Novartis (NVS)

[DewDiligence]

NVS sues AMGN re Aimovig collaboration termination:

https://www.reuters.com/article/us-amgen-novartis-lawsuit/novartis-sues-amgen-over-migraine-treatment-aimovig-idUSKCN1RG21I

Novartis AG sued Amgen Inc on Thursday, accusing the U.S. biotechnology company of trying to wrongfully back out of agreements to jointly develop and market migraine prevention drug Aimovig, and keep the profits for itself.

…Amgen, in an emailed statement, said it is seeking to terminate the collaboration agreements with Novartis and obtain damages, but termination would not be effective until the litigation is resolved.

In its complaint, Novartis said it has spent at least $870 million on Aimovig since it began collaborating in August 2015 with Amgen, which previously controlled rights to the drug. Novartis accused Amgen of trying to wrongfully back out of their collaboration agreements based on the pretext that the Swiss company’s Sandoz unit was working with Alder Biopharmaceuticals Inc on a possible Aimovig rival.

… “The [ALDR] program about which Amgen has complained is being terminated,” Novartis said, and the lack of a breach means Amgen’s April 2 notice terminating the [Aimovig] collaboration agreements should be deemed void.

[DewDiligence]

FDA approves NVS’ Mayzent* for MS—including SPMS:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634469.htm

a/k/a siponimod, BAF312.

[Invest83838]

If NVS Does BO AMRN,


This board will become very active ))

[DewDiligence]

WSJ opines on the “new” Novartis:

https://www.wsj.com/articles/novartis-ceo-bets-on-cutting-edge-science-to-remake-drug-giant-1542629461

[DewDiligence]

NVS R&D Day slides (170 pages):

https://www.novartis.com/sites/www.novartis.com/files/2018-11-r-d-day-investor-presentation.pdf

[DewDiligence]

PFE-NVS clinical-trial collaboration in NASH: #msg-144519047.

[DewDiligence]

NVS 3Q18 results:

https://globenewswire.com/news-release/2018/10/18/1623092/0/en/Novartis-delivered-strong-growth-and-innovation-during-the-third-quarter-including-progressing-advanced-therapy-platforms-to-drive-future-growth.html

[DewDiligence]

NVS receives CRL for Ilaris in CVD: #msg-144301592.

[DewDiligence]

NVS acquires ECYT for $2.1B:

https://investor.endocyte.com/news-releases/news-release-details/endocyte-enters-agreement-be-acquired-novartis-ag-21-billion

[DewDiligence]

AMGN, NVS launch Humira biosimilars in Europe, pursuant to prior settlements with ABBV (#msg-134970085, #msg-144157243):

https://uk.reuters.com/article/us-abbvie-biosimilars/amgen-novartis-kick-off-fight-for-abbvie-blockbuster-drug-in-eu-idUKKCN1MQ1QT

Two additional Humira biosimilars—from MYL and Samsung—are expected to launch in Europe soon.

No pricing information on Humira biosimilars in Europe has been publicly disclosed yet.

The formulation and method-of-use patents that ABBV has used to keep Humira biosimilars off the market in the US until 2023 did not stand up to challenge in Europe.

[DewDiligence]

ABBV settles global Humira-patent litigation with NVS: #msg-144157243.

[DewDiligence]

PDUFA date for NVS’ BAF312 in SPMS—>Mar 2019 (with priority review voucher):

https://globenewswire.com/news-release/2018/10/08/1617727/0/en/Novartis-announces-FDA-and-EMA-filing-acceptance-of-siponimod-the-first-and-only-drug-shown-to-meaningfully-delay-disability-progression-in-typical-SPMS-patients.html

In the EU, an MAA has been submitted, and regulatory action is expected in late 2019.

[DewDiligence]

Doctors and insurance companies will soon get wise to this and Entresto sales will plummet.

It's hardly a secret that Diovan is one of the components of Entresto.

