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.

It’s been an event­ful year-plus for GSK’s vac­cine en­ter­pris­es. Shin­grix, their shin­gles vac­cine, has proven a block­buster, pulling in near­ly $1 bil­lion through the first half of 2019 — sell­ing so well, in fact, it led to short­ages. Mean­while, the British gi­ant’s Vi­iV sub­sidiary shook Gilead’s strong­hold on the HIV mar­ket with FDA ap­proval for their two-drug reg­i­men of Dova­to and Ju­lu­ca and some for­ti­fy­ing Phase III da­ta.

In May, how­ev­er, GSK un­cer­e­mo­ni­ous­ly cut two oth­er vac­cine pro­grams, one for strep pneu­mo­nia and a can­di­date for the uni­ver­sal flu vac­cine, in a Q1 re­view.

“Those two have been stopped, ex­act­ly as I have just been out­lin­ing, be­cause of the ear­ly da­ta that came through,” CEO Em­ma Walm­s­ley told re­porters at the time. “It is not some­thing that’s worth pur­su­ing and we want to be very strict on that, and that con­tin­ues to build on quite an ag­gres­sive pro­gram of stop­ping as­sets when they need to be, and dou­bling down.”

That kind of ruth­less ad­her­ence to da­ta has be­come com­mon­place at GSK, since Walm­s­ley took the CEO post in 2017 and Hal Bar­ron took over the long-strug­gling R&D arm in 2018.

Em­ma Walm­s­ley

The new lead­er­ship has tried to win­now the phar­ma gi­ant’s pipeline to re­fo­cus around key as­sets and ac­quire new ones where in-house com­pounds fall short. Most no­tably, they bought out Tesaro for $5 bil­lion last De­cem­ber, ac­quir­ing not on­ly their PARP in­hibitor Ze­ju­la but al­so drugs to in­hib­it check­points PD-1, TIM-3 and LAG-3.

In­vestors re­coiled at the stick­er price and the amount of Tesaro debt GSK ab­sorbed, pre­cip­i­tat­ing the British gi­ant’s largest slide in a decade, per Reuters. But Bar­ron re­cent­ly told End­points News the deal was cru­cial in re­build­ing the ag­ing com­pa­ny’s shaky pipeline.

“Frankly, they had 10 to 15 pro­grams that they would have loved to have done but didn’t have the band­width, the scale, the re­sources for,” Bar­ron told End­points News’ at the UK Bio Sum­mit ear­li­er this month. “So we came in and said frankly your pro­grams you’re not do­ing are more valu­able and in­ter­est­ing than the ones at the bot­tom of our ef­fi­cien­cy fron­tier, so we killed 11 pro­grams.”

Mon­ey from those 11 pro­grams was fun­neled in­to Tesaro projects. It’s not yet two years in­to Bar­ron’s tenure, but GSK’s lead­er­ship have thus far em­braced the bloody job of pipeline cut­ting with free-ax­ing glee, hap­pi­ly ex­plain­ing to in­vestors and re­porters the long-term strat­e­gy be­hind the moves.

Since then GSK has on­ly culled more, slash­ing an Ebo­la vac­cine and two res­pi­ra­to­ry drugs, while bet­ting un­spec­i­fied mil­lions on Rick Klaus­ner’s $600 mil­lion cell ther­a­py start­up Lyell, which aims at sol­id tu­mors.

Jen­nifer Doud­na

Mean­while, the gi­ant has slow­ly shift­ed the rest of the lead­er­ship team, bring­ing on can­cer ex­perts like Mer­ck KGaA’s Maya Mar­tinez-Davis and No­var­tis and As­traZeneca vet Jonathan Symonds. They’ve al­so paired up with 23andMe and with lead­ing fig­ures such as CRISPR-Cas9 pi­o­neer Jen­nifer Doud­na and Jonathan Weiss­man as part of Bar­ron’s ef­fort to re­shape how the in­dus­try choos­es drug tar­gets, shift­ing from mice to­ward the hu­man genome.

“We do these stud­ies in iso­genic mice and de­cide that some con­trived mod­el is use­ful for hu­man dis­eases and frankly these are tiny lit­tle fur­ry things that live 3 years and don’t have any­thing sim­i­lar to our im­mune sys­tem,” Bar­ron told End­points. “Then we con­vince our­selves that that’s a great tar­get, we take it through and it fails 90% of the time.”

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 64,900+ biopharma pros reading Endpoints daily — and it's free.

The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 64,900+ biopharma pros reading Endpoints daily — and it's free.

Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 64,900+ biopharma pros reading Endpoints daily — and it's free.

Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.