My­lan claims win in Lan­tus patent bat­tle, but le­gal war with Sanofi is far from over

Ear­li­er this week, the FDA took aim at es­ca­lat­ing in­sulin prices that have forced di­a­bet­ics to ra­tion out the drug as out-of-pock­et costs soar. Now, the US Patent and Trade­mark Of­fice has de­nied Sanofi’s claim on two patents for its top-sell­ing Lan­tus, in re­sponse to a pe­ti­tion from My­lan, al­though on­go­ing lit­i­ga­tion be­tween the two com­pa­nies in US courts could still sub­vert a po­ten­tial launch of the gener­ic drug­mak­er’s copy­cat ver­sion.

Sanofi $SNY, No­vo Nordisk $NVO and Eli Lil­ly $LLY — the tri­fec­ta that pro­duce the li­on’s share of in­sulin — have come un­der pres­sure in re­cent years in re­sponse to surg­ing prices (the av­er­age price of in­sulin near­ly tripled be­tween 2002 and 2013).  Rev­enue from Sanofi’s di­a­betes fran­chise, which is down down near­ly 30% since 2015, is large­ly de­pen­dent on the in­sulin glargine in­jec­tion Lan­tus. Sales from the long-act­ing ver­sion of hu­man in­sulin shrank to rough­ly €1.8 bil­lion (about $2 bil­lion) in the first half of this year.

On Thurs­day, My­lan $MYL said that the US patent and re­view board (PT­AB) had ruled in its fa­vor, con­clud­ing two of Sanofi’s for­mu­la­tion patents were ‘un­patentable’. But last year, the French drug­mak­er ini­ti­at­ed patent in­fringe­ment lit­i­ga­tion against My­lan’s (and Bio­con’s) NDA that in­cludes these two for­mu­la­tion patents cov­er­ing Lan­tus, as well as oth­er patents cov­er­ing the Lan­tus SoloSTAR in­jec­tion pen.

No date for the rul­ing has been set yet, al­though lit­i­ga­tion pro­ceed­ings have en­sured that the ap­proval of My­lan and Bio­con’s Lan­tus copy­cat is sub­ject to a 30-month stay which ex­tends to ear­ly 2020.

“We be­lieve that it is un­like­ly that the PT­AB rul­ing on the for­mu­la­tion patents will have an im­pact on My­lan’s tim­ing for a launch of its glargine prod­ucts.  The PT­AB de­ci­sion alone does not af­fect the ex­ist­ing 30-month stay and My­lan does not have ten­ta­tive FDA ap­proval for its prod­ucts at this time,” a Sanofi spokes­woman told End­points News in an emailed state­ment.

Aside from pric­ing pres­sure, Lan­tus is al­ready suf­fer­ing from com­pe­ti­tion from Lil­ly’s Basaglar, which was launched in late 2016, af­ter the set­tle­ment of a sim­i­lar case with Lil­ly the pre­ced­ing year. CVS and Unit­ed Health have re­placed Lan­tus in fa­vor of Basaglar in their for­mu­la­ries.

The sit­u­a­tion with in­sulin — as point­ed out by Scott Got­tlieb ear­li­er this week — is in­fi­nite­ly com­plex. Al­though they are tech­ni­cal­ly bi­o­log­i­cal prod­ucts – that hit the mar­ket decades ago – they are clas­si­fied as drugs and ap­proved via NDAs, thwart­ing the de­vel­op­ment of biosim­i­lars. In­stead, com­pa­nies like Lil­ly and My­lan have de­vel­oped or are de­vel­op­ing what are called fol­low-on bi­o­log­ics, which are es­sen­tial­ly copy­cat ver­sions of the prod­uct, but are not sub­sti­tutable with the brand­ed prod­uct.

Mer­ck and part­ner Sam­sung Bioepis, mean­while, elect­ed to halt the de­vel­op­ment of their Lan­tus fol­low-on bi­o­log­ic ear­li­er this year.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better.

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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Ger­man Mer­ck bests US Mer­ck in UK copy­right tus­sle of Mer­ck v. Mer­ck

Before Merck and Merck, there was only Merck.

A single company was founded as a drugmaker in the pre-Bismarckian days of an industrializing Germany that, in 1891, decided to launch an outpost in New York. It was a successful idea, launching a smallpox vaccine just 7 years later, until World War I, when the US government seized the US branch under the Trading with the Enemy Act, splitting the global corporation in two and setting off a century of intercontinental brand confusion.