HALOBETASOL REFORMULATED: Mayne Pharma Acquires FDA-approved Foam

Mayne Pharma has acquired the US and Australian rights to halobetasol foam 0.05% for a structured investment of up to $32 million. Under the terms of the asset purchase, license and commercialization agreement, Mayne Pharma has also acquired the approved US regulatory filing, medical and technical data, and a portfolio of pending US patent applications.

The foam formulation was FDA approved in May 2018 and Mayne Pharma is planning for the commercial launch of this product in early 2019. The product received three years of marketing exclusivity and has four pending patent applications with the US Patent and Trademark Office.

The market for potent topical corticosteroids is estimated at $600m with approximately 10 million units sold per annum, of which halobetasol dosage forms (cream, ointment and lotion) account for $64 million and 0.8 million units. The halobetasol market has been growing 10 pcercent per year over the last three years.

NEW AAD Melanoma Guidelines: Surgical Removal Remains Gold Standard

The American Academy of Dermatology's (AAD) new melanoma guidelines shed light on risk of melanoma prognosis during pregnancy, the role of formal genetic testing in at-risk families, and other aspects of care for primary cutaneous melanoma.

Surgical excision remains the gold standard of melanoma treatment, while Mohs surgery or other forms of staged excision may be considered for certain subtypes of melanoma on some parts of the body, the guidelines state. Topical therapy or traditional radiation may be considered as second-line therapy in limited cases when surgery is not possible; the guidelines do not recommend electronic brachytherapy for melanoma due to a lack of scientific evidence.

According to the new guidelines, published in the Journal of the American Academy of Dermatology, evidence is lacking that pregnancy increases a woman's risk of developing melanoma or affects the prognosis of the disease. The guidelines indicate that any decisions regarding the management of melanoma in pregnant women should be based on patient health and disease stage, while counseling on future pregnancies should be based on the individual's history and melanoma risk.

The guidelines also recommend that patients with a family history of melanoma receive education and counseling about genetic risk. According to the guidelines, formal genetic testing may not be appropriate and should be considered on an individual basis after counseling.

Adult AD May be Even More Prevalent than Previously Believed

As many as 16.5 million adults in America have atopic dermatitis (AD), according to a new study from the Perelman School of Medicine at the University of Pennsylvania, which also projected 6.6 million of these adults have disease that would be classified as moderate to severe, leading to a decrease in quality of life. The new findings appear in the Journal of Investigative Dermatology.

Researchers surveyed 1,278 adults sampled from the GfK Knowledge Panel, a probability-based online panel that is thought to be representative of the adult population of the United States. Among those respondents, 7.3 percent met the criteria for diagnosis of AD. Sixty percent of those with AD classified as mild, 29 percent as moderate, and 11 percent as severe. Since the panel is representative of the country's population, researchers used U.S. census population data to project that 16.5 million American adults are living with AD, with 6.6 million of those cases being moderate to severe. Patients with AD and those with more severe disease also had higher scores in other patient-reported outcome measures, including the Dermatology Life Quality Index, indicating a worse impact on quality of life and an increased likelihood of anxiety or depression as measures by the Hospital Anxiety and Depression Scale.

“We tend to think of this disease as a children's disease, but our data show that's not the case,” says the study's lead author Zelma C. Chiesa Fuxench, MD, MSCE, an assistant professor of Dermatology at Penn, in a news release. “Our findings show this disease affects seven percent of the population, far more than other inflammatory conditions like psoriasis, which only affects about three percent. Yet psoriasis has eight biologic treatments available for patients, whereas atopic dermatitis only has one that's approved.”

“These findings show a disconnect between the prevalence of this disease—and its impact on patient quality of life—compared to the resources being dedicated to developing systemic therapies,” Dr. Chiesa Fuxench says. “With only one approved biologic available, it's clear the need is not being met.”

Dr. Chiesa Fuxench says the numbers also hint at larger questions about this population, including whether they developed the condition as they got older or whether they had it as children and stopped seeking treatment at some point during their lives due to unhappiness with or poor response to currently available therapies. Many patients, she notes, are told they will grow out of the disease, but these data suggest that may not be the case, and that the disease may change over time. She also notes the medical and social impact of AD can also lead to a financial impact for many patients.

The study's senior author was Peck Ong, MD, an associate professor of Clinical Pediatrics at the Keck School of Medicine of the University of Southern California and an attending physician at Children's Hospital Los Angeles.

This study was completed in collaboration with the Asthma and Allergy Foundation of America in partnership with the National Eczema Association, sponsored by Sanofi Genzyme and Regeneron. Sanofi Genzyme and Regeneron manufacture dupilumab, but had no involvement in this research.

Cancer Patients Can Now Use Skin Creams During Radiation Therapy

Contrary to the advice most cancer patients receive when they go through radiation treatment, topical skin treatments, unless applied very heavily, do not increase the radiation dose to the skin and can be used in moderation before daily radiation treatments, according to a new study from the Perelman School of Medicine at the University of Pennsylvania.

While 91 percent of clinicians surveyed said they advised patients to avoid these skin treatments and 83 percent of patients surveyed said they'd received this guidance from their doctors, testing showed there was no difference in the radiation skin dose with or without these creams. The findings appear in JAMA Oncology.

Nearly two-thirds of all cancer patients in the United States will undergo radiation therapy as part of their treatment, and as many as 90 percent of those patients will experience radiation dermatitis. Both prescription and over-the-counter topical treatments are commonly used to give patients relief, some of which—such as silver sulfadiazine cream—contain heavy metals. However, patients have historically been advised to avoid using these treatments in the hours before radiation therapy to avoid increasing the amount of radiation absorbed by the skin.

The study tackled two key areas. First, it established that it's still common practice for physicians to advise patients to avoid applying skin care products prior to daily radiotherapy. Second, it largely debunked the myth that their use increases the amount of radiation the skin receives, thus causing more damage to the skin, unless an extremely thick layer of cream is used.

For the first part of the study, researchers utilized OncoLink, an online cancer service dedicated to patient and provider education that is run by Penn's Radiation Oncology unit. They developed a survey to find out what percentage of providers advise their patients to avoid topical agents just before radiation treatments and what percentage of patients say they received that advice. Of the 105 doctors and nurses who said they regularly manage radiation dermatitis for their patients, 96 of them (91 percent) said they regularly tell patients not to use skin creams during the hours before radiation treatment. On the patient side, 111 out of 133 respondents (83 percent) said they received the advice from their healthcare providers.

To address the question of whether these topical agents really do increase the dose of radiation to the skin, Researchers used optically stimulated luminescent dosimeters (OSLDs)—a common device for measuring the amount of surface radiation absorbed with each dose. They used three squares of paper: one with nothing on it, one with a layer of the petroleum-based over-the-counter ointment Aquaphor, and one with silver sulfadiazine cream, which is only available by prescription. They placed the squares of paper in the beam's path and measured the absorbed radiation dose with OSLDs. They ran the experiment with varying degrees of thickness for both products. While the surface dose did increase when a very thick layer of the topical agent was applied, researchers found no increase in the surface dose with a moderately thick layer.