[debunker1]

Entresto will flop

All they've done is capitalize on the benefits of switching someone with CHF and COPD from and ACE inhibitor to an ARB, any ARB.

These days pretty much everyone with CHF also has COPD.

They are using a massive marketing campaign with many TV commercials to try and convince people that Entresto is something new when it's mainly comprised of the same drug (valsartan) that was their once big time seller they called DIOVAN, they recently lost patent protection on.

Their trial did not include a true head to head comparison of valsartan vs valsartan/sacubitril.

They try and convince people that using an ARB instead of an ACE inhibitor for CHF is something new, ARB's have been around for years and there are many examples from many companies.

Doctors and insurance companies will soon get wise to this and Entresto sales will plummet.

Never before in history has a pharma tried such an attempt at repackaging and re-patenting a drug that they lost patent protection on in this manner, people will catch on eventually.

[DewDiligence]

NVS sells US small-molecule-generics business to India’s Aurobindo for $900M plus $100M in contingent payments:

https://in.reuters.com/article/us-novartis-sandoz-aurobindo-pharma/novartis-sells-u-s-generics-assets-to-indias-bargain-hunting-aurobindo-idINKCN1LM0D4

Such a low price for this business would have been unthinkable a few years ago.

[DewDiligence]

NVS 2Q18 PR:

https://globenewswire.com/news-release/2018/07/18/1538689/0/en/Novartis-delivers-solid-growth-in-second-quarter-and-continues-transformation-to-a-focused-medicines-company.html

[DewDiligence]

NVS reports soft 2Q18—but re-iterates full-year guidance:

https://www.wsj.com/articles/novartis-backs-2018-outlook-after-sales-grow-1531892742

[DewDiligence]

NVS seeks to divest Alcon—will take enormous loss relative to $50B (cumulative) acquisition price:

https://www.bloomberg.com/news/articles/2018-06-29/novartis-to-spin-off-alcon-buy-back-up-to-5-billion-of-stock

[debunker1]

Entresto is nothing more than an attempt by Novartis to extend the patent life of Diovan (Valsartan). There is nothing to prove that Entresto is any better than the now generically available Valsartan.

There are other things to watch for with regards to Novartis integrity, such as making facilities managers from a failed pump and dump like ArQule into an "automation guru". There are so many highly qualified people in the industry to choose from for such roles yet they hired a "facilities manager", how embarrassing, these pharmaceutical companies don't even make an honest effort anymore.

[DewDiligence]

NVS slides from “Meet the Management” Investor Day:

https://www.novartis.com/sites/www.novartis.com/files/2018-05-meet-the-management-group-presentation.pdf

[DewDiligence]

Data support 12-week dosing of RTH258 for some wet-AMD patients: #msg-140425036.

[DewDiligence]

FDA approves Tafinlar/Mekinist for adjuvant BRAF-V600+ melanoma:

https://globenewswire.com/news-release/2018/04/30/1490316/0/en/Novartis-receives-FDA-approval-of-Tafinlar-Mekinist-for-adjuvant-treatment-of-BRAF-V600-mutant-melanoma.html

[DewDiligence]

NVS acquires AVXS for $8.7B in cash:

https://www.sec.gov/Archives/edgar/data/1114448/000117184318002601/f6k_040918.htm

[DewDiligence]

NVS PR on consumer-JV sale to GSK:

https://www.sec.gov/Archives/edgar/data/1114448/000117184318002301/f6k_032718.htm

[DewDiligence]

NVS seeking bids for US small-molecule-generics business:

https://www.reuters.com/article/us-novartis-genericdrugs/novartis-readies-to-auction-u-s-generic-pills-business-sources-idUSKCN1G01SW

FoBs and “complex” generics such as Copaxone are not part of the planned divestiture.

