Treve­na forges plan to take once-re­ject­ed opi­oid across fin­ish line, af­ter 'pro­duc­tive' FDA meet­ing

Tiny Treve­na may have a new lease on life for its con­tro­ver­sial opi­oid painkiller — re­ject­ed by the FDA last No­vem­ber cit­ing the dearth of drug safe­ty da­ta — fol­low­ing a scathing in­ter­nal staff cri­tique and lop­sided ex­pert pan­el re­view.

The com­pa­ny’s shares $TRVN swelled near­ly 120% on Mon­day af­ter Treve­na said the agency had agreed that the drug’s ex­ist­ing safe­ty data­base would suf­fice for a par­tic­u­lar dose of the drug — help­ing forge a path for­ward for the biotech to re­sub­mit its mar­ket­ing ap­pli­ca­tion.

The IV in­jec­tion, oliceri­dine, was de­vel­oped to help adult pa­tients man­age mod­er­ate to se­vere acute pain. It is de­signed to in­duce a sim­i­lar anal­gesic ef­fect as mor­phine, but work faster and re­duce the messy side ef­fects of se­da­tion, res­pi­ra­to­ry de­pres­sion and slow­ing gas­troin­testi­nal motil­i­ty. But mixed tri­al re­sults and gaps in safe­ty da­ta in­clud­ing QT in­ter­val da­ta — the time the heart mus­cle takes to recharge be­tween beats — prompt­ed the reg­u­la­tor to even­tu­al­ly re­ject the opi­oid in ear­ly No­vem­ber. At the time, the agency asked for a big­ger safe­ty data­base for the drug, as well as “cer­tain ad­di­tion­al non­clin­i­cal da­ta and val­i­da­tion re­ports”.

Car­rie Bour­dow

On Mon­day, Treve­na said its cur­rent safe­ty da­ta would sup­port la­bel­ing at a max­i­mum dai­ly dose of 27 mg, and that the FDA had agreed that the com­pa­ny con­duct a study (in­clud­ing place­bo- and pos­i­tive-con­trol arms) in healthy vol­un­teers to amass the re­quest­ed QT in­ter­val da­ta.

The Chester­brook, Penn­syl­va­nia-based drug de­vel­op­er in­tends to sub­mit a pro­to­col and analy­sis plan to the FDA short­ly and, up­on re­ceipt of reg­u­la­to­ry feed­back, ex­pects to ini­ti­ate the study in the first half of 2019. The com­pa­ny added it does not need any more ef­fi­ca­cy da­ta to re­sub­mit its mar­ket­ing ap­pli­ca­tion for the drug, but did not pro­vide any de­tails on when that re­sub­mis­sion could be ex­pect­ed.

CEO Car­rie Bour­dow said she was “en­cour­aged by the pro­duc­tive dis­cus­sion” with the FDA in a state­ment.

Max­ine Gowen

Back in 2016, un­der the be­hest of CEO Max­ine Gowen, Treve­na had sug­gest­ed an end-of-Phase II meet­ing with the FDA had cul­mi­nat­ed in a gen­er­al agree­ment about the Phase III de­sign for oliceri­dine, and that Gowen was “very pleased” with the dis­cus­sion. But it was on­ly last year that it was re­vealed that the FDA had in fact in­di­cat­ed oth­er­wise — the agency had dis­agreed with pro­posed dos­ing and the pri­ma­ry end­point in the late-stage pro­gram. This rev­e­la­tion prompt­ed at­tor­neys at Bern­stein Lieb­hard to ac­cuse Treve­na ex­ecs, par­tic­u­lar­ly for­mer CEO Max­ine Gowen, of mis­lead­ing in­vestors for rough­ly two years.

FDA pol­i­cy dic­tates it must not re­lease any in­for­ma­tion re­lat­ed to dis­cus­sions with drug spon­sors un­til a drug is up for re­view. Com­mis­sion­er Scott Got­tlieb had ini­tial­ly made promis­es to arm the agency to re­veal more in­for­ma­tion, for in­stance the reg­u­la­tor’s rea­son­ing be­hind is­sued CRLs, but that has not come to fruition.

Mean­while, the FDA’s ap­proval of an­oth­er opi­oid amidst a na­tion­al cri­sis of opi­oid abuse, mis­use and ad­dic­tion that kills about 130 Amer­i­cans each day will like­ly cause more fric­tion. Acel­Rx’s $ACRX ap­proval for its opi­oid Dsu­via last year sparked a flur­ry of in­tense crit­i­cism, even prompt­ing a mem­ber of the FDA’s own ex­pert pan­el to call out the agency’s at­ti­tude to­ward opi­oids as “will­ful blind­ness that bor­ders on the crim­i­nal.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid 19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Dai­ichi Sankyo sinks $200M in­to new gene ther­a­py tech from Ul­tragenyx

In a leap to the gene therapy space, Daiichi Sankyo has dropped $200 million to access Ultragenyx’s manufacturing technology, providing the rare disease biotech with plenty of cash and a stock boost amid a general cash crunch.

For $125 million in cash and a $75 million equity investment, Daiichi Sankyo has bought a non-exclusive license to the IP around two platforms with which it plans to develop AAV-based gene therapy products. The Japanese pharma is purchasing the stock $RARE at $60 per share, more than a third above its current price of $44.43.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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