Rid­ing a wave of pos­i­tive PhI­II read­outs, Pfiz­er gets a snap re­view for lung can­cer drug da­comi­tinib

Pfiz­er’s de­ci­sion to hand over four years of work on a port­fo­lio of off-the-shelf CAR-T drugs doesn’t mean that they’re any less fo­cused on their all-im­por­tant late-stage on­col­o­gy pipeline. And the FDA helped make that ap­par­ent to­day by hand­ing the phar­ma gi­ant a fast-tracked pri­or­i­ty re­view for da­comi­tinib — one of their top late-stage can­cer drugs in line for an ini­tial ap­proval lat­er this year.

Pri­or­i­ty re­view in can­cer, which is be­com­ing more of an in­dus­try stan­dard these days, cuts four months off the process, giv­ing Pfiz­er a PDU­FA date some­time in Sep­tem­ber. (Some play­ers like to be coy about the ac­tu­al date.)

The drug is be­ing aimed at first-line non-small cell lung can­cer af­ter the TKI scored a beat over gefi­tinib, with a me­di­an pro­gres­sion-free sur­vival rate of 14.7 months in the head-to-head ARCHER 1050 study com­pared with 9.2 months in pa­tients treat­ed with gefi­tinib.

The drug fits in with a pack of can­cer drug de­vel­op­ment ef­forts at Pfiz­er, led by a dri­ve to keep Xtan­di com­pet­i­tive in prostate can­cer while look­ing for some new hits for Baven­cio, a PD/L1 check­point in­hibitor that’s suf­fered a cou­ple of set­backs in the clin­ic. Ta­la­zoparib, the PARP in­hibitor picked up in the Medi­va­tion buy­out, hit in Phase III for breast can­cer last De­cem­ber, though the da­ta seem to fit in with ri­vals. In ad­di­tion, Pfiz­er is al­so hus­tling ahead with lor­la­tinib for ALK-pos­i­tive cas­es — al­so award­ed a pri­or­i­ty re­view in Feb­ru­ary — and glas­deg­ib, an oral SMO in­hibitor ini­tial­ly cod­ed PF-04449913, for acute myeloid leukemia, based on Phase II re­sults.

Pfiz­er re­cent­ly spelled out all of its near-term hopes in the clin­ic, but over­looked a sur­pris­ing win that was wait­ing days ago for a long ig­nored ther­a­py called tafamidis. The Pfiz­er tri­al, called AT­TR-ACT, test­ed its drug tafamidis in pa­tients with transthyretin car­diomy­opa­thy, an in­her­it­ed con­di­tion in which pro­teins don’t fold in­to their nor­mal shapes cor­rect­ly. And it is shap­ing up as a ri­val to the big block­buster hope at Al­ny­lam.

Have a new drug that promis­es to fight Covid-19? The FDA will see you now

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: 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).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.