Pan­dem­ic fears force Chi­nese biotech to post­pone Hong Kong IPO meet­ings — Bloomberg

At the same time the coro­n­avirus out­break orig­i­nat­ing from Wuhan is boost­ing shares prices of a raft of (most­ly over­seas) drug­mak­ers, it ap­pears to have al­so forced at least one do­mes­tic biotech to slow down its IPO plans in Hong Kong.

In­no­Care Phar­ma — a Bei­jing-based com­pa­ny fo­cused on can­cer and au­toim­mune dis­eases with a lead drug now lined up at Chi­na’s reg­u­la­tor — has de­cid­ed to post­pone in­vestor meet­ings in­tend­ed to gauge de­mand for the HKEX list­ing, Bloomberg re­port­ed. Ac­cord­ing to anony­mous in­sid­ers, In­no­Care had planned to raise about $200 mil­lion.

De­pend­ing on whether and how quick­ly a pan­dem­ic en­sues, this could mark the first of many IPO dis­rup­tions.

While the ma­jor ports be­tween main­land Chi­na and Hong Kong re­main open for the time be­ing (a con­tro­ver­sial arrange­ment in the sup­pos­ed­ly se­mi-au­tonomous city), many of the in­sti­tu­tion­al in­vestors back­ing pub­lic de­buts and the bookrun­ners they hire are in cri­sis mode.

Banks have start­ed to ask em­ploy­ees com­ing back from main­land Chi­na to work from home for two weeks — rough­ly the in­cu­ba­tion pe­ri­od for the 2019-nCoV — po­ten­tial­ly mak­ing meet­ings with com­pa­ny ex­ecs dif­fi­cult. Fur­ther­more, trav­el re­stric­tions have put face-to-face dis­cus­sions on hold, with one Eu­ro­pean banker telling Bloomberg that he’s go­ing to stay over­seas for longer.

But a cou­ple of phar­ma com­pa­nies al­ready list­ed, whether in Hong Kong or main­land Chi­na, of­fered some rare bright spots amid a cat­a­stroph­ic rout for Chi­na’s stock mar­ket once it re­opened fol­low­ing the 10-day Lu­nar New Year hol­i­day.

As­cle­tis, the first pre-rev­enue biotech to join the HKEX, en­joyed a 19% surge to HK$4.95 af­ter it no­ti­fied in­vestors that it’s co­or­di­nat­ing with med­ical in­sti­tu­tions to launch clin­i­cal tri­als of its ex­per­i­men­tal com­bo of ASC09 and ri­ton­avir. It con­tin­ues an up­ward trend that be­gan days ago when the biotech said it’s sub­mit­ted an emer­gency use ap­pli­ca­tion to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion to use the ther­a­py, orig­i­nal­ly de­signed for HIV, as a treat­ment for the 2019-nCoV in­fec­tion.

Well-known play­ers such as Shang­hai Phar­ma, Harbin Phar­ma­ceu­ti­cal Group and Han­soh al­so scored sin­gle-dig­it gains, de­spite not os­ten­si­bly do­ing any­thing to com­bat the coro­n­avirus.

It didn’t float all boats, though. De­spite an­nounc­ing that it’s set up a ded­i­cat­ed team to en­able de­vel­op­ment of neu­tral­iz­ing an­ti­bod­ies to the virus, WuXi Bi­o­log­ics shares stayed some­what flat at HKD$99.65.

In its fil­ings from Oc­to­ber In­no­Care in­di­cat­ed that it would al­lo­cate much of the IPO pro­ceeds to its lead drug, ore­labru­ti­nib, a BTK in­hibitor that’s been ac­cept­ed by the NM­PA for re­view in re­lapsed or re­frac­to­ry chron­ic lym­phoblas­tic leukemia and small lym­phoblas­tic lym­phoma. Two oth­er clin­i­cal-stage as­sets tar­get pan-FGFR and FGFR4, re­spec­tive­ly, fol­lowed by six drug can­di­dates ex­ecs want to bring in­to Phase I.

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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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.

Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

Mo­tion de­nied: Gilead still on the hook for $1.5B in dam­ages over CAR-T patent dis­pute with Bris­tol My­ers Squibb

Gilead’s bid to overturn a jury verdict that ordered it to pay Bristol Myers Squibb about $752 million for CAR-T patents owned by its subsidiary Juno Therapeutics has ended in vain.

The ruling leaves Gilead vulnerable to an even bigger $1.5 billion payment that Bristol is now demanding — adding fuel to the fiery criticism some analysts are already heaping on its $11.9 billion Kite buyout.

In a 30-page document unsealed on Monday, Judge James Otero of the district court in Los Angeles struck down several different arguments for a new decision. Here are Morgan Stanley analysts’ takeaways:
The court, in particular, denied Kite’s contentions (1) that Juno’s patent is invalid, (2) the damages award was unreasonable, and (3) that a new trial should take place. The court also denied Kite’s argument that its infringement was not willful.
Gilead is likely to appeal to the federal circuit, they noted, but the odds are not in their favor as the same standard for evidence will be applied in that court. Appeals typically take 16 months.

A quiver of ar­rows for im­mune dis­or­ders: Pan­dion scores $80M in fresh fund­ing

Scientists began with making recombinant versions of naturally-occurring human proteins, then graduated to monoclonal antibodies. Now, rather than replicating moieties within the body, researchers are modifying these molecules to have precise biology in a functional manner.

This technology, referred to as bispecific antibodies, is already being employed to fight cancer. In early 2018, Pandion Therapeutics was born to reverse-engineer the science into the realm of autoimmune and inflammatory disorders.

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).