RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Bei­jing-based rare dis­ease and on­col­o­gy play­er has raised $98 mil­lion to help fund the ex­pan­sion of its pipeline as well as a com­mer­cial port­fo­lio.

CAN­bridge put out word Tues­day that the glob­al pri­vate eq­ui­ty play­er Gen­er­al At­lantic joined forces with Chi­nese CRO Wuxi AppTec to lead the Se­ries D, with both ready to chip in an ex­tra $10 mil­lion each un­der the right con­di­tions. The syn­di­cate in­cludes RA Cap­i­tal Man­age­ment, Hud­son Bay Cap­i­tal Man­age­ment, Yuan­Ming Pru­dence Fund and Tigermed.

The new in­fu­sion sets CAN­Bridge up for an IPO in a year or two, ac­cord­ing to CFO Glenn Has­san.

A spe­cial­ist in rare ge­net­ic dis­eases, CAN­bridge has been col­lab­o­rat­ing with WuXi Bi­o­log­ics, a sis­ter com­pa­ny of the CRO, on dis­cov­er­ing and de­vel­op­ing new drugs for its tar­get in­di­ca­tions.

Like a num­ber of top Chi­na drug play­ers, CAN­bridge is get­ting start­ed with some ex­ist­ing meds in-li­censed for the Asian mar­ket while fol­low­ing up with some more orig­i­nal work. Its drug Hunterase is an en­zyme re­place­ment ther­a­py un­der re­view now by Chi­nese reg­u­la­to­ry au­thor­i­ties. And the biotech has high hopes for Ner­l­ynx, the breast can­cer drug from Puma.

CAN­bridge has about 60 staffers on the ground in Chi­na, about half of whom sup­port the com­mer­cial or­ga­ni­za­tion, CEO James Xue told End­points News from their Cam­bridge, MA of­fice.

“We are def­i­nite­ly build­ing what I would say as one of the most ro­bust com­mer­cial plat­form for rare dis­ease in the Greater Chi­na re­gion that would re­al­ly en­able us to do what we call high-touch launch and op­er­a­tions of rare dis­ease prod­ucts,” he said.

Hav­ing repo­si­tioned the com­pa­ny to fo­cus on rare dis­ease rather than just on­col­o­gy, Xue — the for­mer gen­er­al man­ag­er of Gen­zyme — said the Chi­nese mar­ket is warm­ing up to rare dis­ease drugs. Take the up­take of Cerezyme, which launched in Chi­na in 2008 un­der his watch. It wasn’t un­til the end of 2012 that en­zyme re­place­ment ther­a­py re­ceived mu­nic­i­pal re­im­burse­ment from Shang­hai; but in the fol­low­ing years cov­er­age has ex­pand­ed in­to about 10 provinces and cities, with up to 100% cov­er­age.

Aware­ness is al­so clear­ly spread­ing from the pa­tient and physi­cian lev­el to the pol­i­cy­mak­ers, with rare dis­ease lan­guage and lists of­fi­cial­ly writ­ten in­to law. And the ag­gres­sive price ne­go­ti­a­tions that gov­ern­ment of­fi­cials have been do­ing for the Na­tion­al Re­im­burse­ment Drug List is a sign that they are mak­ing room for dis­eases cur­rent­ly com­plete­ly un­cov­ered, he added.

“Those are the el­e­ments or the mov­ing parts grad­u­al­ly in place that would al­low us to hope for and al­so plan for rare dis­ease mar­ket in a way that its re­im­bursed mar­ket is around the cor­ner,” he said.

So­cial im­age: James Xue, CAN­bridge CEO

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.