Ab­b­Vie hatch­es plans for a ma­jor new R&D hub close to its part­ners in Bay Area's buzzy Oys­ter Point

Ab­b­Vie has signed on to be the first ten­ant of a mas­sive new re­search cen­ter in Oys­ter Point, join­ing a flock of bio­phar­ma peers that’s set up shop in the in­creas­ing­ly pop­u­lar South San Fran­cis­co neigh­bor­hood.

The North Chica­go, IL-based drug­mak­er — whose Stem­cen­tryx sub­sidiary has an op­er­a­tion in the area — is leas­ing al­most 480,000 square feet in the Gate­way of Pa­cif­ic, a 1.4 mil­lion square foot cam­pus un­der con­struc­tion by Bio­Med Re­al­ty. Ink­ing a deal for 10 years, Ab­b­Vie will oc­cu­py a 12-sto­ry tow­er in a space that could even­tu­al­ly hold 1,500 work­ers, the San Fran­cis­co Busi­ness Times re­port­ed.

The new fa­cil­i­ty will “rep­re­sent a Bay Area hub for Ab­b­Vie’s on­col­o­gy busi­ness,” which is cur­rent­ly spread be­tween three dis­tinct lo­ca­tions in the re­gion, Ab­b­Vie spokesper­son Ilke Limon­cu tells End­points News.

“This fu­ture fa­cil­i­ty will al­so fur­ther strength­en our pres­ence in the Bay Area and bring to­geth­er our cur­rent three sites to im­prove col­lab­o­ra­tion and help us grow Ab­b­Vie’s on­col­o­gy sci­ence, re­search, in­no­va­tion and pa­tient care am­bi­tions,” he writes in an email.

The new lo­ca­tion would make Ab­b­Vie a neigh­bor of Genen­tech’s Gate­way cam­pus, while plac­ing it just 10 min­utes away from mul­ti­ple part­ners at Cal­i­co, Cy­tomX and Alec­tor.

When Ab­b­Vie and Cal­i­co re­newed their mon­ster dis­cov­ery deal in June, each com­mit­ting $500 mil­lion more to their al­liance, the Google-backed an­ti-ag­ing biotech made the un­usu­al move to an­nounce that it’s built a team of 150-plus around an HQ base in South San Fran­cis­co, with plans to add more.

Big names and fledg­ling biotechs alike have tak­en a lik­ing to the R&D hub in San Fran­cis­co, with Oys­ter Point in par­tic­u­lar buzzing with new oc­cu­pants. Sang­amo un­veiled plans to build a new HQ right on a ma­ri­na late last year, while As­traZeneca is bring­ing staffers from var­i­ous biotechs it ac­quired to­geth­er at its Cove at Oys­ter Point site.

“The core of Ab­b­Vie’s ini­tia­tive is fo­cused on the tal­ent, in­no­va­tion and cul­ture in the Bay Area,” Di­no Per­az­zo, a rep­re­sen­ta­tive of Ab­b­vie from re­al es­tate bro­ker­age CBRE’s life sci­ence prac­tice, told the San Fran­cis­co Busi­ness Times. “Theirs is the first of what will like­ly be many phar­ma ini­tia­tives com­ing to the Bay Area in the near fu­ture.”

While the the first phase of Gate­way of Pa­cif­ic is ex­pect­ed to com­plete in 2019 — with 431,000 square feet in phase II space to come lat­er — Ab­b­Vie won’t be­gin to move in un­til 2021, when its cur­rent Cal­i­for­nia leas­es ex­pire, Limon­cu con­firms.


Im­age: GATE­WAY OF PA­CIF­IC

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

GSK of­floads two vac­cines in $1.1B deal as it works to re­vive the pipeline

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

Pfiz­er gets some en­cour­ag­ing PhI­II news on a fran­chise sav­ior, but is a dos­ing ad­van­tage worth the $295M up­front?

Close to 3 years after Opko tried to defend itself as shares tumbled on the news that its long-acting growth hormone had failed to outperform a placebo, the Pfizer partner $PFE is back. And this time they’re pitching Phase III data that demonstrates their drug is non-inferior — or maybe a tad better — than their well-known but fading standard in the field.
The comparator drug here is Genotropin, which earned a marginal $142 million for Pfizer last year — down 9% from the year before. Approved 24 years ago, biosimilars are now in development that Pfizer would like to stay out in front of. The market leader here is Norditropin, a growth hormone from Novo Nordisk which uses the same basic ingredient as Genotropin which the pharma giant sells with a kid-friendly self-injectable pen. That would also present some big competition if the new therapy from Opko/Pfizer makes it to the market.
The new data, says researchers, underscore that a weekly injection of somatrogon performed as well or slightly better than Genotropin (somatropin) in young children with growth hormone deficiency. Investigators tracked height velocity at 10.12 cm/year, edging out the older drug’s 9.78 cm/year. That 0.33 difference may not prove compelling to payers, though, who have been known to overlook dosing advantages in favor of lower costs.
That message may have weighed on the stock reaction this morning, with a 30%-plus hike $OPK giving way to more marginal gains.
Back in late 2016, Opko had to defend itself against a devastating Phase III setback as their initial late-stage trial failed against a sugar pill. Opko later blamed that setback on outliers in the study, though it wasn’t able to expunge the failure.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca's Farx­i­ga scores FDA nod to cut risk of hos­pi­tal­iza­tion for heart fail­ure in di­a­bet­ics

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,500+ biopharma pros reading Endpoints daily — and it's free.

Alex­ion clinch­es aHUS ap­proval for Ul­tomiris as the clock ticks on Soliris con­ver­sion

Alexion has racked up a second approval for Ultomiris, the successor therapy to Soliris, as its mainstay blockbuster therapy faces a patent review process that could drastically shorten its patent exclusivity.

The FDA OK for atypical hemolytic uremic syndrome (aHUS) on Friday was widely expected after Alexion posted a full slate of positive Phase III data in January. But regulators also flagged concerns about serious meningococcal infections, slapping a black box warning on the label and mandating a REMS.

FDA ap­proval lets Foamix set its maid­en ac­ne ther­a­py on course for US mar­ket launch

Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.

The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.

Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world: By blocking that protein, the theory goes, one can stop cancer cells from fooling macrophages. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.