Axovant Sciences, Inc.

About a year ago, drugmaker Roivant Sciences set up a new subsidiary around a promising inflammatory disease treatment it had just partially licensed from Pfizer.On Monday, Roivant, a biotechnology company founded a decade ago by U.S. presidential candidate Vivek Ramaswamy, said it will sell that subsidiary to Roche for approximately $7.1 billion.The deal, and its quick and spectacular return for Roivant, spotlights a pharmaceutical industry gold rush for more effective drugs to treat immune system conditions. It follows Sanofis alliance with Teva Pharmaceutical on a medicine similar to Roivants, Merck & Co.s $10.8 billion acquisition of Prometheus Biosciences and Takedas $4 billion purchase of a psoriasis medicine from Nimbus Therapeutics.Through the deal, Roche will acquire the subsidiary, called Telavant, and gain rights to the drug in the U.S. and Japan. The Swiss pharmaceutical company is also promising a near-term milestone of $150 million.Code-named RVT-3101, Roivants treatment is being studied for inflammatory bowel disease, a common gut ailment that encompasses ulcerative colitis and Crohns disease. It works by blocking a regulatory protein known as TL1A, the same target as Prometheus and Tevas drugs.Mid-stage trial results in ulcerative colitis showed that, after 14 weeks, Roivants treatment cleared up signs of disease in about 30% of patients treated with the dose intended for further study. The drug also led to improvements on imaging exams in slightly more than one-third of trial participants.More recent data unveiled by Roivant in June proved those benefits endured and even grew through one year, raising expectations among Wall Street analysts of the drugs blockbuster potential.We strongly believe this novel TL1A directed antibody has the transformational potential to make a significant difference for patients living with inflammatory bowel disease and potentially other diseases, said Roche CEO Thomas Schinecker in a statement.Roche plans to advance the drug into a global Phase 3 clinical trial in inflammatory bowel disease as soon as possible. The companies expect their deal to close in either the fourth quarter or the first quarter of next year.Its not unusual for drugs cast off by one pharma to later end up at another. But the speed by which RVT-3101 passed from Pfizer to Roivant and then to Roche, all while increasing dramatically in value, is.Still, Pfizer retained 25% ownership in the subsidiary Roivant set up around the drug a stake now worth about $1.7 billion as well as the rights to sell it outside of the U.S. and Japan.Under the deal, Roche will also hold an option to collaborate with Pfizer on a next-generation version of the drug, an antibody directed at both TL1A and another therapeutic target called p40. That treatment is now in Phase 1 testing.For Roivant, the deal is a high-profile success for its business model, whereby it develops or licenses experimental medicines it then houses in subsidiaries, or Vants, that it can spin off or sell. One of these Vants, dubbed Dermavant, last year won U.S. approval for a plaque psoriasis cream, while another, Priovant, is developing a Pfizer drug for an inflammatory skin condition and for lupus.A third, Immunovant, recently released promising trial data for an experimental autoimmune disease drug, results that may have helped catalyze Roivants deal with Roche.Yet Roivant has hit setbacks, too. An early Vant called Axovant gained attention for licensing a shelved GSK drug for Alzheimers and raising hundreds of millions of dollars on its revitalized potential. But late-stage testing showed the drug didnt work, causing Axovant to pivot, change its name and eventually shut down.Ramaswamy, who has launched a long-shot campaign to win the Republican nomination for president in the 2024 election, resigned as chairman of Roivants board in February. He had stepped down as the companys CEO in 2021, handing leadership over to current chief executive Matthew Gline. '

