FDA Approves Dermira’s Qbrexza Cloth to Treat Primary Axillary Hyperhidrosis
The FDA has approved Qbrexza (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients nine years of age and older. Qbrexza is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation.
Approval is based on results from two Phase 3 clinical trials, ATMOS-1 and ATMOS-2, which evaluated the efficacy and safety of Qbrexza in patients with primary axillary hyperhidrosis. Both trials assessed the absolute change from baseline in sweat production (the weight or amount of sweat a patient produced) following treatment with Qbrexza and the proportion of patients who achieved at least a four-point improvement from baseline in their sweating severity, as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument. The PRO was developed in consultation with the FDA and in accordance with the agency’s 2009 guidance on PRO instruments.
“Primary axillary hyperhidrosis is a condition that has negatively impacted many of my patients for most of their lives,” says Dee Anna Glaser, MD, professor and interim chair, Department of Dermatology at Saint Louis University School of Medicine and a renowned hyperhidrosis expert. “I look forward to Qbrexza’s potential to be a meaningful treatment option that will not only reduce a person’s sweat, but will reduce the overall impact this condition has on their daily life.”
The most common side effects observed following topical application of Qbrexza to the underarms were dry mouth, dilated pupil (mydriasis), sore throat (oropharyngeal pain), headache, urinary hesitation, blurred vision, dry nose, dry throat, dry eye, dry skin and constipation. The most common local skin reactions were erythema, burning/stinging, and pruritus.
Qbrexza is expected to be available nationwide in pharmacies beginning in October 2018.
FDA Approves Braftovi in Combination with Mektovi for Advanced BRAF-mutant Melanoma
The FDA has approved Array BioPharma Inc.’s Braftovi (encorafenib) capsules in combination with Mektovi (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma.
“We are thrilled with the approval of Braftovi + Mektovi, which help fill a critical unmet need for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer,” says Ron Squarer, Chief Executive Officer, Array BioPharma, in a news release. “As presented at ASCO, Braftovi + Mektovi is the first targeted treatment to demonstrate over 30 months median overall survival in a Phase 3 trial. These products represent a new standard of care for BRAF-mutant melanoma patients and we sincerely thank the patients and dedicated researchers who participated in our clinical program.”
Braftovi and Mektovi are now available to order through select specialty pharmacies in the US market.
The approval of Braftovi + Mektovi is based on results from the Phase 3 COLUMBUS trial, which demonstrated the combination doubled median progression-free survival (mPFS) compared to vemurafenib, alone (14.9 months versus 7.3 months, respectively. Only five percent of patients who received Braftovi + Mektovi discontinued treatment due to adverse reactions.
The most common adverse reactions (≥25 percent) in patients receiving Braftovi + Mektovi were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.
As the company reported in February 2018, Braftovi + Mektovi reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.001] in the planned analysis of overall survival (OS) from the COLUMBUS trial. Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib as a monotherapy. These positive results add to the growing body of clinical evidence supporting the BRAF/MEK inhibitor combination therapy and Array and its partners are working to formally submit these results with global regulatory authorities.
Array BioPharma is committed to providing access and reimbursement support to all patients. Array offers a $0 copay for eligible, commercially-insured patients. For more information about treatment of Braftovi in combination with Mektovi, visit braftovimektovi.com.
LEO Pharma and Advancing Innovation in Dermatology Partner to Help Finance Accelerator Fund
LEO Pharma and its Boston-based R&D innovation unit LEO Science & Tech Hub and Advancing Innovation in Dermatology (AID) will each contribute $500,000 into the recently created Advancing Innovation in Dermatology Accelerator Fund. This non-profit fund is unique in its approach for supporting product innovation for dermatology. LEO and AID have a joint mission to accelerate early stage research and development projects with the potential to impact the lives of people living with skin conditions.
William Ju, MD, FAAD, President and a Co-founding Trustee of Advancing Innovation in Dermatology, Inc. says, “We are grateful for LEO Pharma’s generosity and partnership and are excited to build collaborations that will spark the translation of science and engineering innovations into products that meaningfully improve patient outcomes.”
“Our vision for this initiative is to build a sustainable investment model that will spur further innovation in the dermatology space,” says Michael Sierra, PhD, Vice President of LEO Science & Tech Hub, “We are excited to fill what we see as a major void in the early development process and are committed to keeping the patient at the center of all endeavors.”
