No­var­tis chris­tens new UK HQ in West Lon­don, kick­ing off its big in­clisir­an CV tri­al

Swiss drug­mak­er No­var­tis has joined its big phar­ma com­pa­tri­ot GSK by of­fi­cial­ly mov­ing its UK head­quar­ters to West Lon­don.

The move to White City — op­po­site Im­pe­r­i­al Col­lege Lon­don’s cam­pus — was planned in 2018. The re­lo­ca­tion from No­var­tis’ site at Frim­ley in Sur­rey in­clud­ed some 600 staffers to the 54,000-square-feet at The West­Works, part of the re­birth of the old BBC Me­dia Vil­lage cam­pus in the White City area that is now con­sid­ered home to an emerg­ing life sci­ences clus­ter with com­pa­nies such as Au­to­lus, Gam­ma Delta and Syn­thace.

Al­ice Gast Roy­al Acad­e­my (Thomas An­gus)

There are un­prece­dent­ed op­por­tu­ni­ties for acad­e­mia, busi­ness­es and en­tre­pre­neurs in White City as our cam­pus pro­vides strength and lead­er­ship in mol­e­c­u­lar sci­ences, bio­engi­neer­ing and pub­lic health and close prox­im­i­ty to our med­ical re­search and trans­la­tion work at Ham­mer­smith Hos­pi­tal. Im­pe­r­i­al and No­var­tis’ prox­im­i­ty will en­hance our col­lab­o­ra­tion as we work to­geth­er to tack­le health­care chal­lenges of our time,” Pro­fes­sor Al­ice Gast, pres­i­dent of Im­pe­r­i­al Col­lege Lon­don, said in a state­ment.

Fol­low­ing a rib­bon-cut­ting cer­e­mo­ny by UK Sec­re­tary of State for Health and So­cial Care Matt Han­cock on Tues­day, chief Vas Narasimhan con­cur­rent­ly al­so an­nounced the start of a large-scale NHS clin­i­cal tri­al test­ing the use of in­clisir­an in im­prov­ing car­dio­vas­cu­lar out­comes (in­clud­ing heart at­tack or stroke).

It may not have yet se­cured ap­proval, nor re­viewed by UK’s price-ef­fec­tive­ness watch­dog NICE — but the cho­les­terol ther­a­py in­clisir­an at the heart of last year’s No­var­tis $9.7 bil­lion buy­out of the Med­i­cines Com­pa­ny will be made wide­ly avail­able to pa­tients at risk of heart dis­ease in the Na­tion­al Health Ser­vice (NHS), the UK agency said last month. NHS Eng­land will agree to a pop­u­la­tion-lev­el com­mer­cial arrange­ment with No­var­tis to make the bian­nu­al shot wide­ly avail­able to pa­tients as soon as 2021.

No­var­tis traces its roots to Geigy, a chem­i­cals and dyes trad­ing com­pa­ny found­ed in Basel, Switzer­land in the mid­dle of the 18th cen­tu­ry; Ci­ba, which be­gan pro­duc­ing dyes in 1859; and San­doz, a chem­i­cal com­pa­ny found­ed in Basel in 1886. In 1996, No­var­tis was borne out of a merg­er be­tween Ci­ba-Geigy and San­doz.

Ac­cord­ing to No­var­tis, the com­pa­ny is the sin­gle largest in­dus­try spon­sor of clin­i­cal tri­als in the UK. With Im­pe­r­i­al, the com­pa­ny has sup­port­ed clin­i­cal stud­ies span­ning healthy ag­ing, im­munol­o­gy and in­flam­ma­tion, as well as re­search in­to chron­ic ob­struc­tive pul­monary dis­ease, liv­er fi­bro­sis, and ovar­i­an can­cer.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.