My­ovan­t's re­l­u­golix clears first uter­ine fi­broids PhI­II test, but com­pe­ti­tion from Ab­b­Vie/Neu­ro­crine makes in­vestors jit­tery

Vivek Ra­maswamy’s bet on Take­da’s re­l­u­golix has worked — sort of.

Vivek Ra­maswamy

Less than three years af­ter the pro­lif­ic deal­mak­er spawned My­ovant as part of his um­brel­la of ‘Vants’ with a record $218 mil­lion IPO, the treat­ment in-li­censed from the Japan­ese drug­mak­er passed muster in a late-stage study in women with uter­ine fi­broids, which are com­mon non-can­cer­ous fe­male re­pro­duc­tive tract tu­mors. But in­vestors were not quite as im­pressed as the com­pa­ny’s shares $MY­OV tum­bled in ear­ly Tues­day trad­ing.

The oral drug, which is an an­tag­o­nist of the go­nadotropin-re­leas­ing hor­mone (GnRH) re­cep­tor, is de­signed to sup­press es­tro­gen pro­duc­tion in women. It is be­ing test­ed in twin piv­otal stud­ies in­volv­ing women with uter­ine fi­broids and heavy men­stru­al bleed­ing, called LIB­ER­TY 1 and LIB­ER­TY 2.

My­ovant on Tues­day un­veiled the re­sults of the first Phase III tri­al, which en­rolled 388 women and test­ed re­l­u­golix (40 mg) in com­bi­na­tion with fe­male hor­mones estra­di­ol (1 mg) and norethin­drone ac­etate (0.5 mg). In the tri­al, pa­tients re­ceived ei­ther re­l­u­golix com­bi­na­tion ther­a­py for 24 weeks; re­l­u­golix monother­a­py for 12 weeks fol­lowed by re­l­u­golix com­bi­na­tion ther­a­py for the next 12 weeks; or place­bo once dai­ly for 24 weeks.

In the study, 73.4% of women re­ceiv­ing once-dai­ly oral re­l­u­golix com­bi­na­tion ther­a­py achieved the re­spon­der cri­te­ria com­pared with 18.9% of women re­ceiv­ing place­bo (p < 0.0001) — meet­ing the main goal. A re­sponse was de­fined as a men­stru­al blood loss vol­ume of less than 80 mL and a 50% or greater re­duc­tion from base­line in men­stru­al blood loss vol­ume dur­ing the last 35 days of the 24-week treat­ment pe­ri­od. On av­er­age, women re­ceiv­ing re­l­u­golix com­bi­na­tion ther­a­py al­so ex­pe­ri­enced an 84.3% re­duc­tion in men­stru­al blood loss from base­line, which was a key sec­ondary end­point.

Ab­b­Vie $AB­BV and Neu­ro­crine Bio­sciences’ $NBIX ther­a­py elagolix (brand­ed as Orilis­sa), which was ap­proved last year to treat en­dometrio­sis, is al­so be­ing eval­u­at­ed for use in uter­ine fi­broids. It is has a sim­i­lar mech­a­nism of ac­tion com­pared to re­l­u­golix but is tak­en twice-dai­ly. The com­pa­nies have re­port­ed da­ta from two piv­otal six-month stud­ies. In one late-stage study, 68.5% (p<0.001) of elagolix-treat­ed women with uter­ine fi­broids achieved clin­i­cal re­sponse com­pared to place­bo (8.7%), in the sec­ond tri­al 76.2% (p<0.001) of elagolix-treat­ed women with uter­ine fi­broids achieved clin­i­cal re­sponse com­pared to place­bo (10.1%). A reg­u­la­to­ry sub­mis­sion for elagolix in uter­ine fi­broids is an­tic­i­pat­ed in mid-2019.

Phil Nadeau

“Re­l­u­golix will fol­low Neu­ro­crine’s GnRH an­tag­o­nist Orilis­sa to the U.S. mar­ket. How­ev­er, re­l­u­golix has cer­tain dif­fer­en­ti­at­ing fea­tures (once-dai­ly dos­ing, full es­tro­gen sup­pres­sion) that should al­low it to cap­ture share, par­tic­u­lar­ly in sit­u­a­tions such as uter­ine fi­broids or se­vere en­dometrio­sis where high GnRH sup­pres­sion is nec­es­sary,” Cowen’s Phil Nadeau wrote in a note in Feb­ru­ary, es­ti­mat­ing that in 2025 re­l­u­golix will gen­er­ate $1.15 bil­lion in uter­ine fi­broid sales.

Ob­sE­va $OB­SV is al­so cur­rent­ly de­vel­op­ing a GnRH re­cep­tor an­tag­o­nist called Lin­zagolix for uter­ine fi­broids — da­ta from its late-stage study is ex­pect­ed in the fourth quar­ter of this year.

“(G)yne­col­o­gists re­in­forced our the­sis that the clin­i­cal pro­file of the GnRH an­tag­o­nists could ad­dress a sig­nif­i­cant un­met need in uter­ine fi­broids and en­dometrio­sis, and that giv­en the het­ero­gene­ity in pa­tient re­sponse, there is like­ly to be a de­mand for all the three Gn­RHs”, SVB Leerink an­a­lysts wrote in a note pub­lished last month.

Da­ta from LIB­ER­TY 2 is ex­pect­ed in the third quar­ter of 2019, and if pos­i­tive, the two tri­als will form the ba­sis of a mar­ket­ing ap­pli­ca­tion that is planned for the fourth quar­ter, My­ovant said.

My­ovant’s in­vestors are not quite as en­thu­si­as­tic. Ab­b­Vie (our Go­liath) will file its mar­ket­ing ap­pli­ca­tion in the com­ing months, and if ap­proved will have some time to es­tab­lish it­self be­fore My­ovant (our David) makes it to the mar­ket, by which time it will be much hard­er for the small­er play­er to take a bite out of Ab­b­Vie’s mar­ket share. My­ovant’s stock $MY­OV was down about 29% at $12.22 in morn­ing trad­ing.

Baird’s Bri­an Sko­r­ney is­sued a glow­ing re­view of the My­ovant da­ta. “The first Phase 3 da­ta set in uter­ine fi­broids hit all the check box­es for an ap­prov­able, com­pet­i­tive pro­gram. We think the stock free-fall re­flects a sell-the-news dy­nam­ic, ex­ac­er­bat­ed by an ab­sence of ef­fi­ca­cy dif­fer­en­ti­a­tion and fi­nanc­ing con­cerns. We are buy­ers on the dip and con­tin­ue to be­lieve re­l­u­golix has block­buster po­ten­tial in uter­ine fi­broids and en­dometrio­sis,” he said in note on Tues­day.

“But I think the over­ar­ch­ing pres­sure on the stock is due to the fi­nanc­ing needs ahead of a launch that is prob­a­bly ~2 years away,” he added in an email to End­points News.

Uter­ine fi­broids are al­most al­ways be­nign tu­mors that emerge in or on the mus­cu­lar walls of the uterus. They can cause symp­toms such as ab­nor­mal uter­ine bleed­ing, heavy or painful pe­ri­ods, ane­mia, ab­dom­i­nal pain, back­ache, in­creased ab­dom­i­nal girth and bloat­ing, uri­nary fre­quen­cy or re­ten­tion, con­sti­pa­tion or painful defe­ca­tion, preg­nan­cy loss, painful in­ter­course and, in some cas­es, in­fer­til­i­ty. Be­tween 20% to 80% of women de­vel­op fi­broids by the time they reach age 50, ac­cord­ing to HHS es­ti­mates.

Lynn Seely

Take­da $TAK has an eq­ui­ty stake in My­ovant, which is al­so eval­u­at­ing re­l­u­golix as a treat­ment for en­dometrio­sis in women, as well as ad­vanced prostate can­cer in men. The biotech is run by Lynn Seely, the for­mer CMO of Medi­va­tion.

The in­fec­tious for­mer hedge fund man­ag­er Ra­maswamy has whipped up a pletho­ra of com­pa­nies un­der his um­brel­la firm Roivant, by con­vinc­ing in­vestors that lu­cra­tive re­turns can be made by tak­ing ex­per­i­men­tal drugs gath­er­ing dust on big phar­ma shelves all the way across the fin­ish line. His first big bet on Alzheimer’s/de­men­tia as­sets — much like every­thing else in the bat­tered field — failed spec­tac­u­lar­ly at his sem­i­nal Ax­o­vant $AX­ON}, but he has rein­vig­o­rat­ed the com­pa­ny in­to a gene-ther­a­py play­er. Mean­while, his en­thu­si­asm for the strat­e­gy has not with­ered, as he has birthed var­i­ous oth­er ‘Vants’ fo­cus­ing on dif­fer­ent ill­ness­es and ther­a­peu­tic ap­proach­es.

Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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