Philippe Pouletty (Credit: Deinove)

No pain, no gain: Com­pa­ny-build­ing French VC scores €250M for life sci­ences fund

In the Truf­fle Cap­i­tal play­book, you ei­ther go big or go home.

The French VC firm does not both­er with pitch­es from com­pa­nies vy­ing for in­vest­ment — in­stead, it sources the raw ma­te­r­i­al to build com­pa­nies from scratch. On Wednes­day, it un­veiled a €250 mil­lion boost to in­vest in the life sci­ences, in par­tic­u­lar, the realm of in­ter­ven­tion­al med­ical de­vices.

The recipe for in­vest­ment is ar­du­ous. The firm ap­prais­es about 1000 un­pub­lished patent ap­pli­ca­tions from the top 50 uni­ver­si­ties across the Unit­ed States and Eu­rope. Af­ter whit­tling the list to five per year, it goes about ne­go­ti­at­ing ex­clu­sive glob­al li­cens­es.

A ma­jor source of ‘dis­rup­tive’ sci­ence and tech­nol­o­gy is acad­e­mia, but on­ly some 20% to 30% of patents from uni­ver­si­ties give rise to com­pa­nies be­cause aca­d­e­m­ic re­searchers tend to want to re­main with­in the halls of acad­e­mia, Philippe Poulet­ty, co-founder and chief of Truf­fle Cap­i­tal, not­ed in an in­ter­view with End­points News. “So you have maybe 70% of patent ap­pli­ca­tions which are left aside if you will.”

Once the tech­nol­o­gy is li­censed, Truf­fle in­vents a name for the com­pa­ny, hires the man­age­ment team and puts in mil­lions to de­vel­op the tech — all the while re­main­ing the largest, typ­i­cal­ly soli­tary share­hold­er. In the last 15 years, the firm has backed more than 70 com­pa­nies — of which 80% were cre­at­ed by or with the sup­port of Truf­fle teams. Al­to­geth­er, 13 com­pa­nies, such as Abi­vax, have gone on to make pub­lic de­buts, while Truf­fle has made 17 ex­its, in­clud­ing sales to Stryk­er and Boston Sci­en­tif­ic.

Truf­fle — which is named af­ter the fa­mous black truf­fles of Périg­ord, a re­gion east of Bor­deaux in south-west France in­hab­it­ed by its co-founders — sets up its star­tups in France, but the Eu­ro­pean ap­petite for in­vest­ment is eclipsed by in­vestors in the Unit­ed States, Poulet­ty ac­knowl­edged.

Get­ting be­tween €30 to €50 mil­lion in a Se­ries A fund­ing is pos­si­ble, but cer­tain­ly, Eu­ronext is not as pow­er­ful nor as deep as Nas­daq, he not­ed.

“So that means that when you want to grow fur­ther the com­pa­ny to the com­mer­cial stage, it’s more dif­fi­cult,” he said. “So M&A is of­ten the pre­ferred route, which is why we’ve sold a num­ber of com­pa­nies, which is not great for the Eu­ro­pean econ­o­my be­cause most of the buy­ers are US com­pa­nies…soon they will be Chi­nese com­pa­nies.”

But the in­vest­ment cli­mate in Eu­rope is ripe for change, he added, not­ing that the French and Ger­man au­thor­i­ties are think­ing of putting to­geth­er a raft of in­cen­tives to chan­nel more in­vest­ment in­to the biotech and tech in­dus­tries.

“So I’m quite op­ti­mistic that in the next five years, you should see com­pa­nies be­ing able to grow like in the US on Nas­daq and do­ing big sec­ondary of­fer­ings.”

Cre­at­ed in 2001, Truf­fle Cap­i­tal has raised over €1.1 bil­lion so far. Aside from its fin­tech in­ter­est, the firm’s Bio­MedTech strat­e­gy is fo­cused on tech­nol­o­gy that helps pa­tients more ef­fi­cient­ly and cost-ef­fec­tive­ly with­in the fields of car­di­ol­o­gy, neu­rol­o­gy, der­mo-cos­met­ics, on­col­o­gy, gas­troen­terol­o­gy, and or­tho­pe­dics.

