Roivant Sciences GmbH

WALTHAM, Mass.--( BUSINESS WIRE )--Scipher Medicine, a leader in precision medicine for autoimmune diseases, and Roivant, a global biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter, today announced a strategic partnership to advance rheumatology drug discovery and development by integrating Scipher’s real-world clinical and genomic data insights into Roivant’s research and development efforts. This collaboration will leverage Scipher's unique data and intelligence derived from its PrismRA® precision medicine diagnostic. Financial terms were not disclosed. Scipher's PrismRA® test uses 19 genomic markers to identify patients who are unlikely to respond to specific rheumatoid arthritis (RA) therapies, enabling personalized treatment decisions. By integrating data and insights derived from the development and commercialization of PrismRA®, Roivant will leverage a unique and powerful data asset to inform its drug development pipeline. "This strategic partnership unites the strength of precision medicine with real-world evidence to accelerate the development and delivery of transformative therapies," said Reg Seeto, Scipher’s CEO. Reg continued, “By combining Scipher's unique rheumatology data assets with Roivant’s proven track record of bringing innovative medicines to market, we are poised to advance personalized medicine and improve patient lives." "We are excited to partner with Scipher Medicine to further enhance our data and insight capabilities,” said Brett Venker, Head of Real World Evidence at Roivant. "The combination of genetic data with longitudinal patient records offers a powerful opportunity to uncover deeper insights into disease progression and treatment response, enabling more precise and informed decision-making. Integrating Scipher's rich dataset will empower us to generate critical insights, accelerate our decision-making process, and advance the development of potentially transformative therapies for patients." About Scipher Medicine Scipher Medicine is driving the probability of success at each stage of drug development from discovery to commercialization by leveraging AI with network biology, and proprietary data, through our SPECTRA Rx and Dx platforms. Scipher has the industry’s largest RA genomic data asset and biobank in addition to EMR data for over 3 million rheumatology patients. For more information, please visit www.sciphermedicine.com . About PrismRA® PrismRA is a revolutionary blood test bringing precision medicine to the treatment of rheumatoid arthritis, which affects 20 million patients globally. From a routine blood draw, the PrismRA test analyzes an individual’s molecular signature, helping identify who is unlikely to adequately respond to TNFi therapy, the world’s largest selling drug class, so non-responders can be prescribed alternative effective therapy and avoid unnecessary dose escalations or drug cycles. Providers now have objective data to inform therapeutic decision-making and give patients the best chance of achieving treatment targets and improving clinical outcomes. For more information, please visit PrismRA.com .

Teva and Sanofi announced positive mid-stage results ahead of schedule for their inflammatory bowel disease candidate as they look to keep pace in an anti-TL1A race with Merck and Roche. The duo’s duvakitug met the primary endpoints in a Phase 2b trial evaluating patients with ulcerative colitis and Crohn’s disease, two forms of IBD, Teva and Sanofi said Tuesday morning. In ulcerative colitis, 36.2% of patients taking a low dose of duvakitug and 47.8% of patients taking a high dose achieved clinical remission, compared to 20.45% of placebo patients at week 14. P-values came in at 0.05 and 0.003 for the low and high doses, respectively. In Crohn’s disease, 26.1% of low-dose duvakitug patients and 47.8% of high-dose patients saw an endoscopic response as measured by a scoring system for Crohn’s severity, compared to 13% on placebo (p-values were 0.058 for the low dose and <0.001 for the high dose). While 0.05 is typically considered the gold standard for assessing statistical significance, a Teva spokesperson said the Phase 2 study had a “one-sided test at a significance of 0.1.” The partners said duvakitug was “generally well-tolerated,” with similar rates of treatment-emergent adverse events occurring in the treatment and placebo arms. Sanofi put down €469 million ($500 million) upfront in a deal to co-develop and co-commercialize duvakitug with Teva in October 2023. The anti-TL1A contest also includes Roche, which put down $7.1 billion upfront in late 2023 to acquire Roivant’s subsidiary Telavant and RVT-3101. Merck is also a rival, following its acquisition of Prometheus Biosciences and its MK-7240 in a deal worth $10.8 billion. The duvakitug topline results came earlier than expected, due to “significant acceleration in patient recruitment,” Sanofi and Teva said back in July. As a result, they skipped an interim analysis which was originally planned for the second half of this year. Now, the partners said they plan to initiate a Phase 3 trial in 2025 in IBD “pending regulatory discussions.” A Teva spokesperson declined to share further specifics on the timing of Phase 3 initiation or the dose that will be taken forward. Each company will share the development costs globally, while Sanofi will lead Phase 3 development. Teva will lead commercialization in Europe, Israel and certain other countries, and Sanofi will take the commercial lead in North America, Japan and other parts of Asia, and the rest of the world. Editor’s Note: A correction has been made to reflect that Teva and Sanofi are studying duvakitug in inflammatory bowel disease, not irritable bowel disease.

Organon won a label expansion on Friday for the steroid-free topical cream it picked up from its October acquisition of Dermavant. Vtama, also known as tapinarof, is now approved to treat adults and children two years and older with atopic dermatitis, according to an FDA notification . The agency had delayed its decision last month, notifying Organon that the submission of additional datasets from a long-term extension study would push its action date to March. But the approval ended up coming months ahead of schedule. Organon struck a $1.2 billion deal for Dermavant in September, including $175 million upfront and a $75 million milestone payment hinging on an approval in atopic dermatitis. The deal included commercial milestone payments of up to $950 million. Vtama was first approved in 2022 for adults with plaque psoriasis. Dermavant, formerly a Roivant subsidiary, previously said that the atopic dermatitis market is three to four times larger than the plaque psoriasis market. As of May 2024, more than 385,000 Vtama prescriptions had been written in plaque psoriasis, according to Roivant. Vivek Ramaswamy’s team announced a deal to acquire Vtama from GSK back in 2018 for close to $200 million upfront.