David Simmons. PPD via YouTube

What are bio­phar­ma com­pa­nies hir­ing CROs for these days? PPD spells it out in bid for $100M IPO

More than eight years af­ter PPD was tak­en pri­vate in a $3.9 bil­lion deal, the 35-years-old con­tract re­search or­ga­ni­za­tion is brac­ing for the pub­lic mar­ket again with a $100 mil­lion ask.

Hav­ing served all of the top 50 bio­phar­ma com­pa­nies in the world by R&D spend­ing and over 300 biotech fledg­lings, PPD’s fil­ings high­light­ed the en­trenched role CROs play in an in­dus­try chas­ing an ever dwin­dling re­turn on in­vest­ment by push­ing for faster time­lines and tack­ling pay­er re­sis­tance to pricey ther­a­pies.

PPD high­light­ed five key trends that it be­lieves will dri­ve high­er de­mand for its ser­vices:

  • Growth in R&D spend­ing: Be­tween 2008 to 2018, R&D bud­gets rose around 3.3% an­nu­al­ly, PPD reck­oned;
  • In­creased lev­els of out­sourc­ing: “Out­sourc­ing pen­e­tra­tion as a per­cent­age of to­tal de­vel­op­ment spend­ing by bio­phar­ma­ceu­ti­cal com­pa­nies in­creased from ap­prox­i­mate­ly 36% in 2007 to ap­prox­i­mate­ly 49% in 2018”;
  • In­creased com­plex­i­ty in clin­i­cal de­vel­op­ment: New ther­a­peu­tic modal­i­ties, more tar­get­ed drug de­vel­op­ment and new reg­u­la­to­ry re­quire­ments have made clin­i­cal tri­als hard­er to de­sign and re­cruit — high­light­ing the need for ex­perts;
  • Biotech­nol­o­gy sec­tor growth: With over $150 bil­lion of cap­i­tal raised for biotech com­pa­nies in the last three years, there’s plen­ty of fu­el for new play­ers to car­ry on their R&D projects;
  • In­creas­ing im­por­tance to prove val­ue of new ther­a­pies: Re­al-world ev­i­dence is be­com­ing more cen­tral to every drug pro­gram.

It is of course not the on­ly play­er cap­i­tal­iz­ing on this de­mand. On the clin­i­cal de­vel­op­ment side, which ac­counts for rough­ly 80% of its rev­enue, it list­ed IQVIA, ICON, Parex­el, PRA Health Sci­ences, Lab­Corp (Co­v­ance busi­ness), Sy­neos Health and Med­Pace as its ma­jor com­peti­tors. As for lab­o­ra­to­ry ser­vices, Lab­Corp, Sy­neos, Q2 So­lu­tions, ICON, Eu­rofins Sci­en­tif­ic, WuXi AppTec, BioAg­i­lytix and SGS were cit­ed as chief ri­vals.

Christo­pher Scul­ly

Un­like the drug de­vel­op­ers PPD serves, its IPO is not de­signed to fund any ex­pan­sion in ser­vices or ca­pa­bil­i­ties — its rev­enue, which neared $3 bil­lion by Sep­tem­ber of 2019, got it cov­ered — but to re­deem bonds is­sued as part of a re­cap­i­tal­iza­tion en­gi­neered by its biggest pri­vate eq­ui­ty back­ers in 2017.

Hell­man & Fried­man and the Car­lyle Group, the two play­ers re­spon­si­ble for tak­ing PPD off the Nas­daq in 2011, re­main the largest stock­hold­ers. The for­mer holds the li­on’s share at 56.7%, while the lat­ter kept 23.8%. Af­ter jump­ing on board in the 2017 re­cap­i­tal­iza­tion, Blue Spec­trum and GIC — in­vest­ing on be­half of Sin­ga­pore and Abu Dhabi, re­spec­tive­ly — each claimed 9.2% of the stock, to be back on the Nas­daq as $PPD

David Sim­mons, the Pfiz­er vet who took PPD’s helm in 2012, is in for 1.1%. His com­pen­sa­tion pack­age for 2019 to­taled $6.2 mil­lion, dou­ble that of 2018, most­ly thanks to op­tion awards. Fel­low Pfiz­er alum and CFO Christo­pher Scul­ly got $1.2 mil­lion while COO William Shar­baugh re­ceived $1.7 mil­lion.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Bob Duggan (Duggan Investments)

Biotech bil­lion­aire Bob Dug­gan flies the white flag as Sum­mit hunts a new own­er, or part­ner, for sole clin­i­cal-stage ef­fort

Bob Duggan’s Summit Therapeutics $SMMT is running out of moves for its sole clinical-stage candidate.

The biotech issued a terse statement in an SEC filing that it’s pulling the plug on the only active clinical trial for ridinilazole, which has been through a failed late-stage trial for C. difficile. A pediatric study is being curtailed as Summit says it decided a few days ago to either partner out the therapy or get a buyer — if they can find one.

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Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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