Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da los­es Het­lioz patent court de­ci­sion, vows to ap­peal and ask for stay on Te­va, Apo­tex com­peti­tors

A fed­er­al judge in­val­i­dat­ed four of Van­da Phar­ma­ceu­ti­cals’ patents for sleep med Het­lioz on Tues­day, ef­fec­tive­ly open­ing the door to gener­ic tasimelteon com­pe­ti­tion from Te­va, Apo­tex and oth­ers. Van­da plans to ap­peal and is ask­ing for a stay against the com­pe­ti­tion in the mean­time.

“Van­da in­tends to ap­peal the de­ci­sion to the Unit­ed States Court of Ap­peals for the Fed­er­al Cir­cuit and to re­quest a stay of mar­ket en­try by Te­va and Apo­tex while the ap­peal is pend­ing,” the com­pa­ny said in a state­ment.

Mean­while, a Te­va spokesper­son said in an email to End­points News that it is “pleased by the de­ci­sion,” but de­clined fur­ther com­ment as Van­da’s new ap­peal is pend­ing.

US dis­trict court judge Colm Con­nol­ly’s straight­for­ward de­ci­sion found that the de­fen­dants Te­va and Apo­tex’s pro­posed prod­ucts do not in­fringe on Van­da’s RE604 patent, and ad­di­tion­al­ly found Van­da’s four as­sert­ed patents “in­valid for ob­vi­ous­ness.”

Van­da had al­ready set­tled with a third pos­si­ble gener­ic tasimelteon from MSN Labs and Im­pax al­most a year ago, ink­ing a non-ex­clu­sive li­cens­ing agree­ment that would go in­to ef­fect in 2035. How­ev­er, the terms of the deal stip­u­late that MSN and Im­pax would be able to en­ter the mar­ket ear­li­er if re­lat­ed to the patent lit­i­ga­tion there would be sub­se­quent mar­ket en­try “of cer­tain oth­er third-par­ty gener­ic ver­sions.”

The rul­ing caused Van­da stock $VN­DA to tum­ble by about 30%, from $11 be­fore the rul­ing on Tues­day morn­ing to around $7.50 in Wednes­day mid­day trad­ing.

The loss comes as Van­da is em­broiled in a sep­a­rate Het­lioz is­sue with the FDA. In No­vem­ber, Van­da wrote a let­ter to the FDA de­mand­ing a hear­ing for its sN­DA on Het­lioz for the treat­ment of jet lag. Van­da at­tor­ney Paul Hugh­es gave the FDA a Christ­mas Eve dead­line to set it up.

The lat­est Van­da let­ter fol­lowed a let­ter in Oc­to­ber from CDER di­rec­tor Pa­trizia Cavaz­zoni to Van­da not­ing the sN­DA would not be ap­proved be­cause of a lack of sub­stan­tial ev­i­dence as had been laid out in a CRL in 2019. Cavaz­zoni said in the Oc­to­ber let­ter that Van­da could file for a hear­ing if it can show “gen­uine and sub­stan­tial is­sue of fact that re­quires a hear­ing to re­solve.”

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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Bill Anderson, incoming Bayer CEO (David Paul Morris/Bloomberg via Getty Images)

Bay­er taps Roche's Bill An­der­son to lead phar­ma gi­ant as CEO

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

DC court over­rules PhRMA's bid to shut down drug im­ports from Cana­da

The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.

Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.