Viatris seeks Japan approval for first GAD treatment

PITTSBURGH - Viatris Inc. (NASDAQ:VTRS), a global healthcare company with a market capitalization of $9 billion and currently considered undervalued according to InvestingPro analysis, announced today that it has submitted applications to Japan’s Ministry of Health, Labor and Welfare (MHLW) for the approval of Effexor SR Capsules (venlafaxine hydrochloride) to treat adults with generalized anxiety disorder (GAD). The company, which maintains a healthy 41.7% gross profit margin and pays a notable 6.4% dividend yield, continues to expand its global presence. This comes as a significant development since there are currently no approved treatment options for GAD in Japan.

The company’s Phase 3 study in Japan, which was placebo-controlled, randomized, double-blind, and multicenter, demonstrated the anxiolytic superiority of venlafaxine over placebo at 8 weeks, as measured by the Hamilton Anxiety Rating Scale (HAM-A). This development comes as Viatris maintains a solid financial position with a current ratio of 1.65 and generates significant free cash flow, demonstrating its capacity for continued research and development investments. The study met all seven secondary efficacy endpoints. These findings, along with data from a long-term extension study, form the basis of the applications submitted to the MHLW.

Philippe Martin, Viatris Chief R&D Officer, stated, "The filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalized anxiety disorder to adults in Japan." He emphasized the importance of the Phase 3 efficacy and safety studies in laying the groundwork for the applications.

GAD is characterized by persistent and excessive worry, with symptoms that can include sleep disturbances, muscle tension, restlessness, irritability, and difficulty concentrating. These symptoms often impair social, occupational, or other areas of functioning. According to the World Health Organization, 2.6% of the Japanese population will suffer from GAD in their lifetime, with recent studies suggesting that the disorder may be significantly underdiagnosed.

Effexor is already approved in Japan for the treatment of major depressive disorder in adults and is approved for GAD in over 80 countries outside Japan. Selective serotonin reuptake inhibitors (SSRIs) and SNRIs like Effexor are recommended as first-line drug therapies for GAD in other countries.

The information in this article is based on a press release statement from Viatris Inc. The company is known for bridging the divide between generics and brand medications, aiming to address global healthcare needs. Viatris supplies medicines to approximately 1 billion patients annually and has an extensive portfolio that includes treatments for a wide range of health challenges. With annual revenue of $14.7 billion and analysts forecasting profitability this year, Viatris demonstrates strong market presence. For deeper insights into Viatris’s financial health and growth potential, including additional ProTips and comprehensive valuation metrics, visit InvestingPro, where you’ll find detailed analysis and expert research reports.

In other recent news, Viatris Inc. has reached a settlement framework to address opioid-related claims in the United States, agreeing to pay up to $335 million over nine years. This settlement is not an admission of wrongdoing and aims to aid state and local efforts to combat opioid issues. In another development, Jefferies adjusted its price target for Viatris to $13, maintaining a Buy rating, while Piper Sandler lowered its target to $10, retaining a neutral stance. The analysts cited operational challenges at Viatris’ Indore facility as a factor influencing their revisions. Furthermore, S&P Global Ratings downgraded Viatris’ credit rating to ’BB+’ from ’BBB-’ due to high leverage expectations, partly due to an FDA warning letter concerning the Indore site. Despite these challenges, Viatris continues to generate strong free cash flow, allowing for product pipeline enhancements and debt reduction. The company also appointed Hemanth J. Varghese as Chief Strategy Officer, anticipating his role in driving future growth. These developments reflect ongoing strategic adjustments and financial maneuvers within Viatris as it navigates current challenges and prepares for future expansion.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.