The work has al­ready be­gun. Five com­pa­nies have been cre­at­ed with this new in­jec­tion of funds, in­clud­ing Holi­Stick Med­ical, which is fo­cused on treat­ing se­ri­ous car­diac ail­ments with­out open-heart surgery; Ski­nosive, which is work­ing on tech­nol­o­gy to pre­vent skin can­cers; and Art­e­drone, whose au­tonomous mi­cro-ro­bots are be­ing en­gi­neered to pre­vent and treat cere­brovas­cu­lar is­sues. An­oth­er three are slat­ed for 2020, and the plan is to cre­ate up to a dozen com­pa­nies in to­tal.

“We build the com­pa­ny, we have 90% own­er­ship, and if we suc­ceed, we can say, thanks to Truf­fle oth­er­wise this com­pa­ny would not ex­ist,” Poulet­ty said. “If we fail, we say we were stu­pid and we don’t ac­cuse some­one else of mis­takes. It’s our suc­cess or our mis­takes.”

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
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What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

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Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Brex­it fears, Wood­ford woes over­shad­owed UK biotech and cut 2019 fi­nanc­ing by al­most half

The venture tide might have subsided, the IPO window may be closing and certain listed biotechs may be having a tough time amid Neil Woodford’s well-publicized demised, but there’s still plenty to celebrate in the UK BioIndustry Association’s eyes.

Overall investment in UK biotech last year fell from the record-breaking £2.2 billion levels of 2018 to £1.3 billion — including £679 million in venture capital, a meager £64 million in IPOs plus £596 million when you add up all public financings, according to a new report from the BIA.

Blue­print Med­i­cines po­ten­tial­ly de­lays Ay­vak­it de­ci­sion; Con­trol beats treat­ment in mesothe­lioma tri­al

→ Blueprint Medicines filed an amendment to its application to get the gastrointestinal stromal tumor (GIST) drug Ayvakit approved in fourth-line GIST, the company disclosed in the prospectus for a new $325 million public offering.  Blueprint got a big accelerated OK on the drug this month in a particular mutation, but because the FDA decided to split their review in two, they didn’t hear on fourth-line GIST. They were supposed to hear before February 14, but this amendment could push that date back by 3 months. Blueprint wrote that the amendment is designed to allow the company to comply with the FDA’s request for data from the Phase III Voyage trial before they give a judgment.

Io­n­is, Akcea boost­ed by a pos­i­tive PhII for their No­var­tis castoff car­dio drug — and they plan to push ahead in­to piv­otals

Late last year Novartis abandoned a cardio drug from Ionis’ spinoff Akcea just after the pharma giant snapped up inclisiran, going the RNAi way in guarding against heart disease in the $9.7 billion Medco buyout.

Now the pharma goliath — which is headed down the PCSK9 road with a drug it believes can be used in a mass population — can get a clearer picture of just what they gave up.

Akcea $AKCA and the mother company $IONS put out a statement early Wednesday saying that their Phase II study of AKCEA-APOCIII-LR delivered solid efficacy data, with the high dose clearly outperforming placebo in significantly reducing triglycerides as a means to cutting the risk of cardiovascular disease. In addition, investigators concluded that the drug slashed apoC-III, very low-density lipoprotein and remnant cholesterol while boosting “good” HDL levels.

Hal Barron and Emma Walmsley, GSK

GSK’s ‘break­through’ BC­MA can­cer drug gets a pri­or­i­ty re­view — and a big win for the on­col­o­gy R&D team

After largely whiffing the past 2 years on the pharma R&D front, GlaxoSmithKline research chief Hal Barron has seized boasting rights to a key win that puts them back in the cancer drug development game.

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Who are the young bio­phar­ma lead­ers shap­ing the in­dus­try? Nom­i­nate them for End­points' spe­cial re­port

Update: Nominations open through end of day, Monday, January 27

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.