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Allergan Ramps Up Eye Implant After FDA Approval

Eye drugs are a longtime staple of Irvine? Allergan Inc., and the company? arsenal is about to pick up a new weapon in the coming weeks.

The Food and Drug Administration has cleared Allergan? Ozurdex implant for treating a retinal, or back-of-the-eye, disease.

Ozurdex is a biodegradable polymer that? placed in the back of a patient? eye and releases dexamethasone, an anti-inflammatory drug. The product will be used to treat a swelling condition that is caused by leaking or blocked retinal veins that threatens eyesight.

Allergan got Ozurdex in 2003 when it bought Oculex Pharmaceuticals Inc., a venture-backed startup eye drug maker from Sunnyvale, for $230 million.

Allergan plans to make Ozurdex available to doctors and patients in the third quarter. The company said that Ozurdex can be implanted in a patient? eye from a doctor? office, eliminating the need for a hospital visit.

Allergan had a relationship with Oculex that dated back to the beginning of the decade. It signed a licensing and research deal in 2001 to work on compounds for treating serious conditions affecting the retina and the back of the eye. That deal excluded the implant, which was then known as Posurdex.

Device Makers Could Tamp R & D;

A senior medical device research analyst with Newport Beach-based Roth Capital Partners LLC says that tough economic times may lead to near-term research and development cuts.

If the economy continues to weaken, device makers could cut their research and development expenditures in the near term in an effort to maintain profitability, analyst Matt Dolan told the Wall Street Transcript, an industry newsletter.

The research and development-related concerns echo some feedback Dolan? heard about medical device mergers and acquisitions, he said.

?anagement teams are saying, ?e are going to hold off on acquiring any technologies requiring a significant investment in R & D; until we can obtain better visibility into the market? outlook,? he said.

Roth believes that any perceived hesitancy for new technology investments by larger device makers and other buyers is affected by what Dolan said are ?wo major variables.?

They are: reduced hospital spending and its subsequent impact on companies that sell into hospitals.

?ospitals are facing the same level of financial uncertainty that the rest of the economy is experiencing, particularly when it comes to customer (patient) volumes and the debt markets that regulate near-term spending patterns,?Dolan said.

Hospitals?margins are starting to get tighter, driving down their spending ability, Dolan said.

?ompanies that sell big-ticket items into hospitals are under pressure right now, forcing management teams to be more cautious about investments back into R & D;,?Dolan told the Transcript.

In the long term, Dolan expects that ?nnovative medical technologies?will be able to find large, profitable opportunities to pursue and that research and development dollars will need to be spent in the next several years to drive growth for bigger market players.


Spectrum Gets $10M

Spectrum Pharmaceuticals Inc., an Irvine maker of cancer and other drugs, received $10 million from a pair of unidentified institutional investors earlier this month in a previously announced offering of 1.7 million shares of its stock.

Spectrum said it was going to use the proceeds for general corporate purposes.

Chief Executive Rajesh Shrotriya said he appreciates the investors?continued support as Spectrum awaits an upcoming regulatory deadline for Zevalin, a well-traveled chemo-therapy drug that the company is attempting to revive.


Bits and Pieces:

Tustin drug developer Peregrine Pharmaceuticals Inc. reported earlier this month what it called ?ositive early data?from three clinical trials for its bavituximab cancer drug candidate. Peregrine is studying bavituximab in combination with docetaxel, another chemotherapy drug, in advanced breast and lung cancers ?Clarient Inc., an Aliso Viejo provider of cancer testing services, launched a gene mutation test that will help doctors select therapies for non-small-cell lung cancers ?ChromaDex Corp., an Irvine-based maker of research tools for dietary supplements and the food and beverage industries, said it received a $100,000 grant from the National Science Foundation that it will use to develop plant-based oxidants for commercial use in drugs, medically beneficial food, natural chemicals and cosmetics.

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