Trou­bled Teva's suc­ces­sor to Co­pax­one just failed a big PhI­II test for mul­ti­ple scle­ro­sis

Copy­right (c) Flash 90 2013

Af­ter years of set­backs, de­lays and sundry frus­tra­tions, a deeply trou­bled Te­va says that a late-stage tri­al for laquin­i­mod — long billed as a suc­ces­sor to the ag­ing flag­ship ther­a­py Co­pax­one for mul­ti­ple scle­ro­sis — failed the test on the re­laps­ing-re­mit­ting form of the dis­ease.

Te­va’s drug — her­ald­ed as its bright­est pipeline prospect — did not meet the pri­ma­ry end­point, try­ing to sig­nif­i­cant­ly im­prove the time to dis­abil­i­ty pro­gres­sion com­pared to place­bo af­ter three months.

Michael Hay­den, Te­va

In­ves­ti­ga­tors are still test­ing this drug for pri­ma­ry pro­gres­sive MS and Hunt­ing­ton’s dis­ease, but with the lat­est sting­ing fail­ure, it’s un­like­ly that an­a­lysts will as­cribe much po­ten­tial val­ue to the drug. At the be­gin­ning of 2016 Te­va — part­nered with Ac­tive Biotech — was forced to sus­pend use of the high­est dose of laquin­i­mod due to car­dio side ef­fects. Nev­er­the­less, the com­pa­ny was pre­dict­ing that it could win with low­er dos­es and prep for a launch af­ter com­plet­ing stud­ies this year.

Shares of Ac­tive {$AC­TI: STO} dropped 66% on the news.

In the mean­time, with gener­ic com­pe­ti­tion loom­ing for Co­pax­one, Roche re­cent­ly won an ap­proval for Ocre­vus as a new ther­a­py for both re­laps­ing-re­mit­ting and pri­ma­ry pro­gres­sive MS, look­ing to dis­rupt a mar­ket in which Bio­gen is see­ing rev­enue be­gin to wane for Tec­fidera.

Te­va, though, is in a jam. Last year the com­pa­ny bought Al­ler­gan’s big gener­ics port­fo­lio just as gener­ic drug prices were be­gin­ning to erode. That trig­gered a move to re­or­ga­nize and cut costs, which is still just be­gin­ning. Now the com­pa­ny, which had tried to con­tin­ue to de­vel­op brand­ed drugs while al­so pur­su­ing the gener­ics mar­ket, finds it­self with lim­it­ed prospects in the clin­ic to ex­cite an­a­lysts — if that’s still pos­si­ble.

In ear­ly April Te­va did win an ap­proval for Auste­do to treat Hunt­ing­ton’s chorea, a drug they bought two years ago with ex­pec­ta­tions of a quick OK. Last fall Te­va in­cit­ed a con­sid­er­able amount of spec­u­la­tion about how it could one day ri­val Neu­ro­crine in tar­dive dysk­i­ne­sia with Auste­do. But their mixed re­sults al­so sparked more than a lit­tle kick­back from an­a­lysts who pre­fer In­grez­za. The FDA hand­ed Te­va’s drug — ac­quired 2 years ago in a $3.5 bil­lion Aus­pex buy­out — as­signed them an Au­gust 30 PDU­FA date.

In the ab­sence of a game plan, Te­va is stick­ing with op­ti­mism in the face of de­feat, putting the best face on an ug­ly fail­ure.

“We have learned a great deal from the CON­CER­TO tri­al and we will con­tin­ue our analy­sis of the da­ta,” said Michael Hay­den, Pres­i­dent of Glob­al R&D and Chief Sci­en­tif­ic Of­fi­cer at Te­va. “Al­though we are dis­ap­point­ed by not meet­ing the pri­ma­ry end­point, we did see pos­i­tive re­sults on a num­ber of sec­ondary and ex­plorato­ry end­points which fu­els our be­lief in the po­ten­tial of laquin­i­mod as a pos­si­ble treat­ment for neu­rode­gen­er­a­tive dis­eases. While we have no cur­rent plans to fur­ther pur­sue laquin­i­mod in RRMS, we are con­tin­u­ing to study it in two oth­er tri­als.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.