Israeli drug maker Teva Pharmaceutical Industries Ltd. said last month it plans to stop making a sedative that came under scrutiny by regulators for production issues at its Irvine plant.
Teva said it will stop making propofol, which is used during surgery and was made until earlier this year in Irvine.
Propofol gained notoriety in the death of Michael Jackson last summer.
Teva recalled some propofol last year after high levels of toxins were found at its Irvine plant. The Food and Drug Administration found “significant” manufacturing violations at the plant.
The company said its data show the drug to be safe and effective when used properly and plans to quit making it for business reasons.
Denise Bradley, a Teva spokeswoman, told the Associated Press that propofol is hard to make and that the company gets little or no profit from it.
In addition, Teva is facing some 250 lawsuits connected to the drug, including some connected to a hepatitis C outbreak in 2008 that infected as many as 114 people.
There has been a shortage of propofol since last fall, according to the FDA.
Manufacturing problems forced Teva and Hospira Inc., a suburban Chicago drug and device maker, to suspend making propofol and recall some of their versions of the drug.
Teva, whose U.S. headquarters is in a suburb of Philadelphia, hasn’t made propofol since mid-April, but is planning to sell its remaining supply.
Hospira said it can’t resume selling propofol until the FDA approves changes to its manufacturing procedures.
Teva came to Orange County through its late 2003 buy of Irvine-based Sicor Inc., a generic drug maker.
Smile Officially Drops IPO
A jittery market for initial public offerings killed an OC healthcare services company’s plans.
Santa Ana-based Smile Brands Group Inc. officially withdrew plans to offer its stock late last month.
Smile, a provider of services for dentists that operates Bright Now Dental and other brands had been looking to raise $130 million after expenses in its offering.
Smile said in a Securities and Exchange Commission filing that it was withdrawing the offering “in light of general market conditions.”
Smile first postponed plans for its offering in early May, amid volatility on Wall Street.
A Reuters report citing an undisclosed underwriter indicated that Smile would drop plans for an offering after its shares were likely to price below what the company expected. Smile was set to price at $14 a share, below an expected range of $16 to $18, according to Reuters.
Smile, which has annual revenue of about $455 million, had stood to be the biggest local public offering since 2007, when Mission Viejo-based nursing home operator Ensign Group Inc. went public and raised $64 million.
Smile had planned to sell 7.35 million shares and use proceeds from the offering to pay loans.
The company provides support services to more than 1,100 dentists and hygienists in 300 offices.
Freeman Spogli & Co., a Los Angeles-based private equity firm, is Smile Brands’ majority shareholder. Other investors include the California State Teachers’ Retirement System.
Sapien Valve’s Survival Rate
Edwards Lifesciences Corp., an Irvine heart valve maker, said that its Sapien transcatheter heart valve demonstrated positive one-year mortality rates in a post-market study.
Data presented at EuroPCR, an industry conference in Paris, showed an 81% one-year survival rate in patients who received their valves through an artery in the leg, and a 72.1% survival rate in patients whose valves were delivered via a small incision in the ribs.
Separately, Edwards said it received European Union clearance for a Sapien valve that’s designed to treat children and adults who suffer from a congenital heart disease.
In the U.S., the Sapien pulmonic valve is a device that’s being studied in a clinical trial to assess its safety, Edwards said.
The device maker said it’s completed a feasibility study of that valve and is progressing into the clinical trial’s pivotal portion with the goal of receiving a “humanitarian device exemption” from the Food and Drug Administration.
