Martin Shkreli. AP Images

Retrophin paid Mar­tin Shkre­li 'undis­closed sum' to set­tle years­long le­gal dis­putes

Re­mem­ber when Retrophin dis­closed in June that it’s fi­nal­ly set­tled up the four-year le­gal saga with founder and for­mer CEO Mar­tin Shkre­li? In an up­date for in­vestors on Wednes­day, the com­pa­ny added that it had paid an undis­closed sum to the in­fa­mous biotech ex­ec and fi­nancier as part of the agree­ment — though it won’t say how much.

Shkre­li, who’s serv­ing a 7-year prison sen­tence for de­fraud­ing in­vestors of his hedge funds, had “agreed to ex­tin­guish his rights to fu­ture ad­vance­ment of le­gal fees and in­dem­ni­fi­ca­tion by the com­pa­ny (oth­er than for cer­tain pend­ing lit­i­ga­tion), and to abide by cer­tain stand­still re­stric­tions,” the com­pa­ny added in a 10-Q fil­ing first re­port­ed by CN­BC.

Retrophin filed a law­suit against the “Phar­ma Bro” in 2015, a year af­ter he was forced out of the com­pa­ny. Shkre­li sub­se­quent­ly brought a coun­ter­suit, and ear­li­er this year added an­oth­er ac­cu­sa­tion di­rect­ly against three di­rec­tors of the board ear­li­er this year seek­ing more than $30 mil­lion in dam­ages. He lashed out against Retrophin’s board chair­man Gary Lyons, for­mer com­pa­ny CEO (and cur­rent di­rec­tor) Stephen Ase­lage, and the com­pa­ny’s for­mer lawyer, Mar­garet Valeur-Jensen.

But be­fore the ar­bi­tra­tion hear­ing was sched­uled to take place, the two sides reached a “com­pre­hen­sive set­tle­ment cov­er­ing all of the dis­putes be­tween them.”

It was all memo­ri­al­ized on June 17, 2019:

Un­der the terms of the Set­tle­ment Agree­ment, each of the par­ties’ pend­ing claims and coun­ter­claims were dis­missed with prej­u­dice (and Mr. Shkre­li dis­missed, with prej­u­dice, the SD­NY Ac­tion), and the par­ties, in­clud­ing Retrophin on be­half of Mr. Ase­lage, Dr. Valeur-Jensen, and Mr. Lyons, grant­ed on an­oth­er a broad mu­tu­al re­lease of claims.

When prompt­ed by CN­BC, both Retrophin and Shkre­li’s civ­il lawyer, Ed­ward Kang, de­clined to di­vulge the size of the pay­ment but said they were pleased the case is over.

Af­ter leav­ing Retrophin Shkre­li went on to start Tur­ing Phar­ma­ceu­ti­cals, where he stirred up a storm of crit­i­cism and quick­ly be­came the ar­che­typ­al vil­lain of the bio­phar­ma world with his de­ci­sion to jack up the price of an old HIV drug, Dara­prim, by more than 5,000%. He re­port­ed­ly kept a hand on the wheels at the com­pa­ny, now rechris­tened Phoenixus, co­or­di­nat­ing busi­ness be­hind bars with a con­tra­band cell phone.

He has since been trans­ferred from Fort Dix, New Jer­sey to an­oth­er low-se­cu­ri­ty prison in Al­len­wood, Penn­syl­va­nia.

His crim­i­nal con­vic­tions, of course, had noth­ing to do with the price-goug­ing con­tro­ver­sy. In­stead, he was pun­ished for ly­ing re­peat­ed­ly to his in­vestors at MSMB Cap­i­tal Man­age­ment and MSMB Health­care about the per­for­mance of his in­vest­ments with their mon­ey, and the amount of cash he had to work with. He was al­so con­vict­ed of se­cu­ri­ties fraud re­lat­ed to Retrophin — which was found­ed un­der the MSMB um­brel­la.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.