Will J&J come up with a big enough trea­sure trove to win an Acte­lion buy­out?

Jean-Paul Clozel, Acte­lion CEO

J&J and Acte­lion have made it of­fi­cial. The phar­ma gi­ant is in­volved in talks to ac­quire the Swiss biotech, which had a mar­ket cap of $16.4 bil­lion, be­fore word of the buy­out talks first sur­faced in Bloomberg.

“There can be no as­sur­ance any trans­ac­tion will re­sult from these dis­cus­sions,” notes J&J $JNJ , which could eas­i­ly re­quire up to a 50% pre­mi­um to com­plete a deal like this. Acte­lion’s mar­ket cap, mean­while, surged to about $20 bil­lion as in­vestors bet that a deal would come through.

CEO Jean-Paul Clozel, who split away from Roche to es­tab­lish the com­pa­ny, a spe­cial­ist in pul­monary ar­te­r­i­al hy­per­ten­sion, has spent years pooh-poohing talks about a po­ten­tial buy­out. But Acte­lion (SIX: ATLN) has al­so been a con­stant­ly cit­ed takeover tar­get for the likes of J&J and Sanofi, which would both  be at­tract­ed by ris­ing sales for new prod­ucts Op­sum­it and Up­travi, which have come on­line as Tr­a­cleer rev­enue has be­gun to fade.

Clozel isn’t like­ly to give up his com­pa­ny with­out bat­tling for a big pay­out. He’s squared off against a share­hold­ers re­volt in the past and stuck to his guns on the com­pa­ny’s R&D strat­e­gy, which has paid off hand­some­ly.

“Sim­i­lar deals have been at a 40+% pre­mi­um and we view CHF240/share as a pos­si­ble floor take­out val­ue,” notes Jef­feries Pe­ter Welford to­day. “We still view 2H17-18E as per­haps a more like­ly time­line and see hur­dles to an agreed deal, but the high­ly prof­itable and long life­cy­cle PAH fran­chise is like­ly at­trac­tive.”

“We at Acte­lion–the board of di­rec­tors, the man­age­ment, the em­ploy­ees–are all build­ing a com­pa­ny and not think­ing about be­ing sold the next day,” Clozel told Bloomberg back in the spring. “If we want to con­tin­ue to cre­ate share­hold­er val­ue, the best for us is to re­main in­de­pen­dent.”

J&J man­age­ment, which has its own sound rea­sons for pay­ing top dol­lar for the com­pa­ny, may per­suade him oth­er­wise. But they’re al­so like­ly to take their time on get­ting a deal done, es­pe­cial­ly if Clozel throws up the bar­ri­cades.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

A Canadian CDMO with roots in Seattle is coming to the east coast.

Altasciences announced the acquisition of Calvert Laboratories Wednesday, a preclinical CRO in Pennsylvania. The move will complement Altasciences’ Seattle-area operations.

Headquartered in Laval, Canada, Altasciences operates six facilities that run the gamut on early drug development: preclinical safety testing, clinical pharmacology, bioanalytical, CRO services, and even CDMO capacity. Novo Holdings scooped them up in February with the goal of courting small and medium-sized biopharma clients. CEO Chris Perkin said back in February that the move would help the company foster its ambitious growth plan, and this acquisition and the presence it brings to the east coast is evidence.