BioNTech CEO Ugur Sahin (File photo)

Hong Kong strife holds up al­most $100M of BioN­Tech's Se­ries B haul

Late on Mon­day, it was re­vealed that Ger­man can­cer drug de­vel­op­er BioN­Tech is eye­ing a $100 mil­lion pub­lic list­ing in the Unit­ed States, two months af­ter the can­cer-fo­cused com­pa­ny un­veiled a her­culean $325 mil­lion in an up­sized round of fi­nanc­ing.

In the IPO fil­ing, how­ev­er, the Mainz-based drug de­vel­op­er re­vealed that shares worth about $97 mil­lion that were ex­pect­ed to be bought by an undis­closed Hong Kong-based in­vestor have been de­layed, in part due to the po­lit­i­cal un­rest in Hong Kong and the on­go­ing trade dis­pute be­tween the Unit­ed States and Chi­na.

“(T)he pay­ment may be in­def­i­nite­ly de­layed, or po­ten­tial­ly not re­ceived at all. In the event that this in­vestor is not able to fund the pur­chase of the shares and we do not make al­ter­na­tive arrange­ments for the pur­chase of the shares, we may de­mand that the shares be trans­ferred back to us for no con­sid­er­a­tion. We in­tend to make use of this right in case the funds have not been paid by the an­tic­i­pat­ed pub­lic of­fer­ing,” the fil­ing said.

The trade ten­sion be­tween Chi­na and the Unit­ed States has re­ver­ber­at­ed in the bio­phar­ma in­dus­try.

Last year the Com­mit­tee on For­eign In­vest­ment in the Unit­ed States (CFIUS) — a fed­er­al in­ter­a­gency com­mit­tee chaired by the US Trea­sury De­part­ment — ex­pand­ed its re­view of for­eign in­vest­ment in the biotech­nol­o­gy sec­tor, cit­ing na­tion­al se­cu­ri­ty rea­sons, trig­ger­ing con­cern that US biotechs may have trou­ble ac­cess­ing Chi­nese mon­ey.

And in re­cent months, MD An­der­son Can­cer Cen­ter sanc­tioned five of its own re­searchers — three of whom were eth­ni­cal­ly Chi­nese — for pur­port­ed­ly vi­o­lat­ing con­flict of in­ter­est poli­cies, al­leg­ing ‘for­eign in­flu­ence’, af­ter the NIH re­quest­ed the in­sti­tu­tion in­ves­ti­gate their con­duct.

BioN­Tech’s Ju­ly round of Se­ries B fundrais­ing — mark­ing one of the largest sin­gle pri­vate fund­ing rounds for a Eu­ro­pean biotech — was up­sized and led by Fi­deli­ty Man­age­ment & Re­search. New and ex­ist­ing in­vestors par­tic­i­pat­ed, in­clud­ing Red­mile Group, In­vus, Mi­rae­As­set Fi­nan­cial Group, Plat­inum As­set Man­age­ment, Jeb­sen Cap­i­tal, Steam Athena Cap­i­tal, BVCF Man­age­ment and the Stru­eng­mann Fam­i­ly Of­fice. Two-thirds of the fund­ing came from new in­vestors, BioN­Tech said.

Jeb­sen Group, the par­ent com­pa­ny of Jeb­sen Cap­i­tal, is based in Hong Kong. BVCF Man­age­ment says it was found­ed as Chi­na’s first US dol­lar fund.

Found­ed in 2008, BioN­Tech counts the Strüng­mann group, a fam­i­ly firm led by Ger­man bil­lion­aires and iden­ti­cal twins Thomas and An­dreas Strüng­mann, as its largest share­hold­ers and the source of BioN­Tech’s ini­tial seed cap­i­tal.

Most of BioN­Tech’s clin­i­cal as­sets are mes­sen­ger RNA ther­a­pies (mR­NA), a fam­i­ly of treat­ments in which a nat­ur­al sys­tem is har­nessed to send the body a sig­nal to pro­duce its own drug — in this case, to fight can­cer. The com­pa­ny al­so has cell ther­a­pies and an­ti­bod­ies in its ar­se­nal. Al­to­geth­er, the com­pa­ny has 20 prod­uct can­di­dates, of which eight have en­tered in­to nine on­go­ing clin­i­cal tri­als. BioN­Tech’s com­peti­tors, such as Cure­Vac and the uni­corn Mod­er­na $MR­NA — which re­cent­ly pulled off a his­toric $604 mil­lion US IPO — are square­ly fo­cused on mR­NA.

Hel­mut Jeg­gle, who is re­spon­si­ble for the life sci­ence ini­tia­tives of the Strüng­mann broth­ers, holds about 50.35% of BioN­Tech’s shares, while the com­pa­ny’s CEO Ugur Sahin has a 18.80% stake.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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