Pfiz­er grabs a sol­id en­dorse­ment from FDA in­sid­ers for their knock­off of Am­gen’s flag­ship drug Epogen

Pfiz­er’s sec­ond at­tempt to win an FDA OK for Hos­pi­ra’s biosim­i­lar of Am­gen’s fast-de­clin­ing ane­mia drug, Epogen, is on course to a like­ly ap­proval — with few or no fire­works planned for an up­com­ing pan­el re­view.

Re­ject­ed by the FDA back in the ear­ly biosim­i­lar days of 2015, reg­u­la­tors start­ed off their re­view by giv­ing a clear nod to the sec­ond ef­fort, which comes af­ter the phar­ma gi­ant ac­quired Hos­pi­ra and its pipeline of knock­offs for $16 bil­lion.

Usu­al­ly in these reg­u­la­to­ry re­views, the FDA likes to spot­light the hard is­sues that it wants its in­de­pen­dent ex­perts to de­bate. This time, they’re ba­si­cal­ly be­ing asked to rub­ber stamp a de­ter­mi­na­tion that the copy­cat comes close enough to the orig­i­nal to war­rant an ap­proval.

In reg­u­la­tors’ words:

The to­tal­i­ty of an­a­lyt­i­cal da­ta sup­port the de­ter­mi­na­tion that “Epo­et­in Hos­pi­ra” is high­ly sim­i­lar to US-li­censed Epogen/Pr­o­crit notwith­stand­ing mi­nor dif­fer­ences in clin­i­cal­ly in­ac­tive com­po­nents. The an­a­lyt­i­cal sim­i­lar­i­ty as­sess­ment was con­duct­ed us­ing mul­ti­ple or­thog­o­nal physic­o­chem­i­cal and func­tion­al meth­ods. The re­sults sup­port a demon­stra­tion that “Epo­et­in Hos­pi­ra” is high­ly sim­i­lar to US-Epogen/Pr­o­crit based on analy­ses of pri­ma­ry and high or­der struc­ture, gly­co­sy­la­tion, bi­o­log­i­cal ac­tiv­i­ty, prod­uct re­lat­ed species, and sta­bil­i­ty pro­files, in­clud­ing degra­da­tion prod­ucts and degra­da­tion path­ways.

Epogen has been a flag­ship prod­uct at Am­gen for years now. But No­var­tis’ San­doz and oth­ers were quick to start lin­ing up cheap­er biosim­i­lars for it once de­vel­op­ers got se­ri­ous about the field. For Am­gen, which has its own biosim­i­lars in the pipeline, the move on Epogen puts grow­ing pres­sure on a phar­ma com­pa­ny that needs to find new prod­ucts to gin rev­enue.

Am­gen had thought that its PC­SK9 drug Repatha could help fill the gap, but pay­ers have been throw­ing ob­sta­cles in its course, ham­per­ing sales ef­forts. Just a cou­ple of days ago, Am­gen was al­so hand­ed a ma­jor set­back on ro­mosozum­ab, af­ter in­ves­ti­ga­tors spot­ted a height­ened risk on car­dio events that will at least de­lay the pro­gram or pos­si­bly even kill it.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.