New York gam­bles $1.15B in new funds and in­cen­tives in search of a biotech jack­pot

Of all the biotech hub wannabes in the world, and they are le­gion, New York has per­haps one of the best claims on top-rank sta­tus. Man­hat­tan is home to some of the world’s great­est re­search in­sti­tu­tions, in­clud­ing some in­volved di­rect­ly in the im­muno-on­col­o­gy rev­o­lu­tion now un­der­way. And it has a small but grow­ing hub in Mid­town to help house a boom.

To­day, it al­so can add a $650 mil­lion ini­tia­tive from the gov­er­nor to help spark a boom. And then New York May­or Bill de­Bla­sio fol­lowed up with a $500 mil­lion ef­fort aimed at cre­at­ing 9,000 biotech jobs over the next 10 years.

The city pro­gram in­cludes $100 mil­lion in­vest­ment for a new life sci­ences cam­pus on Man­hat­tan’s East Side or in neigh­bor­ing Long Is­land City; a $50 mil­lion in­vest­ment to cre­ate new work space at 8 top re­search in­sti­tu­tions; $20 mil­lion in new seed funds;  and $300 mil­lion in tax in­cen­tives.

Gov­er­nor An­drew Cuo­mo’s ad­min­is­tra­tion has come up with a mix of tax in­cen­tives and new ven­ture cash to make New York state top of mind for any up-and-com­ing biotech in the world look­ing for some­place to call home. The list of good­ies in­cludes:

  • $250 mil­lion in tax in­cen­tives that can be doled out in $10 mil­lion al­lot­ments to ex­ist­ing biotechs. This in­cludes a 15% tax cred­it on ap­proved R&D ex­pens­es for new life sci­ence com­pa­nies. And there’s a 25% tax cred­it for an­gel in­vestors who in­vest in biotechs, worth up to $250,000.
  • There’s a new $200 mil­lion-plus ven­ture fund, which the state is pro­vid­ing $100 mil­lion to in match­ing cash, for ear­ly-stage com­pa­nies. There’s grant and prize mon­ey avail­able to star­tups, which will be doled out in com­pe­ti­tions look­ing for the best and bright­est up­starts.
  • There’s al­so a $200 mil­lion pro­gram to back up cap­i­tal in­vest­ments, with land and of­fice space avail­able at dozens of state col­leges.

The goal here is to ri­val the two gold­en states in biotech: Mass­a­chu­setts and Cal­i­for­nia. Just like every­body else in the eco­nom­ic de­vel­op­ment game, New York state and city of­fi­cials are shoot­ing for brag­ging rights to be­ing home to an in­dus­try that is known for good, high-pay­ing jobs fo­cused on de­vel­op­ing im­por­tant new drugs.

But these lo­cal ini­tia­tives rarely pan out as elect­ed of­fi­cials like to boast they will. Flori­da Gov­er­nor Jeb Bush in­vest­ed heav­i­ly in new re­search in­sti­tu­tions, look­ing to build the foun­da­tion for a life sci­ences in­dus­try of their own. But they nev­er at­tract­ed the kind of re­search sup­port need­ed, and now some of the in­sti­tu­tions are sim­ply falling apart af­ter fail­ing to gen­er­ate the jobs they promised. Cal­i­for­nia has seen lit­tle tan­gi­ble progress with its stem cell ini­tia­tive. And Texas is still try­ing to seed the in­dus­try with can­cer re­search cash.

New York at least doesn’t have to start from scratch. But it still has a long way to go.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Daphne Zohar (PureTech)

PureTech bags $200M from sale of Karuna shares — still siz­zling from promis­ing schiz­o­phre­nia da­ta

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

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