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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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