Bris­tol My­ers set­tles an­ti-gener­ic HIV drug scheme al­le­ga­tions for al­most $11M

Al­though Bris­tol My­ers Squibb isn’t ad­mit­ting to any wrong­do­ing, the bio­phar­ma com­pa­ny agreed to pay al­most $11 mil­lion to set­tle al­le­ga­tions filed in a Cal­i­for­nia dis­trict court that the com­pa­ny took part in an un­law­ful scheme with oth­er phar­ma com­pa­nies like Gilead and Janssen to pro­tect their HIV drug prof­its while slow­ing gener­ic com­pe­ti­tion.

Specif­i­cal­ly, the com­plaint filed in 2019 al­leged that as im­mi­nent gener­ic com­pe­ti­tion to Gilead’s HIV drugs — Viread, Emtri­va, Tru­va­da and oth­ers — ap­proached, Gilead agreed with each of BMS, Janssen, and Japan To­bac­co to cre­ate and mar­ket FD­Cs that com­bined their third agents with Gilead’s NR­TIs.

“Col­lec­tive­ly, the un­law­ful agree­ments be­tween Gilead and each of its co­con­spir­a­tors ef­fec­tive­ly fore­closed com­pe­ti­tion for drugs es­sen­tial to cART reg­i­mens. In 2018, the agree­ments cov­ered more than 75% of all sales of NR­TIs [nu­cle­o­side/nu­cleotide re­verse tran­scrip­tase in­hibitors], more than 50% of all sales of third agents, and more than 75% of all sales of boost­er drugs for use in a cART reg­i­men in the Unit­ed States,” the com­plaint said.

Each agree­ment al­so in­clud­ed a so-called “No-Gener­ics Re­straint” clause, ac­cord­ing to the suit, by which BMS and the oth­ers agreed not to cre­ate or mar­ket a com­pet­ing fixed-dose com­bi­na­tion made with gener­ic or com­pa­ra­ble ver­sions of Gilead’s NR­TIs even af­ter the patents ex­pired.

“In ex­change, they each shared in the supra­com­pet­i­tive prof­its that the im­pair­ment of com­pe­ti­tion made pos­si­ble,” the com­plaint said.

Gregg Gon­salves

The Gilead/BMS agree­ment al­so pre­vent­ed any oth­er man­u­fac­tur­er from com­pet­ing against their HIV drug Atripla, even af­ter Gilead’s patents ex­pired. Gilead and BMS lat­er broad­ened the scope of their agree­ment to in­clude block­ing gener­ic com­pe­ti­tion for a BMS HIV drug, atazanavir sul­fate or Rey­ataz.

In ad­di­tion to the $10.8 mil­lion (and $200,000 for pro­vid­ing no­tice to the pay­ers), the pro­posed set­tle­ment, which a judge ten­ta­tive­ly ap­proved this week, pro­vides that BMS will for­ev­er waive en­force­ment of con­trac­tu­al pro­vi­sions that would oth­er­wise pro­hib­it Gilead from mak­ing, or li­cens­ing oth­ers to make, a ver­sion of Evotaz for­mu­lat­ed with gener­ic atazanavir (i.e., a gener­ic of BMS’s Rey­ataz).

Gregg Gon­salves, an as­so­ciate pro­fes­sor of epi­demi­ol­o­gy at Yale who was al­so one of the plain­tiffs in the case, told End­points News, “What is im­por­tant to me is that we have se­cured in­junc­tive re­lief as part of this set­tle­ment, in which BMS will stop these an­ti-com­pet­i­tive, col­lu­sive agree­ments with oth­er HIV drug man­u­fac­tur­ers that raise prices for in­di­vid­u­als and pay­ors, re­strict­ing gener­ic ac­cess to the com­bi­na­tion an­ti­retro­vi­ral ther­a­py mar­ket.”

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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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.

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.

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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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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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.

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.