Xavier Becerra, HHS Secretary (Greg Nash/Pool via AP Images)

HHS lines up No­var­tis, Lil­ly, As­traZeneca and 3 oth­er drug­mak­ers for fines due to drug dis­count vi­o­la­tions

As drug­mak­ers con­tin­ue to bat­tle Pres­i­dent Biden’s HHS in court over al­leged 340B drug dis­count vi­o­la­tions, HHS sent let­ters on Wednes­day to six com­pa­nies in­form­ing them that their vi­o­la­tions have been re­ferred to the HHS Of­fice of the In­spec­tor Gen­er­al, which can levy $5,000 fines each.

At is­sue is whether the com­pa­nies have to of­fer dis­count pric­ing to safe­ty-net providers through cer­tain con­tract phar­ma­cy part­ner­ships. The com­pa­nies, in­clud­ing No­var­tis, Eli Lil­ly, As­traZeneca, No­vo Nordisk, Sanofi, and Unit­ed Ther­a­peu­tics, have raised con­cerns that the 340B drug dis­count pro­gram has grown be­yond what it was ini­tial­ly tasked to do, and now lines the pock­ets of cov­ered hos­pi­tals and oth­er providers. The com­pa­nies al­so de­cid­ed to stop of­fer­ing the low­ered prices to some con­tract phar­ma­cies.

In May, HHS told the com­pa­nies to com­ply with its 340B statu­to­ry oblig­a­tions and to im­me­di­ate­ly be­gin of­fer­ing cov­ered out­pa­tient drugs at the 340B ceil­ing price to cov­ered en­ti­ties. But Lil­ly, No­vo Nordisk, and No­var­tis sub­se­quent­ly sued HHS, claim­ing the statute doesn’t re­quire them to work with such con­trac­tors.

Lil­ly spokesper­son An­toinette Forbes told End­points News: “We are dis­ap­point­ed to see HRSA’s con­tin­ued at­tempt to cir­cum­vent the le­gal process.”

“Noth­ing in the statute con­tem­plates — let alone re­quires — that man­u­fac­tur­ers agree to ship drugs nom­i­nal­ly pur­chased by cov­ered en­ti­ties di­rect­ly to ‘con­tract phar­ma­cies’ for dis­pens­ing to both pa­tients and non-pa­tients of the cov­ered en­ti­ty alike. And yet that is pre­cise­ly what HRSA has pur­port­ed to man­date here,” No­var­tis said in its suit.

No­var­tis spokesper­son Caryn Mar­shall al­so told End­points that it’s “con­fi­dent” its 340B pol­i­cy “is in full com­pli­ance with the 340B statute and all bind­ing reg­u­la­tions.”

But HHS is push­ing ahead with the fines re­gard­less, con­clud­ing these ac­tions vi­o­late the 340B statute, and the OIG now will de­ter­mine whether the com­pa­nies are li­able for “know­ing­ly and in­ten­tion­al­ly” over­charg­ing 340B hos­pi­tals and oth­er providers.

Oth­ers that re­ceived the let­ters main­tain that they’re act­ing in com­pli­ance with the law.

Nico­las Kress­mann, spokesman for Sanofi, told End­points the com­pa­ny has been look­ing in­to 340B-priced claims since Oc­to­ber 2020 and that it will pay Med­ic­aid and oth­er in­sur­ers’ re­bate in­voic­es ac­cu­rate­ly. “We con­tin­ue to be­lieve this in­tegri­ty ini­tia­tive com­plies with the 340B statute,” he said.

Michael Bach­n­er, spokesper­son for No­vo Nordisk, added that his com­pa­ny “dis­agrees with the claims made by HRSA in its let­ter, which are al­so the sub­ject of pend­ing lit­i­ga­tion com­menced by No­vo Nordisk and sev­er­al oth­er man­u­fac­tur­ers. We stand be­hind the poli­cies we have put in place to ad­dress the sig­nif­i­cant and well-doc­u­ment­ed abus­es in the 340B pro­gram, re­sult­ing in pro­gram in­ter­me­di­aries such as for prof­it con­tract phar­ma­cies prof­it­ing at the ex­pense of pa­tients.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.