Christian Antoni, MD, PhD, Senior Vice President of Global Development at LEO Pharma adds, “LEO Pharma is proud to be involved in progressing innovations in dermatology by working together with renowned thought leaders and entrepreneurs in order to truly impact society.”
The AID Accelerator Fund was created to support new breakthroughs that address unmet clinical needs. Designed to bridge the gap between government or other initial funding and commercial investment at a stage far earlier and riskier than what traditional venture capitalists or angel investors would typically accept, the fund will provide both seed capital and in-kind intellectual property and advisory services to entities in which it invests. Focused on driving innovative technologies within the field of dermatology, the fund will have a particular emphasis on product development.
In addition to LEO’s financial support, Michael Sierra will serve as a member of the steering committee where he will help guide investment decisions and also act as a strategic advisor for the projects. He will be joined on the steering committee by other founding partners from Advancing Innovation in Dermatology, Inc., Pepper Hamilton LLP, Brickell Biotech and Aclaris Therapeutics.
BrightGuard Installs Free Sunscreen Dispensers at New York City Public Pools and Beaches
Through its ongoing partnership with non-profit sponsor and donor IMPACT Melanoma and sunscreen provider Coppertone, BrightGuard has installed 134 sunscreen dispensers throughout New York City (NYC) public pools and beaches. BrightGuard—the first automated sunscreen dispenser company offering free, high-quality SPF 30 sunscreen—is providing this to the city for the second consecutive year at no cost to the city or its residents.
“IMPACT Melanoma and Coppertone are incredible partners in the fight against skin cancer,” says BrightGuard co-founder, Ryan Warren. “This incredible collaboration has enabled us to provide free and accessible sunscreen to help reduce the risks of sun exposure throughout the city. Ultimately, our aim is to increase awareness of sun safety and encourage people everywhere to protect themselves from the sun’s harmful UV rays.”
BrightGuard dispensers have now been installed at 53 public pools and 11 beaches in various locations throughout Bronx, Brooklyn, Manhattan, Queens, and Staten Island. BrightGuard’s two co-founders were inspired to create the unique touch-free public sunscreen dispenser company after a friend was diagnosed with melanoma at a young age. Its dispensers are currently found in various schools, parks, sports arenas and other public places across the country.
The initiative was co-sponsored by IMPACT Melanoma—a national non-profit organization dedicated to education, prevention and taking action in the fight against skin cancer. Committed to skin cancer prevention and early detection, IMPACT Melanoma provides a variety of award-winning programs which aim to raise awareness and educate the public about skin cancer, as well as support services for those struggling with the disease. Its offerings include support groups, educational programs and patient advocacy.
Co-sponsor of the initiative, Coppertone, provided Coppertone Sport sunscreen. Coppertone, a leader in sun protection for over 40 years is dedicated to inspiring kids and families to adopt healthy sun safe behaviors while enjoying their time outdoors. Sunscreen application should be a family activity—parents modeling sun care habits early on can create a lasting impression for their children. That’s why Coppertone partnered with BrightGuard to bring sunscreen that stays on strong through heat, sweat and water to stop 97 percent of damaging UV rays—SPF 30 or higher—to families across the country.
In addition to producing the hardware and spearheading the collaboration, the BrightGuard team will work with NYC Parks leadership to maintain the dispensers—including regular and frequent visits to ensure the dispensers are filled with plenty of Coppertone sunscreen. Dispensers will be up and running at the designated areas through September 9.
Dermatology Authority Adds Credentialing and Licensing Support Services
Dermatology Authority has added credentialing and licensing to their list of support services. The requirements for licensing and credentialing differ from city to city, state to state, and procedure to procedure. Dermatology Authority keeps tabs on the requirements and agencies that license and credential providers and practices. The company says it will focus on:
• Commercial Payors
• Practice Setups (NPI, CLIA, DOH)
• Hospital Privileges
• Provider Licensing
• DEA Application
• DME Credentialing
• CDS Credentialing
“All of the Dermatologists we work with to help find them positions will need to be licensed and credentialed, so it only made sense for us to add this to list of services. We want to make the onboarding process of adding providers as easy of possible for both the practice and the physicians,” states Kim Campbell, CEO of Dermatology Authority. “Dermatology Authority understands the importance of timely and accurate payor enrollment and they bring leading credentialing industry experience to each one of their clients. By adding this service, they’ll navigate medical professionals through any inconveniences and issues ofcredentialing and licensing resulting in successful medical licensing in all 50 states.”
eRelevance Launches Suite of Services to Support Lead Conversion
eRelevance Corporation’s new suite of tech-powered services are designed help small to medium businesses grow more cost-effectively. The services drive more demand, lower advertising costs, and improve lead conversion.
