Irvine Pharmaceutical Services Inc. makes prototypes for some of the biggest drug makers in the world from a modest, three-building operation here.
The Irvine-based company and its affiliate, Avrio Biopharma, are known as what’s called contract research organizations. They specialize in developing and manufacturing small lots of different versions of drugs that customers want to submit to the Food and Drug Administration.
Irvine Pharmaceutical is expecting increases in manufacturing.
“We have a manufacturing facility here that’s going to take off,” said Assad Kazeminy, Irvine Pharmaceutical’s chief executive and founder “We have a lot of interest, including a lot of Big Pharma.” The company anticipates sales of $30 million this year, Kazeminy said.
“I tell you, I can write a book about the last two years,” he said. “We had quite a lot of challenges but we stayed strong—we showed our people that we are committed to staying in business and doing well.”
Outsourcing helps Irvine Pharmaceutical and similar companies. The number of clinical trials that are outsourced could grow to 60% to 70% from a current level of 25%, according to Dow Jones News Services.
The drug industry niche is growing at a 15% rate annually and estimated to reach $27 billion this year, a recent report from San Antonio-based market researcher Frost & Sullivan shows.
Small Lots
All of Irvine Pharmaceutical’s manufacturing is done in small lots.
The company can make a number of versions of a drug. Clients decide which to submit to the FDA for approval.
Irvine Pharmaceutical says it works with 18 of the top 20 drug makers in the world, although “we don’t say which ones,” said Yvonne Verburgt, the company’s vice president of business development.
A fact sheet provided by the company cites Pfizer Inc. of New York, Indianapolis-based Eli Lilly & Co., and Chicago’s Abbott Laboratories as examples of the types of company it works with.
• Headquarters: Irvine
• Founded: 1988 as Irvine Analytical Laboratories; changed name in 2007
• Business: drug manufacturing with specialty in small-batch prototypes
• Yearly revenue: estimated $30 million
• Notable: Upswing driven by consolidation, outsourcing among Big Pharma; considering new plant here
Another graphic gives examples of eight of the top 10 “biotech companies,” it works with, a roster that includes Irvine-based drug maker Allergan Inc.
The company has a sales staff and works trade shows and scientific conferences for customers, Verburgt said. It stands apart from competitors with a depth of scientific leadership thanks to a staff of many with doctorate degrees and other researchers.
The company also touts its relatively small size as a selling point.
Irvine Pharmaceutical offers dedicated project and account management teams for individual customers, according to Verburgt.
Besides drug and device makers, Irvine Pharmaceutical does work for various regulatory bodies, including United States Pharmacopeia, an industry standard bearer, and the FDA.
Irvine Pharmaceutical has about 200 workers, all in Irvine.
It’s looking to stay independent.
“We’re not going to buy any company at this time (and) we’re not going to sell the company,” Kazeminy said.
A public offering could come to raise money to build a larger manufacturing operation, he said.
Irvine Pharmaceutical and competitors have seen the market expand in the past decade, as drug and device makers have sought to cut costs by farming out research.
A recent consolidation trend in Big Pharma also points to continued growth.
Competition
Large contract research organizations include Pharmaceutical Product Development Inc. of Wilmington, N.C., and Covance Inc. of Princeton, N.J.
Those companies also handle large production runs.
Earlier this year, Pharmaron Holding Ltd., an Irvine company with Chinese roots, raised $40 million in a third round of venture capital funding.
Pharmaron is using that money to expand its services, which include testing and drug production for drug makers.
Irvine Pharmaceutical was founded in 1988.
The company was once known as Irvine Analytical Laboratories. It changed its name in 2007 to reflect changes in its business.
