Roivant's board of directors has approved a share repurchase program for up to $1.5 billion of the company's common shares, including an agreed repurchase of the entire Sumitomo Pharma stake for $648 million
Sumitomo Pharma repurchase reduces shares outstanding by 9%
In the Phase 2 NEPTUNE study of once-daily oral brepocitinib in non-infectious uveitis (NIU), the 45 mg results represent the best Treatment Failure rates observed to date among active NIU studies measuring this registrational endpoint
29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met the pre-specified primary efficacy endpoint of Treatment Failure at week 24 (lower failure rates reflect greater treatment benefit). The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm
All secondary efficacy endpoints were also positive and dose responsive, including measurements of potential benefit on prevention and treatment of uveitic macular edema
NEPTUNE represents the seventh positive Phase 2 study for brepocitinib with over 1,400 subjects and patients treated with brepocitinib in clinical trials. Brepocitinib was generally safe and well-tolerated in the study; no new safety and tolerability signals were identified
Brepocitinib is well positioned to support a potential multi-blockbuster franchise in specialty autoimmunity with an ongoing pivotal study in dermatomyositis on track to read out in calendar year 2025 and expected initiation of a pivotal program in NIU in the second half of calendar year 2024
Roivant will host an investor call to discuss the updates at 8 a.m. EDT on Tuesday, April 2, 2024
BASEL, Switzerland and LONDON and NEW YORK, April 02, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis (NIU), showing the strongest efficacy data in NIU observed to date. Roivant also announced that its board of directors has authorized a share repurchase program for up to $1.5 billion of the company's common shares, including the repurchase of all 71.3 million shares held by Sumitomo Pharma at a purchase price of $9.10 per share. The aggregate purchase price for the Sumitomo Pharma transaction is approximately $648.4 million and will reduce Roivant's shares outstanding as of February 9, 2024 by approximately 9%.
"The striking NIU data underscore Roivant's continued commitment to developing effective medicines in underserved indications with high unmet need, such as for these patients who are at risk of blindness. We are extremely pleased to share these positive data. We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma. This transaction along with further potential buybacks reduces shareholder concentration and efficiently retires shares, increasing our continuing shareholders' exposure to developments in NIU and to the rest of our upcoming clinical data and company progress," said Matt Gline, CEO of Roivant.
The NEPTUNE study enrolled 26 subjects with active NIU who were randomized 2:1 to brepocitinib 45 mg once daily or brepocitinib 15 mg once daily. Patients, physicians, and the study team were blinded to dose. All subjects received a 60 mg/day prednisone burst at study entry for two weeks and were tapered off prednisone per protocol by week 8 (six-week steroid taper). Subjects were evaluated for Treatment Failure, a registrational composite endpoint comprising multiple measures of ocular inflammation and visual acuity, as well as discontinuation due to intercurrent events or initiation of rescue therapy. The study's primary efficacy endpoint was the Treatment Failure rate at week 24.
At week 24, 29% (5/17) of subjects in the brepocitinib 45 mg arm and 44% (4/9) of subjects in the brepocitinib 15 mg arm met Treatment Failure criteria, with lower failure rates reflecting greater treatment benefit. The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm. These observed results represent approximately twice the observed benefit as seen in the corresponding registrational study for the only approved non-steroidal therapy in NIU.
All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose responsive. Of patients in the brepocitinib 45 mg arm who met the threshold for uveitic macular edema at baseline, 43% achieved resolution of macular edema by week 24. No patients in the brepocitinib 45 mg arm who entered the study without macular edema developed macular edema by week 24.
Safety and tolerability were consistent with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely prescribed JAK inhibitors. Additional safety and efficacy data will be presented at a future medical conference.
"Non-infectious uveitis is a devastating disease that can lead to severe visual impairment and contribute to tens of thousands of cases of legal blindness in the United States each year, including many instances of irreversible blindness," said Quan Dong Nguyen, MD, MSc, FARVO, FASRS, NEPTUNE investigator and Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Pediatrics at Stanford University School of Medicine. "Current treatment options provide inadequate benefits to many patients; thus, novel pharmacotherapeutic agents with better efficacy and more convenient methods of administration are urgently needed. Brepocitinib's striking results on multiple endpoints of clinical significance position the drug to become a potentially transformative once-daily oral therapy for this debilitating disease and reinforce the distinctive mechanistic benefits of dual TYK2/JAK1 inhibition for highly inflammatory autoimmune diseases with multiple pathogenic cytokines, such as non-infectious uveitis."
"The NEPTUNE study was designed to minimize likelihood of false signals of benefit, by tapering patients with active disease from 60 mg/day of prednisone to 0 mg/day in just six weeks, more than twice as fast as steroid tapers in precedent studies," said Ben Zimmer, CEO of Priovant. "Against that backdrop, we are thrilled to see a failure rate of only 29% in the brepocitinib 45 mg arm, better than any precedent study was able to achieve even with more lenient tapers. The magnitude and consistency of dose-dependent benefit across multiple independent measurements of inflammation, visual acuity, and macular edema give us high confidence heading into Phase 3. The results further point to a potentially highly differentiated product profile for brepocitinib in NIU—an orphan indication with high prevalence, severe morbidity, and few other therapies approved or in development."
