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Valeant Stops Hep B Trial, Analyst Keeps ‘Hold’ Rating

One Wall Street analyst is keeping a “hold” rating on Aliso Viejo-based Valeant Pharmaceuticals International.

Megan Murphy of Lazard Capital Markets issued a note earlier this month maintaining a “hold” rating on Valeant after the drug maker said it stopped giving its pradefovir hepatitis B treatment to patients.

The drug maker decided to stop giving the treatment to patients in an extension clinical study as a precautionary measure at the request of Schering-Plough Corp. The request stemmed from results of a two-year oral carcinogenicity study that Schering-Plough did on laboratory mice and rats.

The study showed that the number of rats and mice with tumors increased in animals that had the highest dose levels of the drug, and slightly increased at intermediate dose levels.

Valeant licensed development and commercialization rights for pradefovir to Schering-Plough in January for $19.2 million. Schering-Plough is working with San Diego-based Metabasis Therapeutics Inc. on the hepatitis B drug project.

Valeant originally licensed pradefovir from Metabasis in 2000.

Murphy said that pradefovir represented about $1.70 of her current valuation of $18 to $20 for the drug maker’s shares.

“We have not removed the asset from our fair value, but we could see greater risk to its viability, and the competitiveness of the class could weigh on any decisions regarding its future,” Murphy wrote.

She said her projection for pradefovir called for a 2010 launch.

Murphy also touched on a couple of Valeant’s other candidates, retigabine for epilepsy and viramidine for hepatitis C. Those drugs could be candidates between now and the end of 2007 for either a licensing or partnering deal with other companies, she said.

Stock catalysts included second-phase data for viramidine, whose progress has concerned some investors and analysts, due in the fourth quarter, along with a pair of clinical studies for retigabine, Murphy wrote.


Stem Cell Update

Hans Keirstead, co-director of the University of California, Irvine’s Sue and Bill Gross Stem Cell Research Center, and his colleagues earlier this month launched a project designed to develop stem cell lines that genetically match human patients.

The lines would allow scientists to better study a range of conditions, ranging from diabetes to Parkinson’s disease, according to UCI. They also would provide a basis for potential patient-specific stem cell treatments for those conditions, UCI said in a release.

Stem cells are the master cells that give rise to each specialized cell in the body. During organ and tissue development, stem cells transform into particular specialized cells, such as those in the heart or liver, when prompted either by environment, such as an embryo, or internal genetic programs.

If researchers are able to succeed in controlling the processes that direct stem cell transformation, it’s believed that stem cells can be used as a source of healthy replacement cells for diseased or injured tissue.

The project goes like this: A patient’s DNA is going to be transplanted into a donated unfertilized egg cell in order to generate stem cells that match the patient.


ICU Diversifies

George Lopez, the founder and chief executive of San Clemente-based ICU Medical Inc., has famously argued that diversification doesn’t necessarily help a company.

A twist: ICU has made some efforts to add products to its core Clave needle-less intravenous connection device. The latest example came earlier this month, when it acquired SimpleChoice, a line of insulin pump products, from Norcross, Ga.-based SpectRx Inc. Terms of the deal weren’t disclosed.

SpectRx products are used with insulin pumps worn by diabetics to help control their glucose levels. SpectRx, in a statement, said that it was selling SimpleChoice in order to focus on bringing its non-invasive cervical cancer detection technology to market.


ClinPhone Expands

ClinPhone, a British company that provides technology for drug makers conducting clinical trials, has doubled its space in the University Research Park near the University of California, Irvine, campus. ClinPhone signed a five-year lease for 22,000 square feet of space in the 101 Academy Drive building. Terms of lease weren’t disclosed.

ClinPhone needed the space because it bought DataLabs Inc.,an Irvine medical software company that received early backing from Merck & Co.,in October for some $69 million.

DataLabs previously occupied 10,200 square feet of space in the complex. The company makes software for drug trials.


Bits and Pieces:

CoreValve Inc., an Irvine medical device maker, said its less-invasive replacement heart valve system received European Union approval. Even with that, CoreValve said it didn’t immediately plan to market Percutaneous ReValving. Instead, it’s going to have an expanded clinical devaluation at a small number of study centers A. Thomas Bender, who is retiring later this year as chief executive of Lake Forest-based Cooper Cos. Inc., gave a presentation on the contact lens and women’s surgical instrument maker at a recent Citigroup healthcare conference Irvine drug maker Cortex Pharmaceuticals Inc. said a study was released that shows that its Ampakine drug candidate could be used to fight memory problems caused by Huntington’s disease, a neurological disorder. Separately, Cortex completed a patent licensing deal with the University of Alberta in Edmonton. The deal could broaden the use of Ampakine to prevent and treat opiate- and barbiturate-induced respiratory depression, Cortex said Patient Care Technology Systems, a Mission Viejo unit of Riviera Beach, Fla.-based Consulier Engineering Inc., said it’s working with Sonitor Technologies AS of Norway to jointly market software and devices to manage hospital workflow.

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