Recent Developments

The average wait time for an appointment with a pediatric dermatologist is six weeks. It’s no surprise, then, that Robert Sidbury, MD noticed that he and colleagues were spending increasingly more time providing a growing number of unofficial “consults” for children with skin diseases. These consults, which are not reimbursed, may be associated with concerns about medicolegal liability as well as patient privacy. So Dr. Sidbury decided to study them. “Some of the tensions existed but weren’t really documented or talked about,” Dr. Sidbury says. “I felt like it needed to be brought up in a more official way across the literature.”

The survey revealed that more than 45 percent of pediatric dermatologists surveyed said they received at least six consults per week, and about half spent six minutes or more per case. Only three percent of consults are compensated or captured in work relative value units. The vast majority of respondents (87 percent) did not document or have a practice or institutional policy in place to address these consultations, and almost as many (80 percent) were uncertain if their existing liability insurance covered such activities. (Pediatr Dermatol; 36(5):607-610)

Technology has made it more convenient for non-dermatologists to share images and request a “quick peek,” Dr. Sidbury says. “Sometimes that’s absolutely sufficient and it helps triage,” he says, but it can be “not appropriate and/or overwhelming.”

“Shadow consults” may resemble store-and-forward teledermatology consults but lack the formal structure of telemedicine. “Many of us are not even entirely sure what the hospital liability policy is surrounding these, because these are patients who we don’t know yet. We’re seeing their images, we are commenting with our names attached to those comments. It’s hard to get away from the fact that there could be medical, legal liability—our disclaimers notwithstanding.”

Despite medicolegal considerations, Dr. Sidbury says that most pediatric dermatologists feel a responsibility to support patients. “We want to be collaborative, we want to be helpful, and saying ‘no’ doesn’t feel very good,” he says. There may also be concern that referring physicians may turn to other dermatologists if the pediatric dermatologist refuses a shadow consult. Nonetheless, Dr. Sidbury was surprised to find that more pediatric dermatologists don’t refuse shadow consults.

Dr. Sidbury was also surprised to see how many of his colleagues were seeing more than 10 cases per week at five minutes or more per case. “Just do the math,” he says. “A not insignificant number of folks were in essence seeing another whole clinic a week. And I guess that volume surprised me a bit.”

Unofficial consults potentially increase access to care, benefit patients, and foster professional collegiality. “Most pediatric dermatologists are willing and even excited to do some [unofficial consults], because they serve such a good purpose, however, they can become overwhelming and are not always in the patient’s or provider’s best interest.” Dr. Sidbury says.

FDA Approves Arazlo Lotion for Acne

The FDA has approved Ortho Dermatologics’ Arazlo (tazarotene) Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older. It is the first tazarotene acne treatment available in a lotion form, and has been shown to provide strong efficacy with favorable tolerability.

Approval was based on data from two Phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance and Arazlo was shown to be well-tolerated.

In a Phase 2, head-to-head study, Arazlo and Tazorac (tazarotene) Cream 0.1% showed similar treatment success rates and similar reductions in inflammatory and non-inflammatory lesions over 12 weeks. While there were no significant differences in patient satisfaction or quality of life between the two treatments and both were well-tolerated, there were numerically about double the number of treatment-related adverse events with Tazorac (5.6 percent with Tazorac versus 2.9 percent with Arazlo).

“Many of my patients with moderate to severe acne can benefit from the efficacy of tazarotene, but struggle to stay on treatment due to tolerability issues,” adds Emil Tanghetti, MD, lead Arazlo study investigator and founder, Center for Dermatology and Laser Surgery in Sacramento, CA. “Tazarotene has typically been reserved only for patients with severe acne, but offering it in a well-tolerated lotion formulation that includes hydrating agents can help more patients with most types of acne take advantage of its efficacy. I look forward to adding Arazlo to my practice armamentarium.” For more from Dr. Tanghetti on how he’s using this product in his practice, read “New in My Practice”.

Avita Medical: FDA APPROVES IDE of Clinical Feasibility Study For RECELL System in Vitiligo

The FDA approved Avita Medical’s Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL Autologous Cell Harvesting Device for repigmentation of depigmented lesions associated with stable vitiligo.

The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required at point of care. It was FDA approved in September 2018 for use in the treatment of acute thermal burns in patients age 18 years and older.

