With debt loom­ing, brow­beat­en di­et pill mak­er Orex­i­gen goes bank­rupt -- shares slide

Di­et pill mak­er Orex­i­gen Ther­a­peu­tics is wav­ing the white flag Mon­day morn­ing af­ter a years-long bat­tle to bring its fi­nances in­to the black. With crush­ing debt loom­ing, the com­pa­ny is fil­ing Chap­ter 11 bank­rupt­cy in a last-ditch ef­fort to set­tle its ac­counts.

This is not the first time the com­pa­ny has tried to right the ship. Back in Oc­to­ber, Orex­i­gen $OREX an­nounced it was seek­ing bid­ders for the com­pa­ny’s as­sets. The last straw for the drug­mak­er’s suf­fer­ing bal­ance sheet was a mas­sive debt pay­ment that came due thanks to slow sales of Orex­i­gen’s lead prod­uct, Con­trave. The San Diego-based com­pa­ny was sup­posed to reach $100 mil­lion in sales by the end of 2017, but came in shy at just un­der that fig­ure. As part of the loan terms, that fail­ure trig­gered a pay­ment Orex­i­gen could not af­ford.

Michael Narachi

“While we have been work­ing close­ly with our note­hold­ers and have the sup­port of a con­trol­ling num­ber of se­nior se­cured note­hold­ers, our debt covenant re­quire­ments and near-term cash flow needs have ne­ces­si­tat­ed the pro­tec­tion af­ford­ed by a court-dri­ven process,” said Michael Narachi, Orex­i­gen’s CEO, in a state­ment.

The past few years have been tu­mul­tuous for Orex­i­gen, with the com­pa­ny’s stock plum­met­ing 96% 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 is 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 has been inch­ing — al­beit slow­ly — to­wards prof­itabil­i­ty for the past 15 years. It wasn’t enough.

Late last year, 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. Plus, the com­pa­ny re­cent­ly won its long patent bat­tle with gener­ic drug­mak­er Ac­tavis, giv­ing Orex­i­gen mar­ket ex­clu­siv­i­ty un­til 2030. Narachi was hope­ful that this de­vel­op­ment would sweet­en the pot for po­ten­tial buy­ers.

No dice, ap­par­ent­ly.

In a state­ment, Orex­i­gen said a con­trol­ling num­ber of its se­nior se­cured note­hold­ers made a $35 mil­lion com­mit­ment to the com­pa­ny, pro­vid­ing Orex­i­gen with “suf­fi­cient liq­uid­i­ty to con­duct its busi­ness in an un­in­ter­rupt­ed man­ner, fund its chap­ter 11 case, in­clud­ing the sale of its as­sets, and to con­tin­ue to meet its op­er­a­tional and fi­nan­cial oblig­a­tions.”

Orex­i­gen’s stock is down 17% in pre-mar­ket trad­ing, sell­ing at $1.16 per share.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.