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.”

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.