Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DR­RX got a bad­ly need­ed shot in the arm Mon­day morn­ing as Gilead’s busy BD team lined up ac­cess to its ex­tend­ed-re­lease plat­form tech for HIV and he­pati­tis B.

Gilead, a leader in the HIV sec­tor, is pay­ing a mod­est $25 mil­lion in cash for the right to jump on the plat­form at Durect, which has been us­ing its tech­nol­o­gy to come up with an ex­tend­ed-re­lease ver­sion of bupi­va­caine. The FDA re­ject­ed that in 2014, but Durect has been work­ing on a come­back.

That pro­gram has had more than its share of prob­lems. In the fall of 2017 the com­pa­ny’s Phase III study of their long-act­ing ver­sion — part­nered with No­var­tis — failed against a com­par­i­son arm us­ing reg­u­lar bupi­va­caine, as the FDA in­sist­ed. The stock col­lapsed. 

The deal an­nounced to­day comes with some hefty biobucks added in mile­stones. There’s $75 mil­lion for de­vel­op­ment and reg­u­la­to­ry mile­stones in the first pack­age, plus $70 mil­lion in sales goal cash. On top of that, Gilead will add up to $150 mil­lion for each new de­vel­op­ment pro­gram it adds to its pipeline out of the pact.

For Gilead, it’s the lat­est in a string of large and small deals aimed at mak­ing over the pipeline with part­ners. The big deal land­ed just days ago, with their $5 bil­lion up­front to al­ly them­selves with Gala­pa­gos.

In­vestors liked the sound of to­day’s news. Cu­per­ti­no, CA-based Durect has seen its share price cut in half over the past year, slid­ing well be­low the crit­i­cal $1 mark. This morn­ing, though, shares popped 36%, get­ting back close to a buck a share. 

Durect CEO James Brown not­ed: “We’ve been work­ing to­geth­er on this pro­gram as a fea­si­bil­i­ty project, and are now de­light­ed that Gilead has cho­sen to ad­vance this ef­fort in­to a for­mal de­vel­op­ment pro­gram.”

So­cial im­age: Gilead, AP Im­ages

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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Mer­ck’s $1B cash gam­ble pays off with a sur­pris­ing PhI­II car­dio suc­cess for Bay­er’s heart drug veri­ciguat

More than 3 years after Merck stepped up and paid $1 billion in cold, hard cash to gain the US commercial rights to Bayer’s high-risk heart drug vericiguat in a broad-ranging cardio alliance, the partners say their Phase III study has come through with promising data and a date with regulators.
We don’t have the data, and won’t until they put it out at an upcoming scientific session, but Merck touted the results, saying that their big Phase III VICTORIA study hit the primary endpoint  — with vericiguat combined with available therapies reducing “the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.”
Depending on the hard data, and how it breaks out with the combinations used, this drug could pose a threat to Novartis’ blockbuster drug Entresto.
The drug is a soluble guanylate cyclase (sGC) stimulator, which Bayer and Merck have had high hopes for. Evidently, so did cardiologists. Cowen’s last analysis set potential sales at $400 million in 2024, but that number could go up significantly now.
Cowen’s Steve Scala noted this morning:
Vericiguat could be a lucrative product for Merck, and one with potentially under-appreciated value. At Cowen’s Therapeutics Conference in September 2019, 80% of specialists anticipated a positive result from VICTORIA whereas only 51% of investors shared this optimism.
Investigators recruited more than 5,000 patients at more than 600 centers in 42 countries for this study — one of the most expensive propositions in R&D. Millions of people in the US suffer from heart failure with reduced ejection fraction when the failing heart fails to contract properly to eject blood into the system. Bayer holds ex-US rights to the drug and also stands to earn cash from the $1.1 billion in milestones Merck agreed on for their collaboration.
Remarkably, the drug was pushed into Phase III despite failing the mid-stage trial — though investigators flagged a success at the high dose of 10 mg. In VICTORIA, researchers started patients at 2.5 mg and then titrated up to 5 and then 10 mg.

Alk­er­mes forges $950M biotech buy­out deal in a bold bet on an ear­ly-stage CNS drug plat­form

Alkermes $ALKS is investing $100 million cash and committing up to $850 million more in milestones in a big wager on a very early-stage CNS discovery platform. And the biotech is adding $20 million more to fund next year’s new research work on the platform it’s acquiring in today’s buyout with an eye to expanding the research work in oncology.

The biotech, helmed by Richard Pops, is buying Rodin Therapeutics, which had focused early on Alzheimer’s disease. Pops’ buyout, though, isn’t focused solely on the most troublesome sector in pharma R&D.

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Eye­ing one of the first RNAi ther­a­pies and cho­les­terol block­buster, Med­Co shows de­tailed in­clisir­an da­ta

The main question was not whether it would work; it was if it would be safe.

The Medicines Company is out with new data on its LDL cholesterol drug inclisiran, and they confirm the first, tentative answers: Yes. They also keep MedCo on track for an imminent  FDA submission for one of the first RNAi therapies and a drug that could flip the cholesterol market. An EU application will follow in the first quarter of 2020.

Image: Associated Press

Af­ter a late-stage miss, No­var­tis touts an­oth­er En­tresto analy­sis to con­vince the FDA to ex­pand the block­buster's la­bel

Fresh after getting its keenly watched sickle cell treatment endorsed by the FDA, Novartis is pulling out all the stops to expand the use of heart therapy Entestro using a raft of analyses after the drug “narrowly” failed a crucial late-stage test.

Entestro is a top seller for Novartis and is currently approved for HFrEF (formerly known as systolic heart failure) — in these patients the heart muscle does not contract effectively, reducing the level of oxygen-rich blood pumped into to the body. The drug is administered twice daily and is designed to cut the strain on the failing heart.

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UP­DAT­ED: Karuna clears PhII hur­dle in schiz­o­phre­nia, takes aim at a piv­otal in block­buster hunt -- shares soar

When Karuna went public last year, the biotech cited one small Eli Lilly study of their anti-psychotic xanomeline that delivered a whopping 24-point average improvement in schizophrenics’ PANSS score over placebo — far and above the average 9-10 point advantage cited for the average drug approved for use among these patients.

Now, after wrapping a big Phase II of a xanomeline combo with a sizable 182 patients, the margin on success has shrunk considerably, but the team $KRTX can still count on a solidly positive average outcome as well as — crucially — the safety profile they were looking for.

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(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Dutch di­ag­nos­tics play­er Qi­a­gen con­firms buy­out talks fol­low­ing re­port of Ther­mo Fish­er's in­ter­est

Several bidders have laid their eyes on Dutch diagnostics firm Qiagen — and Thermo Fisher is reportedly one of them.

Qiagen, which is listed on the NYSE, notified investors on Friday that “it has begun a review of potential strategic alternatives after receiving several conditional, non-binding indications of interest for the acquisition of all issued and outstanding shares of the Company.” It didn’t name any of the potential buyers.