nasal spray doesn’t have any aftertaste, Anido said.
“One of the first things you do on the formulation side is to make sure you mask that taste as much as possible,” he said.
Making sure there’s no aftertaste, according to Anido, will help patients accept and ask for the drug.
Ista acquired the U.S. rights to nasal bepotastine in September for $2 million from Japan’s Tanabe Seiyaku Co.
At the time it got the nasal rights, Ista said that clinical trials for the eye formulation of bepotastine suggested the drug could improve nasal allergy symptoms.
In early March, shares of Ista slumped more than 20% after the company hit regulatory snags with a new version of flagship Xibrom.
Ista had a market value of about $70 million last week.
The company pulled a drug application for Xibrom QD, a new formulation of the eye pain relief drug.
Ista is now planning a new clinical trial for Xibrom QD.
I-Flow Improves
After posting improved fourth-quarter results earlier this month, Lake Forest-based I-Flow Corp. got a positive review from Lazard Capital Markets.
Lazard medical technology associate analyst Assaf Guterman maintained a “buy” rating on the device maker and said he saw several potential near-term catalysts, including what he called reaching permanent profitability.
“We expect the company to turn profitable in (the first half),” Guterman wrote in a research note. “(Permanent) profitability appears imminent.”
I-Flow’s “minimal” fourth-quarter operating loss of $21,000, which was adjusted for an impairment charge relating to its sale of subsidiary InfuSystem Corp., “suggests a high likelihood that I-Flow could turn profitable” as soon as this year’s first half, Guterman said.
I-Flow’s fourth-quarter results were mainly affected by a one-time gain of $45.4 million from its sale of InfuSystem to HAPC Inc. in October for $100 million.
With the gain, I-Flow posted a net profit of $40.4 million in the quarter, compared to $135,000 in 2006’s fourth quarter.
Consumer Plans Growing
Workers in Orange County and throughout Southern California haven’t necessarily gone for consumer-directed health plans.
But that doesn’t appear to be the case in the rest of the country, a trade group contends.
A study done for the American Association of Preferred Provider Associations by Mercer Human Resources Consulting shows that 12.5 million Americans enrolled in consumer-directed health plans in 2007, a 25% rise from 2006.
Consumer-directed plans, also known as “consumer-driven” plans, have been touted for several reasons as an answer to rising healthcare costs.
They usually combine a medical savings account, where members can use pre-tax money to pay for health services, along with a high-deductible health insurance plan for catastrophic illnesses.
The health insurance plans in consumer- directed healthcare often follow the preferred-provider association model, which usually is marked by a wider network and more flexibility in doctor access.
Proponents of consumer-directed plans say they can help control costs by making participants more aware of what they’re paying for.
Opponents say that those plans can lead to “cherry picking” of healthier people, leaving traditional health insurance plans with a sicker, costlier group of members.
In Southern California, anecdotal evidence suggests that consumer-driven healthcare hasn’t necessarily caught on.
Reasons for that include competitive pricing among health maintenance organizations as well as HMOs’ historic entrenchment in the region.
Bits and Pieces:
Zeev Kain, a Yale University anesthesiologist known for his efforts in helping children through stress and pain of surgery, is the new chair of the University of California, Irvine’s anesthesiology department. Kain also will serve as UC Irvine’s Medical Center’s chief anesthesiologist and associate dean for clinical research at UCI’s School of Medicine PrimeGen Biotech LLC of Irvine and Unidym Inc., a subsidiary of Pasadena-based Arrowhead Research Corp., are working together to find new ways of using carbon nanotubes in stem cell medicine. PrimeGen specializes in what are called “pluripotent” stem cells, which are derived from adult tissues, such as skin Cortex Pharmaceuticals Inc., an Irvine drug developer, said the German Federal Institute for Drugs and Medical Devices approved its request to start two clinical studies for its Ampakine CX717 drug candidate. Cortex has had several issues with CX717 in the U.S., including a FDA regulatory setback in October.
