Eye­ing Eylea's $5B sales, No­var­tis touts sol­id 12-week dos­ing da­ta for its ri­val RTH258

No­var­tis is rolling out new da­ta that build on its case for the com­pa­ny’s block­buster hope­ful RTH258, an in­ves­ti­ga­tion­al ther­a­py that might carve away a con­sid­er­able chunk of Re­gen­eron’s $5 bil­lion Eylea fran­chise if ap­proved.

Vas Narasimhan

The new da­ta, which came from a sec­ondary analy­sis of two Phase III tri­als, show a com­pelling case for the drug as a treat­ment for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion. The drug al­ready showed im­pres­sive suc­cess in those tri­als last fall, when it per­formed well in a head-to-head com­par­i­son to Eylea. Sim­ply put, No­var­tis’ CEO Vas Narasimhan said the drug was “con­sis­tent­ly su­pe­ri­or” to its Re­gen­eron ri­val.

Now, No­var­tis is call­ing at­ten­tion to RTH258’s con­ve­nience fac­tor com­pared to Eylea and oth­er ther­a­pies.

Dirk Sauer

“Ever since Lu­cen­tis was first in­tro­duced more than 10 years ago as a month­ly in­jec­tion, physi­cians have been try­ing to find a way to space out treat­ments,” said Dirk Sauer, head of No­var­tis’ oph­thal­mol­o­gy unit. “They’re try­ing to find a way to re­duce the bur­den for the pa­tient, but al­so to re­duce the bur­den for the physi­cian — they have lots of pa­tients com­ing back every month for in­jec­tions.”

Re­gen­eron’s Eylea can be tak­en once every 8 weeks, which is nicer for pa­tients and docs, but No­var­tis plans to go a step fur­ther. The com­pa­ny is bet­ting that its 12-week reg­i­men will win over a big slice of the mar­ket. In the da­ta rolled out to­day, No­var­tis said pa­tients in the tri­als had an 87% and 83% prob­a­bil­i­ty of suc­cess­ful­ly con­tin­u­ing a 12-week in­ter­val through week 48.

That’s big, Sauer said, con­sid­er­ing Re­gen­eron and oth­ers’ ap­par­ent dif­fi­cul­ty with this dos­ing sched­ule. Not to be out­done, Re­gen­eron told End­points News back in No­vem­ber that it was test­ing its own 12-week treat­ment cy­cle with Eylea. I checked back with Re­gen­eron last week, and a com­pa­ny spokesper­son said Re­gen­eron’s sBLA for its 12-week Eylea treat­ment was ac­cept­ed by the FDA and has a PDU­FA date of Au­gust 11.

But Sauer said that doesn’t nec­es­sar­i­ly steal No­var­tis’ edge.

“I can’t spec­u­late on the FDA la­bel for Eylea or for ours, but the da­ta are not the same,” Sauer said. “We did a prospec­tive analy­sis, while they went back and did a ret­ro­spec­tive analy­sis. Ret­ro­spec­tive analy­ses, from an an­a­lyt­i­cal and sta­tis­ti­cal point of view, are weak­er.”

Plus, Sauer said, Re­gen­eron doesn’t have 12-week treat­ment da­ta from its first year, on­ly its sec­ond. In the third year, the com­pa­ny went back to an 8-week reg­i­men, Sauer said, which might mean pa­tients lost vi­su­al acu­ity.

Still, Re­gen­eron may be slight­ly ahead in the race for ap­proval. Sauer said RTH258 should be filed with the FDA lat­er this year. But it could take a year to 18 months for the drug ac­tu­al­ly reach­es the mar­ket.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

No­var­tis is ax­ing 150 ear­ly dis­cov­ery jobs as CNI­BR shifts fo­cus to the de­vel­op­ment side of R&D

Novartis is axing some 150 early discover jobs in Shanghai as it swells its staff on the drug development side of the equation in China. And the company is concurrently beefing up its investment in China’s fast-growing biotech sector with a plan to add to its investments in local VCs.

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No­var­tis is eye­ing a multi­bil­lion-dol­lar Med­Co buy­out as Jer­sey biotech nears NDA — re­ports

To get from Novartis’ US headquarters to the Medicines Company, you make a left out of a square concrete building on NJ-Route 10, follow it past the sun orange veranda of Jersey’s Hot Bagels and the inexplicable green Vermont cabin that houses the Whippany Railway Museum until you turn right and immediately arrive at a rectangular glass building. It should take you about 12 minutes.

