Jack Kenny, CEO of Meridian Bioscience

Ko­re­an di­ag­nos­tics biotech goes transpa­cif­ic, agree­ing to shell out $1.5B to take Merid­i­an pri­vate

A Ko­re­an di­ag­nos­tics play­er that made mil­lions of Covid-19 tests in the ear­ly stages of the pan­dem­ic is now ex­pand­ing in­to the US mar­ket.

Cincin­nati-based Merid­i­an Bio­science put up no­tice Thurs­day morn­ing that it’s go­ing to be ac­quired by SD Biosen­sor, ac­com­pa­nied by in­vest­ment firm SJL Part­ners for $1.53 bil­lion in cash.

How the trans­ac­tion will work, ac­cord­ing to Merid­i­an, is that a “new­ly formed af­fil­i­ate ve­hi­cle” formed by SD Bio and SJL will ac­quire the com­pa­ny. In ex­change, Merid­i­an share­hold­ers will re­ceive $34 per share, a 32.4% pre­mi­um over the com­pa­ny’s share price $VI­VO when an of­fer was first made af­ter mar­ket close on March 17. The biotech’s price at that time was $25.67 per share.

Young Shik Cho

The deal is ex­pect­ed to close some­time in Q4 2022.

SD Biosen­sor chair­man Young Shik Cho said in a state­ment that “We are pleased to be a fam­i­ly with Merid­i­an Bio­science as a great part­ner for ac­cel­er­at­ing our en­try in­to the U.S. IVD (in vit­ro di­ag­nos­tics) mar­ket.”

SD Biosen­sor was the same com­pa­ny that Gingko Bioworks ac­quired its 50 mil­lion rapid anti­gen tests from in 2020.

Merid­i­an, formed in 1976, sells di­ag­nos­tic tests for dif­fer­ent dis­eases, in­clud­ing Covid-19 — along with test­ing reagents.

As part of the merg­er agree­ment, the new­ly formed “ve­hi­cle” will get all of Merid­i­an’s out­stand­ing shares. And the trans­ac­tion is not com­plete­ly set in stone yet — while Merid­i­an’s board has al­ready agreed to the deal, the trans­ac­tion is sub­ject to a few more things. Those in­clude ap­proval by Merid­i­an share­hold­ers, re­ceipt of re­quired reg­u­la­to­ry ap­provals, and the ab­sence of spec­i­fied “ma­te­ri­al­ly ad­verse out­comes” of Merid­i­an’s pre­vi­ous­ly dis­closed and on­go­ing in­ves­ti­ga­tion by the DOJ, among oth­ers.

That DOJ in­ves­ti­ga­tion is around Merid­i­an’s sub­sidiary, ac­cord­ing to the com­pa­ny’s most re­cent 10-K with the SEC in No­vem­ber 2021. Back in 2018, Merid­i­an’s sub­sidiary Mag­el­lan re­ceived a sub­poe­na from the DOJ re­gard­ing its Lead­Care prod­uct line — a blood test to de­tect lead poi­son­ing. Last year, the de­part­ment is­sued four more sub­poe­nas — two for an ex-em­ploy­ee and a cur­rent em­ploy­ee to tes­ti­fy be­fore a grand ju­ry in H1, and two more for both wit­ness­es and doc­u­ments in H2. The in­ves­ti­ga­tion is still on­go­ing.

Once the trans­ac­tion clears, Merid­i­an not­ed that SDB will own ap­prox­i­mate­ly 60% and SJL will own ap­prox­i­mate­ly 40% of the com­pa­ny, which will no longer be trad­ed or list­ed on a pub­lic ex­change.

The re­lease added that SDB and SJL plan “to op­er­ate Merid­i­an as an in­de­pen­dent en­ti­ty fol­low­ing the com­ple­tion of the trans­ac­tion and the Com­pa­ny’s lead­er­ship team and head­quar­ters are ex­pect­ed to re­main in place.”

An­a­lysts with William Blair not­ed that the of­fer was 4.5 times the last 12 months of Merid­i­an’s sales. Not­ed in the re­port,

In terms of per­for­mance, Merid­i­an has been a stand­out in a dis­as­trous year for the sec­tor (and broad­er mar­ket) with the stock up 65% year-to-date and up 52% over the last 12 months.De­spite this, in­vestor in­ter­est had been rather lim­it­ed un­til the last cou­ple of weeks when we start­ed to re­ceive a flur­ry on in­ter­est on the name with a fo­cus on why the stock had been so strong.

Merid­i­an de­clined to com­ment for this sto­ry. How­ev­er, Merid­i­an CEO Jack Ken­ny said in a re­lease that “We are ex­cit­ed to an­nounce this new chap­ter for Merid­i­an af­ter the many years spent trans­form­ing the Com­pa­ny for sus­tain­able growth.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.