The vitiligo study is slated to begin in the first half of this year. Avita Medical will collaborate with a medical center to conduct a pilot study with 10 patients who have vitiligo lesions that have been stable for at least one year. Areas of the vitiligo lesion will be randomly treated with slightly varying cell suspensions prepared using RECELL to confirm response rates and optimal suspension parameters.

The randomized controlled study’s primary effectiveness measure is the percent area of repigmented skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment. Additional effectiveness data collected over the course of the 24-week study will include degree of repigmentation achieved and patient rating of repigmentation. Of note: Use of the RECELL System in patients undergoing reconstruction of skin defects not associated with a burn injury is limited by Federal law to investigational use.

“Based on the outcomes of the feasibility study, we anticipate proceeding with a pivotal clinical trial to pursue FDA approval of the RECELL System as a cell-based repigmentation treatment option for stable vitiligo,” says Dr. Mike Perry, Avita Medical Chief Executive Officer.

BTL Files Patent Infringement Lawsuit

BTL Aesthetics’ US affiliate has filed a lawsuit against Allergan plc, Ireland and its affiliates, and Zimmer MedizinSysteme GmbH, Germany, and its affiliate, in the US Federal District Court for the District of Delaware.

The lawsuit asserts that the Cooltone device, manufactured by Zimmer for Allergan, infringes on BTL’s U.S. patents, and that Allergan’s Coolsculpting, when used before, or after the Cooltone therapy, infringes on BTL’s US patent for the therapeutic application of the two technologies.

BTL is seeking an injunction and monetary damages. The lawsuit is intended to prevent Allergan from importing and selling Cooltone systems in the US, and to prevent Allergan from marketing Cooltone alone or in conjunction with Coolsculpting therapy.

CLOSE UP with Michael Rendl, MD

A discovery out of a lab in the Mount Sinai Hospital in New York City may pave the way toward new and effective treatments for hair loss. When the dermal sheath contracts, it can stimulate stem cells for growth of a new hair in the cycle. The dermal sheath can’t be controlled voluntarily, but it can potentially be controlled by drugs that can block sheath contraction, stopping follicle regression and preventing the loss of the existing hair before a new hair can grow, explains lead study author Michael Rendl, MD, Professor of Cell, Developmental and Regenerative Biology, and Dermatology and the Associate Director of the Black Family Stem Cell Institute at the Icahn School of Medicine at Mount Sinai. The findings were published in Science, and Dr. Rendl explained the significance of the work and shed light on why and how it may the prevent progression of androgenetic alopecia early on.

Why is this topic important to study?

Dr. Rendl: Many people suffer from hair loss. Currently most effective treatments are generic drugs, finasteride, and minoxidil, that can positively affect the progression of male pattern baldness. Replacement of already lost follicles by transplanting follicles from an unaffected area to an affected skin area is an effective and permanent solution, but occurs late in the progression of hair loss. Identifying ways to arrest existing follicles in the destruction phase of the cycle could prevent progression of androgenetic alopecia hair loss early on by locking in existing hair follicles before they miniaturize in successive growth cycles.

Describe the research and your findings.

Dr. Rendl: Hair follicles undergo life-long cycles of hair growth, then follicle destruction and re-growth from stem cells activated by dermal papilla cells. While many details are already understood it has been unclear for a long time how the hair shaft moves up and how the dermal papilla get to the stem cells moving from the base to the follicle tip where the stem cells are. We found an answer for the mechanism that involves contraction by the dermal sheath as a previously unidentified smooth muscle. Sheath contraction pushes the hair shaft up and pulls the dermal papilla through a connection with the dying epithelial strand.

What is the next step?

Dr. Rendl: We are now exploring how effective contraction blocking is in human hair follicles in the dish. A key step will be to find out what happens to the follicles arrested in the destruction phase of the hair cycle after contraction blocking and whether this can be safe long-term. There will be considerable effort necessary to develop sheath contraction blocking as a potential new treatment modality for therapeutically manipulating the hair cycle.

