Arcutis and Sato Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Japan
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The strategic collaboration between Arcutis Biotherapeutics and Sato Pharmaceutical represents a significant move in the pharmaceutical industry, specifically within the immuno-dermatology sector. The licensing agreement for topical roflumilast in Japan opens a new market for Arcutis, potentially increasing its revenue streams through upfront payments, milestone payments and royalties. The upfront payment of $25 million provides immediate non-dilutive capital, which is crucial for Arcutis to fund ongoing research and development without diluting shareholder equity. The potential additional $40 million tied to regulatory and sales milestones aligns the interests of both companies towards successful development and commercialization.
Topical roflumilast, as a next-generation phosphodiesterase type 4 (PDE4) inhibitor, offers a non-steroidal treatment option for patients with inflammatory skin diseases. This class of drugs works by modulating the inflammatory response, which is particularly relevant for conditions such as plaque psoriasis, seborrheic dermatitis and atopic dermatitis. The effectiveness and safety profile of roflumilast could position it as a strong competitor in the Japanese market, where there is a demand for new and improved dermatological treatments.
For investors, the deal signifies Arcutis's potential for international expansion and diversification of its revenue sources. It also indicates the company's ability to leverage its product portfolio to enter into strategic partnerships, which can be a positive indicator of management's business acumen and the company's future growth prospects.
The licensing of topical roflumilast for multiple dermatological conditions in Japan is a noteworthy development in the field of medical research. Roflumilast's mechanism of action as a PDE4 inhibitor targets a specific pathway involved in the inflammatory process. The clinical data suggesting its efficacy in clearing skin and reducing itch provides a promising therapeutic alternative to corticosteroids, which are commonly associated with a range of side effects when used long-term. This is particularly important in chronic skin conditions that require ongoing management.
From a research perspective, the potential expansion to additional dermatological conditions in the future underscores the versatility of roflumilast and its therapeutic potential beyond the current indications. The ongoing clinical development in Japan will be closely watched by the medical community, as it will provide further data on the drug's efficacy and safety within a diverse patient population. This could influence treatment guidelines and prescribing habits in the region, with possible global implications.
Japan represents a significant market for dermatological treatments, with a growing patient population seeking innovative therapies for skin conditions. The collaboration between Arcutis and Sato leverages Sato's established presence and market knowledge in Japan, which is critical for navigating the regulatory landscape and achieving market penetration. The exclusive license for both cream and foam formulations of topical roflumilast provides Sato with a competitive advantage in the dermatology space.
From a market perspective, the deal could serve as a catalyst for further market growth and innovation in the sector. The introduction of a novel, non-steroidal option like roflumilast may disrupt the current treatment paradigm and stimulate competition, potentially benefiting patients through more treatment choices and possibly driving down costs. Additionally, the success of this partnership could encourage other pharmaceutical companies to explore similar strategic collaborations to access untapped markets.
- Arcutis to receive a
$25 million upfront payment, and is eligible to receive potential development and commercial milestone payments (totaling$40 million ), as well as tiered, double-digit royalties - Agreement offers pathway to potentially offering a novel non-steroidal topical option to the millions of Japanese patients suffering from inflammatory skin diseases
WESTLAKE VILLAGE, Calif. and TOKYO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, and Sato Pharmaceutical Co., Ltd., a leading pharmaceutical company, today announced that the companies have entered into a strategic collaboration and licensing agreement for the development, manufacture, and commercialization of topical roflumilast in Japan. Sato will receive an exclusive license for both the cream and foam formulations of topical roflumilast, a next generation phosphodiesterase type 4 (PDE4) inhibitor, for multiple dermatological conditions including plaque psoriasis, seborrheic dermatitis, atopic dermatitis, and potentially additional dermatological conditions in the future.
“We are delighted to partner with Sato, who share our mission to provide meaningful innovation to individuals suffering from immune-mediated skin diseases. This partnership, built on topical roflumilast’s strong product profile, expands the market opportunity for this effective and well-tolerated steroid-free treatment for multiple skin conditions, and provides meaningful non-dilutive capital for us,” said Frank Watanabe, president and chief executive officer, Arcutis. “Sato’s enduring corporate commitment to helping patients achieve a more positive and enjoyable life makes them an ideal partner to bring topical roflumilast to the millions of people suffering from inflammatory skin diseases in Japan.”
“We are excited to partner with Arcutis, a leader in medical dermatology, on the heels of their successful U.S. launches of topical roflumilast in plaque psoriasis and seborrheic dermatitis. We eagerly anticipate the on-going clinical development and potential approvals in atopic dermatitis and scalp psoriasis. Topical roflumilast has been shown to effectively clear skin and reduce itch, with a safe and well-tolerated profile. With this collaboration, we believe we can make an impact for individuals suffering from immune-mediated skin diseases in Japan,” said Seiichi Sato, president and chief executive officer, Sato.
Under the terms of the agreement, Arcutis will receive an upfront payment of
Sato will be responsible for development, manufacturing, and commercialization of roflumilast cream and roflumilast foam and other topical roflumilast presentations in Japan. Arcutis will continue to be responsible for the development and commercialization of ZORYVE® (roflumilast) cream and ZORYVE® (roflumilast) foam in the United States and other geographies, excluding Greater China and Southeast Asia.
About Topical Roflumilast
Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective PDE4 inhibitor being investigated as a once-daily, nonsteroidal, topical treatment for multiple dermatologic conditions. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators.
INDICATIONS
ZORYVE cream
ZORYVE foam,
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.
The most common adverse reactions (≥
The most common adverse reactions (≥
Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including two FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, and X.
About Sato
Sato Pharmaceutical Co., Ltd., operating under its corporate philosophy of “Healthcare Innovation,” is a pharmaceutical company that provides effective, safe, and high-quality products for practicing selfcare, while always keeping the health of its customers in mind. In addition to its main consumer healthcare business, Sato Pharmaceutical also develops and provides highly original products primarily in the field of dermatology.
Forward Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for topical roflumilast to simplify disease management; the potential of real-world use results of topical roflumilast, as well as the commercial launch of ZORYVE cream in plaque psoriasis and ZORYVE foam in seborrheic dermatitis in the United States and other geographies. These forward-looking statements also include statements about the development and commercialization of topical roflumilast by our new partner in Japan, the potential receipt of payments associated with achievement of certain milestones, and the potential royalties from sales of commercialized products in Japan. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
asheldon@arcutis.com
Investors
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
FAQ
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