Huntington Mayor Steve Williams (L) and Attorney General Patrick Morrisey (AP Photo/Leah M. Willingham)

West Vir­ginia judge rules in fa­vor of drug dis­trib­u­tors in opi­oid suit

Three ma­jor drug dis­trib­u­tors are off the hook for what may have been a $2.5 bil­lion pay­ment af­ter a fed­er­al judge found them not li­able for the opi­oid epi­dem­ic in parts of West Vir­ginia, one of the hard­est-hit ar­eas of the coun­try.

De­spite dis­trib­ut­ing more than 51.3 mil­lion dos­es of oxy­codone and hy­drocodone to phar­ma­cies in Ca­bell Coun­ty and the city of Hunt­ing­ton over less than a decade, McKesson, Amerisource­Ber­gen and Car­di­nal Health didn’t cause an over­sup­ply of opi­oids in the area, Judge David Faber ruled on Mon­day.

“Doc­tors, 99% of whom were act­ing in good faith, de­ter­mined the to­tal vol­ume of pre­scrip­tion opi­oids that phar­ma­cies or­dered from de­fen­dants and dis­pensed pur­suant to those pre­scrip­tions,” Faber wrote in his opin­ion.

The rul­ing fol­lows a months-long tri­al, in which pros­e­cu­tors ar­gued that the de­fen­dants cre­at­ed an opi­oid epi­dem­ic in Ca­bell Coun­ty and Hunt­ing­ton through their whole­sale dis­tri­b­u­tion of pre­scrip­tion opi­oids. The coun­ty and city were hit hard by the epi­dem­ic, with opi­oids ac­count­ing for more than 80% of over­dose deaths in Ca­bell Coun­ty from 2001 to 2018.

In 2017, more than 10% of peo­ple in Hunt­ing­ton, Ca­bell Coun­ty and Wayne Coun­ty were ad­dict­ed to opi­oids or had been in the past, ac­cord­ing to court doc­u­ments.

The state of West Vir­ginia tracked more than 6,000 over­dose deaths from 2001 to 2015, the doc­u­ments state. For­mer Bu­reau for Pub­lic Health com­mis­sion­er Rahul Gup­ta once called the state “ground ze­ro” for the na­tion­al opi­oid epi­dem­ic.

“The opi­oid cri­sis has tak­en a con­sid­er­able toll on the cit­i­zens of Ca­bell Coun­ty and the City of Hunt­ing­ton,” Faber wrote on Mon­day. “And while there is a nat­ur­al ten­den­cy to as­sign blame in such cas­es, they must be de­cid­ed not based on sym­pa­thy, but on the facts and the Law.”

Faber added that “there is noth­ing un­rea­son­able about dis­trib­ut­ing con­trolled sub­stances to ful­fill legal­ly writ­ten pre­scrip­tions.”

Mean­while, Hunt­ing­ton May­or Steve Williams said in an emailed state­ment that his “dis­ap­point­ment can­not be mea­sured.”

In their com­plaint, pros­e­cu­tors ac­cused the dis­trib­u­tors of sell­ing enough opi­oids in West Vir­ginia be­tween 2006 and 2014 to ac­count for “611 pain pills for every man, woman and child in the state.”

Plain­tiffs ac­cused the dis­trib­u­tors — as well as man­u­fac­tur­ers, phar­ma­cies and phar­ma­cy ben­e­fit man­agers — of en­gi­neer­ing “a dra­mat­ic shift in how and when opi­oids are pre­scribed” and fail­ing to main­tain ef­fec­tive con­trols.

“This case was al­ways about hold­ing these dis­trib­u­tors ac­count­able and pro­vid­ing our doc­tors, nurs­es, coun­selors, first re­spon­ders and so­cial work­ers with some of the re­sources need­ed to com­bat the opi­oid cri­sis,” Williams said in the state­ment. “We will work along­side our coun­sel to en­sure the fight con­tin­ues on be­half of so many who lost their lives and liveli­hoods to the opi­oid epi­dem­ic.”

The city and coun­ty sought $2.5 bil­lion from McKesson, Amerisource­Ber­gen and Car­di­nal Health to ad­dress the cri­sis, ac­cord­ing to a Reuters re­port. The state of West Vir­ginia opt­ed out of a $26 bil­lion set­tle­ment with the dis­trib­u­tors last year.

The state has since reached set­tle­ments with a suite of com­pa­nies for their role in the opi­oid epi­dem­ic, in­clud­ing J&J, which agreed to pay $99 mil­lion ear­li­er this year to clear up claims against it. Te­va and Al­ler­gan al­so struck a set­tle­ment with West Vir­ginia back in April, worth $161.5 mil­lion.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.

Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

Flori­da judge dis­miss­es Zan­tac can­cer claims against GSK, oth­er phar­mas

GSK can breathe a little easier after a Florida federal judge dismissed thousands of claims that Zantac and related heartburn products caused cancer, triggering a boost in premarket trading on Wednesday.

Plaintiffs in the sprawling multidistrict litigation (MDL) at first attempted to link popular ranitidine heartburn products to 10 types of cancer, but later withdrew breast, kidney, colorectal, prostate and lung. On Tuesday, Judge Robin Rosenberg tossed the remaining claims in liver, bladder, pancreatic, esophageal, and stomach cancers, upon determining that the allegations were based on “flawed” and “unreliable” evidence.