新基多款重磅藥物涉及專利糾紛和專利懸崖,BMS是否放棄交易?

新基製藥的潛在重磅藥物 ozanimod 商業化的一個潛在障礙是知識產權。過去幾周,百時美施貴寶一直在忙於平息投資者對這筆交易的擔憂,該公司正在努力淡化風險。

新基多款重磅藥物涉及專利糾紛和專利懸崖,BMS是否放棄交易?

As if Bristol-Myers Squibb didn’t have enough to worry about, what with major investors trying to scuttle its $74 billion acquisition of Celgene, now a new concern has emerged—and it involves one of the six drug candidates that BMS executives have cited as justification for the massive merger.

似乎百時美施貴寶沒有足夠的擔心,主要投資者試圖阻止其對新基的740億美元收購,現在又出現了一個新的擔憂——這涉及到百時美施貴寶高管們認為是大規模合併的理由之一的六個候選藥物之一。

That drug is ozanimod, Celgene’s multiple sclerosis treatment, which analysts had pegged as a potential blockbuster until the FDA handed the company a crushing refuse-to-file notice early last year. The FDA asked for more data on preclinical and clinical pharmacology, forcing Celgene to delay its application for approval until this year.

這種藥物是新基的多發性硬化症治療藥物 ozanimod ,分析人士將其作為一種潛在的重磅炸彈,直到 FDA 在去年早些時候向該公司發出了一份令人沮喪的拒絕備案通知。FDA 要求更多關於臨床前和臨床藥理學的數據,迫使新基將ozanimod的申請推遲到今年。

But now Credit Suisse analysts have spotted another potential hurdle to the commercialization of ozanimod: intellectual property. BMS, which has been scrambling over the last few weeks to quell investors’ concerns about the deal, is downplaying the risk, but that’s of no comfort to the analysts.

但如今,瑞信分析師發現,ozanimod商業化的另一個潛在障礙是知識產權。過去幾周,百時美施貴寶一直在忙於平息投資者對這筆交易的擔憂,該公司正在淡化風險,但這對分析師來說並不是什麼安慰。

Credit Suisse learned that Novartis holds a key patent on the class of medicines to which ozanimod belongs, S1P modulators. The patent covers dose titration, 「a critical component of ozanimod’s product profile as all three proposed indications currently require dose titration,」 Credit Suisse said in a note sent to investors earlier this week. Celgene is also developing the drug to treat ulcerative colitis and Crohn’s disease.

瑞士信貸了解到諾華擁有奧扎尼莫德所屬的一類藥物 S1P 調製器的關鍵專利。瑞士信貸在本週早些時候發給投資者的一份報告中表示,該專利涵蓋劑量滴定,「這是 ozanimod 產品系列的一個關鍵組成部分,因為所有三個擬議的適應症目前都需要劑量滴定。」新基也在開發治療潰瘍性結腸炎和克羅恩病的藥物。

The analysts initially sent out a note saying BMS was aware that the patent could be a roadblock, but after the company’s investor-relations folks stepped in, Credit Suisse tweaked its warning. While Credit Suisse fears the patent could present a problem, the revised note said, BMS executives 「believe they will be able to manage through this hurdle and are not overly concerned about it.」

分析師最初發出一份報告稱,百時美施貴寶意識到該專利可能是一個路障,但在該公司的投資者關係人士介入後,瑞信調整了其警告。儘管瑞士信貸擔心該專利可能會帶來問題,但修訂後的報告表示,百時美施貴寶高管「相信,他們將能夠克服這一障礙,而不是過分擔心。」


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