Roivant Sciences’ strategy to find shelved drug candidates and abandoned research from Big Pharma has paid off. A compound that Roivant obtained from GlaxoSmithKline now has FDA Approved for the treatment of the inflammatory skin disease plaque psoriasis, giving the company its first product to commercialize on its own.
The drug, Tapinarof, is being developed by Roivant subsidiary Deravant Sciences. The company will market the topical cream under the name “Vtama.” While other topical products are available to treat plaque psoriasis, many of these products first entered the market for other indications. Deravant said its product is the first new topical drug approved for plaque psoriasis in 25 years.Mark Lebwohl of the Icahn School of Medicine at Mount Sinai and lead author of the Phase 3 study post The drug Deravant has the potential to become the topical treatment of choice for patients with plaque psoriasis, it said in a prepared statement last year in the New England Journal of Medicine.
“After more than 20 years of minimal innovation in topical psoriasis treatment, I believe the approval of Vtama cream is an important step in establishing new treatment options for adults with mild, moderate and severe plaque psoriasis,” Lebwohl said.
Psoriasis is a chronic disease in which the body’s immune system attacks its own cells. The result of this attack is highlighted as red and dry patches on the skin. According to Dermavant, the condition affects about 8 million people in the United States and as many as 125 million people worldwide. Plaque psoriasis, the most common form of psoriasis, causes darker, thicker raised patches on the skin that can be itchy and painful.
Plaque Psoriasis Treatment Includes drugs that work by suppressing the immune system. Topical steroids are widely used for this condition, but long-term use can lead to thinning of the skin, and these drugs lose their effectiveness over time. These drugs can also cause problems if they are used on sensitive areas, such as the face and genitals. Several biologics have been approved for psoriasis, including products from Amgen, AbbVie, Johnson & Johnson, Eli Lilly and Sanofi. But these injectable drugs circulate throughout the body, which means that side effects can occur throughout the body. These blockbuster drugs are also very expensive. For both of these reasons, physicians typically put patients on topical products first, and only try biologics if the disease doesn’t respond.
Vtama is a steroid-free cream developed for once-daily application to the skin, including sensitive areas. The drug is a small molecule designed to block inflammatory proteins called cytokines. It is also designed to promote the normal appearance of the skin while reducing oxidative stress that contributes to inflammatory skin conditions. Deravant said in an article Investor introduction Its drugs could replace steroids as the standard of care for plaque psoriasis.
The FDA’s approval of Deravant’s drug was based on results from two pivotal studies that enrolled more than 1,000 patients. In both studies, the drug met the primary goal of a statistically significant improvement in skin appearance after 12 weeks of treatment, compared to the cream without the active ingredient. Adverse events reported in the study were mild to moderate and included inflammation of the hair follicles, nose and throat irritation, and contact dermatitis, which is red and itchy skin due to allergic reactions. Unlike biologics approved for plaque psoriasis, Vtama’s drug label does not warn of any serious adverse reactions. In addition, topical creams had long-lasting effects once treatment was discontinued and skin clearance lasted for a median of four months.
Deravant set a wholesale price of $1,325 for a tube of Vtama, which is more expensive than some topical plaque psoriasis products currently available, but less than the $1,950 wholesale price of Incyte’s topical cream Opzelura. Incyte product approved last September to cover atopic dermatitis, a different autoimmune skin disease. Doctors are free to prescribe atopic dermatitis products for plaque psoriasis, and they often do. In its investor presentation, Deravant said Vtama’s price reflects its differentiated image and drug label, reflecting the strongest skin-clearing effects of topical plaque psoriasis products.
although Roivant diversifies its drug development approach, whose original business model involved finding drug assets that were overlooked or stagnant at Big Pharma, and then acquiring the rights to them. Around each compound, the company established subsidiaries, called “Vants”, each of which shared the resources of the parent company. Deravant is currently one of 14 Vant companies.
Dermafan in 2018 £150m to be paid to GlaxoSmithKline (approximately $191 million) for Tapinarof’s worldwide rights, excluding China. Dermavant will pay GSK £100 million ($133 million) as the drug is approved in the US. According to the purchase agreement, payment must be made within 70 days of the approval decision. GlaxoSmithKline no longer owes any payments, royalties or other payments. However, Dermavant took on GlaxoSmithKline’s obligations to British Columbia-based Welichem Biotech, from which the British pharmaceutical giant bought Tapinaloff. Under the agreement, Dermavant is responsible for paying Welichem up to C$80 million (approximately US$61 million) in development milestone payments and up to C$100 million (approximately US$76 million) related to commercialization milestones.
While Vtama marks Roivant’s first drug approval, it’s not the first for Vant to pass regulatory requirements. In 2019, Japan’s Sumitomo Dainippon Pharmaceutical spent $3 billion to acquire 5 Vants. These companies continue to receive FDA approval overactive bladderadvanced prostate cancer, Uterine fibroids bleedingand Congenital arrhythmia in children.
Deravant’s primary asset plans to go beyond plaque psoriasis. Last September, the company started a Phase 3 study testing the drug for atopic dermatitis. The program will enroll up to 800 participants, including adults and children with moderate to severe disease. Preliminary data from both studies are expected in the first half of next year. Deravant’s chief medical officer, Philip Brown, said the company is also exploring additional potential uses for the drug in dermatology and other immunological indications.
Image via Roivant Sciences Investor Presentation
