Irvine-based Ista Pharmaceuticals Inc. is getting closer to rolling out an eye allergy drug.
A Food and Drug Administration advisory panel unanimously cleared Ista’s Bepreve drug candidate for treating eye itchiness caused by allergies.
Ista shares, which had a recent market value of about $140 million, got a boost on the news late last month. The FDA generally approves drugs recommended by its advisory panels. A final decision is due in September.
Some analysts have said that Bepreve could account for about $12 million in sales for Ista in 2010 if it’s approved. Ista hasn’t given guidance for 2010. Analysts project its sales will come in at $124 million next year.
Before the panel’s decision, FDA reviewers said Bepreve didn’t cause serious safety problems in clinical trials.
The drug’s safety could be a key selling point for Ista, as many allergy drugs can cause drowsiness, dry mouth and other side effects.
The most frequent side effect for Bepreve study participants was a mild, fleeting change in taste. About 25% of participants reported the side effect.
Ista acquired the rights to Bepreve in 2006 from Senju Pharmaceutical Co., a Japanese drug maker.
Last month, Bepreve and other parts of Ista’s drug development pipeline got a favorable review on the Seeking Alpha investor Web site.
Bepreve could be a major catalyst for Ista, based on the U.S. eye allergy drug market, which is more than $600 million yearly, according to author Dan Weiss.
“Based on strong clinical results and the existence of the product in Japan without major safety issues, the odds of an approval appear to be very high,” Weiss said.
Weiss touted several other Ista products that are being developed, including a once-daily version of its flagship Xibrom drug for treating pain after cataract surgery, and T-Pred, a topical anti-inflammatory drug. Both I-Pred and the daily version of Xibrom are in third-phase clinical trials.
Weiss predicted Ista would be operationally profitable in the late part of this year and post a net profit in 2010. He said Ista “looks very attractive for speculative investors.”
But Weiss also noted that “as with all younger biotechnology and pharmaceutical companies, there are significant risks inherent” with Ista.
Those include its $104 million of long-term debt, along with a history of operating losses and regulatory uncertainty, Weiss said.
Separately, Ista said it added two positions to its executive team: Brian Drazba as vice president of finance and chief accounting officer, and Glenn Davis as vice president of legal and chief compliance officer. Drazba most recently was senior vice president and chief accounting officer at Lake Forest-based Insight Health Services Holdings Corp.
Davis’ background includes serving as general counsel for several divisions of Allergan Inc., an Irvine drug maker.
Skilled Restatement
Foothill Ranch-based nursing home operator Skilled Healthcare Group Inc. said last week it wrapped up a restatement of more than three years of financial statements with a charge to past earnings of $8.4 million.
The charge was in line with Skilled’s guidance when it announced the restatement in early June.
The company’s shares fell about 20% in the weeks after the initial announcement. They gained about 7% last week on final word of the restatement with a market value of about $275 million.
Skilled restated results from Jan. 1, 2006, through March 31 of this year because it understated reserves for accounts receivables.
It blamed the error on a former employee “who acted in a manner inconsistent with the company’s accounting and disclosure policies and practices.”
The restatement prompted Skilled to lower its profit outlook for the year.
Skilled now sees earnings of $38 million to $40 million, down from an earlier forecast of $40 million to $42.5 million.
Alabama Medicaid Wars
Watson Pharmaceuticals Inc., a prescription and generic drug maker based just over the county line in Corona, and some 70 other drug makers are facing a big headache: a lawsuit filed by the state of Alabama over Medicaid pricing.
Late last month, lawyers for Alabama and Watson questioned about 50 potential jurors who could hear the Medicaid drug pricing lawsuit.
Alabama Attorney General Troy King sued the drug makers in 2005 for allegedly causing the state’s Medicaid program to pay too much for prescription drugs. Watson’s prescription lineup includes OxyContin, a controversial pain reliever, and Rapaflo, a drug that relieves male urinary problems caused by an enlarged prostate.
Allen Chao, Watson’s cofounder, lives in Anaheim Hills. Chao stepped down as Watson’s chairman at the end of 2008.
Chao and his family are noted for their philanthropy,the Chao Family Comprehensive Cancer Center at the University of California, Irvine, bears their name.
Alabama, meanwhile, already has settled drug pricing lawsuits against 16 other companies for a total of $124 million. Those suits included one against Chicago-based Abbott Laboratories, parent company of Santa Ana-based eye device and contact lens maker Abbott Medical Optics Inc.
Alabama also has had four lawsuits against drug makers go to trial, with the state winning judgment against each of those companies totaling $352 million. Defendants in those trials are appealing.
Bits and Pieces:
B. Braun Medical Inc., a unit of Germany’s B. Braun Melsungen AG that has a large operation in Irvine, recently had three of its medical devices recognized by Medical Device and Diagnostic Industry, a trade publication. Those devices include the Excel and PAB IV containers, which are made in Orange County Irvine drug developer Cortex Pharmaceuticals Inc. said that a paper published in Anesthesiology, an industry journal, showed that its Ampakine CX717 compound helped protect against respiratory depression and sleep apnea in rats InstaMed Inc., a healthcare payment processing company with offices in Newport Beach and Philadelphia, said its software platform and network received certification from the Council for Affordable Quality Healthcare’s committee on operating rules for information exchange Hoag Memorial Hospital Presbyterian in Newport Beach said it opened a center to care for voice and swallowing disorders Discovery Practice Management, a Los Alamitos company that operates eating disorder treatment programs for teenagers, said it opened a location in Seattle.