“We are uniquely focused on changing small businesses forever by bringing big-company consumer engagement capability to them as affordable, turnkey services,” says eRelevance Co-founder and CEO Bob Fabbio. “We have consistently heard from SMBs that they face challenges trying to grow in a cost-effective manner through customer and prospect engagement because of limited tool capabilities and lack of time and expertise. With this suite of services, we’ve changed the game for small businesses in terms of their ability to grow and thrive.”
The eRelevance suite of services:
• eRelevance Customer Engage engages customers through targeted, multi-channel campaigns that increase the lifetime value of existing customers.
• eRelevance Prospect Engage captures and quickly engages prospects with a targeted, multi-channel approach that maximizes the return on marketing spend.
• eRelevance Connect follows up on customer and prospect responses to marketing campaigns, then connects them with scheduling resources, increasing the likelihood of conversion and minimizing lost revenue.
• eRelevance Capture captures responses from email blasting and advertising efforts, and tracks return on investment.
MORE HEADLINES FROM DERMWIRE.COM
First EB Patient Enrolled in PK Study of Diacerein 1% Ointment
The first patient has been enrolled in a new Phase 1 study evaluating the pharmacokinetics (PK) and safety of Castle Creek Pharmaceuticals’ diacerein 1% ointment (CCP-020) under maximum use conditions in patients with epidermolysis bullosa (EB) at the UNC-Chapel Hill Dermatology & Skin Cancer Center.
Alana Sine is New CFO at Merz North America
As Chief Financial Officer (CFO) of Merz North America, Alana Sine will lead the finance function for North America, overseeing financial reporting, governance, strategic planning, tax & treasury, and collaboration with Merz’s global headquarters in Frankfurt, Germany, on financial matters. She will report to Bob Rhatigan, CEO of Merz North America and join the North America Leadership Team (NALT).
Michael Mazen Jafar is New Chief Marketing Officer at Evolus
Evolus, Inc. has expanded its management team with the appointment of Michael Mazen Jafar as Chief Marketing Officer. Mr. Jafar joins Evolus from Allergan where he most recently served as Vice President, Medical Aesthetics. At Allergan Mr. Jafar led the commercial launch of Juvéderm Voluma, which has been recognized as not only one of the largest launches in the medical aesthetics category, but also the most successful, as measured by year one sales.
Derm Brands Among Top Skincare Social Influencers
Engagement Labs’ TotalSocial ranking of the top personal care and beauty brands in the US based on social influence show several popular dermatology brands in the Top 10, including Dove, Neutrogena, and L’Oreal. The analysis is unique in that it combines offline and online consumer conversations. It is based on Engagement Labs’ proprietary TotalSocial data and analytics, which continuously measures the most important drivers of brand performance in both face-to-face and social media conversations.
New Patient-Centered Panel Helps BioPharmX Define its Role in the Future of Dermatology
BioPharmX Corporation has formed a Special Advisory Council of thought leaders from various disciplines to help the company embrace patient centricity in its products, pricing, and market access considerations.
The advisors, who bring decades of experience in fields beyond dermatology—ranging from regulatory pathways to market access and from infectious diseases to antibiotic resistance—will inform the company’s efforts by providing the kind of strategic expertise needed to position BioPharmX as a leader in patient-centric dermatology. The Special Advisory Council will collaborate with the company’s scientific and medical team and its Medical Advisory Board, a group of dermatologic experts in acne and rosacea who have been instrumental in guiding BioPharmX in the treatment of these diseases.
Patient-centricity has been a decades-long goal for the healthcare industry. But larger companies have struggled to retrofit their products and services around patient-centered care models. BioPharmX, designed to be a more nimble organization, says it is committed to ensuring its products are dedicated to the patient, from developing cosmetically elegant products that are easy to use, tolerable and with minimal side effects, to making sure those products are reasonably priced and available to the patients who seek them.
“There has never been a greater need for patient-centricity in dermatology,” says Dr. Julie Harper, president of the American Acne and Rosacea Society and member of the company’s Medical Advisory Board. “I look forward to collaborating with these distinguished colleagues to drive innovative solutions and improve access to care.”
