FDA ap­proves first gener­ic drug to re­ceive CGT des­ig­na­tion

The FDA on Wednes­day ap­proved sev­er­al ver­sions of Apo­tex’s potas­si­um chlo­ride oral so­lu­tion as the first gener­ic drugs to re­ceive a Com­pet­i­tive Gener­ic Ther­a­py (CGT) des­ig­na­tion.

Thanks to the FDA Reau­tho­riza­tion Act of 2017 (FDARA), the CGT des­ig­na­tion al­lows gener­ic drugs to come to mar­ket faster than they oth­er­wise would have, but on­ly in cas­es where there is one ap­proved com­peti­tor gener­ic drug in the ac­tive sec­tion of the Or­ange Book.

Those re­ceiv­ing a CGT des­ig­na­tion may re­ceive re­view en­hance­ments and ex­pe­dit­ed re­view of their ab­bre­vi­at­ed new drug ap­pli­ca­tions (AN­DAs). Ap­pli­cants for drugs that re­ceive a CGT des­ig­na­tion are al­so el­i­gi­ble for a 180-day pe­ri­od of mar­ket­ing ex­clu­siv­i­ty if they are the first ap­proved ap­pli­cant for that CGT and meet oth­er con­di­tions.

And in a unique twist, un­der a spe­cial for­fei­ture rule for CGTs, the ap­pli­cant must com­mer­cial­ly mar­ket the CGT with­in 75 days af­ter the date of ap­proval of its AN­DA or it will for­feit its ex­clu­siv­i­ty.

Though the CGT is on­ly for gener­ics with one com­peti­tor, in an up­date to the agency’s Man­u­al of Poli­cies and Pro­ce­dures (MAPP) in June 2017 on the pri­or­i­ti­za­tion of the re­view of AN­DAs, FDA says: “Gener­ic prod­ucts for which there are few­er than three AN­DAs ap­proved for the ref­er­ence list­ed drug (RLD) and for which there are no block­ing patents or ex­clu­siv­i­ties on the RLD may re­ceive ex­pe­dit­ed re­view.”

The potas­si­um chlo­ride oral so­lu­tion prod­ucts ap­proved Wednes­day (potas­si­um chlo­ride oral so­lu­tion USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are el­i­gi­ble for 180 days of CGT ex­clu­siv­i­ty and were ap­proved in the first cy­cle of re­view, FDA said.

FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment: “The quick im­ple­men­ta­tion of this new path­way is part of our broad­er ef­fort to fos­ter gener­ic com­pe­ti­tion and help ad­dress the high cost of drugs.”

FDA in June 2017 al­so re­leased two lists of gener­ic drugs, each of which con­tain more than 100 ac­tive in­gre­di­ents, in­clud­ing one “for which FDA could im­me­di­ate­ly ac­cept an AN­DA with­out pri­or dis­cus­sion,” and the sec­ond for drugs “in­volv­ing po­ten­tial le­gal, reg­u­la­to­ry, or sci­en­tif­ic is­sues which should be ad­dressed with the Agency pri­or to sub­mis­sion of an AN­DA.”

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion. 


Zachary Brennan

managing editor, RAPS

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat a stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Francesco De Rubertis

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Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

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No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

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The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

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So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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