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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

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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15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

VMLY&R execs Claire Gillis and Walter Geer listen to Olympic gold medalist Tianna Bartoletta talk about the importance of diversity at Cannes Lions 2022 (Clara Bui/Endpoints News)

#Can­nes­Lions2022: Why does di­ver­si­ty mat­ter in cre­ativ­i­ty? Olympic gold medal­ist and VM­LY&R ex­plain

CANNES – When Olympic gold medalist Tianna Bartoletta went to the hospital to deliver her son last year, she packed signed advanced directives and her will in her bag. Why? Her past experience with the healthcare system while training for the 2020 Tokyo Olympics.

She was training in sprint and long jump — after winning two golds in 2016 and one in 2012 — when she began to notice changes in her period. While Bartoletta initially rationalized it as stress or training too hard, it kept getting worse — to the point where she had dizzy spells and episodes of passing out. So she went to the doctor.

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From left to right: Shaheed Peera, Ivor Horn, Sommer Bazuro and Pat Setji speak about diversity, equity and inclusion at Cannes Lions 2022 (Clara Bui/Endpoints News)

#Can­nes­Lions2022: Ad­dress­ing clin­i­cal tri­al di­ver­si­ty prob­lems will take 're­al work now,' pan­elists say

CANNES —  As a young scientist, Sommer Bazuro was looking at oncology data when she realized that the patient population was not at all representative of the demographics most likely to suffer and die from cancer.

Thinking it must be an isolated incident, she turned to peer-reviewed publications and began talking to oncologists, only to discover that a lack of diversity in clinical trials was par for the course. Black and Hispanic patients typically don’t even reach levels of representation consistent with the general population.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”