Gilead gets a block­buster boost from an FDA OK of HIV triplet Bik­tarvy — and ri­val GSK fires back

Un­der the gun as an­a­lysts watch the moun­tain of cash gar­nered from its hep C fran­chise melt away, Gilead $GILD got some good news to­day with the FDA’s ap­proval of its big triplet for HIV. And their ri­vals at Glax­o­SmithK­line swift­ly re­tal­i­at­ed, fil­ing a fed­er­al law­suit in the US ac­cus­ing Gilead of in­fring­ing on its HIV patents.

Known as BIC/F/TAF in the trade, com­bin­ing the nov­el bicte­gravir with the back­bone com­bi­na­tion of emtric­itabine/teno­fovir alafe­namide in­to a sin­gle dai­ly pill, the FDA not­ed its ap­proval in the record books. And it will re­place a reg­i­men that once re­quired a mul­ti­tude of pills to keep the virus un­der con­trol.

Gilead will call this new oral ther­a­py Bik­tarvy, and the con­sen­sus on peak sales is right at $6 bil­lion a year, mak­ing it one of the biggest drugs in the in­dus­try’s pipeline. And not every­one is sat­is­fied that Gilead will top out there. Leerink’s Ge­of­frey Porges is all in on a mega suc­cess sto­ry.

We cur­rent­ly fore­cast $1bn of sales for Bik­tarvy dur­ing 2018, which is most­ly in the US giv­en the tim­ing of EU ap­proval. Our long-term fore­cast is for Bik­tarvy to reach glob­al sales of $10bn by 2025 and this is con­sid­er­ably above re­cent con­sen­sus es­ti­mates of $6.1bn.

Some of that mon­ey, of course, will be can­ni­bal­ized out of ex­ist­ing sales at Gilead, but the HIV fran­chise re­mains a big and grow­ing part of the com­pa­ny as it tack­les its new work with Kite on CAR-T.

Gilead faces some ma­jor league com­pe­ti­tion from Glax­o­SmithK­line’s HIV unit Vi­iV, which wres­tled an ear­ly ap­proval for their sin­gle pill reg­i­men Ju­lu­ca last No­vem­ber. It sells for $2,579 a month, lead­ing some an­a­lysts to spec­u­late that they could put pres­sure on Gilead’s pric­ing, which has yet to be re­vealed. GSK is al­so ex­pect­ed to reap about $5 bil­lion in an­nu­al sales from its ri­val ther­a­py.

Al­most im­me­di­ate­ly, GSK — which is fac­ing painful gener­ic com­pe­ti­tion for Ad­vair — re­spond­ed to the news of the FDA OK Wednes­day af­ter­noon by fil­ing a patent in­fringe­ment suit against Gilead in fed­er­al court. From their state­ment:

Vi­iV Health­care will seek to prove that Gilead Sci­ences Inc’s triple com­bi­na­tion HIV drug con­tain­ing the HIV in­te­grase in­hibitor bicte­gravir in­fringes Vi­iV Health­care’s patent cov­er­ing Vi­iV Health­care’s do­lute­gravir and many oth­er com­pounds that in­clude do­lute­gravir’s unique chem­i­cal scaf­fold…. Vi­iV Health­care will … seek fi­nan­cial re­dress for patent in­fringe­ment.

R&D chief Nor­bert Bischof­berg­er not­ed dur­ing the com­pa­ny’s Q4 call yes­ter­day that the PDU­FA date for the triplet was set for Feb­ru­ary 12, and this com­pa­ny is primed and ready to roll on the com­mer­cial front. He said:

BIC/FTC/TAF met its pri­ma­ry ob­jec­tive of non-in­fe­ri­or­i­ty at 48 weeks across all four stud­ies and no par­tic­i­pants failed BIC/F/TAF for treat­ment-emer­gent vi­ro­log­i­cal re­sis­tance. Ad­di­tion­al clin­i­cal tri­als of BIC/F/TAF are on­go­ing, in­clud­ing a ded­i­cat­ed study in women as well as a study in ado­les­cents liv­ing with HIV. We plan to present da­ta from these stud­ies at sci­en­tif­ic con­fer­ences in 2018.

Im­age: Gilead CEO John Mil­li­gan Bloomberg via Get­ty Im­ages

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.