The Special Advisory Council includes:
• R. Todd Plott, MD, an expert on oral minocycline formulation, clinical trials and regulation, who holds six patents related to Solodyn® oral minocycline and was appointed to the FDA Dermatologic & Opthalmic Drug Advisory Committee 2014-2019.
• Mark D. Kaufmann, MD, associate clinical professor of dermatology at the Icahn School of Medicine at Mount Sinai, an expert on market access and formulary, with extensive experience working with companies to place novel drugs on appropriate formularies.
• George Zhanel, PharmD, PhD, professor in the Department of Medical Microbiology and Infectious Diseases at Max Rady College of Medicine, University of Manitoba, coordinator of antibiotic resistance in the Departments of Medicine and Microbiology at the Health Sciences Centre in Winnipeg, and director of the Canadian Antimicrobial Resistance Alliance. He is an expert on antibiotic resistance.
• Kenneth J. Tomecki, MD, vice chairman of the Department of Dermatology at Cleveland Clinic, an expert on infectious diseases with a passion for patient-centric care, medical education and clinical research.
• James J. Leyden, MD, emeritus professor of dermatology at the University of Pennsylvania. In addition to 50 years of experience with acne and rosacea, he is an expert on regulatory issues and has consulted for the Food and Drug Administration, the Federal Trade Commission and drug regulation agencies in England, Germany and Austria.
BioPharmX has successfully completed a Phase 2b trial for BPX-01 for acne and is preparing for Phase 3 trials, and has reported positive interim results from a feasibility study for BPX-04 for rosacea and is preparing for a Phase 2 trial.
DermTech Initiating Study to Assess DNA Damage and Reversal
DermTech, Inc. has initiated enrollment in a clinical study to assess DNA damage induced by an excimer laser and evaluate the potential of T4 endonuclease topical DNA repair enzyme and photolyase cream to reduce this DNA damage as measured through gene expression analysis. The study is being conducted in healthy volunteers and subjects with a history of skin cancer, at a single-site under Dr. Ronald L. Moy, past president of the American Academy of Dermatology and American Society for Dermatologic Surgery. The purpose of the study is to mimic DNA damage as seen with acute excessive sun exposure and determine if the use of DermTech’s proprietary non-invasive adhesive patch kits can detect this DNA damage through a panel of markers. The skin is then subsequently assessed to see if topical products can reduce this damage. Clinical study results are expected Q4 2018.
“The ability to assess and quantify RNA gene expression and DNA damage in the skin will give us a better way to rate sunscreens and medications that can reverse and prevent sun damage. This new methodology could revolutionize our application of sun damage prophylaxis and treatment regimens,” says Dr. Moy.
Life Sciences Industry Eyes $1.5 Trillion Milestone
The life sciences industry is nearing a $1.5 trillion milestone, according to an analysis from Frost & Sullivan. The firm’s Global Life Sciences Industry Outlook, 2018 report finds that healthcare digitization and consumerization, the explosion of patient data, and the emergence of value-based reimbursement models are propelling the growth. They cite a convergence of biopharmaceuticals, drug delivery devices, and companion diagnostics —enabled by digital connectivity— as driving regulatory and commercial changes.
“The scope for synergies among disciplines is attracting big tech companies such as Google, Amazon, Facebook, Apple (GAFA) to the life sciences industry,” said Unmesh Lal, Program Manager, Transformational Health. “The adoption of artificial intelligence (AI) and cloud-based solutions for drug discovery and clinical trial workflow is improving the overall efficiency of production. Additionally, pathology and research laboratories are increasingly adopting health analytics solutions to track the test utilization and efficiently tackle reimbursement issues.”
Frost & Sullivan identify opportunities in the following areas:
• AI and cloud deployment in pharma research and development (R&D)
• Convergence of molecular diagnostics and big data analytics
• Smart genomics
• Biopharma partnerships with contract development and manufacturing organizations (CDMO) and contract research organizations (CRO)
• Liquid biopsy and companion diagnostics
• Biotech expansion into CAR-T and gene therapies.
Dermatology News for Smart Speaker to Continue
In response to user demand, Dermatology News for Smart Speaker, available for the Amazon Echo device, is continuing. Enable the “Dermatology News” skill, then ask Alexa to “Play Dermatology News.”
Dermatology News for Smart Speaker, powered by DermWire.com, is an editorially independent program made possible with advertising support from Ortho Dermatologics.