Ra­maswamy notch­es his 5th biotech start­up in 3 years af­ter ink­ing a deal with Mer­ck for PhI­II urol­o­gy drug

Vivek Ra­maswamy has launched an­oth­er new biotech com­pa­ny.

Ra­maswamy’s um­brel­la group Roivant Sci­ences notched its 5th “-vant” start­up — Urovant Sci­ences — af­ter bag­ging a Phase III-ready urol­o­gy drug from Mer­ck.

Talk­ing from the tar­mac as he was prepar­ing to jet his way to Eu­rope, the 30-some­thing en­tre­pre­neur tells me you can now ex­pect the busi­ness de­vel­op­ment team at Basel-based Roivant to go af­ter more deals to beef up the pipeline — a strat­e­gy that has marked his first four com­pa­ny launch­es over just the last three years.

Vivek Ra­maswamy

Mer­ck has tak­en this new lead drug — an oral β3-adren­er­gic ag­o­nist blad­der re­lax­er — all the way through a suc­cess­ful Phase IIb study as MK-4618. An ex-US Phase III study has been com­plet­ed with a thou­sand pa­tients and now the new­ly launched fledg­ling will take their drug straight in­to a reg­is­tra­tion study lat­er this year, says the Roivant CEO.

Mer­ck has “clear­ly in­vest­ed a lot in the pro­gram through sev­er­al large stud­ies that have been done to date,” says Ra­maswamy. But urol­o­gy is not a core fo­cus at Mer­ck, while Roivant’s BD team has been scour­ing the plan­et for late-stage as­sets like this that they can hus­tle in­to piv­otal tri­als.

That’s how he start­ed Ax­o­vant $AX­ON in 2014, gain­ing an Alzheimer’s drug from Glax­o­SmithK­line for on­ly $5 mil­lion up­front with mile­stones and a roy­al­ty share from any rev­enue that may re­sult. Ra­maswamy re­cent­ly re­cruit­ed David Hung in as CEO of Ax­o­vant as they look to reap piv­otal da­ta af­ter 15 straight years of set­backs in the field, in­clud­ing fail­ures for sev­er­al oth­er symp­to­matic drugs that use the same mech­a­nism.

But while any­one else may have stayed fixed on that orig­i­nal lead, the ex-hedge fund man­ag­er has gone on to be­come one of the best-fi­nanced deal mak­ers in the in­dus­try. Ax­o­vant and My­ovant, a women’s health play­er, both had stel­lar IPOs. Der­ma­vant (der­ma­tol­ogy) and En­zy­vant (rare dis­eases) fol­lowed, but so far have re­mained pri­vate. And more biotechs are on the way as each of his com­pa­nies work to build pipelines and add new ther­a­pies to the clin­ic.

“Once you have a beach­head prod­uct in an area you con­tin­ue to build out that pipeline,” says Ra­maswamy, who plans to take these com­pa­nies all the way in­to com­mer­cial­iza­tion work.

Don’t look for any num­bers in the re­lease. What­ev­er they are, it’s not ma­te­r­i­al to the phar­ma gi­ant’s num­bers and Mer­ck is well known for be­ing loathe to di­vulge any specifics around deals or any kind.

The next step at Urovant, says Ra­maswamy, is to set up dis­cus­sions with the FDA on the Phase III pro­gram. And he has sev­er­al in­ter­est­ing can­di­dates for CEO as he gets ready to build the new team.

Says Ra­maswamy: “Stay tuned.”

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

Deborah Dunsire. Lundbeck

Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation for a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.