2016 went out like a lamb in the bio­phar­ma M&A world. Will it roar back in 2017? Plus, top 10 deals

Deal­mak­ers ev­i­dent­ly spent the fourth quar­ter of 2016 large­ly in hi­ber­na­tion as they wait­ed out a big US elec­tion cy­cle that seemed to raise more ques­tions than it an­swered.

In a look back over a rel­a­tive­ly qui­et year, EP Van­tage, the ed­i­to­r­i­al arm at Eval­u­ate, con­clud­ed that 2016 may not have end­ed any­where close to any of the records set dur­ing the boom, but I would add that the num­bers re­flect some con­sid­er­able fi­nan­cial mus­cle that could be flexed in the year to come.

The macro num­bers tell the sto­ry.

Look­ing over the chart, be­low, on the quar­ter­ly M&A num­bers, you can see that 2016 came in well be­low the spikes of the pre­vi­ous two years. But it still looked good com­pared to the build up to the boom.

Deals skewed def­i­nite­ly to­ward mar­ket­ed drugs, char­ac­ter­is­tic of 6 of the top 10 deals. But you can al­so see an ap­petite for risk in two of the rest of the pack, where Ab­b­Vie paid top dol­lar for Stem­cen­trx — a $5.8 bil­lion ac­qui­si­tion that still leaves some an­a­lysts shak­ing their heads — and an­oth­er $1.7 bil­lion buy­out pact Al­ler­gan made for To­bi­ra as it wheeled and dealed through­out 2016.

The av­er­age M&A deal val­ue pulled back on­ly slight­ly from 2015:

And the com­bined val­ue of deals for ven­ture-backed as­sets swelled over the 5 years tracked by Eval­u­atePhar­ma, to a hefty $10.4 bil­lion last year, up from an ane­mic $2.2 bil­lion in 2012.

Per­haps, notes the an­a­lysts at Eval­u­atePhar­ma, it’s pos­si­ble that a de­cline in the last two years on biotech val­u­a­tions over­all will set up a bounce back in 2017. But they are left skit­tish by lin­ger­ing ques­tions over the type of tax re­form that Trump can get across the fin­ish line in Wash­ing­ton DC as well as the kind of reg­u­la­to­ry re­form he has in mind.

I sus­pect that we’ll have those an­swers in line by the end of Q1, though, which leaves plen­ty of time for new deals. I’ll al­so note that M&A trends in bio­phar­ma are heav­i­ly swayed by megadeals, which have been few and far be­tween. In 2016, we saw just one: Shire’s $32 bil­lion deal to ac­quire Bax­al­ta. And we’ve al­ready seen some mid-sized deals this year that could leave the bal­ance sheet in the plus col­umn come the end of 2017.

We’ll leave you with the top 10 deals of 2016, as a re­minder of the po­ten­tial, and pit­falls, for what lies ahead.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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