Bill Haney, Skyhawk

Fat­ten­ing the bankroll, Bill Haney adds can­cer R&D pow­er­house Mer­ck to Sky­hawk's ros­ter of part­ners out to drug RNA

What­ev­er Bio­gen learned about Sky­hawk in the 6 months since it an­ted up $74 mil­lion to get a col­lab­o­ra­tion go­ing with their R&D team on drug­ging RNA for neu­rode­gen­er­a­tion, it must have been a pos­i­tive ex­pe­ri­ence.

Dean Li Linkedin

The big biotech has al­ready come back to the bar­gain­ing ta­ble and signed up to ex­pand the range of tar­gets on their dis­cov­ery list. And this morn­ing Sky­hawk is al­so an­nounc­ing that phar­ma gi­ant Mer­ck has stepped up with its own ini­tia­tive on neu­rode­gen­er­a­tion while adding can­cer to the RNA menu of col­lab­o­ra­tive spe­cial­ties at the up­start drug dis­cov­ery unit for the first time.

Sky­hawk chief Bill Haney wasn’t be­ing ex­plic­it about the terms — Mer­ck, in par­tic­u­lar, is tra­di­tion­al­ly loathe to dis­cuss the fi­nan­cial de­tails in­volved in their dis­cov­ery pacts — but fac­tor in the $149 mil­lion in hard up­fronts al­ready an­nounced with Bio­gen, Cel­gene and Take­da (al­so on neu­rode­gen­er­a­tion), and Haney tells me lit­tle Sky­hawk has round­ed up “quite a bit of mon­ey” with its deals in just 18 months. With the eq­ui­ty Haney has at­tract­ed or put in, the bankroll push­es well past the $200 mil­lion mark. 

The mile­stones? They stretch up in­to the bil­lions. Mer­ck alone at­tached a $600 mil­lion deal to­tal on every pro­gram they opt­ed for.

Tyler Jacks Jacks Lab

Dean Li, the head of dis­cov­ery at Mer­ck Re­search Labs, says the phar­ma gi­ant sees this deal as an op­por­tu­ni­ty to do some­thing brand new in RNA splic­ing, with a plan to go af­ter some cur­rent­ly un­drug­gable goals. (And no, he didn’t say which ones.)

Haney, a doc­u­men­tary film­mak­er and busy biotech en­tre­pre­neur, placed a heavy em­pha­sis on grow­ing the com­pa­ny with deal cash since he and the in­sid­ers at the com­pa­ny put up $8 mil­lion in seed mon­ey at the be­gin­ning of 2018. And while Sky­hawk wasn’t the first of the group of star­tups to un­veil plans to dis­cov­er small mol­e­cules that could be used to drug RNA, they’ve come up with the most im­pres­sive ros­ter of al­liances in the field.

Tai Wong Linkedin

Haney al­so runs Drag­on­fly, which in­cludes Tyler Jacks at MIT — a mar­quee sci­en­tist in the on­col­o­gy world — as one of the co-founders. Af­ter serv­ing as an un­of­fi­cial ad­vis­er at Sky­hawk for some time now, Jacks has now for­mal­ly ac­cept­ed the role of head of the sci­en­tif­ic ad­vi­so­ry board at the com­pa­ny, which has built up a staff of 40 in Cam­bridge with a full-time equiv­a­len­cy group of 120. 

Sky­hawk has been grow­ing fast, but Haney says it’s al­so been run­ning at a de­lib­er­ate speed. The team pur­pose­ful­ly held back on open­ing up talks on the on­col­o­gy front un­til last Jan­u­ary’s JP Mor­gan con­fab. Can­cer is where the in-house pro­gram is fo­cused, with 2 pro­grams set to en­ter the clin­ic near-term. And now that they are div­ing deep­er in­to can­cer with some plans to ex­plore vir­gin ter­ri­to­ry in R&D, he’s brought in Bris­tol-My­ers vet Tai Wong as VP of on­col­o­gy bi­ol­o­gy. Wong spent 19 years at Bris­tol run­ning the on­col­o­gy drug dis­cov­ery unit. Then he jumped to Pelo­ton, which was ac­quired by Mer­ck for $2.2 bil­lion.

It’s a small world.

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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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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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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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

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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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FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

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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