Valeant fi­nal­ly wins long-de­layed FDA OK for its glau­co­ma drug, which is more good news for Aerie

For­mer Valeant $VRX CEO Michael Pear­son (re­mem­ber him?) was will­ing to get past his gag re­flex when it came to drug R&D and cheer on the ex­per­i­men­tal la­tanoprostene bun­od oph­thalmic so­lu­tion as a block­buster in the mak­ing. Now, more than two years af­ter it was first sub­mit­ted, the FDA has sanc­tioned the drug’s mar­ket­ing af­ter Valeant was fi­nal­ly able to get past two re­jec­tions based on the agency’s prob­lems with its man­u­fac­tur­ing fa­cil­i­ty in Tam­pa.

Picked up in the $8.7 bil­lion buy­out of Bausch + Lomb, the drug will now be sold as Vyzul­ta. Valeant’s shares were up a lit­tle more than 4% in pre-mar­ket trad­ing on Fri­day.

Joseph Pa­pa

The OK trig­gers a $17.5 mil­lion pay­ment to Nicox — which out-li­censed it to Bausch + Lomb and wound up with Valeant as a part­ner — and a $15 mil­lion out­lay to Pfiz­er un­der its old li­cens­ing agree­ment.

The OK al­so marks good news for Aerie $AERI, which de­pends on the very same fa­cil­i­ty for its drug Rho­pres­sa, now un­der re­view at the FDA.

Aerie is look­ing at a Feb­ru­ary 28, 2018 PDU­FA date for its glau­co­ma drug, which is al­so to be made at the very same fa­cil­i­ty. Some of the shorts had bet that Valeant’s woes would be left at Aerie’s door steps, but that chance has all but dis­ap­peared now. An ex­pert FDA pan­el en­dorsed the drug a cou­ple of weeks ago, and there seems noth­ing to stop a near-term ap­proval.

Fed­er­al in­spec­tors have been crit­i­cal of the Tam­pa fa­cil­i­ty in the past, cit­ing them for a range of is­sues, in­clud­ing find­ing met­al par­tic­u­lates in sam­ples.

Score one de­layed point for Pear­son’s suc­ces­sor, Joseph Pa­pa, who was brought in to clean up the mon­u­men­tal mess left by Pear­son’s years-long deal­mak­ing spree. In a state­ment, Pa­pa said:

With to­day’s ap­proval of Vyzul­ta, our cus­tomers and their pa­tients with glau­co­ma now have a new treat­ment op­tion that can help pro­vide con­sis­tent and sus­tained IOP low­er­ing, the on­ly mod­i­fi­able risk fac­tor that can help slow down the pro­gres­sion of the dis­ease. We ex­pect to make this new ad­vance­ment avail­able for those who suf­fer with glau­co­ma be­fore the end of the year.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a plan to near­ly dou­ble its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

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. 

Jason Kelly. Mike Blake/Reuters via Adobe

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.