Allergan Inc. is seeing its flagship Botox make headlines again.
The company’s shares fell recently on news that the Food and Drug Administration is reviewing the safety of the main ingredient of Botox in the wake of deaths and injuries that some think could be related to the drug.
But analysts and market watchers are upbeat about Allergan because the review isn’t targeting Botox’s cosmetic use.
The review shouldn’t hurt sales of Botox Cosmetic, which has a clean safety record, said Jefferies & Co. analyst Peter Bye said.
The FDA is focusing on the use of Botox for medical purposes, Allergan said.
The review is related to high doses of Botox for managing juvenile cerebral palsy, according to Allergan. The company is working with the FDA to “ensure that it has all of the information necessary to make an informed and reasonable judgment.”
Regulators also are looking at Myobloc, a similar product put out by Solstice Neurosciences Inc. of San Francisco.
Allergan praised some of the regulators’ actions, including a teleconference “in which it provided helpful clarification and context, explaining that this review involves only ‘a relative handful of serious adverse events.'”
The use of Botox to treat juvenile cerebral palsy is approved in some 60 countries and has been used by doctors in this country for more than a decade. But it’s not officially approved here as a cerebral palsy treatment.
Once a drug is approved for any use, doctors can use it as they see fit. Botox originally was approved to treat muscle spasms but was widely used to smooth wrinkles before it was officially approved as a cosmetic treatment a few years back.
Earlier this decade, Allergan had to deal with fallout from news stories about Botox.
There was an unsuccessful lawsuit by a Hollywood wife against her doctor and Allergan. Then in Florida, four people were injected with a rogue formulation of the toxin that makes up Botox.
Allergan is taking a page from those incidents in how it responds to the FDA’s safety probe.
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Botox Cosmetic: not subject of FDA review |
Back then, Allergan stressed that Botox had more than a decade of safety data behind it. In Florida, Allergan stressed how Botox wasn’t involved and tried to downplay media reports of “fake Botox.”
The company took part in the Florida investigation with an eye toward patient health and safety, said Douglas Ingram, the company’s executive vice president and general counsel, in a 2005 interview.
Grubb Buys Medical Offices
Grubb & Ellis Co., which is based in Santa Ana, said it acquired five medical office buildings in Florida and Kansas. Terms weren’t disclosed.
The five buildings total some 162,000 square feet. Grubb & Ellis, in a release, said the buildings are on the campuses of or affiliated with Hospital Corporation of America, a Brentwood, Tenn.-based for-profit hospital chain.
The buildings are in Overland Park, Kan., and Largo, Brandon and Lakeland, Fla.
Grubb & Ellis’ healthcare investment arm previously was known as NNN Healthcare REIT. It changed its name after Santa Ana-based NNN Realty Advisors Inc., parent of Triple Net Properties LLC, acquired Grubb & Ellis last year.
Avanir Narrows Loss
Avanir Pharmaceuticals Inc., an Aliso Viejo-based drug maker, posted a narrower net loss in the December quarter and also updated its progress on its Zenvia drug candidate.
Avanir said it lost $5.5 million compared with a loss of $13.6 million in the year-ago quarter. The company had revenue of $2.1 million in the quarter.
Avanir expects to announce “top-line” results next quarter for a study on Zenvia for relieving nerve pain in people with diabetes, said Randall Kaye, the company’s chief medical officer, in a release.
Additionally, Kaye said that Avanir was gaining momentum in a trial that will look at Zenvia for treating involuntary emotional expression disorder, which is marked by uncontrollable laughing or crying, and remains on track to report data in the second half of 2009.
Bits and Pieces:
Bristol Newport Medical LP sold the 7,015-square-foot second floor of Bristol Newport Medical Plaza in Costa Mesa to physician Sarbpaul Bhalla for $3.8 million, or $546 per square foot. David Bolt, Chris Bates, Pat Scruggs and Gary Stache of CB Richard Ellis Group Inc.’s Newport Beach office represented Bristol Newport Medical LP Cerritos-based Millennium Dental Technologies Inc. reported that a laser-assisted procedure it developed was effective in treating gum disease.
