Ag­ile bris­tles af­ter FDA's third snub, promis­ing a fight for its con­tra­cep­tive

Ag­ile Ther­a­peu­tics is start­ing to get testy af­ter suf­fer­ing yet an­oth­er snub from the FDA, an­nounc­ing this morn­ing that it sim­ply doesn’t agree with the reg­u­la­tors’ as­ser­tion that its con­tra­cep­tion patch is faulty.

The com­pa­ny is strap­ping on box­ing gloves over the mat­ter, as the FDA’s re­quests could sink the com­pa­ny fi­nan­cial­ly — un­less it finds new ways to cov­er the bills.

Ag­ile’s once-week­ly, low-dose con­tra­cep­tive patch called Twirla is a com­bi­na­tion hor­mon­al patch that con­tains ethinyl estra­di­ol and lev­onorgestrel.

Al Al­tomari

Fol­low­ing the com­pa­ny’s sec­ond bid for ap­proval last De­cem­ber, the FDA is­sued a com­plete re­sponse let­ter not­ing con­cerns with Ag­ile’s ad­he­sion test meth­ods. In re­sponse, the com­pa­ny pro­posed that its pa­tient com­pli­ance pro­grams should ap­pease any con­cerns.

Fri­day morn­ing, Ag­ile said its meet­ing with the reg­u­la­tor brought bad news. The FDA isn’t con­vinced that the com­pli­ance pro­grams fix the prob­lem, and still feels that Ag­ile’s ad­he­sive for the patch is no good. The FDA has sug­gest­ed the ad­he­sive be com­plete­ly re­for­mu­lat­ed and re-test­ed. Af­ter fix­ing the ad­he­sion prob­lem, Ag­ile would have to prove bioe­quiv­a­lence to the ear­li­er ver­sion of the patch.

Ag­ile isn’t tak­ing the news ly­ing down, is­su­ing a state­ment Fri­day that it “dis­agrees with the FDA’s con­clu­sions on the ad­he­sion of Twirla and our pa­tient com­pli­ance pro­grams.” Al Al­tomari, the com­pa­ny’s chair­man and CEO, had this to say:

We be­lieve we have demon­strat­ed an ad­he­sion pro­file for Twirla that sup­ports ap­proval based on ex­ten­sive da­ta from our Phase II stud­ies, in­clud­ing an ex­treme con­di­tions tri­al, and our three Phase III tri­als. We al­so be­lieve that we have planned com­pli­ance and ed­u­ca­tion pro­grams that can ad­dress the is­sues raised by the FDA and will sup­port pa­tient use of the prod­uct once it is ap­proved.  While we will con­tin­ue to eval­u­ate all of our op­tions on next steps, we ex­pect we will pur­sue for­mal dis­pute res­o­lu­tion.  We will pro­vide an up­date when we move for­ward.

This isn’t the first time Ag­ile’s been re­ject­ed by the FDA. The com­pa­ny sub­mit­ted the patch for FDA ap­proval back in 2013 but struck out. At the time, reg­u­la­tors asked the com­pa­ny to do ad­di­tion­al clin­i­cal tri­al work and pro­vide the FDA with ex­tra in­for­ma­tion on man­u­fac­tur­ing.

The FDA’s re­cent de­ci­sion puts Ag­ile in a tough po­si­tion fi­nan­cial­ly. The com­pa­ny’s stock was dec­i­mat­ed back in De­cem­ber with news of the sec­ond re­jec­tion, drop­ping near­ly 50% overnight and bare­ly re­cov­er­ing since. Now, Al­tomari says the com­pa­ny’s go­ing to have to get cre­ative to stay op­er­a­tional.

“In light of the feed­back from the FDA, we al­so are re-eval­u­at­ing our busi­ness plan to iden­ti­fy ways to ex­tend our abil­i­ty to fund the com­pa­ny’s op­er­a­tions,” Al­tomari said.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.