Mer­ck KGaA gets a thumbs up for once-dead MS drug; Aveo shares soar as ti­vo makes a come­back

→  Cladrib­ine is back. Once giv­en up for dead by Mer­ck KGaA, the mul­ti­ple scle­ro­sis drug has been en­dorsed by the CHMP in Eu­rope, set­ting up a like­ly ap­proval. Long­time Mer­ck KGaA watch­ers will re­call that Mer­ck killed the pro­gram af­ter the FDA and the EMA quashed in­ad­e­quate ap­pli­ca­tions 6 years ago — an em­bar­rass­ing set­back that trig­gered a ma­jor over­haul of the com­pa­ny’s R&D group. “The pos­i­tive opin­ion from the CHMP is an ex­tra­or­di­nary de­vel­op­ment for Mer­ck, af­firm­ing our be­lief in Cladrib­ine Tablets as a po­ten­tial im­por­tant treat­ment op­tion for pa­tients liv­ing with mul­ti­ple scle­ro­sis,” said Belén Gar­i­jo, CEO Health­care and mem­ber of the ex­ec­u­tive board of Mer­ck. “We now ea­ger­ly await the Eu­ro­pean Com­mis­sion de­ci­sion, and the op­por­tu­ni­ty to make a dif­fer­ence in the MS treat­ment par­a­digm.”

 Cladrib­ine wasn’t the on­ly come­back sto­ry of the day. The CHMP al­so rec­om­mend­ed ap­proval of Aveo’s $AVEO drug tivozanib (Fo­tiv­da) for ad­vanced re­nal cell car­ci­no­ma, send­ing the mi­cro­cap’s shares up more than 70% Fri­day morn­ing.  The Eu­ro­pean Com­mis­sion is ex­pect­ed to make its fi­nal de­ci­sion with­in 67 days. Its ap­proval would trig­ger a $4 mil­lion re­search and de­vel­op­ment re­im­burse­ment pay­ment from EU­SA, and the pos­si­bil­i­ty of up to $12 mil­lion in ad­di­tion­al mile­stones.

→  Ex­ec­u­tives are un­der fire for sell­ing drugs that trig­gered se­ri­ous ad­verse events for three in­fants. Paul Elmer, pres­i­dent and own­er of Phar­makon, and Caprice Bear­den, di­rec­tor of com­pli­ance, are fac­ing fed­er­al charges of en­gag­ing in com­merce with adul­ter­at­ed drugs in an in­dict­ment un­sealed on Thurs­day. The in­dict­ment al­leges that the com­pa­ny was no­ti­fied 70 times that the po­ten­cy of their drugs did not match the la­bels, but that they con­tin­ued to send them out re­gard­less, with­out no­ti­fy­ing the FDA or care providers.

→  Bio­pro­cess­ing com­pa­ny Repli­gen is merg­ing with Spec­trum, which spe­cial­izes in fil­tra­tion and pu­rifi­ca­tion, for $359 mil­lion in cash and stock.

→  Gen­Sight Bi­o­log­ics (Eu­ronext: SIGHT) raised €22.5 mil­lion in a stock of­fer­ing. The gene ther­a­py com­pa­ny says it will use the cash to prep for a mar­ket launch of GS010 in Eu­rope and the US.

→  GSK is pre­sent­ing re­sults from its Phase III Zoster-048 study at the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing. The re­sults are promis­ing, show­ing that its can­di­date vac­cine, Shin­grix, for the pre­ven­tion of her­pes zoster (shin­gles) in­duces a strong im­mune re­sponse in old­er adults who have pre­vi­ous­ly been vac­ci­nat­ed against shin­gles with the cur­rent­ly avail­able live-at­ten­u­at­ed zoster vac­cine.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.