Chi­na's Foun­tain Med­ical scores $62M as de­mand for CRO ser­vices surges

Cir­ca 2016, Chi­na se­cured its sta­tus as the sec­ond-biggest mar­ket for pre­scrip­tion drugs. The soar­ing de­mand for med­i­cines has fu­eled the re­turn of key sci­en­tif­ic tal­ent, the ap­petite for spend­ing on drug re­search and de­vel­op­ment, while Chi­na’s cost ad­van­tage has lured multi­na­tion­al phar­ma­ceu­ti­cal mak­ers to set up R&D shops in the re­gion and stim­u­lat­ed the do­mes­tic CRO in­dus­try. In 2007, a for­mer Quin­tiles (now IQVIA) ex­ec­u­tive set up his own CRO in Chi­na — Foun­tain Med­ical De­vel­op­ment Lim­it­ed (FMD) — and on Fri­day, the com­pa­ny un­veiled a $62 mil­lion Se­ries D round of fi­nanc­ing.

Dan Zhang

The com­pa­ny, set up by Dan Zhang, orig­i­nal­ly tar­get­ed a niche mar­ket that has been ne­glect­ed by both glob­al and lo­cal CROs. Glob­al CROs cater large­ly to multi­na­tion­al phar­ma­ceu­ti­cal mak­ers, as lo­cal phar­ma play­ers are of­ten priced out of their ser­vices. Mean­while, do­mes­tic CROs fo­cus on serv­ing lo­cal drug de­vel­op­ers, since they are not usu­al­ly equipped with the re­sources re­quired to con­duct in­ter­na­tion­al mul­ti­cen­ter tri­als.

FMD was cre­at­ed to “an­swer the needs of in­no­v­a­tive, sin­gle com­pound com­pa­nies en­ter­ing the clin­i­cal stage. They are main­ly lo­cal and in­ter­na­tion­al start-ups that are not ful­ly es­tab­lished yet so most of their fi­nanc­ing comes from the gov­ern­ment or grants. Nor­mal­ly, they would be look­ing to start Phase I clin­i­cal tri­als,” Zhang said in an in­ter­view ear­li­er this year with C-suite pub­li­ca­tion PharmaBoard­room.

The CRO in­dus­try in Chi­na — which in­cludes glob­al play­ers such as IQVIA, Lab­Corp and Parex­el and do­mes­tic out­fits in­clud­ing Wuxi AppTec, Phar­maron, and Mei­di­cilon — was worth about $9.7 bil­lion last year, ac­cord­ing to da­ta com­piled by mar­ket re­search com­pa­ny Re­portLink­er, which es­ti­mates that num­ber will climb to rough­ly $34.3 bil­lion by 2025.

In 2017, Chi­na joined the In­ter­na­tion­al Coun­cil for Har­mo­niza­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH), an or­ga­ni­za­tion that brings to­geth­er reg­u­la­tors of the bio­phar­ma­ceu­ti­cal in­dus­try glob­al­ly to as­sess the sci­en­tif­ic and tech­ni­cal as­pects of drug de­vel­op­ment.

With the stan­dard­iza­tion of clin­i­cal re­search in Chi­na through ICH, FMD is now fo­cused on at­tract­ing bio­phar­ma play­ers — in­clud­ing the small­er sin­gle-com­pound biotechs from the Unit­ed States and Eu­rope who pre­vi­ous­ly would have out-li­censed their prod­ucts to multi­na­tion­al phar­ma com­pa­nies or to lo­cal Chi­nese com­pa­nies — to Chi­na.

The new in­jec­tion of funds will en­able “Foun­tain Med­ical to ex­pand and im­prove our ser­vice of­fer­ings to ex­ist­ing glob­al clients, and bet­ter cater to the needs of Chi­nese phar­ma­ceu­ti­cal com­pa­nies with glob­al as­pi­ra­tions as well as multi­na­tion­al com­pa­nies with Chi­na as­pi­ra­tions,” Zhang said in a state­ment on Fri­day.

This round of fi­nanc­ing for FMD — which has more than 1,700 em­ploy­ees world­wide cov­er­ing 55 cities in Chi­na, as well as ma­jor de­liv­ery cen­ters across the Unit­ed States, Eu­ropeJapanIn­dia, and the Philip­pines — was led by Gold­man Sachs, with Lil­ly Asia Ven­tures as co-in­vestor.

Be­fore co-found­ing FMD, Zhang worked with Sig­ma-Tau Re­search as well as Quin­tiles. He is a mem­ber of the grant re­view com­mit­tee for the Na­tion­al Drug De­vel­op­ment Fund of Chi­na and serves as a con­sul­tant for the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA). He is al­so a mem­ber of the ICH E19 Ex­pert Work­ing Group.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

Prakash Raman. Flagship

Flag­ship woos No­var­tis top deal­mak­er Prakash Ra­man in move to get the BD ball rolling ear­ly

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.
The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products. 
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

Kad­mon wax­es rhap­sod­ic on cGVHD re­sults as race with Jakafi heats up

A year ago, Kadmon piqued cautious interest and sent its stock up 20% when it announced positive results from a tiny proof-of-concept study on a new, chronic graft-versus-host-disease treatment. Now interim results are out on the pivotal, and not just the biotech’s executives are gushing about it.

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