Am­gen sharp­ens fo­cus on ge­net­ic se­quenc­ing with $66M in­vest­ment

Re­in­forc­ing its abil­i­ty to iden­ti­fy and val­i­date dis­ease tar­gets, Am­gen $AMGN on Thurs­day said it would fork out £50 mil­lion ($66 mil­lion) to buy shares in pri­vate­ly-held Ox­ford Nanopore Tech­nolo­gies, which has de­vel­oped the first portable DNA/RNA se­quencer and has so far raised near­ly half a bil­lion pounds in fund­ing.

The new in­vest­ment builds on Am­gen’s ac­qui­si­tion of de­CODE Ge­net­ics back in 2012 for $415 mil­lion.

Kári Ste­fáns­son

The Ox­ford, UK-based com­pa­ny, found­ed in 2005, aims to en­able the “ge­net­ic analy­sis of any liv­ing thing, by any per­son, in any en­vi­ron­ment” and is cur­rent­ly val­ued at £1.5 bil­lion. Ox­ford Nanopore’s tech­nol­o­gy uti­lizes nanopores — nano-scale holes made by pro­teins con­tained with­in a syn­thet­ic mem­brane — in com­bi­na­tion with elec­tron­ics to per­form re­al-time DNA and RNA se­quenc­ing for a range of bi­o­log­i­cal re­search ap­pli­ca­tions, in­clud­ing large scale hu­man ge­nomics, can­cer and en­vi­ron­men­tal re­search.

It took over a decade and near­ly $3 bil­lion for sci­en­tists to se­quence the first hu­man genome back in 2003.

De­spite ad­vances in gene-se­quenc­ing plat­forms, in­clud­ing prod­ucts of­fered by Il­lu­mi­na $ILMN, most tech­nolo­gies typ­i­cal­ly de­liv­er a bo­lus of da­ta at the end of a fixed “run” that may be hours or days long. Ox­ford Nanopore’s se­quencers, how­ev­er, pro­vide in­for­ma­tion in re­al time, which could be cru­cial in the field of di­ag­nos­tics, for ex­am­ple. The com­pa­ny’s tech­nol­o­gy is al­so scal­able, un­like many of the bulky de­vices sold by Il­lu­mi­na and Pa­cif­ic Bio­sciences $PACB, rang­ing from pock­et sized to bench-top de­vices. In ad­di­tion, the com­pa­ny’s tech­nol­o­gy se­quences what­ev­er length frag­ment you give it, un­like tra­di­tion­al short read tech­nolo­gies that are pow­ered to se­quence small frag­ments of DNA, typ­i­cal­ly 150-300 bases.

In fact, Il­lu­mi­na it­self is an in­vestor and part­ner of Ox­ford Nanopore, hav­ing joined a cou­ple of fund­ing rounds and inked a mar­ket­ing deal be­tween 2009 and 2010.

“Ox­ford Nanopore’s long-read se­quenc­ing ca­pa­bil­i­ty cre­ates a win­dow in­to parts of the genome that have been out of reach, as well as giv­ing us a much bet­ter han­dle on struc­tur­al vari­ants that con­fer risk of a wide va­ri­ety of dis­eases,” said Kári Ste­fáns­son, founder of Am­gen sub­sidiary de­CODE Ge­net­ics, which has been us­ing Ox­ford Nanopore’s tech­nol­o­gy.

The com­pa­ny, whose prod­ucts are in use in over 80 coun­tries, has raised £451 mil­lion in fund­ing thus far.

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

As FDA’s work­load buck­les un­der the strain, 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.”

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

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.

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.

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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.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”