[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.

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The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

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Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

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We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

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