Priovant intends to initiate a Phase 3 program in NIU in the second half of calendar year 2024. The company would like to thank all of the investigators and patients who participated in the NEPTUNE study.
The ongoing Phase 3 study evaluating brepocitinib in dermatomyositis is expected to be fully enrolled in the third calendar quarter of 2024, with data expected in calendar year 2025.
Share Repurchase Program & Sumitomo Pharma Repurchase
Roivant's board of directors has authorized a common share repurchase program, allowing for repurchases of Roivant common shares in an aggregate amount of up to $1.5 billion. The repurchase program will be funded with available cash and cash equivalents on hand and does not have an expiration date. The timing and total amount of common shares to be repurchased will depend on several factors, including the market price of the company's common shares, general business, macroeconomic and market conditions, and other investment opportunities. Under the repurchase program, purchases may be conducted through open market transactions, tender offers or privately negotiated transactions, including the use of trading plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended.
Pursuant to the share repurchase program, on April 2, 2024, Roivant entered into a share repurchase agreement with Sumitomo Pharma to repurchase all 71,251,083 common shares held by Sumitomo Pharma at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. The repurchase transaction with Sumitomo Pharma is expected to close on or about April 4, 2024.
The repurchase program may be suspended or discontinued at any time. There can be no assurances as to how many additional common shares the company will repurchase under the program, if any, or at what prices any purchases will be made.
Investor Call
An investor call and webcast will be held at 8 a.m. EDT on April 2, 2024, to discuss the Phase 2 NEPTUNE study results for brepocitinib in NIU and Roivant's share repurchase program. To access the conference call by phone, please register online using this registration link. The presentation and webcast details are also available under "Events & Presentations" in the Investors section of the Roivant website at The archived webcast will be available on Roivant's website after the conference call.
Roivant董事會已批准一項公司高達15億美元普通股的股票回購計劃,包括同意以6.48億美元的價格回購住友製藥的全部股份
住友製藥的回購使已發行股票減少了9%
在NEPTUNE對非感染性葡萄膜炎(NIU)每天口服一次brepocitinib的2期研究中,45 mg的結果代表了迄今爲止在測量該註冊終點的活躍NIU研究中觀察到的最佳治療失敗率
在接受45mg佈雷波西替尼的受試者中,有29%和接受brepocitinib 15 mg的受試者中有44%在第24周達到了預先規定的治療失敗的主要療效終點(較低的失敗率反映了更大的治療益處)。在brepocitinib 45 mg組中,因疾病活動(停藥審查)而導致的治療失敗率爲18%
所有次要療效終點也均爲陽性和劑量響應,包括對預防和治療葡萄膜黃斑水腫的潛在益處的測量
