Allergan Inc. and a rival are playing a waiting game with the Food and Drug Administration over silicone breast implants.
Irvine-based Allergan,which entered the implant market through its $3.2 billion buy earlier this year of Inamed Corp.,and Mentor Corp. of Santa Barbara both are working to get silicone implants approved. CNN/Money recently did an article on the companies’ efforts.
Silicone implants have been banned since 1992. Regulators banned silicone for most American women 14 years ago because of growing alarm over ruptured implant shells and leaking gel. Only women who require reconstructive surgery after mastectomies have been allowed to use the implants.
For the larger cosmetic market, women have had to settle for saline-filled implants or get the work done overseas.
Regulators appear ready to give silicone gel implants the green light again. Allergan and Mentor each have received “approvable letters” from the FDA. The move is seen as a step toward final signoff.
Approval is “imminent,” SunTrust Robinson Humphrey analyst Amit Hazan said.
“The companies have been in discussions with the FDA (about) conditions for approval, and my impression is that the discussions are over, that the FDA has gotten everything it needs,” Hazan told CNN/Money.
Jose Haresco, an analyst with Merriman Curhan Ford & Co., a San Francisco-based investment bank with a Newport Beach office, wasn’t as certain that the FDA would clear silicone breast implants this year.
“Everybody said it’s going to happen in 2005, then everybody said it’s going to happen in the first half of 2006, and now everybody’s saying the second half of 2006,” he said. “But I doubt that they would rush this. I am not one of those voices saying it’s going to happen any day now. It’ll happen when it happens.”
Allergan and Mentor declined to tell CNN/Money about their dealings with the FDA or to provide sales estimates. It’s known that Allergan has submitted a more advanced style of breast implant with regulators that’s nicknamed “Gummy Bear” because it’s composed of a number of gel pieces that are clustered together like the rubbery candies.
Allergan and Mentor have included revenue from silicone implants in their sales forecasts, which Aaron Gal, an analyst with Sanford C. Bernstein, told CNN/Money was a sign that the companies believe they will have implants out within months.
Gal estimates that Allergan and Mentor each will have about $200 million in silicone implant sales in 2007, in addition to $140 million each in saline implant sales.
On Wall Street, analysts see Mentor as getting more of a boost because it is less diversified than Allergan, which also sells Botox, its bellwether neurotoxin for medical and cosmetic uses, and is developing Juv & #269;derm, a dermal filler for the lower part of the face that it picked up from the Inamed buy.
Allergan’s stock traded in the $112 range at recent check, giving it a recent market value of $17 billion.
Valeant Launches Cesamet Trial
Valeant Pharmaceuticals International, the Costa Mesa-based drug maker, just launched its Cesamet anti-vomiting drug in the U.S. Now the company wants to know how patients do with it.
Valeant said earlier this month it would explore “the patient benefit in using Cesamet to control chemotherapy-induced nausea and vomiting” and how it might affect such patients’ quality of life.
The trial will look at 40 patients who are receiving treatment for non-small cell lung cancer, breast cancer or colorectal cancer and who haven’t adequately responded to traditional treatments.
The FDA approved Cesamet to treat nausea associated with chemotherapy in May. Cesamet is a cannabinoid, or synthetic chemical based on tetrahydrocannabinol, the active ingredient in marijuana.
Valeant acquired Cesamet in 2004 from Eli Lilly & Co.
Kaiser Architect
Chong/Smith Group, a joint venture based in San Francisco, is the architect on Kaiser Permanente’s new hospital under construction in Irvine. Los Angeles-based CO Architects is working on site development. An Aug. 14 article on the center should have said that Taylor and Associates is an interior design consultant on the project.
Bits and Pieces:
Dr. Vivian Dickerson is the new medical director of women’s health programs and care at Hoag Memorial Hospital Presbyterian in Newport Beach. Dickerson most recently was clinical professor of obstetrics and gynecology at the University of California, Irvine School of Medicine Speaking of UC Irvine, the university said that Paolo Sassone-Corsi joined its faculty as distinguished professor and chair of pharmacology. Sassone-Corsi, who comes to UCI from the National Center for Scientific Research in Strasbourg, France, is responsible for several discoveries advancing molecular genetics IntraLase Corp. of Irvine said it was working with four eye centers, including UCI’s ophthalmology department, to provide access to laser corneal transplantation to patients who suffered vision loss from fusarium keratitis, an eye infection that was linked to contact lens solutions. IntraLase’s offer comes in advance of a planned U.S. rollout of the IntraLase FS technology next month Peregrine Pharmaceuticals Inc. of Tustin said data from an early stage clinical trial of bavituximab, a treatment for chronic hepatitis C, would be presented at the American Association for the Study of Liver Diseases’ annual meeting in October.