DermTech’s PLA Receives Medicare Coverage

The Medicare Administrative Contractor Palmetto GBA MolDx issued a final local coverage determination for DermTech, Inc.’s Pigmented Lesion Assay (PLA). The PLA test is used to help rule out primary cutaneous melanoma and guide biopsy decisions of melanocytic skin lesions with one or more clinical or historical characteristics suggestive of melanoma. Clinicians with sufficient skill and experience to decide whether a pigmented lesion should be biopsied may order the PLA test, with up to two tests allowed per patient for each date of service.

DermTech’s PLA uses RT-PCR (reverse transcriptase–polymerase chain reaction) to measure the gene expression of two genes, LINC00518 (long- intergenic non-coding RNA 00518) and PRAME (preferentially expressed antigen in melanoma) and identify the malignant changes of melanoma on the genomic level.

“We are excited that Palmetto reviewed the clinical dossier for the PLA test and recognized that our test aids in the diagnosis of melanoma and may spare the patient the need for an unnecessary biopsy. It is our mission to enhance the early detection of melanoma through the power of precision genomics, and eliminate unnecessary surgery, leading to improved patient care and lower costs,” said John Dobak, MD, Chief Executive Officer of DermTech.

Almirall Strengthens Early Stage Portfolio with Three New Partnerships

With three new strategic agreements, Almirall, S.A. is set to strengthen its early-stage research portfolio and expand its pipeline in medical dermatology.

Alimirall and 23andMe have signed an agreement allowing Almirall to in-license 23andMe’s bispecific monoclonal antibody designed to block all three members of the IL-36 cytokine subfamily. This family is associated with multiple inflammatory diseases, including various dermatological conditions.

In addition, Almirall and WuXi Biologics signed a strategic collaboration agreement for multiple bispecific antibodies targeting dermatology diseases including atopic dermatitis. Under the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody to discover multiple novel bispecific antibodies. This strategic collaboration permits Almirall to develop the medication under license and maintain ownership for medical use of the resulting components.

Almirall also entered into an option agreement to acquire Bioniz Therapeutics, Inc. for full global rights to BNZ-1, a multicytokine inhibitor that selectively blocks the activity of three cytokines of the same family: IL-2, IL-9 and IL1-15, currently in phase 1/2 development for refractory Cutaneous T-cell Lymphoma. If Almirall exercises the option, it will also enter into a broader research agreement with Bioniz NewCo, using its multiple cytokine inhibitor platform with the objective to deliver at least 3 IND-approved candidates.

BNZ-1 is also being developed for the treatment of alopecia areata. BNZ-01 has been evaluated in Ph1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) and is currently being evaluated in a Phase 1/2a study in CTCL patients and ready to start a Phase 2 PoC study in Alopecia Areata.

Under terms of the agreement, Almirall will make an initial payment of $15 MM to Bioniz in exchange for an option to acquire all Bioniz outstanding shares. Following the availability of phase 1/2 results in CTCL, certain human biomarkers laboratory data and the official FDA End of Phase 2 meeting minutes, Almirall will have 60 days to exercise its option. If Almirall elects to exercise its option, the company will pay an option exercise fee of $47 MM in different installments in the following years. Almirall will make additional payments upon the achievement of certain development, regulatory and commercial milestones.

Sebacia Seeks to Shine with Gold and Silver

Sebacia has acquired all assets related to Sienna Biopharmaceuticals’ SNA-001 (silver photoparticle technology), including all related intellectual property owned or licensed by Sienna and the 510(k) application for light hair removal that was submitted to FDA in September 2019. The acquisition of these assets enables Sebacia to resolve the outstanding patent interference litigation between The General Hospital Corporation and Sienna Biopharmaceuticals.

Additionally, Sebacia, which is preparing a targeted commercial launch of Sebacia Microparticles in the US for treatment of acne early this year, has appointed Chuck Abraham as Chief Executive Officer.

According to Mr. Abraham, “This acquisition enables Sebacia to secure Sienna’s silver photoparticle intellectual property, effectively resolving all existing patent conflicts with Sienna, while also establishing Sebacia as a leader in the use of microparticles and laser energy in dermatology. Consolidating the IP within Sebacia allows us to move forward and focus on making our innovative gold microparticle treatment for acne available to dermatologists and their patients and gives us an even deeper pipeline of potential additional indications.”

