Ista Pharmaceuticals Inc., an Irvine drug maker, has struck a financing deal and is hopeful three key products could get regulatory approval within the next 12 to 18 months.
Late last month, Ista said three long-term shareholders agreed to provide it with up to $65 million worth of funding.
Deerfield Management, a New York-based healthcare investment fund, along with Sprout Group and Sanderling Ventures, two Bay Area firms, are providing the funding through a credit line.
Ista also paid off $40 million of its outstanding debt in conjunction with the deal.
The drug maker has been making “solid progress” on drugs under development, Chief Executive Vince Anido said.
Ista is set to file an application with the Food and Drug Administration for Bepreve, a drug to fight eye allergies, by the end of the year.
And the drug maker expects third-phase trial results for a once-daily formulation of its flagship Xibrom drug to treat cataract pain for an early 2009 regulatory filing.
It also is awaiting trial results to supplement another filing for the T-Pred steroid for treating inflammatory eye disease.
Anido called those drugs “three opportunities to build on our history of strong revenue growth.”
Ista topped last year’s Business Journal list of fast-growing public companies by revenue. It’s set to rank among the top on this year’s fast-growing list on Oct. 20 with sales growth of 1,227% for the three years through June 30. The company has yearly sales of about $68 million.
|
|
Xibrom: faces generic competition next year |
Ista’s revenue growth comes from Xibrom, Vitrase, a spreading agent for other drugs during cataract surgery, and Istalol, an eye drop to treat glaucoma.
The original version of Xibrom accounts for some 70% of Ista’s sales.
Analysts have said the drug maker needs to have a new version because the original could be subject to generic competition as early as 2009.
On the financing, Anido said the deal culminated five months of assessing Ista’s business and strategic options. The company sought to ensure that it could fund future growth while minimizing shareholder dilution, he said.
Getting the financing removed a cloud that’s been on the drug maker since April when disappointing clinical trial results for the once-daily Xibrom led investors to hammer its stock.
Ista also had to deal with an analyst’s warning in late July about the company possibly running out of money.
For the year, Ista shares are down more than 70% with a recent market value of about $50 million.
ICU Signs Buying Group Deal
ICU Medical Inc., a San Clemente device maker, has signed a five-year deal with North Carolina-based Premier Inc., a buyer of equipment and supplies for hospitals with an office in San Diego.
The deal calls for ICU to make its Clave and MicroClave needleless intravenous connector systems, custom intravenous sets and new “safe handling” oncology devices to Premier’s members.
ICU’s cancer products include Genie, a device that gets medicines out of their bottles safely, and Spiros, an intravenous connector that helps deliver chemotherapy drugs.
The company’s oncology products “do a tremendous job of protecting the healthcare worker, (who) we believe has been completely ignored all these years,” said Scott Lamb, ICU’s chief financial officer, in an earlier interview.
Premier buys for some 2,000 hospitals and more than 50,000 other healthcare providers.
The power of hospital buying groups was the subject of controversy involving another local medical device maker, Irvine-based Masimo Corp.
Earlier in the decade, buying groups came under the scrutiny of Congress after Masimo told of its struggles to get contracts with Premier and Novation LLC, a rival out of Irving, Texas. Masimo eventually signed deals with large groups.
Peregrine’s Nasdaq Reprieve
Peregrine Pharmaceuticals Inc., a Tustin drug developer, said late last month that Nasdaq officials granted it a request for a six-month extension for continued listing on the exchange.
The decision is subject to a requirement that on or before Jan. 20, Peregrine’s closing stock price has to be $1 or more for a minimum of 10 prior consecutive trading days.
Last week, Peregrine’s shares were trading at about 35 cents with a market value of $80 million.
Peregrine said Nasdaq made its decision after a hearing about the drug maker’s plan to regain and sustain compliance with Nasdaq’s minimum bid price requirement.
The plan includes a bid to get approval for a reverse stock split at the company’s Oct. 21 shareholder meeting.
