Emergent's Narcan opioid overdose nasal spray is getting first generic competition from Teva and Sandoz (via Emergent Biosolutions)

Te­va and No­var­tis’ San­doz launch Nar­can gener­ics on same day, brand mar­keter Emer­gent re­mains in play

Te­va and No­var­tis’ San­doz re­cent­ly launched gener­ic ver­sions of Nar­can on the same day, but it like­ly wasn’t a co­in­ci­dence. Both first-to-mar­ket gener­ics for Nar­can, an opi­oid over­dose res­cue nasal spray, are FDA ap­proved, but on­ly San­doz’ ver­sion is au­tho­rized by Nar­can’s brand mar­keter Emer­gent BioSo­lu­tions.

Emer­gent, which ac­quired Adapt Phar­ma and the Nar­can nasal spray in 2018, has been in a pro­tract­ed patent lit­i­ga­tion with Te­va over its gener­ic ver­sion. The FDA ap­proved Te­va’s nalox­one hy­drochlo­ride nasal spray in April 2019 as the first Nar­can gener­ic, but Emer­gent filed a law­suit al­leg­ing Te­va in­fringed on Adapt patents. A de­ci­sion in 2020 ruled in fa­vor of Te­va, but Emer­gent ap­pealed. This past sum­mer a three-judge US Court of Ap­peals pan­el heard Emer­gent’s case but had yet to ren­der a fi­nal de­ci­sion.

Te­va didn’t an­swer ques­tions about the launch tim­ing, but Emer­gent re­leased a state­ment not­ing Te­va’s launch “pri­or to res­o­lu­tion of the re­lat­ed patent lit­i­ga­tion.”

Emer­gent’s state­ment al­so point­ed out its long his­to­ry work­ing with pub­lic health of­fi­cials to “ed­u­cate and safe­guard peo­ple who may be at risk of an opi­oid over­dose,” and said it wel­comes ad­di­tion­al so­lu­tions to help fight the opi­oid epi­dem­ic. Emer­gent said it will up­date any 2022 fi­nan­cial ef­fect when it presents year-end re­sults.

In re­sponse to fol­low-up ques­tion­ing, an Emer­gent spokesper­son said the com­pa­ny is not plan­ning any le­gal ac­tion in re­sponse to the Te­va launch.

Mean­while, San­doz an­nounced the de­but of its Emer­gent-au­tho­rized gener­ic Nar­can on the same day as Te­va in De­cem­ber. When asked about tim­ing, a spokesper­son said in an email that the launch was “based on our agree­ment with Emer­gent.”

The au­tho­rized gener­ic from San­doz means it is the ex­act same prod­uct as the brand­ed Nar­can with a dif­fer­ent la­bel and sold at a gener­ic price. The deal with Emer­gent al­so en­sures the brand li­cen­sor a por­tion of those sales. Emer­gent in turn pays roy­al­ties to the orig­i­na­tor of the Nar­can nasal spray, Opi­ant Phar­ma­ceu­ti­cals.

Along with the new Nar­can gener­ics, oth­er drug­mak­ers have en­tered the nalox­one hy­drochlo­ride nasal spray mar­ket through dif­fer­ent dos­ing mech­a­nisms. Nar­can is a 4-mg spray dose, but Hik­ma Phar­ma­ceu­ti­cals got its FDA ap­proval for Kloxxa­do in April for an 8-mg in­tranasal dose while Adamis Phar­ma­ceu­ti­cals’ FDA nod for Zimhi in Oc­to­ber is a 5-mg in­jectable dose. On the hori­zon is po­ten­tial­ly even more com­pe­ti­tion from Opi­ant it­self. Its nasal nalme­fene, an­oth­er in­ves­ti­ga­tion­al treat­ment for opi­oid over­dose, se­cured an FDA fast track des­ig­na­tion in No­vem­ber.

What they’re all purs­ing is a slice of the un­for­tu­nate­ly grow­ing opi­oid over­dose treat­ment mar­ket. Opi­oid over­dose deaths in­creased 40% dur­ing the pan­dem­ic from May 2019 through June 2020 — but even as pan­dem­ic pan­ic eas­es, the opi­oid epi­dem­ic is still rag­ing. The CDC re­port­ed more than 75,000 opi­oid over­dose deaths from April 2020-2021, an in­crease of 35%.

Emer­gent sales of Nar­can have in­creased in tan­dem. Its most re­cent third quar­ter sales of $133 mil­lion notched a 50% in­crease year-over-year. Sales through nine months were al­most $314 mil­lion, al­ready top­ping its full 2020 rev­enue of $311 mil­lion. Emer­gent has de­liv­ered 26 mil­lion Nar­can de­vices in the US since its 2016 de­but.

In 2018, Adapt did some re­gion­al TV test­ing of a Nar­can ad en­cour­ag­ing con­cerned par­ents of young peo­ple on pain meds to stock the med at home in case of ac­ci­den­tal over­dose. How­ev­er, mar­ket­ing of nalox­one in gen­er­al has been lim­it­ed to di­rect ap­peals to pub­lic health of­fi­cials in com­mu­ni­ties, first re­spon­der or­ga­ni­za­tions and hos­pi­tals. Most states have adopt­ed laws that al­low di­rect sales to con­sumers at phar­ma­cies.

Still nei­ther Te­va nor San­doz have plans to mar­ket the Nar­can gener­ics to con­sumers.

A Te­va spokesper­son said in an email, “We don’t mar­ket/pro­mote gener­ic prod­ucts; they are pre­scribed as name-brand and then sup­ple­ment­ed by doc­tors or phar­ma­cies.”

San­doz sim­ply said its Nar­can gener­ic is avail­able “to peo­ple in the US via re­tail phar­ma­cies and in­sti­tu­tions, in­clud­ing hos­pi­tals,” and added that its prod­uct web­site will fea­ture re­sources for phar­ma­cists.

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.

(Image: Shutterstock)

Suf­fer­ing in si­lence: COPD pa­tients face fre­quent symp­toms, dis­sat­is­fac­tion with meds, but don't talk to docs — sur­vey

Most COPD patients suffer symptoms daily, but contrary to the typical advice doled out in pharma TV commercials, they’re not talking to their doctors about it. A new Phreesia point-of-care survey finds that fewer than half (44%) of chronic obstructive pulmonary disease (COPD) patients have detailed discussions about symptoms with their doctors.

Meanwhile, two-thirds of patients said COPD has a “substantial impact” on their everyday lives.

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.