Urovan­t's over­ac­tive blad­der drug scores in mid-stage tri­al

Urovant Sci­ences said its ex­per­i­men­tal over­ac­tive blad­der drug vibegron im­proved symp­toms in a large mid-stage study, a wel­come sig­nal for the com­pa­ny as it eval­u­ates the drug fur­ther in a phase III ini­ti­at­ed ear­li­er this year.

The phase IIb two-stage tri­al en­rolled more than 1,300 pa­tients with OAB symp­toms. In the first stage, pa­tients ei­ther re­ceived once-dai­ly oral vibegron (3 mg, 15 mg, 50 mg or 100 mg), the uri­nary in­con­ti­nence drug toltero­dine (4 mg); or a place­bo for eight weeks. In the sec­ond stage, pa­tients were giv­en ei­ther vibegron (100 mg); toltero­dine (4 mg); a com­bi­na­tion vibegron (100 mg) and toltero­dine (4 mg); or place­bo for four weeks. The ob­jec­tive of the study was to eval­u­ate the safe­ty and ef­fi­ca­cy of vibegron as a once-dai­ly oral treat­ment for OAB pa­tients, re­gard­less of urge in­con­ti­nence.

Kei­th Katkin, Urovant CEO

Pa­tients giv­en the high­er dos­es of vibegron (50 mg and 100 mg) ex­pe­ri­enced sta­tis­ti­cal­ly sig­nif­i­cant de­creas­es in the dai­ly rate of uri­na­tion (p=0.007 and p<0.001 re­spec­tive­ly), ur­gency uri­nary in­con­ti­nence episodes (p<0.001 and p<0.001 re­spec­tive­ly), to­tal in­con­ti­nence episodes (p=0.005 and p=0.007) and ur­gency episodes (p=0.024 and p<0.001) at week 8. In the sec­ond tranche of the study, the ef­fi­ca­cy of vibegron monother­a­py on the pri­ma­ry end­point — re­duc­tion in uri­na­tion — was al­so sta­tis­ti­cal­ly sig­nif­i­cant, the com­pa­ny said.

Toltero­dine, sold as De­trol by Pfiz­er $PFE in the Unit­ed States, be­longs to a class of drugs called an­timus­carinics that are de­signed to in­hib­it mus­cle con­trac­ture and have been the on­ly avail­able treat­ments for decades. But they’re not de­signed specif­i­cal­ly for the blad­der and are as­so­ci­at­ed with a host of un­pleas­ant ad­verse-ef­fects, mak­ing them an un­pop­u­lar choice with pa­tients, es­pe­cial­ly in the el­der­ly.

Tri­al da­ta in­di­cat­ed that the mag­ni­tude of max­i­mal re­spons­es with the two high­er vibegron dos­es was of­ten nu­mer­i­cal­ly greater than toltero­dine, re­searchers wrote in the jour­nal Eu­ro­pean Urol­o­gy. “In ad­di­tion, these re­sults pro­vide the proof of con­cept that con­comi­tant dos­ing of vibegron and an an­timus­carinic can pro­duce mod­est symp­tom im­prove­ment ver­sus an an­timus­carinic alone”, they not­ed.

In the tri­al, all vibegron dos­es were well tol­er­at­ed. The in­ci­dence of dry mouth was high­er with pa­tients giv­en toltero­dine than those on vibegron monother­a­py, Urovant said.

The ex­act cause of OAB is un­known, which makes it dif­fi­cult to treat. More than 30 mil­lion over the age of 40 suf­fer symp­toms in the Unit­ed States ac­cord­ing to Urovant $UROV.

End­points News / Pharm­cube BI­IS18 Con­fer­ence in Shang­hai

Click on the im­age to see the full-sized ver­sion

Urovant is one of Vivek Ra­maswamy’s many “vants”, which are sub­sidiaries un­der the con­glom­er­ate Roivant Sci­ences brand. Last week Ra­maswamy told End­points News at the #BI­IS18 sum­mit that his strat­e­gy can be un­der­stood as an “Al­pha­bet for health­care”, a ref­er­ence to Google co-founder Lar­ry Page’s play­book of set­ting loose Google, YouTube, and even com­pa­nies like Cal­i­co and Ver­i­ly as se­mi-au­tonomous units that are led by the moth­er­ship. To date, Ra­maswamy has raised $3 bil­lion for his com­pa­nies and vibegron is one of 34 pro­grams in the “vant” clin­ic.

Urovant in-li­censed the glob­al rights, in­clud­ing Japan, to vibegron — an oral be­ta-3 adren­er­gic ag­o­nist — from Mer­ck $MRK. Vibegron is al­so be­ing test­ed for the treat­ment of OAB in men with be­nign pro­sta­t­ic hy­per­pla­sia and the treat­ment of pain as­so­ci­at­ed with ir­ri­ta­ble bow­el syn­drome. Mean­while, Urovant’s sec­ond ex­per­i­men­tal treat­ment, hMaxi-K, is a gene ther­a­py for pa­tients with OAB symp­toms who have failed oral phar­ma­co­log­ic ther­a­py.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

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Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

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The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

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