Clo­vis soars as a new round of PhI­II Rubra­ca da­ta looks promis­ing — but ro­ci scan­dal bites again with $142M set­tle­ment

Shares of Clo­vis On­col­o­gy soared 50% Mon­day morn­ing, af­ter the biotech re­port­ed a sol­id slate of pro­gres­sion-free sur­vival da­ta for its PARP drug Rubra­ca (ru­ca­parib) that will help it line up right along­side ri­vals in the field, pos­si­bly elim­i­nat­ing an ad­van­tage held by Tesaro for ac­cess to a wider group of ovar­i­an can­cer pa­tients.

Soon af­ter the da­ta hit, though, Clo­vis re­vealed in an SEC fil­ing that it had ten­ta­tive­ly reached a deal to set­tle a class ac­tion law­suit brought by share­hold­ers af­ter Clo­vis’ dis­as­trous set­back on rocile­tinib, re­ject­ed by the FDA af­ter ques­tions arose about the dodgy da­ta that had been cir­cu­lat­ed about that can­cer ther­a­py ahead of the FDA’s de­ci­sion. The biotech is set­ting aside $142 mil­lion in cash and stock to set­tle al­le­ga­tions that it ac­tive­ly mis­led in­vestors on ro­ci. And Clo­vis al­so dis­closed that it is un­der in­ves­ti­ga­tion by the SEC as well as the Jus­tice De­part­ment over the ro­ci case.

Rubra­ca, though, looks bet­ter than ever.

In­ves­ti­ga­tors re­port­ed that the drug hit all three pri­ma­ry end­points for pro­gres­sion-free sur­vival in tu­mor BR­CA-mu­tant, HRD-pos­i­tive and over­all in­tent-to-treat pop­u­la­tions. It al­so hit a key sec­ondary end­point for an in­de­pen­dent re­view of those re­sults.

If it all holds up at the FDA, the da­ta should pave the way to broad­er use of the drug, Clo­vis’ on­ly mar­ket­ed ther­a­py. And it may well end up eat­ing in­to Tesaro’s mar­ket share, a point that helped dri­ve down its shares by 8% this morn­ing.

Clo­vis says that it will file a sup­ple­men­tal ap­pli­ca­tion “with­in the next four months for a sec­ond-line and lat­er main­te­nance treat­ment in­di­ca­tion for all women with plat­inum-sen­si­tive ovar­i­an can­cer who have re­spond­ed to their most re­cent plat­inum ther­a­py.”

The new da­ta comes as mar­ket leader As­traZeneca, with Lyn­parza, lines up to com­pete with Clo­vis and Tesaro with com­pa­ra­ble PARPs. It al­so adds pres­sure on Pfiz­er, which picked up a PARP in its $14 bil­lion Medi­va­tion buy­out, which con­tin­ues to look like a heav­i­ly in­flat­ed price for the as­sets the phar­ma gi­ant net­ted in the deal.

Leerink’s Michael Schmidt says he was im­pressed by Rubra­ca’s lat­est per­for­mance. He not­ed:

The re­sults look par­tic­u­lar­ly im­pres­sive when com­pared to pre­vi­ous com­peti­tor da­ta and we think should sup­port a broad la­bel for Rubra­ca in a broad 2L main­te­nance pa­tient pop­u­la­tion, in­de­pen­dent of BR­CA/HRD sta­tus and test­ing. We re­cent­ly ini­ti­at­ed cov­er­age of CLVS with an OP rat­ing (LINK). The top-line da­ta re­port­ed this morn­ing clear­ly re­flect the best-case out­come for CLVS high­light­ed in our pri­or re­port in­di­cat­ing that ef­fi­ca­cy of the 3 lead­ing PARP in­hibitors looks very com­pa­ra­ble and we ex­pect shares to trade up sig­nif­i­cant­ly. With best-case da­ta in hand, we think CLVS should be a prime take­out can­di­date, and we re­it­er­ate our OP rat­ing on the stock.

Over the last few weeks we’ve been treat­ed to a num­ber of stores about Tesaro’s auc­tion to sell the com­pa­ny. As to­day’s news about the PFS da­ta spreads, that could put a crimp on the high end of the mar­ket val­u­a­tions be­ing ap­plied to its drug, Ze­ju­la.

Clo­vis, mean­while, is find­ing it hard to put the ro­ci scan­dal be­hind it. The biotech was forced to re­state its da­ta sub­mit­ted for an ap­proval of rocile­tinib, prompt­ing an em­bar­rass­ing and dev­as­tat­ing drop in the num­ber of re­spons­es that the biotech had claimed for their drug. An FDA pan­el sub­se­quent­ly re­ject­ed the drug, fol­lowed by a for­mal re­jec­tion by the agency, prompt­ing Clo­vis to re­struc­ture and lay off staffers while bury­ing ro­ci as a los­er. Share­hold­ers filed dozens of law­suits as a re­sult, forc­ing the com­pa­ny to go on the de­fen­sive. Clo­vis had ear­li­er not­ed in SEC fil­ings that it was un­der fed­er­al in­ves­ti­ga­tion, but had not dis­closed who was han­dling the probe.

“Based on these en­cour­ag­ing da­ta, it is clear that ru­ca­parib demon­strates a clin­i­cal­ly mean­ing­ful im­pact in de­lay­ing dis­ease re­cur­rence in women in this tri­al with ad­vanced ovar­i­an can­cer,” said Robert Cole­man, the prin­ci­pal in­ves­ti­ga­tor for the ARIEL3 study. “The PFS and safe­ty re­sults achieved in this study are par­tic­u­lar­ly promis­ing, be­cause they sug­gest women are able to stay on ru­ca­parib for a pro­longed pe­ri­od of time while gain­ing ben­e­fit. It is al­so clin­i­cal­ly sig­nif­i­cant that ru­ca­parib not on­ly sus­tained the most re­cent re­sponse to plat­inum, but in some pa­tients al­so en­hanced that re­sponse, in­clud­ing the elim­i­na­tion of resid­ual tu­mor.”

Fangliang Zhang, AP Images

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.

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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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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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.

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.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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.