Take­da’s post-merg­er deals con­tin­ue as OTC sub­sidiary is pre­pared for sale

Take­da has been bur­dened un­der moun­tains of debt since ac­quir­ing Shire for $62 bil­lion 18 months ago, but one of the com­pa­ny’s biggest moves yet to re­lieve the stress could be on the hori­zon.

The Japan­ese phar­ma is prepar­ing a bid­ding war for its $3.7 bil­lion over-the-counter sub­sidiary, a sale that would dwarf pre­vi­ous spin­offs. Any trans­ac­tion would be the lat­est in what’s been a long string of sell-offs, as Take­da march­es un­flinch­ing­ly to­ward its ul­ti­mate goal of shed­ding $10 bil­lion in as­sets.

Take­da has been ac­tive­ly shop­ping out “non-core” op­er­a­tions at a break­neck pace. Just last month, South Ko­rea’s Cell­tri­on bought a slew of “non-core” OTC and pre­scrip­tion drugs for $278 mil­lion from the Japan­ese phar­ma. And in April, Take­da sold a sep­a­rate OTC port­fo­lio and two man­u­fac­tur­ing sites for $670 mil­lion to the Ori­farm Group in Den­mark.

The sales haven’t al­ways gone smooth­ly, how­ev­er. Take­da spun off its Xi­idra dry-eye drug to No­var­tis for $3.4 bil­lion in May 2019, but this past June the EMA shot down the pro­pos­al de­spite FDA ap­proval in the US. No­var­tis was forced to yank its mar­ket­ing cam­paign for the drug, re­sult­ing in a $200 mil­lion loss at Take­da in the sec­ond quar­ter of 2020.

The Big Phar­ma al­so teamed up with Fra­zier in May 2019 to spin out Phan­tom Phar­ma­ceu­ti­cals to de­vel­op its for­mer GI drug vono­prazan. Take­da fur­ther di­vest­ed from oth­er drug port­fo­lios, ne­go­ti­at­ing a $200 mil­lion sale with Swiss phar­ma Aci­no and an $825 mil­lion sale with Brazil­ian phar­ma Hy­pera with­in the last nine months.

Take­da hopes to reach its $10 bil­lion goal and fin­ish its debt re­duc­tion some­time be­tween March 2022 and March 2024. The sell-offs have not pre­vent­ed the com­pa­ny from en­gag­ing in oth­er po­ten­tial deals, as Neu­ro­crine Bio­sciences pur­chased a pipeline of ex­per­i­men­tal psy­chi­atric drugs for $2 bil­lion last month.

Take­da Con­sumer Health­care, the sub­sidiary that man­u­fac­tures pop­u­lar prod­ucts like Ali­namin vi­t­a­min tablets and the Ben­za cold med­i­cine line, would re­port­ed­ly sell for around $3.7 bil­lion and al­low Take­da to fo­cus on “high­er prof­itabil­i­ty” drugs like can­cer treat­ments.

A cadre of high-pro­file suit­ors emerged as the fi­nal bid­ders last month, such as Black­stone, Bain Cap­i­tal and Taisho Phar­ma­ceu­ti­cal, ac­cord­ing to a Reuters re­port. CVC Cap­i­tal is al­so in play, with Taisho re­port­ed­ly be­ing the front-run­ner.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Lon­za hits the ex­it on gel and liq­uid cap­sules, of­fload­ing 2 pro­duc­tion sites to NextPhar­ma

With the contract manufacturing market on a hot streak with the Covid-19 vaccine rollout, Lonza has opened its war chest in recent months for a suite of expansions. But now, with its focus elsewhere, the company is looking to contract its capsule offerings for pharma.

The CDMO giant will offload its lipid capsule production sites in Ploërmel, France, and Edinburgh, UK, as part of a plan to exit the pharmaceutical capsules space while maintaining its market foothold in consumer health and nutrition, the company said Tuesday.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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News brief­ing: Beam bags a $260M pri­vate place­ment; mi­Ra­gen re­brands to Virid­i­an Ther­a­peu­tics

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.