Allergan Inc.’s plan to market Botox for migraines got a boost this month, thanks to some favorable second-phase clinical trial results.
The Irvine drug maker said it reached a deal with the Food and Drug Administration to start a large third-phase trial to look at the safety and effectiveness of Botox for people who suffer from chronic daily migraines or other headaches that hit 16 or more days each month.
Allergan’s announcement came in the wake of a study published in Headache, a medical journal, which showed that Botox, when compared to a placebo, reduced headache attacks in migraine patients who have chronic daily headaches.
Botox isn’t yet approved for any sort of headache disorder.
Last year, its “off label” use,or prescription by a doctor to treat something other than what it is approved for,was the subject of a sensational lawsuit against Allergan and Dr. Arnold Klein, a celebrity doctor and Allergan consultant.
Botox is approved for reducing wrinkles and treating severe underarm sweating and neck spasms.
IntraLase’s Eventful April
It’s been quite a month for IntraLase Corp., the Irvine-based maker of lasers for eye surgery.
In the first week of April, more than 1.2 million IntraLase shares,a massive jump from the 28,900 volume of the prior day,traded. Most of it was selling: The stock dropped more than $2 to $15.
IntraLase isn’t exactly sure what happened. But Shelley Thunen, the company’s chief financial officer, said the drop could have come with the expiration of the six-month lockup period after IntraLase’s initial public offering last year.
“When you go public, the shares that were already issued pre-IPO are not permitted to be sold,” she said. “When the volume goes up and there are more holders selling, it’s not atypical to see the stock down.”
Separately, IntraLase said that a federal judge granted its request for a temporary restraining order that keeps Escalon Medical Corp., a Wayne, Pa.-based company, from taking any action to end its licensing deal with IntraLase.
Escalon licensed its laser-related intellectual property to IntraLase in 1997.
Last June, Escalon said it was quitting its licensing pact with IntraLase “due to deficiencies in the payment in certain royalties that (Escalon) believes are due under the license agreement.” That set off a series of court actions.
In another IntraLase item, the company said on its Web site that Franklin Jepson, director of investor relations, died March 30.
Jepson, who was 58, joined IntraLase last July and was responsible for establishing the device maker’s internal and external communications prior to its October offering.
Jepson’s career also included 16 years at Bausch & Lomb Inc., the Rochester, N.Y.-based eye care company. He left behind his wife Kendra and three children.
More Money for SkinMedica
SkinMedica Inc., a drug maker just south of the county line in Carlsbad, closed a $15 million round of financing earlier this month. The funding was a private placement of preferred stock.
Domain Associates LLC, a venture capital firm with offices in Laguna Niguel and Princeton, N.J., was one of SkinMedica’s returning investors in the round.
EuclidSR Partners of New York, a new investor, led the round. As part of the investment, Graham D.S. Anderson, a general partner at EuclidSR Partners, is joining SkinMedica’s board.
SkinMedica markets prescription drugs and “cosmeceuticals”,skin care products sold through a doctor’s office. Its products include Vaniqa, a drug designed to slow the growth of unwanted facial hair in women.
SkinMedica has some OC ties. Chief Executive Rex Bright formerly was president of Allergan’s dermatology division. Dr. Richard Fitzpatrick, the company’s founder and a board member, also worked at Allergan when it was part of SmithKline Beecham PLC.
Talking Stem Cell Research
The Orange County Technology Action Network, OCTANe for short, is presenting “Stem Cells: a State of the Industry Snapshot” as part of its innovation series. The April 27 event is set for the University Club in Irvine.
Speakers include: Susan Bryant, dean of biological sciences at the University of California, Irvine, and member of the Proposition 71 independent citizens oversight committee; Hans Keirstead, a UCI associate professor with the Reeve-Irvine Research Center and the department of anatomy and neurobiology; and Francisco Silva and Steve Gershick of PrimeGen Biotech LLC, an Irvine-based company working on ways to regenerate the potency of adult stem cells.
Information and registration: (949) 824-3425.
Bits and Pieces:
Ista Pharmaceuticals Inc., Irvine, filed an investigational new drug application with the Food and Drug Administration to conduct a secondary clinical trial of ecabet sodium, a prescription drop medication to treat dry eyes UCI’s School of Medicine said its Program in Medical Education for the Latino Community received a $1 million grant from the UniHealth Foundation, which supports activities that improve the health of people in Orange and Los Angeles counties. The program, started last year, combines medical school training focused on Latino health issues with post-graduate work in environmental health, science and policy.
