'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.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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