Manasi Vaidya @manasivaidya22 Prospective candidates at the first Republican primary debate held in Milwaukee, Wisconsin. Last night, the US 2024 election cycle kicked off with the first Republican primary debate involving eight candidates on the stage vying for the role of a frontrunner in the national elections next year. The televised debates provide a platform for the candidates to state their positions on various national policies, including those for the broader healthcare sector. Given the significant role played by US pharma companies, the potential presidential candidate’s approach to wider corporate tax laws and manufacturing investment can also impact the pharmaceutical sector on a more international level. This year’s primary had an additional pharma connection— Roivant Sciences founder Vivek Ramaswamy. Recommended Reports Reports Head and Neck Squamous Cell Carcinoma - Global Drug Forecast and Market Analysis to 2030 GlobalData Reports Pharmaceuticals Industry Mergers and Acquisitions Deals by Top Themes in Q1 2022 - Thematic Research GlobalData View all Companies Intelligence GSK plc Roivant Sciences Ltd Sio Gene Therapies Inc Ira View all Ramaswamy, who sold his profile as an entrepreneur, having “found[ed] multibillion dollar companies”, was at the centre of the stage leading in the polls ahead of other seasoned politicians. Ramaswamy is known for founding a network of biotechs or “-vants” like Dermavant , Axovant, Urovant and others that are listed as subsidiaries of the parent company Roivant Sciences. Over the last decade, the companies have raised hundreds of millions of dollars through venture capital and the stock markets, building a pipeline by in-licensing drugs from other companies. However, only one drug across all companies has crossed the approval line, namely Vtama (tapinarof), which was also licensed by Dermavant from GSK in 2018. Vtama is a topical cream that acts as a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) to treat plaque psoriasis. The drug has also been studied as an atopic dermatitis treatment in Phase III trials, and an NDA is expected in Q1 2024. As per Roivant’s earnings, Vtama gained $16.7m in revenues in Q2. Another high-profile bet, which had initially contributed to the high company valuations, was the Alzheimer’s drug intepirdine developed by Axovant that failed in a Phase III trial in 2017. Axovant, which raised $315m in an IPO in 2015, later changed its name to Sio Gene Therapies and was most recently dissolved in April 2023. Florida Governor Ron DeSantis brought up the ongoing fentanyl crisis in connection to other border issues, but the topic was largely ignored in the debate despite rising overdose cases in the country. The closest the debate got to touching on pharma was when Ramaswamy decried “drugging up people in mental health institutions” with psychiatric drugs like the selective serotonin reuptake inhibitor (SSRI) Zoloft (sertraline) and Seroquel (quetiapine) in favour of opening more institutions and calling for a “tonal reset” in several areas. One notable omission was any discussion of the Inflation Reduction Act (IRA), which was passed last year and is being touted by the Biden administration as a major endeavour to curb rising drug prices. The IRA is said to boost the development of biologics over small molecules, given the longer protection periods for price controls . This was one of three planned Republican debates before the eventual candidate will be announced at the RNC convention next summer, before the general elections in November 2024. Healthcare costs will be expected to be a hot-button topic in the eventual election cycle given inflationary pressures and the lack of a consensus on ways to deal with it across the aisle.

Vivek Ramaswamy is attempting to make a unique transition from being a biotech founder to president of the U.S. For those of us old enough to remember Vivek Ramaswamy as the founder of Roivant and its continuously expanding group of biotech subsidiaries, his presidential campaign at the age of 38 came as a significant shift in his career trajectory. Ramaswamy seems to be positioning himself politically between former President Donald Trump, currently leading the polls as the potential Republican candidate for the 2024 election, and struggling Florida Gov. Ron DeSantis. DeSantis had previously centered his campaign around an "anti-woke" platform, but, following the dismissal of much of his team, he appears to be attempting a minor reset. Outside the life sciences world, Ramaswamy, who was born in Ohio to immigrant parents from India and earned a biology degree from Harvard University and then finished Yale Law School, was something of an unknown and for months polled poorly. However, he has jumped in the polls this summer.  While Trump remains the front-runner, Ramaswamy has surpassed former Vice President Mike Pence and is now in contention with DeSantis for the second position. Some are even considering him as a potential vice presidential candidate, although it seems he's not inclined toward that role.   His political strategy involves appealing to Trump supporters while delicately avoiding direct criticism of Trump in his speeches, unlike Pence and, to a lesser extent, DeSantis. While Trump rallies around the slogan "MAGA" (Make America Great Again), Ramaswamy rallies around the concept of "TRUTH," a slogan prominently displayed at his numerous speeches. Ramaswamy is in many ways a traditional Republican, wary of government as a force in society, and is also “anti-woke” and against most environmental, social and corporate governance policies, especially those that restrict economic growth. However, he also leans outside of its traditional boundaries: At 38, he’s the youngest Republican candidate for president and much younger than the 77-year-old Trump and the 80-year-old President Joe Biden. He has proposed raising the voting age to 25 for the majority of U.S. voters and advocates for significant reductions in the federal workforce. Additionally, he aims to make substantial cuts to institutions such as the FBI and the Education Department. Perhaps strangely given his background, he initially talked very little about the pharmaceutical industry or the FDA, but that changed last month. In a video posted to X, the platform formerly known as Twitter, he said he would look to “gut” the FDA, which he referred to as being "corrupt."  “Countless FDA regulations and actions are hypocritical, harmful & unconstitutional. I will rescind them accordingly," he wrote in a recent post on X. "For years I was coached by industry veterans not to speak out against FDA. It’s well known that if you anger FDA, they will punish you by blackballing review of your drug review applications. 'FDA never forgets' is a quietly-whispered, well-known pharma industry adage. Well, they could only shut me up for so long. Now I speak freely as a citizen.” His financial success predominantly comes from his Roivant biotech business. The core idea behind the Roivant clusters was buying up old pharma castoffs and either retrying in the clinic or tweaking into a new area not tried before. Many of Roivant’s companies were eventually sold off with some having to pivot after major flops, with Axovant the most prominent in the failure department, having to become a gene therapy company after its leading Alzheimer’s disease hopeful failed to make the grade in a key trial. Others had better fortunes, such as Myovant, which along with partner Pfizer got a recent FDA nod for its menstrual bleeding drug Myfembree.  While not the most innovative founder and biotech leader in terms of the science of his companies, Ramaswamy was good at attracting genuine management talent, and, most importantly, cash. This is likely to work in his favor for his run as the Republican nominee. The likelihood of him surpassing Trump's lead is currently quite low. Being a first-time candidate with no prior public office experience puts him at a disadvantage against a former president who still maintains a highly loyal base of supporters.