Shire gains a de­layed FDA OK for ‘block­buster’ dry eye drug li­fite­grast

Nine months af­ter the FDA hand­ed Shire $SH­PG a re­jec­tion for its dry eye drug li­fite­grast, the biotech com­pa­ny says it’s bounced back with a de­layed ap­proval from the FDA. And now Shire will set out to see if it can achieve its ear­li­er fore­cast of more than a bil­lion dol­lars in an­nu­al sales.

Shire will be tack­ling a broad mar­ket in­clud­ing more than 16 mil­lion peo­ple who have been di­ag­nosed with dry eye dis­ease. The com­pa­ny plans to get start­ed mar­ket­ing the eye drop ther­a­py in a few months, sell­ing it as Xi­idra.

Flem­ming Orn­skov, CEO of Shire

The ap­proval marks a clear win for CEO Flem­ming Orn­skov, who brought a de­sire to de­vel­op a pipeline of new oph­thalmic drugs when he took the helm at Shire, based in Dublin with an R&D heart cen­tered in Lex­ing­ton, MA. And the mar­ket loved the news, send­ing Shire share up 5%.

Orn­skov made li­fite­grast a key part of his plan to grow sales to $10 bil­lion a year, ahead of his big ac­qui­si­tion of Bax­al­ta. And he’s had some ups and downs along the way.

This ap­proval, though, marks a sig­nal step ahead for the com­pa­ny, if the drug per­forms on the mar­ket. Once the sub­ject of an Ab­b­Vie takeover at­tempt, which was scut­tled by new fed­er­al rules de­signed to de­rail tax in­ver­sions, Orn­skov has re­mained com­mit­ted to mak­ing Shire in­to a glob­al bio­phar­ma force to be reck­oned with.

In this case, Shire will have to con­tend with Brent Saun­ders and Al­ler­gan, which earned more than a bil­lion dol­lars last year for the lead­ing dry eye treat­ment on the mar­ket, Resta­sis (cy­closporin). The bulk of that mon­ey came from the big U.S. mar­ket.

“As Shire’s first FDA-ap­proved med­i­cine in oph­thalmics, this sig­nif­i­cant mile­stone ad­vances our goal of be­com­ing the glob­al leader in this cat­e­go­ry, where there are un­met pa­tient needs,” Orn­skov said in a state­ment. “We have a ro­bust oph­thalmics pipeline, and we look for­ward to lever­ag­ing Xi­idra as our en­trée in­to the space as we con­tin­ue to de­vel­op ad­di­tion­al in­no­v­a­tive eye care treat­ment op­tions.”

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

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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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

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.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

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.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

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

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

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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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.