Botox Sales Decline
Sales of Botox declined almost 3% worldwide in the fourth quarter of 2008from $339 million to $329 million, reported Allergan Inc., and the company predicted a further decline. For all of last year, Botox (botulinum toxin type A) sales rose $99 million to $1.3 billion. But in the upcoming year, Allergan is forecasting sales of just $1.15 billion to $1.19 billion. Meanwhile, the first full year of sales of Allergan's eyelash-enhancing therapy Latisse (bimatoprost ophthalmic solution) should hit $30 million to $50 million, according to the company. Because overall sales of its products declined in 2008, Allergan announced that it would lay off 5% (460) of its employees. Cuts primarily will come from personnel in sales and marketing of urology products in the United States and Europe.
FDA Turns Down Skin Antibiotic
The Food and Drug Administration has notified Arpida Ltd. that its antibiotic iclaprim is not approvable without more clinical data. The agency said that the Switzerland-based company's new drug application didn't demonstrate that, against complicated skin and skin-structure infections, iclaprim was as effective as comparable products. "After the negative recommendation of the advisory committee of last November, the FDA opinion comes as no surprise," Arpida CEO Jurgen Raths said in a statement. The company will now "develop a viable road map to approval in close consultation with the FDA," Dr. Raths said.
Phase III Eczema Study Starts
The first phase III study of a therapy for chronic hand eczema has begun enrolling patients. Basilea Pharmaceutica AG, also Swiss based, said that its HANDEL (hand eczema research of alitretinoin) study will randomize 600 patients to oral alitretinoin or placebo for up to 24 weeks. There is currently no FDA-approved therapy for severe chronic hand eczema that's refractory to topical steroids. Alitretinoin is a vitamin A derivative and thus is a teratogen. In a statement, National Eczema Association CEO Vicki Kalabokes called the study's start "very exciting news."
Copayments Limit Phototherapy
Ninety percent of dermatologists surveyed by the National Psoriasis Foundation report that copayments for phototherapy are preventing or limiting patients from seeking the treatment. The foundation said that 192 dermatologists responded to its e-mail and fax survey, 61% of whom were in solo or group practices. Most reported seeing about 100 psoriasis patients a year. About 43% said they had seen a decrease in the number of psoriasis patients treated with phototherapy over the past 5 years. The most common reasons for discontinuing therapy included cost to the patient (31%), inconvenience (25%), and availability of a new treatment in a clinical trial (16%). Almost half of the doctors surveyed said they had problems getting reimbursed for phototherapy.
Thermage's New Look
Thermage Inc. has had a makeover to become Solta Medical. Having fully absorbed Reliant Technologies, the manufacturer of aesthetic medical devices began trading on the NASDAQ exchange as Solta in mid-January. The company makes radiofrequency devices and lasers for skin treatments. Soon after Solta's debut, CEO Stephen Fanning told the Wall Street Journal that the company would be shopping for other deals as the economy continues to decline. Included on his list of target product lines: wrinkle fillers.
Psoriasis Chats Are Helpful
A new study in the January Archives of Dermatology finds that on-line communities provide valuable education as well as psychological and social support to psoriasis patients. Researchers at Harvard Medical School, Boston, surveyed users of five frequently used psoriasis support sites sponsored by the National Psoriasis Foundation, the Psoriasis Help Organisation, the Google psoriasis group, the MSN Psoriasis Group, and the Psoriasis Philippine Online Community. Responses came from 260 people over age 18 years. The mean age was 40 years, and 75% were white, 60% were female, 44% were married, and 84% were college educated. The most popular activity on the sites was posting messages, which usually asked for or provided information to. Users were more than twice as likely as the general psoriasis population to have severe psoriasis, said the researchers. Most survey respondents said that the online groups had an improved quality of life, a lessened disease severity, and a widened support network.
FDA Approvals Increase
The FDA approved 21 new molecular entities and 4 new biologic drugs in 2008, compared with 17 new molecular entities and 2 biologics in 2007. Four of the 2008 approvals came in December. The agency has increased the annual number of novel therapies approved in recent years but is still failing to meet statutory deadlines for reviewing and approving products. The FDA said it did not meet the 2008 target of reviewing 90% of approval applications within the time limits. Many of the delays were attributable to resource constraints, the agency explained. FDA analyst Ira Loss of the firm Washington Analysis said the agency has hired 800 new people to review drug and biologic applications, which should help reduce delays by the second half of 2009.