Bank­rupt and weary, di­et pill mak­er Orex­i­gen to sell for $75M to Nal­pro­pi­on

Di­et pill mak­er Orex­i­gen Ther­a­peu­tics can fi­nal­ly turn out the lights. Af­ter a years-long bat­tle to bring its fi­nances in­to the black, the com­pa­ny put its as­sets for sale, filed for bank­rupt­cy, and fi­nal­ly at­tract­ed a buy­er.

Michael Narachi

The San Diego-based com­pa­ny has inked a deal to be pur­chased for $75 mil­lion by Nal­pro­pi­on Phar­ma­ceu­ti­cals, a new­ly-cre­at­ed com­pa­ny cap­i­tal­ized by an in­vestor group that in­cludes Pernix Ther­a­peu­tics, a small-cap pub­lic com­pa­ny in New Jer­sey.

Nal­pro­pri­on is buy­ing all of Orex­i­gen’s as­sets, in­clud­ing world­wide rights to the weight­loss drug Con­trave (mar­ket­ed un­der the brand name Mysim­ba in the EU).

The past few years have been tu­mul­tuous for Orex­i­gen, with the com­pa­ny’s stock plum­met­ing 99% since its height in 2015. De­spite a best-sell­ing weight­loss drug on the mar­ket among its brand­ed com­peti­tors, the com­pa­ny has faced hur­dle af­ter hur­dle, in­clud­ing a le­gal fight to de­fend its patent rights and a lack­lus­ter mar­ket for di­et pills in gen­er­al.

The com­pa­ny’s sole rev­enue dri­ver was Con­trave, which came on the mar­ket in 2014. It quick­ly snagged the biggest share of sales among brand name di­et pills, cap­tur­ing 52% and sur­pass­ing Qsymia, Sax­en­da, and Belviq. The com­pa­ny was inch­ing — al­beit very slow­ly — to­ward prof­itabil­i­ty for the past 15 years. It wasn’t enough.

Back in 2017, CEO Michael Narachi told me he hoped a merg­er or sale would get the com­pa­ny back on track with the abil­i­ty to share costs with an­oth­er or­ga­ni­za­tion. Then last month Orex­i­gen an­nounced a Chap­ter 11 bank­rupt­cy in a last-ditch ef­fort to set­tle its ac­counts (and like­ly at­tract a buy­er).

The deal with Nal­pro­pi­on is sub­ject to high­er and bet­ter of­fers, Orex­i­gen not­ed in a press re­lease, and the of­fer win­dow will close June 21.

Orex­i­gen sent this state­ment in re­sponse to my re­quest for more in­for­ma­tion about the San Diego of­fice, and the fu­ture of the em­ploy­ees work­ing there.

“The em­ploy­ees at Orex­i­gen are an im­por­tant el­e­ment of the val­ue of the com­pa­ny.  Through our in­ter­ac­tions with this po­ten­tial buy­er, we be­lieve they al­so rec­og­nize the con­tri­bu­tions made by our em­ploy­ees.  We plan to con­tin­ue to sup­port our team dur­ing this process.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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AbCellera founder and CEO Carl Hansen (L) and Rallybio CEO Martin Mackay

Rally­bio, Ab­Cellera form new part­ner­ship around an­ti­bod­ies for rare dis­ease

Two biotechs that have been working heavily on different stages of antibody candidate development over the past several years are looking to work together to find potential candidates for rare diseases.

Canadian-based AbCellera and Connecticut-based Rallybio have entered a strategic partnership to find, develop and commercialize antibodies primarily for rare diseases. The multi-year, multi-target deal will seek to combine AbCellera’s antibody “discovery engine” with Rallybio’s expertise in rare diseases. However, the dollar amount for the deal was not disclosed.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting: