Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women ex­pel on av­er­age about 2 to 3 ta­ble­spoons of blood dur­ing their time of the month. But with uter­ine fi­broids, heavy bleed­ing is typ­i­cal — a third of a cup or more. Drug­mak­ers have been work­ing on oral ther­a­pies to try and stem the flow, and as ex­pect­ed, Ab­b­Vie and their part­ners at Neu­ro­crine Bio­sciences are the first to make it across the fin­ish line.

Known chem­i­cal­ly as elagolix, the drug is al­ready ap­proved as a treat­ment for en­dometrio­sis un­der the brand name Orilis­sa. It tar­gets the GnRH re­cep­tor to de­crease the pro­duc­tion of es­tro­gen and prog­es­terone.

Now, elagolix in com­bi­na­tion with two hor­mone drugs — estra­di­ol and norethin­drone ac­etate — has been ap­proved by the FDA. Ab­b­Vie will sell the twice-dai­ly reg­i­men as Ori­ahnn.

Mean­while, com­peti­tors such as My­ovant and Ob­sE­va al­so have ri­val oral GnRH re­cep­tor an­tag­o­nists wait­ing in the wings.

Char­lotte Owens, Ab­b­Vie

“In the ab­sence of head-to-head com­par­isons … it’s re­al­ly hard for us to com­pare and con­trast with drugs that are cur­rent­ly in de­vel­op­ment right now,” said Char­lotte Owens, med­ical di­rec­tor of gen­er­al med­i­cine at Ab­b­Vie, in an in­ter­view.

Ori­ahnn’s ap­proval was based on two six-month piv­otal stud­ies — each study re­quired the reg­i­men to gen­er­ate a sta­tis­ti­cal­ly sig­nif­i­cant im­pact on re­duc­ing blood loss by at least 50% in pa­tients. Each study al­so had an elagolix monother­a­py arm.

In one late-stage study, 68.5% (p<0.001) of elagolix com­bo-treat­ed women with uter­ine fi­broids hit that goal com­pared to place­bo (8.7%), in the sec­ond tri­al 76.2% elagolix com­bo-treat­ed women achieved the end­point com­pared to place­bo (10.1%). How­ev­er, the drug’s side ef­fect pro­file caused pause large­ly due to the loss of bone den­si­ty in pa­tients who re­ceived the Ab­b­Vie drug.

An­a­lysts have sug­gest­ed the Ob­sE­va and My­ovant ther­a­pies could have an edge over the Ab­b­Vie drug, if ap­proved.  But the two ri­vals will have been beat­en to mar­ket and nei­ther have the com­mer­cial prowess that a be­he­moth like Ab­b­Vie can boast of.

Ob­sE­va has test­ed its GnRH drug lin­zagolix in pa­tients with and with­out ABT. Late last year, the Swiss drug­mak­er post­ed da­ta from the PRIM­ROSE 2 tri­al, which test­ed two dos­es of the drug against a place­bo. The re­sults showed 93.9% for women re­ceiv­ing 200 mg of the drug with ABT tri­al saw more than 50% re­duc­tion in bleed­ing, and 56.7% for women re­ceiv­ing 100 mg with­out ABT achieved the same goal, com­pared to 29.4% in the place­bo group.

Al­though an­a­lysts have been en­cour­aged by the pos­i­tive da­ta in pa­tients who re­spond­ed well to the drug de­spite the lack of ABT (women pre­dis­posed to high BMI, CV risk and di­a­betes are typ­i­cal­ly not pre­scribed ABT) in the drug’s safe­ty pro­file, par­tic­u­lar­ly bone den­si­ty loss, did vex in­vestors. The com­pa­ny has an­oth­er piv­otal study that is ex­pect­ed to read out in the com­ing months.

Mean­while, My­ovant Sci­ences is al­so in the mix with its of­fer­ing: re­l­u­golix. The drug, like the Ab­b­Vie reg­i­men, is de­signed for use in com­bi­na­tion with ABT. Cur­rent­ly un­der FDA re­view, the reg­i­men was al­so test­ed in two phase III stud­ies, with the same main goal: 50% or more re­duc­tion in blood loss.

In one study, 71.2% of women re­ceiv­ing re­l­u­golix reg­i­men achieved the clin­i­cal re­sponse they were look­ing for, com­pared to on­ly 14.7% in the con­trol arm. In the oth­er, 73.4% of women on the re­l­u­golix arm achieved the same goal, com­pared with 18.9% of women re­ceiv­ing place­bo.  Cru­cial­ly, though, My­ovant’s did no sig­nif­i­cant dif­fer­ences in terms of bone min­er­al den­si­ty.

“The re­sponse rates demon­strat­ed in these tri­als were com­pa­ra­ble to those shown by Ab­b­Vie’s ap­proved GnRH in­hibitor, Orilis­sa, while main­tain­ing a sta­ble bone min­er­al den­si­ty pro­file with a once-dai­ly op­tion,” Baird’s Bri­an Sko­r­ney wrote in a note ear­li­er this month.

End­points News has con­tact­ed Ab­b­Vie for com­ment on Ori­ahnn pric­ing.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.

Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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