[via AP]

My­lan wins ten­ta­tive US ap­proval for gener­ic ver­sion of Lil­ly's Al­im­ta — it could be years be­fore it can be sold

Lil­ly may have fend­ed off com­pe­ti­tion from a pla­toon of gener­ic drug mak­ers and their patent chal­lenges on its chemother­a­py Al­im­ta, but that has not stopped My­lan from se­cur­ing ten­ta­tive US ap­proval for a copy­cat ver­sion.

Al­im­ta was first ap­proved by the FDA in 2004, and the drug’s la­bel has since seen sev­er­al ex­pan­sions. It’s cleared for use in sev­er­al com­bi­na­tions — in­clud­ing with Mer­ck’s star check­point in­hibitor Keytru­da — in cer­tain pa­tients with NSCLC, as well as some pa­tients with ma­lig­nant pleur­al mesothe­lioma. The treat­ment has al­ready gone off-patent in parts of Eu­rope, and its US patents are set to ex­pire in 2022.

On Wednes­day an FDA fil­ing in­di­cat­ed My­lan’s $MYL gener­ic ver­sion of Al­im­ta had been grant­ed ten­ta­tive ap­proval, which is grant­ed by the agency when a prod­uct meets its safe­ty, ef­fi­ca­cy, and man­u­fac­tur­ing qual­i­ty stan­dards — but is pre­clud­ed from mar­ket­ing due to le­gal pro­tec­tions.

Al­im­ta is Lil­ly’s $LLY third top-sell­er — the drug gen­er­at­ed about $578 mil­lion in the sec­ond quar­ter. As the drug march­es to­wards a patent cliff, the US drug­mak­er has been work­ing on fill­ing the rev­enue gap it will even­tu­al­ly face.

In Jan­u­ary, the In­di­anapo­lis drug­mak­er agreed to pay $8 bil­lion for Loxo On­col­o­gy, which man­aged to get a drug — a site-ag­nos­tic can­cer treat­ment — ap­proved in a rel­a­tive­ly spright­ly five years. But the main at­trac­tion for Lil­ly is Loxo’s ex­per­i­men­tal LOXO-292, which has sig­nif­i­cant com­mer­cial po­ten­tial in pa­tients with NSCLC. Up­on the an­nounce­ment, Stifel an­a­lysts sug­gest­ed the trans­ac­tion was strate­gic: “(A)ap­prox­i­mate­ly 55-60% of the end-mar­ket for LOXO-292 – the val­u­a­tion cen­ter­piece of this trans­ac­tion per LLY – is rep­re­sent­ed by RET-fu­sion NSCLC and thus rep­re­sents a read­i­ly-ac­ces­si­ble op­por­tu­ni­ty re­quir­ing min­i­mal in­fra­struc­ture build-out.”

In March, an­oth­er Lil­ly drug showed po­ten­tial for use in the lu­cra­tive NSCLC mar­ket. The com­pa­ny’s Cyra­mza, in com­bi­na­tion with Roche’s Tarce­va, helped stem the spread and growth of can­cer as an ini­tial treat­ment in cer­tain pa­tients with metasta­t­ic NSCLC in a piv­otal study.

Ear­li­er this month, Lil­ly said a US Court of Ap­peals for the Fed­er­al Cir­cuit ruled in its fa­vor, con­firm­ing that Al­im­ta’s patent would be in­fringed by Pfiz­er’s $PFE Hos­pi­ra and Dr. Red­dy’s ver­sions. My­lan, along with Nep­tune Gener­ics and No­var­tis’ $NVS San­doz unit was hit with the same road­block in April in re­sponse to their le­gal chal­lenge.

If the patent is ul­ti­mate­ly up­held through all re­main­ing cas­es, Al­im­ta will main­tain US ex­clu­siv­i­ty un­til May 2022.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.