Bio­haven touts a pair of PhI­II wins for mi­graine pill, but shares ric­o­chet off of weak da­ta

Bio­haven has re­leased a set of pos­i­tive Phase III da­ta for their fast-act­ing mi­graine drug, which close­ly par­al­lel a ri­val at Al­ler­gan and trail well be­hind Eli Lil­ly’s las­mid­i­tan. And the biotech will now join the scram­ble un­der­way for an ap­proval in a field that’s about to be se­vere­ly dis­rupt­ed.

In­vestors didn’t like the num­bers ear­ly Mon­day morn­ing, send­ing shares $BHVN down 40%. That clear­ly wasn’t the way Bio­haven was bet­ting. The biotech paid Bris­tol-My­ers Squibb $50 mil­lion just a cou­ple of weeks ago to re­struc­ture their li­cens­ing deal, cut­ting the roy­al­ty stream to the sin­gle dig­its. But in the hours up to the close, the stock — backed by some heavy­weight mar­ket play­ers — went on a roller coast­er ride in the red, end­ing the day down 7%.

Al­ler­gan — which will have an­oth­er Phase III tri­al to re­port on — saw its shares rise a bit, while Lil­ly stock jumped close to 2%.

The co-pri­ma­ry end­points for Bio­haven’s oral rimegepant (BHV-3000) was pain free­dom and free­dom from most both­er­some symp­tom 2 hours af­ter tak­ing the pill in two piv­otal stud­ies.

Their pain free­dom rate was 19.2% and 19.6% for the drug, ver­sus 14.2% and 12% for the place­bo arm. Free­dom from MBS was 37.6% and 36.6% ver­sus 25.2% and 27.7% in the sug­ar pill group.

That ev­i­dent­ly may have been sta­tis­ti­cal­ly sig­nif­i­cant, but it wasn’t a big enough spread to con­vince skep­tics won­der­ing about the drug’s clin­i­cal sig­nif­i­cance in a com­pet­i­tive field.

Com­pare rimegepant to Al­ler­gan’s oral CGRP ubro­gepant, where the first Phase III re­port­ed out free­dom for pain at 2 hours for 19.2% and 21.2% for two dif­fer­ent dos­es and 11.8% in the place­bo arm; 38.6% and 37.7% on MBS and 27.8% in the place­bo arm.

Eli Lil­ly’s las­mid­i­tan — which works by hit­ting 5-HT1F re­cep­tors — did even bet­ter, de­spite be­ing dogged by high place­bo rates. Lil­ly $LLY, which paid $960 mil­lion to buy CoLu­cid and las­mid­i­tan, al­so has a CGRP drug that has per­formed in line with the rest of the in­jecta­bles.

Two hours af­ter tak­ing las­mid­i­tan or a place­bo, here were the the lat­est Phase III re­spons­es on free­dom from pain by dosage: 28.6% for 50 mg (p=0.003); 31.4% for 100 mg (p<0.001); 38.8% for 200 mg (p<0.001) and 21.3% for place­bo. In­ves­ti­ga­tors al­so nailed an end­point on free­ing pa­tients of their most both­er­some symp­tom, whether that was nau­sea, sen­si­tiv­i­ty to sound or sen­si­tiv­i­ty to light. The da­ta: 40% for 50 mg (p=0.009); 44.2% for 100 mg (p<0.001); 48.7% for 200 mg (p<0.001) and 33.5% for place­bo.

Back-to-back Phase II­Is, how­ev­er, won’t trans­late in­to a quick FDA fil­ing. Bio­haven not­ed in a re­lease that it won’t be ready to file un­til 2019, keep­ing up with Al­ler­gan on that score.

Vlad Coric

The ri­vals here are bet­ting that they can take mar­ket share for treat­ing mi­graines as heavy­weights com­pete over in­jectable CGRP drugs head­ed to reg­u­la­tors for the pre­ven­tion of acute mi­graine. Am­gen and No­var­tis lead the way on that front, with a drug un­der re­view. Te­va, and Alder are an­gling for a fol­lowup po­si­tion.

The one com­mon char­ac­ter­is­tic of these drugs is that they all per­form in re­mark­ably sim­i­lar ways, leav­ing oral de­liv­ery and price as two fea­tures that these two new ther­a­pies can com­pete on. Al­ler­gan has al­so had to ex­plain some cas­es of liv­er tox in its first Phase III — a con­cern for the class — while Bio­haven says it saw noth­ing to alarm in­ves­ti­ga­tors in its Phase III stud­ies.

Bio­haven CEO Vlad Coric had this to say:

By com­bin­ing pos­i­tive ef­fi­ca­cy re­sults and a fa­vor­able safe­ty pro­file with ease of oral dos­ing, we be­lieve that rimegepant will rep­re­sent a sig­nif­i­cant im­prove­ment over ex­ist­ing treat­ment op­tions.

Bio­haven shares al­so took a beat­ing last fall when their Phase II/III study of tri­grilu­zole demon­strat­ed not on­ly that it didn’t work bet­ter than a place­bo in treat­ing spin­ocere­bel­lar atax­ia, but pa­tients in the study al­so re­port­ed in larg­er num­bers that the place­bo helped them more than the drug.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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