Lonnel Coats, Lexicon president and CEO

Lex­i­con bids farewell to top sell­er Xer­me­lo in re­or­ga­ni­za­tion to­ward R&D pipeline

Three years ago, Lex­i­con Phar­ma­ceu­ti­cals was fly­ing high fol­low­ing the FDA ap­proval and com­mer­cial launch of its Xer­me­lo drug, which treats car­ci­noid syn­drome di­ar­rhea.

But now the com­pa­ny is say­ing good­bye to its top sell­er as it pares down debt and re­or­ga­nizes to fo­cus on its R&D pipeline. In what CEO Lon­nel Coats de­scribed as a “bit­ter­sweet” mo­ment, Lex­i­con an­nounced Thurs­day the sale of Xer­me­lo to TerSera for $155 mil­lion in up­front pay­ments and $4 mil­lion in ex­ist­ing in­ven­to­ry. Lex­i­con can re­ceive an ad­di­tion­al $65 mil­lion in mile­stone pay­ments re­lat­ing to bil­iary tract can­cer and roy­al­ties on fu­ture Xer­me­lo sales.

“The sale of our com­mer­cial prod­uct, Xer­me­lo, to TerSera pro­vides a home for an im­por­tant treat­ment for pa­tients with can­cer,” Coats said in a state­ment.

TerSera will al­so as­sume an on­go­ing Phase II tri­al of Xer­me­lo in bil­iary tract can­cer pa­tients and can hire 20 em­ploy­ees from Lex­i­con who work on the drug.

Coats out­lined the re­or­ga­ni­za­tion in a con­fer­ence call with in­vestors ear­ly Thurs­day morn­ing de­tail­ing the com­pa­ny’s sec­ond quar­ter fi­nan­cials. Though Xer­me­lo sales were up 21 per­cent to $9 mil­lion in the quar­ter com­pared with 2019 Q2, Lex­i­con end­ed the three-month pe­ri­od at a net loss of $69.1 mil­lion.

The com­pa­ny ini­ti­at­ed the sell-off to pay back all $150 mil­lion of an ex­ist­ing loan and will now fo­cus on its LX9211 can­di­date for the treat­ment of di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain. Thanks to the sale, LX9211 will en­ter Phase II and Lex­i­con will have enough run­way to op­er­ate such tri­als through the end of 2021.

Though Xer­me­lo had been a boon for Lex­i­con, Thurs­day’s sale is the lat­est in a long line of set­backs. The Texas-based com­pa­ny had part­nered with Sanofi for $300 mil­lion up­front to de­vel­op a di­a­betes drug, the SGLT1/2 in­hibitor so­tagliflozin. But the FDA re­ject­ed the drug in March 2019, and af­ter mul­ti­ple Phase III fail­ures in type 2 di­a­betes, Sanofi ex­it­ed the deal, pay­ing an­oth­er $260 mil­lion and caus­ing Lex­i­con stock to drop as much as 70 per­cent. US reg­u­la­tors re­ject­ed so­tagliflozin for a sec­ond time last De­cem­ber and Lex­i­con has filed an ap­peal.

At is­sue was the high risk of di­a­bet­ic ke­toaci­do­sis in type 1 di­a­betes, which caused the FDA to split its vote 8-8 in the first re­jec­tion in­ci­dent. It’s a con­di­tion that can be hard to spot, rais­ing the chances of hos­pi­tal­iza­tion for pa­tients who are un­aware that they ur­gent­ly need to take in­sulin. Oth­er SGLT in­hibitors, such as As­traZeneca’s Farx­i­ga, ran in­to sim­i­lar trou­ble.

LX9211 it­self is a small mol­e­cule in­hibitor of adap­tor as­so­ci­at­ed ki­nase 1 (AAK1) and Lex­i­con is ex­plor­ing mul­ti­ple treat­ments for neu­ro­path­ic pain with the can­di­date. Tak­en oral­ly, LX9211 showed a fa­vor­able safe­ty pro­file in Phase I stud­ies, Lex­i­con said, and the com­pa­ny is plan­ning fur­ther Phase II stud­ies.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Mer­ck scoops up a PhII J&J dis­card in a bar­gain-base­ment deal. And this time they’re shoot­ing at NASH

When J&J turned to South Korea’s Hanmi for a GLP-1/glucagon dual receptor agonist obesity drug, the pharma giant paid $105 million in a cash upfront for the licensing rights and plotted a big clinical trial program to test it. A year ago, like a few of Hanmi’s big partners, J&J reviewed their trial data and walked away, handing it back.

Now Merck is stepping up to grab it for their NASH pipeline — and they got it a lot cheaper than J&J.