[Ecomike]

Go baby go!!!! $NVS

[DewDiligence]

NVS 4Q17 results…

PR:
https://www.sec.gov/Archives/edgar/data/1114448/000137036818000004/a180124-99_1.htm

Supplementary financial tables:
https://www.sec.gov/Archives/edgar/data/1114448/000137036818000004/a180124-99_2.htm

CC slides:
https://www.novartis.com/sites/www.novartis.com/files/q4-2017-ir-presentation.pdf

[DewDiligence]

NVS hires oncology chief (from PFE):

https://www.sec.gov/Archives/edgar/data/1114448/000117184318000315/f6k_011118.htm

https://endpts.com/pfizer-oncology-head-liz-barrett-jumps-ship-to-novartis-as-bruno-strigini-retires

[biopharm]

Novartis been researching PS Phosphatidylserine targeting ?

Drug: MBG453
MBG453 is a high-affinity, humanized anti-TIM-3 IgG4 monoclonal antibody which blocks the binding of TIM-3 to phosphatidylserine (PtdSer).

David Epstein bring Jay Bradner and Glenn Dranoff over from Dana Farber to further pursue PS Targeting combinations ?

Novartis Glenn Dranoff been researching PS Targeting and Novartis requires that expertise yesterday, though will Novartis secure all rights? One hell of a week coming up to find out

https://www.nibr.com/stories/discovery/new-recruit-has-big-dreams-cancer-immunotherapy

Dana Farber is where Troy Luster went (also had collaborations with Evotec)

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=129100057

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=102461358

Quote:
Of note, immediately following the anti-PS presentation, the discussion of the three preceding presentations, (abstracts 3003-3005), is led by none other than Dr. Glenn Dranoff himself, well-known and well-published Harvard immunologist, who recently has been studying the therapeutic anti-tumor effects achieved by blocking PS-mediated signaling.

Dranoff's 2008 paper published in the journal Clinical Cancer Research, titled ”Capitalizing on the Immunogenicity of Dying Tumor Cells”, should be "required reading" for anyone interested in how exposed PS is exploited by tumors to elude the cells of the immune system. In the paper, he speaks very broadly about the role of exposed PS in the apoptotic process common to all multicellular organisms, and he outlines experiments in which autologous tumor cells combined with PS-blocking yielded some very impressive experimental anti-tumor results.
3-15-08 CCR:

http://clincancerres.aacrjournals.org/cgi/content/full/14/6/1603

“Anti-PS, ASCO’09, and Glenn Dranoff” - Anti-PS blog, 5-8-09…
http://anti-ps.blogspot.com
http://anti-ps.blogspot.com/2009/05/anti-ps-asco-and-glenn-dranoff-interim.html

Interim data from a phase II clinical trial evaluating anti-PS in advanced breast cancer patients is slated for an oral presentation at the annual ASCO conference this year, (abstract #3005 [6-1-09 10:30am]).

Of note, immediately following the anti-PS presentation, the discussion of the three preceding presentations, (abstracts 3003-3005), is led by none other than Dr. Glenn Dranoff himself, well-known and well-published Harvard immunologist, who recently has been studying the therapeutic anti-tumor effects achieved by blocking PS-mediated signaling.

Dranoff's 2008 paper published in the journal Clinical Cancer Research, titled ”Capitalizing on the Immunogenicity of Dying Tumor Cells”, should be "required reading" for anyone interested in how exposed PS is exploited by tumors to elude the cells of the immune system. In the paper, he speaks very broadly about the role of exposed PS in the apoptotic process common to all multicellular organisms, and he outlines experiments in which autologous tumor cells combined with PS-blocking yielded some very impressive experimental anti-tumor results.
3-15-08 CCR: http://clincancerres.aacrjournals.org/cgi/content/full/14/6/1603

Also worth reading is Dranoff's recent WIPO patent application, in which he discusses tumor vaccines utilizing autologous tumor cells altered to express GM-CSF, combined with PS signaling blockers - including anti-PS antibodies.
http://tinyurl.com/qhtk9r

= = = = = = = =
Dr. Glenn Dranoff profile: http://tinyurl.com/rbfar6
…Associate Professor of Medicine, Harvard Medical School

[sokol]

The market is overvalued and overbought, and 2018's lower tax rates will provide the opportunity to take some profits. A correction is likely to begin next week.

