Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world be­comes in­creas­ing­ly de­pen­dant on Asia for the in­gre­di­ents of its med­i­cines, Sanofi sees busi­ness to be done in Eu­rope.

The French drug­mak­er said it’s cre­at­ing the world’s sec­ond largest ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) man­u­fac­tur­er by spin­ning out its six cur­rent sites in­to a stand­alone com­pa­ny: Brin­disi (Italy), Frank­furt Chem­istry (Ger­many), Haver­hill (UK), St Aubin les El­beuf (France), Újpest (Hun­gary) and Ver­to­laye (France). They have mapped out €1 bil­lion in ex­pect­ed sales by 2022 and 3,100 em­ploy­ees for the new op­er­a­tions head­quar­tered in France.

An IPO on Eu­ronext Paris is al­so in the works, with a de­ci­sion by 2022.

The an­nounce­ment came short­ly af­ter Ax­ios re­port­ed that 150 pre­scrip­tion drugs are now at risk of short­age in the US, span­ning an­tibi­otics, gener­ics and some brand­ed drugs with­out al­ter­na­tives.

Sanofi cites “in­creas­ing med­i­cine short­ages that crit­i­cal­ly im­pact pa­tient care” as im­pe­tus for the new ven­ture, which will sup­port API man­u­fac­tur­ing for “Eu­rope and be­yond.” As a drug­mak­er, it plans to en­list the new en­ti­ty as a long-term sup­pli­er while hold­ing around 30% of its stake.

Al­though fac­to­ries in Chi­na are grad­u­al­ly re­open­ing, re­stric­tions in trav­el and dis­rup­tions at tran­sit hubs are still slow­ing down pro­duc­tion. An In­di­an com­pa­ny that re­lies on ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) from Chi­na told Bloomberg last week that it’s see­ing prices of com­mon­ly used drugs jump by 40% to 70%.

Chi­na ac­counts for 13% of all man­u­fac­tur­ing sites of API for the US mar­ket, fol­low­ing the US (28%), EU (26%) and In­dia (18%), ac­cord­ing to agency da­ta. But the share by vol­ume of in­gre­di­ents from Chi­na that end up reach­ing Amer­i­can pa­tients could be high­er, STAT pre­vi­ous­ly re­port­ed.

The drug sup­ply chain has be­come “longer, more com­plex and frag­ment­ed as com­pa­nies have lo­cat­ed more pro­duc­tion over­seas” and used con­tract man­u­fac­tur­ers more fre­quent­ly, the FDA’s drug short­ages task force wrote in a re­port up­dat­ed a few days ago.

“Al­though typ­i­cal mar­kets would re­spond to a short­age by in­creas­ing pro­duc­tion, lo­gis­ti­cal and reg­u­la­to­ry chal­lenges, es­pe­cial­ly the com­plex­i­ty of the sup­ply chain, can lim­it the abil­i­ty of drug man­u­fac­tur­ers to in­crease pro­duc­tion,” the re­port read.

The US bio­phar­ma in­dus­try has grown re­liant on Chi­na in more ways than one. There have al­so been con­cerns about both pre­clin­i­cal re­search and clin­i­cal stud­ies get­ting de­layed, due to con­tract ser­vice providers’ lim­it­ed work­ing ca­pac­i­ties and strained med­ical sys­tems.

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.