Pfizer/Anacor Merger To Fuel Already Robust AD Pipeline
For years, there were few, if any, promising new treatments for atopic dermatitis (AD), but today the pipeline is robust, and a Pfizer-Anacor merger may help both of the companies’ pipeline candidates gain market share, GlobalData predicts.
Anacor’s lead pipeline candidate is crisaborole, and Pfizer is hoping to launch a topical form of Xeljanz, both treatments are for mild-to-moderate AD. Regeneron and Sanofi’s dupilumab for severe AD is set to launch in the second quarter of 2017.
Crisaborole will face some competition. Medimetriks, for example, has licensed a pipeline candidate from Otsuka and collaborated with Knight Therapeutics in order to strengthen its marketing potential.
Pfizer backing the launch of crisaborole across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, would substantially increase the available patient population for the drug, involving a further six million treatable patients by 2024, the report suggests. Crisaborole has also set itself apart from the competition with significant investment into proving its safety in pediatric patients, a largely underserved demographic.
While Anacor’s crisaborole will benefit from Pfizer in terms of marketing power, its release will subsequently pave the way for Pfizer to launch topical Xeljanz, the report states.
New Psoriasis Drug Taltz Shows Benefit Through 60 Weeks
Three new studies demonstrate the efficacy and safety of Eli Lilly’s Taltz (ixekizumab) through 60 weeks among patients with moderate-to-severe plaque psoriasis. The findings appear in the New England Journal of Medicine. In all three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3, Taltz responders through 12 weeks demonstrated high levels of skin clearance through 60 weeks.
“This group of studies show that patients on Taltz are able to achieve high levels of efficacy, and that the majority of patients are able to maintain or continue to improve their response with continued treatment through 60 weeks,” says study author Kenneth Gordon, MD professor of dermatology at Northwestern University Feinberg School of Medicine in Chicago.
All three studies evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks. All three studies also evaluated response rates with Taltz every four weeks through 60 weeks. In UNCOVER-1 and UNCOVER-2, patients treated with Taltz who achieved clinical response (static Physician’s Global Assessment score [sPGA] 0 or 1) at 12 weeks were re-randomized to receive Taltz (80 mg every four weeks) or placebo through 60 weeks. In UNCOVER-3, all patients completing 12 weeks continued the study receiving Taltz (80 mg every four weeks) through 60 weeks.
In all three studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index score (PASI) 75 and sPGA 0 or 1. In all three studies, sPGA and PASI were also assessed through 60 weeks.
In UNCOVER-1, Taltz given every two weeks was statistically superior to placebo, with high levels of clearance achieved at 12 weeks among patients treated with Taltz, the majority of whom achieved virtually clear (PASI 90) or completely clear skin (PASI 100, sPGA 0).
In UNCOVER-1 and UNCOVER-2, high levels of clearance also were achieved through 60 weeks among patients treated with Taltz every two weeks who achieved clinically meaningful response (sPGA 0 or 1) at 12 weeks, the majority of whom achieved virtually clear or completely clear skin through 60 weeks when treated with Taltz every four weeks.
In UNCOVER-3, high levels of clearance were achieved with Taltz given every four weeks through 60 weeks among patients initially treated with Taltz every two weeks.
Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred.
With David Wong, MD, PhD, CEO, DirectDerm, Palo Alto, CA
We check our cell phones 46 times per day.1
We text instead of call.
We spend tremendous personal and professional bandwidth taking selfies and other photos to post on Facebook, Instagram, or the social media site du jour.
With this as the cultural backdrop, the rise of telemedicine services—in particular, teledermatology—makes perfect sense. And when a national shortage of dermatologists and changes to the healthcare landscape, including an influx of hard-to-follow rules and regulations, are factored in, it becomes clear that we are reaching the teledermatology tipping point.
Teledermatology is convenient, efficient, increasingly reimbursable, and much less time-consuming for all comers, and it’s here to stay. There are currently about 200 telemedicine networks, with 3,500 service sites in the US, according to the American Telemedicine Association. More than half of all US hospitals now use some form of telemedicine.
1. Dermatology is the Telehealth Poster Child
“Dermatology is a predominantly visual-based specialty and because of access to current technology, we all have inexpensive devices such as our phones and tablets readily available that can be used to provide or receive teledermatology services. There is also a shortage of dermatologists and some patients must wait two months to more than six months to see a skin specialist, especially in rural or underserved areas. With DirectDerm, a patient describes their symptoms and uploads photos of the skin problem, and within 48 hours, a board-certified dermatologist will get back to them with a diagnosis and a care plan.”
2. Teldermatology Improves Efficiency
“There are a lot of pressures in healthcare now and there is a push to increase quality of care, improve health at a population level, and reduce costs of care.
Teledermatology can improve quality of care and lower insurance costs by enabling dermatologists to be more efficient and provide accurate, earlier diagnoses and treatment interventions to their patients. There is no question that teledermatology is going to be an increasing component of the new care model.”
3. Teledermatology Saves Lives
“There is a triage system in place. If we suspect melanoma and a biopsy is needed, we can get that patient in immediately rather than place them on a wait list. The sooner melanoma is diagnosed, the better the prognosis.”
4. Teledermatology Won’t Replace Dermatology
“A subset of patients will always need to be seen in person by a dermatologist. Depending on the demographic of the patient population, about 90 percent of patients under guidance of their primary care physician, who come through a teledermatology consult, can be treated without needing an in-person dermatologist follow-up visit. In addition, teledermatology can efficiently triage those patient cases that need to be seen in-person by the dermatologist urgently to the top of the waiting list.”