NEPTUNE是第七項brepocitinib的2期陽性研究,在臨床試驗中有1,400多名受試者和接受佈雷波西替尼治療的患者。在研究中,佈雷波西替尼總體上是安全的,耐受性良好;沒有發現新的安全性和耐受性信號
Brepocitinib完全有能力支持特種自身免疫領域潛在的多重磅專營權,一項正在進行的皮肌炎關鍵研究有望在2025日曆年公佈,並有望在2024日曆年下半年啓動一項有關NIU的關鍵項目
Roivant將於美國東部時間2024年4月2日星期二上午8點舉行投資者電話會議,討論最新情況
瑞士巴塞爾、倫敦和紐約,2024年4月2日(GLOBE NEWSWIRE)——Roivant(納斯達克股票代碼:ROIV)和Priovant Therapeutics今天宣佈了評估佈雷波西替尼治療非前部非感染性葡萄膜炎(NIU)的2期研究(NEPTUNE)的積極結果,顯示了迄今爲止觀察到的最強NIU療效數據。Roivant還宣佈,其董事會已批准一項公司高達15億美元的普通股的股票回購計劃,包括以每股9.10美元的收購價回購住友製藥持有的全部7,130萬股股票。住友製藥交易的總收購價約爲6.484億美元,並將使Roivant截至2024年2月9日的已發行股票減少約9%。
“令人震驚的NIU數據突顯了Roivant持續致力於爲服務不足、需求未得到充分滿足的適應症(例如這些有失明風險的患者)開發有效的藥物。我們非常高興分享這些積極的數據。我們還很高興地宣佈我們的授權股票回購計劃,以及我們同意回購住友製藥擁有的所有股份。這筆交易以及進一步的潛在回購降低了股東集中度,有效地退回了股票,從而增加了我們的股東對NIU發展以及我們即將發佈的其餘臨床數據和公司進展的持續敞口。” Roivant首席執行官馬特·格林說。
NEPTUNE研究招收了26名活性NIU受試者,他們以 2:1 的比例隨機分配給佈雷波西替尼每天一次 45 mg 或brepocitinib 15 mg,每日一次。患者、醫生和研究小組對劑量視而不見。所有受試者在進入研究時都接受了爲期兩週的每天60毫克潑尼松的注射量,並在第8周(類固醇逐漸減少六週)之前逐漸減少了每個方案的潑尼松的使用量。對受試者進行了治療失敗評估,這是一種註冊性複合終點,包括眼部炎症和視力的多種衡量標準,以及因併發事件或啓動救援治療而停藥的情況。該研究的主要療效終點是第24周的治療失敗率。
在第24周,佈雷波西替尼45 mg組中有29%(5/17)的受試者和brepocitinib 15 mg組中有44%(4/9)的受試者符合治療失敗標準,失敗率較低反映出更大的治療益處。在brepocitinib 45 mg組中,因疾病活動(停藥審查)而導致的治療失敗率爲18%。這些觀測結果大約是NIU中唯一獲批准的非甾體療法的相應註冊研究中觀測到的益處的兩倍。
整個第24周的次要療效終點,包括霧霾等級、視力和黃斑厚度,也均爲陽性且劑量響應。在brepocitinib 45 mg組中達到基線葡萄膜黃斑水腫閾值的患者中,有43%的患者在第24周之前實現了黃斑水腫的緩解。截至第24周,brepocitinib 45 mg組中沒有黃斑水腫的患者沒有出現黃斑水腫。
安全性和耐受性與先前對brepocitinib的臨床研究一致,沒有發現新的安全性或耐受性信號。Brepocitinib已在1,400多名受試者和患者中服用,其安全性似乎與已獲批准和廣泛處方的JAK抑制劑一致。其他安全性和有效性數據將在未來的醫學會議上公佈。
拜爾斯眼科研究所海王星研究員兼眼科教授、斯坦福大學醫學院醫學和兒科教授阮全東說:“非傳染性葡萄膜炎是一種毀滅性的疾病,可能導致嚴重的視力障礙,每年在美國造成成千上萬的合法失明病例,包括許多不可逆的失明病例。”“目前的治療方案對許多患者提供的益處不足;因此,迫切需要具有更好療效和更便捷給藥方法的新型藥物治療藥物。Brepocitinib在具有臨床意義的多個終點上取得了驚人的成果,這使該藥物成爲治療這種虛弱性疾病的潛在變革性每日一次的口服療法,並增強了雙TYK2/JAK1抑制對具有多種致病細胞因子的高炎性自身免疫性疾病(例如非感染性葡萄膜炎)的獨特機制優勢。”
Priovant首席執行官本·齊默爾說:“NEPTUNE研究旨在通過在短短六週內將活動性疾病患者的潑尼松從每天60毫克減少到0毫克/天,是先前研究中類固醇逐漸減少的兩倍多,從而最大限度地減少虛假獲益信號的可能性。”“在這種背景下,我們很高興看到brepocitinib 45 mg組的失敗率僅爲29%,這比任何先前研究即使在更寬鬆的情況下也能達到的都要好。通過對炎症、視力和黃斑水腫的多次獨立測量,劑量依賴性益處的規模和一致性使我們對進入第三階段充滿信心。研究結果進一步表明,brepocitinib在NIU中的產品特徵可能具有高度差異化——這是一種孤兒適應症,患病率高,發病率高,其他療法很少獲得批准或正在開發。”
Priovant打算在2024日曆年下半年啓動NIU的第三階段計劃。該公司要感謝所有參與海王星研究的研究人員和患者。
正在進行的評估brepocitinib治療皮肌炎的3期研究預計將於2024年第三日曆季度全面入組,數據預計將於2025年日曆年公佈。
股票回購計劃和住友製藥回購
Roivant董事會已批准一項普通股回購計劃,允許回購總額高達15億美元的Roivant普通股。回購計劃將由手頭的可用現金和現金等價物提供資金,並且沒有到期日。回購普通股的時間和總額將取決於多個因素,包括公司普通股的市場價格、一般業務、宏觀經濟和市場狀況以及其他投資機會。根據回購計劃,可以通過公開市場交易、要約或私下談判的交易進行購買,包括使用經修訂的1934年《證券交易法》第10b5-1條規定的交易計劃。
根據股票回購計劃,Roivant於2024年4月2日與住友製藥簽訂了股票回購協議,以每股收購價9.10美元回購住友製藥持有的全部71,251,083股普通股,總收購價約爲6.484億美元。與住友製藥的回購交易預計將於2024年4月4日左右完成。
回購計劃可以隨時暫停或終止。無法保證該公司將根據該計劃額外回購多少普通股(如果有),也無法保證將以什麼價格進行任何收購。
投資者電話會議
投資者電話會議和網絡直播將於美國東部時間2024年4月2日上午8點舉行,討論NIU和Roivant股票回購計劃中brepocitinib的第二階段研究結果。要通過電話參加電話會議,請使用此註冊鏈接在線註冊。演示和網絡直播的詳細信息也可以在Roivant網站的 “投資者” 部分的 “活動與演講” 下找到。電話會議結束後,存檔的網絡直播將在Roivant的網站上公佈。