Sunovion slammed by FDA re­jec­tion of neb­u­lized LAMA for COPD as ri­val lines up a com­pet­ing NDA

The FDA has re­ject­ed a new COPD ther­a­py from the US sub­sidiary of Sum­it­o­mo Dainip­pon, but there’s no word on what trig­gered the CRL. The set­back of­fers Ther­a­vance Bio­phar­ma $TBPH and its part­ner My­lan a chance to catch up with a promi­nent ri­val ther­a­py that’s wind­ing through the fi­nal months of a late-stage pro­gram.

Late on Fri­day lead­ing in­to the long Memo­r­i­al Day week­end, Sunovion put out a short state­ment say­ing on­ly that reg­u­la­tors had is­sued a com­plete re­sponse let­ter for SUN-101 (dubbed gly­copy­rro­late, which is used with an ex­per­i­men­tal neb­u­liz­er), its top late-stage ther­a­py. The Marl­bor­ough, MA-based biotech added that reg­u­la­tors were not de­mand­ing any new tri­als and that ex­ecs would work with the FDA on mov­ing for­ward.

The twice-dai­ly ther­a­py aimed at be­com­ing the first neb­u­lized long-act­ing mus­carinic an­tag­o­nist for COPD af­ter the com­pa­ny claimed back-to-back suc­cess­es in Phase III — though their lat­est up­date on the da­ta didn’t in­clude key re­sults on trough FEV1.

Sunovion, which was es­tab­lished through a 2010 deal by Sum­it­o­mo Dainip­pon to ac­quire Sepra­cor for $2.6 bil­lion, got this drug 5 years ago in a $430 mil­lion buy­out — $100 mil­lion up front — bag­ging El­e­va­tion Phar­ma­ceu­ti­cals right af­ter it boast­ed about “gold stan­dard” Phase IIb COPD da­ta for its top drug EP-101.

Over the past year the Japan­ese sub has been lead­ing the race with Ther­a­vance, which has boast­ed about the once-dai­ly neb­u­lized ther­a­py it’s been work­ing on. Un­like Sunovion’s lat­est state­ment, Ther­a­vance and its part­ner My­lan post­ed Phase III da­ta, with an eye on fil­ing for an ap­proval for reve­fe­nacin lat­er in the year when their safe­ty study wraps. Their sta­tis­ti­cal­ly sig­nif­i­cant re­sults:

The im­prove­ments in trough FEV1, the pri­ma­ry ef­fi­ca­cy end­point, ver­sus place­bo for the in­tent-to-treat pop­u­la­tions across both stud­ies were 118 mL and 145 mL for 88 mcg and 175 mcg, re­spec­tive­ly (p ≤ 0.001).

Here, by com­par­i­son, are the re­sults Sunovion har­vest­ed:

Place­bo-ad­just­ed change from base­line in trough FEV1 at Week 12 (ITT pop­u­la­tions)

Ther­a­vance and My­lan — which bought in­to the part­ner­ship in 2015 with $45 mil­lion for an up­front and eq­ui­ty stake — say they plan to file for an ap­proval lat­er in the year. Sunovion has not re­leased a time­line of its own.

Sunovion has gen­er­al­ly kept a low pro­file over the last 7 years. But it’s been do­ing a few deals to build up the US pipeline. Last fall CEO Nobuhiko Tamu­ra no­tably bagged Cy­nap­sus and its late-stage Parkin­son’s drug for $640 mil­lion.

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.

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.

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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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.