Mr. Abraham was CEO of OraMetrix, Inc. which developed 3-D technology solutions to improve the quality and efficiency of orthodontic care. Prior positions included leadership roles with eMerge Interactive, Nellcor Puritan Bennett, and General Electric Medical Systems. He attended Mississippi State University and received a Bachelor of Science in Biological/Biosystems Engineering.

Take 5: John Donofrio, EPI Health

Nearly a year into his role as president of EPI Health, based in Charleston, SC, John Donofrio is optimistic about the company’s potential in the medical dermatology space. He’s worked in a variety of roles for a number of well-known pharmaceutical companies, including Glaxo/GlaxoSmithKline and Stiefel and Merz North America. He spoke with Practical Dermatology® magazine about EPI Health’s growth and its future focus.

EPI’s tagline is “Advancing Dermatology.”

John Donofrio: What really matters to us is we’re becoming a valued partner in dermatology. We’re trying to make a difference in the lives of our patients and the healthcare providers we work with. We feel that it’s key to focus on our patients. Our goal is to provide safe and effective products, and provide the best support to healthcare practitioners, and we’re doing that through strong promotion, education, and support in the office and at the pharmacy.

EPI has big aspirations but a small company feel.

Mr. Donofrio: We’re working and living in a company environment where our employees excel, a place where they love to come work and love who they work with…We are focusing on our culture, not by our words, but by our actions each and every day. One of the great things we’ve experienced is extremely talented individuals in our industry have proactively reached out to us to join EPI Health. They’ve been very excited when they do join the team. The energy and excitement have really put a smile on our faces. And that’s a fantastic compliment for a company that wasn’t well known a year ago.

A lot of us came from bigger companies and there’s a lot of pluses and minuses with that. But it makes us feel good as a leadership team and as an organization, that people see what we are building and want to come work with us. Practitioners and healthcare providers have also been very supportive of what we are building at EPI Health.

We have a small company passion and culture and mission, and that’s not going to change as we continue to grow and go forward.

There’s a solid foundation.

Mr. Donofrio: We feel like we have a great formula that we’ve built; we’ve developed a solid product portfolio. In the last two years, we’ve gone from very little presence in our industry to having products in three top categories in dermatology. We’re in atopic dermatitis with Cloderm, we’re in acne with Minolira, and we’re excited to be in rosacea now with the acquisition of Rhofade. We have a fantastic energized team that is a diverse blend of legacy and new employees. We’ve not only invested in products, but operational excellence and the development of our employees has been made a top priority.

Rhofade is a valuable asset.

Mr. Donofrio: The acquisition of Rhofade has brought excitement to EPI Health and we have received significant positive feedback from the dermatology community, which has been great. I believe this acquisition demonstrates our commitment to dermatology. Rhofade is a fantastic product that’s indicated for persistent facial redness or erythema.

Rhofade has been with a few companies, and we embrace the opportunity to help patients with rosacea. There are 16 million rosacea sufferers. Treating redness for patients is a key unmet need and we are excited about the future of this product.

EPI is focused on medical dermatology.

EPI is focused on medical dermatology.

Mr. Donofrio: We’re excited about future investment opportunities, but we’ve got to stay focused on our existing assets. If we’re truly going to live up to our tagline of advancing dermatology, we must also invest in the future of medical dermatology. We are looking at compounds in mid- to late-stage development. Up until now we’ve been looking at marketed access only and focusing on our commercial and operational expertise. So now we have expanded that to really be part of developing assets. We want to partner with companies that excel with those capabilities and not only invest with them and partner with them, but then also be the commercial partner of choice, once those assets become available for commercialization.

We also will look to acquire outright other assets, just like we have with Rhofade, Minolira, and Cloderm, in the right time and the right place.

We’re privately held; our roots go back to 1896. We are not looking to be sold or a quick exit, this is a great thing and one of the many reasons why I and others come to work at EPI Health... We’re looking to be a company that excels in medical dermatology and advances this space. We’ll continue to look at all options, but we want to focus on the assets that we have, our people and the fundamental business that we’ve built and go from there.

We have great products in three of the four top Dermatology areas. Psoriasis is the fourth market of opportunity and we are actively evaluating opportunities in that area that fit our capabilities. We feel like our commercial organization, and our operational team are ready for the growth. Adding a psoriasis product will put EPI Health in a position to become a leader in dermatology.