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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotechs that fit that general description.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Ver­sant-backed, Bris­tol My­ers-stamped Re­pare Ther­a­peu­tics guns for $100M IPO

With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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