FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, en­thu­si­asm for Amarin’s fish-oil pill Vas­cepa bur­geoned when the FDA signed off on ex­pand­ing the cho­les­terol fight­er’s la­bel to in­clude the drug’s ben­e­fi­cial im­pact on car­dio­vas­cu­lar risk, but months lat­er the ex­u­ber­ance for the block­buster-to-be took a big hit when a judge in­val­i­dat­ed key patents pro­tect­ing Vas­cepa.

De­spite Amarin’s $AM­RN pledge to ap­peal — a process that could take months — the rul­ing opened the door for gener­ic com­pe­ti­tion. Hik­ma Phar­ma­ceu­ti­cals, one of three chal­lengers in the Neva­da suit, on Fri­day said that its gener­ic copy of pure EPA, the omega-3 fat­ty acid that con­sti­tutes Vas­cepa, has been ap­proved by the FDA.

An­a­lysts sug­gest­ed that there was a low prob­a­bil­i­ty of a Hik­ma launch any­time soon.

“Giv­en AM­RN’s on­go­ing ap­peal of the dis­trict court’s rul­ing in­val­i­dat­ing Vas­cepa’s patents on ob­vi­ous­ness and the fact the tri­al has been ex­pe­dit­ed by the court, we think it is un­like­ly Hik­ma will launch at-risk and risk po­ten­tial tre­ble dam­ages if AM­RN were to pre­vail on the ap­peal,” Stifel an­a­lysts wrote in a note.

At the mo­ment, Amarin does not have an in­junc­tion in place to stop any po­ten­tial at-risk launch, al­though the com­pa­ny could file one now, Jef­feries’ an­a­lysts said.

“Amarin strong­ly dis­agrees with the rul­ing and will vig­or­ous­ly pur­sue all avail­able reme­dies, in­clud­ing an ap­peal of the Court’s de­ci­sion and a pre­lim­i­nary in­junc­tion pend­ing ap­peal to…pre­vent launch of gener­ic ver­sions of Vas­cepa in the Unit­ed States,” com­pa­ny chief John Thero said in a March press re­lease.

Amarin man­age­ment has al­so in­di­cat­ed that with an ex­pe­dit­ed ap­peal a new rul­ing could po­ten­tial­ly come by the end of 2020 or ear­ly 2021.

“It’s hard to de­fin­i­tive­ly know whether Hik­ma will launch in the near-term and there is al­ways the pos­si­bil­i­ty of the oth­er gener­ic fil­er — Dr. Red­dy’s — al­so re­ceiv­ing ap­proval for their gener­ic Vas­cepa and po­ten­tial­ly launch­ing at-risk. The next ma­jor up­date in the ap­peal will be around 6/16 when the gener­ics file their re­sponse briefs,” Stifel an­a­lysts added.

End­points News has con­tact­ed Hik­ma for com­ment on its launch plans and reached out to Amarin in­quir­ing about whether it in­tends to file an in­junc­tion block­ing the Hik­ma launch.

Amarin’s Vas­cepa, known chem­i­cal­ly as icos­apent eth­yl and an omega-3 fat­ty acid de­rived from fish oil com­posed sole­ly of EPA, was orig­i­nal­ly en­dorsed by the US reg­u­la­tor as a treat­ment for el­e­vat­ed triglyc­erides. How­ev­er, in De­cem­ber the FDA sanc­tioned its use in a much broad­er pa­tient pop­u­la­tion af­ter a land­mark tri­al — RE­DUCE-IT — which showed the pill trig­gered a 25% re­duc­tion in the risk for the first oc­cur­rence of a ma­jor car­dio event, and a 26% re­duc­tion for 3-point MACE, a com­pos­ite of car­dio­vas­cu­lar death, non­fa­tal heart at­tack and non­fa­tal stroke. An­a­lysts pre­dict­ed the new la­bel could sky­rock­et sales to the $2 bil­lion peak mark.

But a stun­ning set­back in late March seem­ing­ly re­versed Amarin’s for­tunes, when gener­ic chal­lengers in­clud­ing Hik­ma and Dr. Red­dy’s won a suit chal­leng­ing five of Amarin’s patents that were set to ex­pire by 2030. Te­va, an­oth­er chal­lenger, signed a set­tle­ment with Amarin to de­lay its gener­ic launch un­til 2029.

Jef­feries Michael Yee has pre­vi­ous­ly sug­gest­ed that gener­ic chal­lengers still face a sig­nif­i­cant hur­dle to bring their wares to the mar­ket, in­clud­ing de­vel­op­ing man­u­fac­tur­ing plants to pro­duce pure EPA. Amarin cur­rent­ly has three such fa­cil­i­ties, it is un­clear whether the gener­ic chal­lengers have ac­cess to one, he added.

As for Amarin, man­age­ment sug­gest­ed an EU fil­ing for Vas­cepa is in the works and is slat­ed for the end of the year. The com­pa­ny has been look­ing for a part­ner for the drug in Eu­rope, but Cowen’s Ken Cac­cia­tore as­sert­ed that sell­ing the EU rights would be the most pru­dent route.

“We con­tin­ue to be­lieve the most wealth-cre­at­ing de­ci­sion would be to sell, as op­posed to li­cense. And we be­lieve a CVR could be es­tab­lished to re­al­ize the po­ten­tial op­tion­al­i­ty of a U.S. ap­peal re­ver­sal,” he wrote. “Giv­en that the work­ing as­sump­tion must be that an ap­peal in the U.S. will not be suc­cess­ful, a li­cense agree­ment for the re­main­ing ex-U.S. rights could set up a sit­u­a­tion where Amarin is sim­ply a pub­licly-trad­ed roy­al­ty com­pa­ny.”

So­cial im­age: John Thero, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Amarin Corp., smiles dur­ing an in­ter­view in New York, U.S., on Wednes­day, Aug. 28, 2019. Thero dis­cussed the com­pa­ny’s plans for its car­dio­vas­cu­lar drug Vas­cepa. Pho­tog­ra­ph­er: Christo­pher Good­ney/Bloomberg via Get­ty Im­ages

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.