[DewDiligence]

NVS’ Investor Day PR and slides:

https://globenewswire.com/news-release/2017/11/13/1184851/0/en/Novartis-highlights-its-differentiated-late-stage-pipeline-at-the-R-D-update-and-investor-event.html

https://www.novartis.com/sites/www.novartis.com/files/2017-11-r-d-day-investor-presentation.pdf

NVS sees its “big-4” prospects as RTH258 (#msg-136129447); AMG 334/Erenumab (#msg-132026403); Cosentyx (#msg- 123968598); and Ilaris/ACZ885/Canakinumab (#msg-136163917).

[Inoviorulez]

https://seekingalpha.com/article/4124174-novartis-looks-challenge-regenerons-turf-will-win-war

[DewDiligence]

NVS reports full dataset for RTH258-vs-Eylea phase-3 trials: #msg-136129447.

[DewDiligence]

NVS submits Kymriah BLA in adult DLBCL: #msg-135827815.

[DewDiligence]

NVS acquires AAAP for $82/ADS: #msg-135797034.

[TERIA]

Merging CRISPR editing and single cell sequencing technologies to uncover the biology of human neuro development diseases. Exciting talk by Novartis Institute for Bio Medical Research at SMi's London Summit on 3D Cell Culture by Max Salick! http://www.3D-CellCulture.com/i

[DewDiligence]

NVS 3Q17 CC slides:

https://www.novartis.com/sites/novartisemea.prod.acquia-sites.com/files/q3-2017-ir-presentation.pdf

[Ecomike]

OK, thanks, also looks like it was a very low volume premarket hit (shorts?) and now in the regular market it is bouncing with some large block buys. But no idea if the Europe market reacted first.

[DewDiligence]

NVS delayed the potential Alcon spin-off until 2019.

[Ecomike]

Why the big drop in NVS today?

[DewDiligence]

Vasant Narasimhan becomes CEO 2/1/18—succeeding Joe Jimenez: #msg-134366063.

[Inoviorulez]

https://seekingalpha.com/article/4103595-novartis-history-made-future-cancer-treatments

[DewDiligence]

Kymriah/CAR-T outcomes-based pricing: #msg-134254831.

[DewDiligence]

FDA approves NVS’ Kymriah (CTL019 CAR-T) for pediatric ALL:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm

[biotech_researcher]

New drug from Novartis helps prevent heart attacks by curbing inflammation

For the first time, a drug has helped prevent heart attacks by curbing inflammation, a new and very different approach than lowering cholesterol, the focus for many years.

Read more: https://www.cnbc.com/2017/08/27/a-first-drug-lowers-heart-risks-by-curbing-inflammation.html

[Inoviorulez]

https://seekingalpha.com/article/4089618-amgen-novartis-first-mover-advantage-must

[malt66]

Sell short this crap along with other big pharma...


Why...?

Either they reprice, face a major collapse in US GDP, or Trump can use executive order violations of 15 USC Chapter 1

https://market-ticker.org/akcs-www?post=232235

[DewDiligence]

NVS 2Q17 CC slides:

https://www.novartis.com/sites/novartisemea.prod.acquia-sites.com/files/q2-2017-ir-presentation.pdf

[Inoviorulez]

https://seekingalpha.com/article/4087475-novartis-wins-fda-panel-backing-new-car-t-therapy-treatment

[DewDiligence]

NVS’ own PR on CTL019 ODAC panel:

https://www.sec.gov/Archives/edgar/data/1114448/000117184317004057/f6k_071217.htm