José Baselga, AstraZeneca (ASCO)

Lyn­parza im­proves sur­vival rate in prostate can­cer, giv­ing As­traZeneca and Mer­ck an­oth­er win on PARP front

As­traZeneca and its part­ners at Mer­ck can tack on an­oth­er key clin­i­cal win for their block­buster can­cer drug star Lyn­parza. Fol­low­ing up on their suc­cess in gain­ing an im­por­tant im­prove­ment on pro­gres­sion free sur­vival for a seg­ment of ad­vanced prostate can­cer pa­tients, the phar­ma gi­ants say they now have ev­i­dence the drug al­so spurs longer over­all sur­vival.

Pas­cal So­ri­ot

Cur­rent­ly un­der pri­or­i­ty re­view with an ac­cel­er­at­ed OK ex­pect­ed soon, the As­traZeneca team re­port­ed their score on OS for pa­tients with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer who have a ho­mol­o­gous re­com­bi­na­tion re­pair gene mu­ta­tion and have pro­gressed on pri­or treat­ment with new hor­mon­al agent drugs — like Xtan­di (en­za­lu­tamide) and Zyti­ga (abi­raterone).

That’s a mouth­ful, but it’s al­so a key ad­vance in the field, where this lead­ing PARP has gone from strength to strength in set­ting the pace for this part of the can­cer R&D world. The hard da­ta on just how big an im­prove­ment they saw will have to wait for a med­ical con­fer­ence some­where on­line.

“Over­all sur­vival in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer has re­mained ex­treme­ly chal­leng­ing to achieve,” not­ed As­traZeneca on­col­o­gy R&D chief José Basel­ga. “We are thrilled by these re­sults for Lyn­parza and we are work­ing with reg­u­la­to­ry au­thor­i­ties to bring this med­i­cine to pa­tients as soon as pos­si­ble.”

What’s good for Lyn­parza could be bad for one of its big ri­vals. An­drew Berens at SVB Leerink not­ed:

While ap­proval was wide­ly ex­pect­ed, this over­all sur­vival ad­van­tage was not an­tic­i­pat­ed, and we be­lieve should prove to be a sig­nif­i­cant com­mer­cial ad­van­tage over com­peti­tor Clo­vis (CLVS, MP), with an up­com­ing PDU­FA date in BR­CA+ mCR­PC pa­tients on May 15.

There’s more da­ta on the way for this drug, which has played a key role in As­traZeneca’s turn­around un­der CEO Pas­cal So­ri­ot. The phar­ma part­ners are pur­su­ing the PRO­pel tri­al, with first da­ta ex­pect­ed next year, test­ing Lyn­parza as a front-line med­i­cine for pa­tients with metasta­t­ic CR­PC in com­bi­na­tion with abi­raterone ac­etate ver­sus abi­raterone ac­etate alone.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.