Reports are out that Novartis may be making that trip. Amid a torrent of Phase III data burnishing MedCo’s chances at a blockbuster cholesterol drug,  Bloomberg News is reporting that Novartis is looking to acquire the Jersey-based biotech.

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UP­DAT­ED: In a land­mark first glimpse of hu­man da­ta from Ver­tex, CRISPR/Cas9 gene ther­a­py sig­nals ear­ly ben­e­fit

Preliminary data on two patients with blood disorders that have been administered with Vertex and partner CRISPR Therapeutics’ gene-editing therapy suggest the technology is safe and effective, marking the first instance of the benefit of the use of CRISPR/Cas9 technology in humans suffering from disease.

Patients in these phase I/II studies give up peripheral blood from which hematopoietic stem and progenitor cells are isolated. The cells are tinkered with using CRISPR/Cas9 technology, and the edited cells — CTX001 — are infused back into the patient via a stem cell transplant. The objective of CTX001 is to fix the errant hemoglobin gene in patents with two blood disorders: beta-thalassemia and sickle cell disease, by unleashing the production of fetal hemoglobin.

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Elizabeth Warren speaks during the Nevada Democrats' "First in the West" event at Bellagio Resort & Casino on November 17, 2019 in Las Vegas, Nevada (Getty Images)

Eliz­a­beth War­ren pro­pos­es us­ing com­pul­so­ry li­cens­ing, an­titrust ac­tions to break bio­phar­ma’s con­trol of drug pric­ing — and here are the block­busters she’s tar­get­ing first

Nancy Pelosi’s drug pricing bill may have sparked some industrial strength headaches on the money side of biopharma, but Elizabeth Warren seems determined to become biopharma’s Nightmare on Pennsylvania Avenue.

Warren, one of the top-ranked candidates for the Democratic presidential nomination backing Medicare for all, is circulating a new plan that promises to break the industry’s grip on drug prices — and she has some very specific examples of how she would do it.

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Badrul Chowdhury. FDA via Flickr

As­traZeneca los­es an­oth­er ex­ec­u­tive to biotech, as Badrul Chowd­hury moves to Savara

Another executive is migrating from the echelons of Big Pharma to the corridors of small biotech.

In April 2018, Badrul Chowdhury took his more than two decades of experience at the FDA to AstraZeneca, where he took on the role of senior vice president and chief physician-scientist for respiratory, inflammation and autoimmunity late-stage development in biopharmaceuticals R&D.

After about a year and a half in this role, Chowdhury is moving to a small Texas biotech called Savara, where he will serve as chief medical officer.

Yiannis Kiachopoulos and Artur Saudabayev, co-founders of Causaly

Lon­don AI up­start, which counts No­var­tis as a cus­tomer, can teach your com­put­er to read

When Amazon developed a machine-learning tool to make its recruitment process more efficient — the man-made system absorbed the gender-bias of its human makers, and the project was aborted. In the field of biopharmaceuticals, the way researchers train their machine learning algorithms can skew the outcome of predictions. But before those predictions can be made, the engine must learn to read to make sense of explosive volume of knowledge out there.

Burt Adelman. Novo Ventures

Here's a $25M seed fund aimed at back­ing some brash new drug ideas out of the Broad

As a former academic and a seasoned drug developer, Burt Adelman knew when he was recruited as a senior advisor to Novo Ventures in 2017 that one of his key priorities needs to be introducing the fund to the network he was so deeply embedded in.

“I was thinking long and hard on how can I, as a Boston insider, help Novo really get inside the ecosystem of Boston biotech?” he recalled in an interview with Endpoints News.

Welling­ton lines up a $393M bankroll for its next round of pri­vate biotech bets — and they’re like­ly think­ing big

Wellington Management made some uncustomary waves at the beginning of the year when it threw its considerable weight against Bristol-Myers Squibb’s $74 billion Celgene buyout. But after Bristol-Myers’ biggest investor conceded that game to the influential proxy firms involved, they’re now going to end the year by rolling out a big new investment fund for a new stable of fledgling biotechs on the private side of the industry.