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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.