In record-set­ting set­tle­ment, No­var­tis’ San­doz unit ad­mits guilt in con­spir­a­cy to fix prices

Be­com­ing the largest drug­mak­er to plead guilty in a wide-rang­ing Jus­tice De­part­ment gener­ics probe, No­var­tis ad­mit­ted to price-fix­ing charges and agreed to a record-set­ting set­tle­ment.

No­var­tis’s gener­ics unit, San­doz, has agreed to pay $195 mil­lion to set­tle crim­i­nal charges that from mid-2013 through mid-2015 it con­spired with com­peti­tors to ar­ti­fi­cial­ly in­flate drug prices on crit­i­cal med­i­cines. The com­pa­ny ad­mit­ted guilt and said the con­spir­a­cy af­fect­ed over $500 mil­lion in sales. The fine is the largest ever paid out in a do­mes­tic an­titrust agency, the Jus­tice De­part­ment said.

San­doz is now the third and largest phar­ma­ceu­ti­cal com­pa­ny to ad­mit guilt in a fed­er­al probe that be­gan in 2014 and has swept up the gi­ants of gener­ics, in­clud­ing My­lan and Te­va Phar­ma­ceu­ti­cals. The drugs af­fect­ed in­clud­ed those for cys­tic fi­bro­sis, arthri­tis and blood pres­sure, ac­cord­ing to the Jus­tice De­part­ment.

Her­itage Phar­ma­ceu­ti­cals and Ris­ing Phar­ma­ceu­ti­cals re­solved their cas­es with sim­i­lar agree­ments.

“To­day’s res­o­lu­tion, with one of the largest man­u­fac­tur­ers of gener­ic drugs, is a sig­nif­i­cant step to­ward en­sur­ing that prices for gener­ic drugs are set by com­pe­ti­tion, not col­lu­sion, and root­ing out an­titrust crimes that cheat­ed Amer­i­can pur­chasers of vi­tal med­i­cines,” US Jus­tice De­part­ment an­titrust at­tor­ney Makan Del­rahim said in a state­ment.

The set­tle­ment comes a month af­ter for­mer San­doz ex­ec­u­tive Hec­tor Ar­man­do Kel­lum plead­ed guilty to a price-fix­ing charge. No­var­tis said the ex­ec­u­tives im­pli­cat­ed in the case are no longer em­ployed at the com­pa­ny and that as part of the agree­ment, they will con­tin­ue to co­op­er­ate with the gov­ern­ment’s in­ves­ti­ga­tion and work to en­hance their com­pli­ance pro­to­cols.

“We take se­ri­ous­ly our com­pli­ance with an­titrust laws, and in reach­ing to­day’s res­o­lu­tion, we are not on­ly re­solv­ing his­tor­i­cal is­sues but al­so un­der­scor­ing our com­mit­ment to con­tin­u­al­ly im­prov­ing our com­pli­ance and train­ing pro­grams and evolv­ing our con­trols,” San­doz pres­i­dent Car­ol Lynch said in a state­ment. “We are dis­ap­point­ed that this mis­con­duct oc­curred in the face of our clear an­titrust com­pli­ance poli­cies and mul­ti­ple train­ings – and in full con­tra­ven­tion of the com­pa­ny’s val­ues.”

The res­o­lu­tion comes amid the lat­est of sev­er­al bad head­lines for No­var­tis. Last week, af­ter the Amer­i­can So­ci­ety of Reti­na Spe­cial­ists is­sued a warn­ing to its mem­bers that the Swiss com­pa­ny’s new eye med­i­cine Beovu could cause dan­ger­ous in­flam­ma­tion, a law­suit came to light in which a No­var­tis em­ploy­ee claimed she was fired for rais­ing those safe­ty con­cerns when the drug was in de­vel­op­ment. That fol­lowed a da­ta in­tegri­ty scan­dal at their gene ther­a­py sub­sidiary AveX­is and ques­tions about the com­pa­ny’s one-year con­tract with Don­ald Trump’s for­mer at­tor­ney Michael Co­hen.

To­day’s set­tle­ment is what’s known as a de­ferred pros­e­cu­tion agree­ment. These agree­ments have be­come pop­u­lar with pros­e­cu­tors in their pur­suit of gener­ics, be­cause they al­low com­pa­nies to con­tin­ue op­er­a­tions, en­sur­ing pa­tients don’t see a short­age in drugs or a change in price.

San­doz, whose $10 bil­lion in an­nu­al sales ac­count for near­ly one fifth of No­var­tis’ rev­enue, is the first high-pro­file gener­ics mak­er to set­tle with the Jus­tice De­part­ment. Gener­ics mak­ers have faced in­creas­ing scruti­ny from the Jus­tice De­part­ment and states at­tor­ney gen­er­al in re­cent years, as prices have fall­en and tight­ened mar­gins for even the most suc­cess­ful com­pa­nies.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Chi­nese rare dis­ease play­er inks first deal around nar­colep­sy drug Wak­ix af­ter grab­bing $80M to build an ecosys­tem

Two months ago, the narcolepsy therapy Wakix propelled Harmony Biosciences to a $128 million debut on Nasdaq. Now, the same drug is serving as the foundation for a Chinese biotech looking to pioneer a rare disease platform in the country.

Citrine Medicine — which closed $80 million in Series A funding in July — was incubated by F-Prime and Eight Roads, two VC funds affiliated with Fidelity Investments that saw an opening in China to replicate in the vibrant orphan drug landscape in the US (and to a lesser extent, Europe).

Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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