Bio­gen dou­bles down on biosim­i­lars pact with Sam­sung Bioepis, bag­ging oph­thal­mol­o­gy, an­ti-TNF drugs

A year af­ter ty­ing a tighter knot with Sam­sung Bioepis on a biosim­i­lars joint ven­ture, Bio­gen is hand­ing over an­oth­er $100 mil­lion to fun­nel sev­er­al more pro­grams to its own pipeline.

In ex­change, the US biotech is bag­ging two new oph­thal­mol­o­gy biosim­i­lars — knock­offs of No­var­tis’ Lu­cen­tis and Re­gen­eron’s Eylea, re­spec­tive­ly. Those are ex­clu­sive com­mer­cial­iza­tion rights for glob­al mar­kets; it can al­so com­mer­cial­ize a slate of an­ti-TNF drugs in Chi­na, in­clud­ing Benepali (etan­er­cept), Fli­cabi (in­flix­imab) and Im­ral­di (adal­i­mum­ab). The part­ners are leav­ing open an op­tion for Bio­gen to pro­long their cur­rent agree­ment in Eu­rope for five years.

SB11, which ref­er­ences Lu­cen­tis (ranibizum­ab), is in Phase III while SB15 3 clin­i­cal tri­al, while SB15, the Eylea copy­cat, is go­ing through pre­clin­i­cal tests.

Michel Vounatsos Bio­gen

“This trans­ac­tion would ex­pand the po­ten­tial for our lead­ing biosim­i­lars busi­ness world­wide, while com­ple­ment­ing Bio­gen’s pres­ence in oph­thal­mol­o­gy,” CEO Michel Vounatsos said in a state­ment.

Bio­gen sig­naled its in­ter­est in eye dis­eases via a re­cent ac­qui­si­tion of Night­star Ther­a­peu­tics, which is de­vel­op­ing gene ther­a­pies for rare reti­nal dis­or­ders. But it’s a mod­est ef­fort to di­ver­si­fy in face of a $12 bil­lion mar­ket op­por­tu­ni­ty in Alzheimer’s, where it has staked much of its hopes.

Last June, Bio­gen shelled out $700 mil­lion to boost its stake in the biosim­i­lar ven­ture to 49.9%, pick­ing up an op­tion plant­ed in a 2011 deal un­der then chief George Scan­gos.

“In Eu­rope, we have been very pleased with Bio­gen’s com­mer­cial­iza­tion ef­forts with our an­ti-TNF med­i­cines, ful­fill­ing the mis­sion of ex­pand­ing ac­cess to high-qual­i­ty med­i­cines to pa­tients across Eu­rope,” not­ed Sam­sung Bioepis CEO Christo­pher Han­sung Ko.

In ad­di­tion to the up­front, Sam­sung Bioepis is al­so el­i­gi­ble for up to $210 mil­lion in mile­stones. Should Bio­gen ex­er­cise the op­tion on its an­ti-TNF port­fo­lio in Eu­rope, a $60 mil­lion fee will be due.

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.

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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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 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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