On top of ex­pir­ing Her­ceptin patents, Roche faces huge roy­al­ty loss­es in 2019

We all know some of Roche’s most valu­able patents are ex­pir­ing soon, not the least of which is the huge rev­enue-dri­ver can­cer drug Her­ceptin. But in its lat­est fi­nan­cial up­date, Roche out­lined a dif­fer­ent set of patents that will soon cut hun­dreds of mil­lions from its bal­ance sheet.

Sev­erin Schwan

In its mid-year earn­ings up­date, Roche warned in­vestors that its “Ca­bil­ly” patents —  which pro­tect a step in the man­u­fac­tur­ing process of cell-based ther­a­pies — would ex­pire in De­cem­ber. For the past 35 years, these patents (grant­ed to Roche’s Genen­tech unit in 1983), have al­lowed Roche to col­lect roy­al­ties from com­peti­tors like Ab­b­Vie, which us­es the process­es to man­u­fac­ture Hu­mi­ra. That drug sold $18.5 bil­lion last year.

The Ca­bil­ly patents have been an ob­ject of spec­u­la­tion over the years as in­vestors tried to es­ti­mate ex­act­ly how valu­able they were to Roche. But now, Roche has trot­ted out an ac­tu­al fig­ure. Last year, the patent roy­al­ties brought in $840.4 mil­lion. That will soon evap­o­rate. And the per year val­ue is high­er than an­a­lysts at Bar­clay’s Cap­i­tal as­sumed, they wrote, “which will like­ly pro­vide a stiff head­wind for 2019.”

It’s a trou­bling prob­lem to have con­sid­er­ing the fact that Roche will soon be los­ing its ex­clu­siv­i­ty on Her­ceptin, whose patent ex­pi­ra­tion is al­so in 2019. Her­ceptin sales makes up a big chunk of the Roches’s to­tal rev­enue, bring­ing in $7 bil­lion in sales last year.

It’s im­por­tant to note, how­ev­er, that Roche post­ed some promis­ing fig­ures in its H1 up­date, in­di­cat­ing that it’s mak­ing some progress com­pen­sat­ing for its up­com­ing loss­es. That’s large­ly thanks to new­ly-launched treat­ments like MS ther­a­py Ocre­vus and breast can­cer drug Per­je­ta. CEO Sev­erin Schwan said they were “well on track to re­ju­ve­nate” their port­fo­lio. The com­pa­ny re­port­ed core op­er­at­ing prof­its rose 10% to $11.3 bil­lion in the first half of the year. Sales rose 7% to $28.3 bil­lion, beat­ing an­a­lysts’ ex­pec­ta­tions.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As biotech IPOs siz­zle on vir­tu­al Wall Street, 3 new play­ers roll the dice on meg­a­money gam­bles top­ping $325M

Back in early January when I interviewed Generation Bio CEO Geoff McDonough on his $110 million mega-raise, he was thinking in terms of taking another 12 to 18 months to get into the clinic and then filing an IPO. They were, after all, still preclinical after 4 years in the lab.

But with investors still clearly focused on biotech during the pandemic, a lot of things are going faster now. Including IPOing, which is sizzling for the right companies.

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Al­ny­lam nabs speedy re­view, set­ting up 3rd pos­si­ble ap­proval in 3 years

After nearly two decades in the haze of preclinical and clinical development, things seems to be coming into focus for Alnylam Pharmaceuticals.

Two years ago the company landed the first approved drug for RNA interference (RNAi), a Nobel Prize-winning technique discovered in plants and pioneered around the turn of the century. Then last year, they landed another approval. Now, fresh off a massive investment from Blackstone, they’ve received an FDA priority review designation for a third therapy, setting them up to potentially nab three different approvals in three consecutive years.

Ax­o­vant spin­out Arvelle ups Se­ries A haul, de­ploy­ing $200M-plus to com­mer­cial­ize epilep­sy drug in Eu­rope

One of the characteristic features of the sprawling biotech group Vivek Ramaswamy has built at Roivant is its ability to whip up big-money financing deals for its subsidiaries. Axovant was a prime example, raising $315 million in an IPO — a monster by 2015 and even today’s standards — with an Alzheimer’s pitch before a spectacular flop forced the company to replot its course directly and pivot to gene therapy.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.