With Big Phar­ma castoffs in hand, Mereo files for $81M IPO; Lon­don's Verona sees stock surge on PhI­Ib COPD da­ta

→ Mereo Bio­Phar­ma, a Lon­don biotech de­vel­op­ing a pipeline of as­sets it snagged from Big Phar­ma shelves, is head­ing to the Nas­daq with hopes of rais­ing around $81 mil­lion in an IPO. The com­pa­ny is al­ready list­ed on the Lon­don Stock Ex­change and plans to use the ex­tra cash to de­vel­op at least three drug can­di­dates through mid-stage tri­als. In an SEC state­ment sig­nal­ing the stock of­fer­ing, Mereo said the mon­ey would fu­el two pro­grams it picked up from No­var­tis and one it got from As­traZeneca. The pro­ceeds should get BPS-804 (setrusum­ab), an ex-No­var­tis rare dis­ease drug for pa­tients with os­teo­ge­n­e­sis im­per­fec­ta, in­to Phase IIb/III tri­als in 2018. The cash will al­so fund the ex-No­var­tis drug BGS-649 for the treat­ment of hy­pog­o­nadotrop­ic hy­pog­o­nadism in obese men through Phase IIb and in­to late-stage tri­als; and AZD-9668, a res­pi­ra­to­ry dis­ease as­set Mereo out-li­censed from As­traZeneca last fall, through proof-of-con­cept tri­als. Mereo plans to list un­der the stock sym­bol $MPH.

→ Lon­don-based Verona Phar­ma saw its Lon­don-list­ed stock (LON: $VRP) jump 19% Mon­day fol­low­ing news that its Phase IIb study test­ing its chron­ic ob­struc­tive pul­monary dis­ease (COPD) treat­ment RPL554 had promis­ing re­sults. The drug showed “a clin­i­cal­ly and sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment” in pa­tients with COPD com­pared to place­bo. “These re­sults are very en­cour­ag­ing and strong­ly sup­port the pro­gres­sion of RPL554 in­to lat­er stage de­vel­op­ment as an in­haled treat­ment for COPD pa­tients,” said Jan-An­ders Karls­son, CEO of Verona Phar­ma, in a state­ment. “The fu­ture clin­i­cal de­vel­op­ment and the po­si­tion­ing of this nov­el treat­ment will be in­formed by these da­ta as well as by the out­come of the clin­i­cal study as an add-on to es­tab­lished com­bi­na­tion ther­a­pies planned to start this year, and our on­go­ing mar­ket re­search.”

AR­MO Bio­Sciences $AR­MO, fresh off a $120 mil­lion IPO, re­port­ed out an ear­ly look at its PhI­II tri­al test­ing AM0010 (pegilode­cakin) with Fol­fox in pa­tients with pan­cre­at­ic can­cer. The in­ter­im analy­sis showed the com­bo was cleared to pro­ceed through the tri­al. The analy­sis, done by the Da­ta Mon­i­tor­ing Com­mit­tee (DMC), was meant to find out if the com­bo was safe based on over­all sur­vival as well as phar­ma­co­ki­net­ics in the first 60 sub­jects en­rolled in the study that re­ceived at least four months of ther­a­py. AR­MO’s CMO Joseph Lev­eque had this to say: “The DMC’s rec­om­men­da­tion sup­ports the safe­ty pro­file we have seen with pegilode­cakin when com­bined with 5-flu­o­roura­cyl and plat­inum-based chemother­a­py which is the ba­sis for a num­ber of dif­fi­cult to treat can­cers.  As such, we be­lieve that pegilode­cakin in com­bi­na­tion with Fol­fox could pro­vide a safe and ef­fi­ca­cious ther­a­peu­tic op­tion for sec­ond-line pan­cre­at­ic duc­tal ade­no­car­ci­no­ma pa­tients.” Fi­nal da­ta are ex­pect­ed in 2020.

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

Genen­tech sub­mits a big plan to ex­pand 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.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

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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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.

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.

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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