5. Teledermatology Works
“Teledermatology significantly improves access to specialized skin care for a group of patients who traditionally had limited options, according to study published online in JAMA Dermatology. The researchers analyzed effects of a collaboration that began in 2012 between DirectDerm and a Medicaid managed care plan with nearly 300,000 enrollees in California. Practices that engaged in teledermatology had a 64 percent increase in the fraction of patients visiting a dermatologist compared with 21 percent in other practices.”
1. Deloitte. Global mobile consumer survey: US edition. http://bit.ly/1AbC8JR
“XeoMen” About Town
In a nod to the growing numbers of men who are interested in cosmetic surgery, Merz Aesthetics is rolling out their aptly named “XeoMen” campaign.
In 2015, men had more than 1.2 million cosmetic procedures, and male cosmetic surgery rose 63 percent over a five-year period ending in 2015, according to statistics from the American Society for Aesthetic Plastic Surgery. (See page 44 for more on this trend.)
To introduce more men to Xeomin, Merz is commandeering an airstream trailer outfitted as a mobile barbershop in late June. In it, male editors on both coasts will be treated to haircuts, hot shaves, and XeoMen treatments (by Deanne Mraz Robinson, MD, director of the Body Sculpting Center at Connecticut Dermatology Group.)
The XeoMen campaign also includes ads that will start running in men’s magazines this summer. Stay tuned. n
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FDA Approves Juvéderm Volbella XC for Use in Lips and Perioral Rhytids
Allergan plc, has received FDA approval to market Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids in adults over the age of 21. In clinical trials, Juvéderm Volbella XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year. Juvéderm Volbella XC will be available to patients in October 2016.
Dermira’s DRM04 Shows Promise for Primary Axillary Hyperhidrosis
Dermira’s DRM04 may help put the brakes on primary axillary hyperhidrosis, according to topline results from two Phase 3 trials. DRM04, an investigational topical anticholinergic product, blocks sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation. Based on the results of these trials, Dermira plans to submit a New Drug Application to the FDA for potential approval of DRM04 in the second half of 2017.
Sernivo Spray Hits Pharmacy Shelves
Sernivo Spray(betamethasone dipropionate) 0.05% for psoriasis is officially available. The spray, from Dr. Reddy’s Laboratories’ US subsidiary, Promius Pharma, LLC, was FDA approved in February of 2016 for the treatment of mild-to-moderate plaque psoriasis in patients 18 years of age or older.
Dupilumab with Topical Corticosteroids (TCS) Superior to TCS Alone in Atopic Dermatitis
Treatment with investigational dupilumab in combination with topical corticosteroids (TCS) significantly improved measures of overall disease severity, according to one-year results of the LIBERTY AD CHRONOS study. Reported by Regeneron Pharmaceuticals, Inc. and Sanofi, the Phase 3 study involved a total of 740 adult patients with moderate-to-severe AD that was inadequately controlled with topical medications. Dupilumab with topical corticosteroids (TCS) was compared to TCS alone.
FDA Accepts Allergan’s NDA Filing for Oxymetazoline HCI Cream for Facial Erythema
The FDA accepted Allergan plc’s New Drug Application filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults. Allergan expects the Prescription Drug User Fee Act date to be in the first half of 2017.
FDA Clears Cynosure’s PicoSure Energy Delivery System for Tattoos and Pigmented Lesions
The FDA granted clearance to Cynosure to market a new Laser Delivery System for PicoSure. Together with the FDA cleared 532nm and 755nm wavelengths, the new 1064nm Laser Delivery System improves multi-wavelength laser technology for removing the full color spectrum of tattoo inks in fewer treatments.
Derm Salaries On The Rise
Starting salaries for dermatologists spiked 13 percent in the last 12 months, according to a new report from Merritt Hawkins.The average annual salary for a dermatologist in 2015-2016 was $444,000, with a low of $250,00 and a high of $650,000, the report found. The new report tracked the 3,342 physician and advanced practitioner recruiting assignments conducted from April 1, 2015 to March 31, 2016. The 2016 Review of Physician and Advanced Practitioner Recruiting Incentives found that starting salaries increased year-over-year in 19 of the 20 medical specialties included in the report.
Allergan’s Teflaro Approved for Pediatric Patients
Allergan’s Teflaro (ceftaroline fosamil) is now indicated for pediatric patients, making it the first branded IV antibiotic approved for this population in more than a decade. The FDA approved the company’s supplemental New Drug Application (sNDA) allowing the antibiotic to be used in pediatric patients two months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria. It is administered by intravenous (IV) infusion in five minutes to one hour.
ASDSA Releases New Sun-Safety Model Legislation
New model legislation from American Society for Dermatologic Surgery Association (ASDSA) provides state governments with a framework to permit the use of sunscreens in school and camp settings. The ASDSA model legislation—SUNucate/Reducing the Risk of Skin Cancer and Excessive UV Exposure in Children Act—coincides with Don’t Fry Day, an educational initiative by the National Council on Skin Cancer Prevention (NCSCP). The model bill allows students to possess and use topical sunscreen products while on school property, at a school-sponsored event or youth camp without a physician’s note or prescription if the product is approved by the FDA for over-the-counter use.