Te­va gets a mixed bag of PhI­II da­ta as it lines up against a (bet­ter?) Neu­ro­crine ri­val for tar­dive dysk­i­ne­sia

Four months af­ter the FDA re­ject­ed Te­va’s “break­through” drug SD-809 for treat­ing chorea as­so­ci­at­ed Hunt­ing­ton’s dis­ease, the phar­ma group is back with a batch of mixed Phase III da­ta on tar­dive dysk­i­ne­sia, the in­vol­un­tary move­ments as­so­ci­at­ed with the de­gen­er­a­tive dis­ease. And once again Te­va is up­beat about the re­sults, say­ing the da­ta clears the way to a new mar­ket­ing pitch lat­er this year.

A year-and-a-half ago Te­va $TE­VA splurged on a $3.5 bil­lion ac­qui­si­tion of Aus­pex, bag­ging the new and what it hoped was an im­proved drug for Hunt­ing­ton’s. Now it’s say­ing that its sec­ond late-stage study shows that the drug is clear­ly a suc­cess, but there are still some sig­nif­i­cant prob­lems to ad­dress.

In­ves­ti­ga­tors say that a high and mid-range dose of their drug hit the pri­ma­ry end­point on the move­ment scale rat­ing for a “mod­i­fied in­tent to treat” group. The low dose failed to sep­a­rate sig­nif­i­cant­ly from the place­bo. But the high dose, mean­while, missed beat­ing the place­bo based on in­ves­ti­ga­tors’ as­sess­ment of how their pa­tients were do­ing.

Te­va’s big pro­gram for this drug puts it in a head-to-head show­down with Neu­ro­crine $NBIX, which not­ed just days ago that it has filed for an ap­proval on the ri­val drug val­be­nazine.

Neu­ro­crine ex­ecs not­ed in their Q2 call with an­a­lysts at the end of Au­gust that they are al­ready build­ing a mar­ket­ing group for the drug, which has al­so achieved a break­through drug des­ig­na­tion that could put it on track to an ap­proval as ear­ly as next spring. The drug is a VMAT2 in­hibitor, de­signed to mod­u­late dopamine re­lease dur­ing nerve com­mu­ni­ca­tion.

Baird’s Bri­an Sko­r­ney com­pared the two drugs, and vot­ed on Neu­ro­crine as the like­ly win­ner in this loom­ing show­down. Val­be­nazine did bet­ter at beat­ing a place­bo, with a 3.1 re­duc­tion com­pared to place­bo ver­sus a 1.9 dif­fer­ence in fa­vor of Te­va’s drug.

Added Sko­r­ney:

With at least a few months’ lead time and po­ten­tial un­cer­tain­ty around the meta­bol­ic pro­file of SD-809, we re­main con­fi­dent that val­be­nazine, now brand­ed as In­grez­za, can gar­ner stronger sup­port from physi­cians at launch.

Jef­feries’ Biren Amin agreed with Sko­r­ney on the time­line, putting Neu­ro­crine in the lead by sev­er­al months.

Te­va’s drug rep­re­sents a big bet for the Is­raeli com­pa­ny, which was hop­ing to be in the first wave of com­pa­nies to get an ap­proval for a deuter­at­ed drug, tak­ing an ex­ist­ing drug — in this case tetra­benazine (Xe­nazine) — and re­design­ing it to break down more slow­ly, a tweak which should make it pos­si­ble to pro­vide low­er dos­ing for max­i­mum ef­fect while im­prov­ing the safe­ty pro­file.

The FDA hasn’t re­quired a head-to-head study against tetra­benazine, which may come back to haunt Te­va if it does get a mar­ket­ing ap­proval. But it has asked for more work ex­am­in­ing the lev­els of metabo­lites in­volved in break­ing down the drug.

The ther­a­py—deutetra­benazine—is a small mol­e­cule in­hibitor of vesic­u­lar monoamine 2 trans­porter, or VMAT2, which is de­signed to reg­u­late the lev­els of dopamine in the brain.

A re­cent sto­ry in Bloomberg high­light­ed an­a­lysts’ pro­jec­tions of about a bil­lion dol­lars a year in an­nu­al rev­enue, if Te­va can make its case to pa­tients put off by the side ef­fects of the orig­i­nal drug, which in­clude de­pres­sion. More re­search work is be­ing done on Tourette syn­drome.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Ed Kaye, Stoke Therapeutics CEO

Stoke touts ear­ly signs of ef­fi­ca­cy for Dravet syn­drome drug

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.