'We will con­tin­ue to fight': Con­tra­cep­tive com­pa­nies re­main hope­ful af­ter House pass­es bill

A day af­ter the House passed a bill that would pro­tect Amer­i­cans’ right to con­tra­cep­tives, biotech ex­ecs say they will keep fight­ing for bet­ter ac­cess to nov­el birth con­trol prod­ucts.

The big ques­tion now is whether the leg­is­la­tion will sur­vive the Sen­ate floor.

The House vot­ed 228-195 on Thurs­day to pass a law that would en­sure the right to ob­tain and pro­vide con­tra­cep­tives. It would al­so al­low pa­tients, providers and fed­er­al or state gov­ern­ments to bring civ­il suits against states or of­fi­cials that vi­o­late the law.

The move comes weeks af­ter the Supreme Court over­turned Roe v. Wade, and Jus­tice Clarence Thomas in­di­cat­ed in his opin­ion that the Court should re­con­sid­er oth­er prece­dents, in­clud­ing one 1965 de­ci­sion that as­sured the right to con­tra­cep­tives.

Eight Re­pub­li­can rep­re­sen­ta­tives joined De­moc­rats in sup­port of the con­tra­cep­tive bill, while some Sen­ate Re­pub­li­cans have in­di­cat­ed they’re on the fence. How­ev­er, there’s a chance the Sen­ate won’t vote un­til af­ter sum­mer re­cess, which be­gins Aug. 5.

Sab­ri­na John­son

“It’s ab­solute­ly an out­stand­ing step,” Daré Bio­science CEO Sab­ri­na John­son said on Fri­day of the House vote.

Her com­pa­ny’s vagi­nal ring, Ovaprene, is about to en­ter a Phase III tri­al this year. “I would love for it to pass in the Sen­ate, but I think re­al­is­ti­cal­ly, giv­en that there were on­ly eight Re­pub­li­cans that sup­port­ed it in the House, I think that it’s go­ing to be a heavy lift,” she added.

Rep. Ang­ie Craig (D-MN) spoke in sup­port of the bill on the House floor on Thurs­day, ar­gu­ing that “an ex­treme GOP, an ex­treme Supreme Court, they want to take away your free­dom and your con­trol over your own lives.”

“It is ab­solute­ly nec­es­sary that we take ac­tion to­day,” she said.

Some Re­pub­li­can sen­a­tors have in­di­cat­ed they’re lean­ing to­ward a yes vote, in­clud­ing Su­san Collins (R-ME) who told the Wash­ing­ton Post that she would “most like­ly” of­fer sup­port. Sen. Lisa Murkows­ki (R-AK) told the Post she was work­ing on bi­par­ti­san leg­is­la­tion to cod­i­fy abor­tion and per­haps con­tra­cep­tion rights.

Saun­dra Pel­leti­er

“What I’m pleased about is that we’re re­al­ly try­ing to be proac­tive, and we rec­og­nize that if we aren’t fierce about this — but I mean fierce — we’re go­ing to ac­tu­al­ly cre­ate im­pli­ca­tions for half of our pop­u­la­tion that are go­ing to be dire,” said Saun­dra Pel­leti­er, CEO of Evofem, which mar­kets a non-hor­mon­al con­tra­cep­tive gel called Phexxi.

“We have to get up, suit our­selves in our ar­mor, be­cause this was too easy to have things tak­en away,” she said of the Court’s de­ci­sion in Dobbs v. Jack­son Women’s Health Or­ga­ni­za­tion.

Be­fore the Supreme Court’s de­ci­sion, Evofem strug­gled to get cov­er­age for Phexxi. Now in­sur­ers are start­ing to lis­ten, Pel­leti­er said. Pay­ers cov­er 75% per­cent of prod­uct claims, up from 55% a year ago.

“We just all be­lieve in the same is­sues,” in­clud­ing mak­ing a broad range of con­tra­cep­tives avail­able and af­ford­able to women, said Ag­ile Ther­a­peu­tics CEO Al Al­tomari. Ag­ile mar­kets its birth con­trol patch Twirla as a low­er dose and more con­ve­nient op­tion for women. “We’re al­ready walk­ing the walk … We will con­tin­ue to fight.”

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.

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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.

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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.”

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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.

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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.

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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.