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Wednesday, August 30, 2017
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What Could Trump's Meltdown Mean for Biotech?


What Could Trump's Meltdown Mean for Biotech?

For a little while, it looked like healthcare reform might really happen. A Senate GOP bill that would have largely repealed and reshaped Obamacare was passed to the Senate floor...More...
Phase 2 results catalyzed some huge stock moves this past month. Galapagos' GLPG1690 raised a lot of hopes about idiopathic pulmonary fibrosis, because early results appear to be better than what we've seen from past products. That has helped the company tack on over $800 million in market cap since the results came out. Esperion Therapeutics got a big bump from results showing that its combination therapy sharply lowered LDL cholesterol levels in the vast majority of patients, but the stock has since drifted back to around where it was before the announcement. Still, you have to put that in context—shares of Esperion have approximately quadrupled in the past year. And then there's MyoKardia, which has added $1 billion to its market cap since reporting phase 2 results for its cardiomyopathy drug mavacamten. -KT
Bristol-Myers' (BMY) Stock Topples as Kidney Cancer Drug Flunks Phase III Study
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Galapagos (GLPG.BR)' Phase II Results With GLPG1690 are 'Extremely Exciting'
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Esperion (ESPR) Stock Gains On Strong Phase II Data
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MyoKardia Shares Surge on Positive Phase II Results for Heart Muscle Disease
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Biogen (BIIB) Shows Off More Positive Alzheimer's Trial Data
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Merck CEO Ken Frazier deserves kudos for his decision to leave the President's American Manufacturing Council following Trump's statements about white supremacist violence in Charlottesville. J&J CEO Alex Gorsky? Maybe not so much. He said he would stay on the council before finally reversing course—after Trump tweeted that the panel was being dissolved anyway. Gorsky, like many other CEOs on the council, did denounce the racist violence but argued it was better to have a voice in the Administration. For the record, Frazier quit on Monday and was quickly joined by Under Armour CEO Kevin Plank and Intel CEO Brian Krzanich. On Tuesday, he was joined by Scott Paul of the Alliance for American Manufacturing and AFL-CIO President Richard Trumka. Then on Wednesday, 3M CEO Inge Thulin left. The council was dissolved shortly thereafter. -KT
What You Need to Know About Merck's (MRK) Fearless CEO Ken Frazier
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Shire (SHPG) CFO Quits for Boston-Based Microbiome Startup
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Biotech Startups Flock to the Suburbs Over Rising Rent Prices
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Jounce (JNCE) Names Ex-Ariad's (ARIA) Top Dealmaker as Its New CBO
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Former Google (GOOG) Exec Steps Down as GRAIL CEO
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More Career Track News
Investors who've been waiting for Gilead to do something about its flagging hepatitis C franchise can hopefully find some satisfaction in the company's latest move. By spending nearly $12 billion on Kite Pharma, Gilead is doubling down on oncology and catapulting itself to the forefront of cellular therapy. It also comes at a time when things are looking rockier than ever for its top-selling drugs (see Rockville Files). Investors seem to view the move as at least modestly positive, bidding up the share price of Gilead slightly as shares of Kite (and rival Juno) soared.

When a big pharma company decides to leave a partnership and return product rights to a biotech, that's usually a bad sign. But in the case of Ionis Pharmaceuticals, it's probably a boon to shareholders. With pivotal trial data already in and a regulatory submission underway, GlaxoSmithKline's decision to drop Inotersen probably says more about the priorities of new CEO Emma Walmsley than it does about the chances of approval. Inotersen is widely regarded as a potential second fiddle to Alnylam's Patisiran, despite the fact that the latter drug hasn't yet produced phase 3 data and requires IV rather than subcutaneous dosing. That may make the overall profile unattractive to GSK, but it can certainly still bring benefits to Ionis. On the downside, Ionis still has to decide whether it needs to find another marketing partner, and the 11th-hour decision may make it harder for them to quickly ramp up commercialization efforts, assuming approval. -KT
AstraZeneca PLC (AZN) Jumps Deeper Into mRNA Drugs With Ethris Deal
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Biosimilars Giant Takes the Plunge Into Original Biotech Drugs Via Takeda (TKPYY) Deal
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GlaxoSmithKline (GSK) Ditches Ionis Pharma's (IONS) Inotersen and IONIS-FB-LRx
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LabCorp (LH) Scoops Up Giant CRO for Approximately $1.2B Cash
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Gilead (GILD) Goes Big, Pays $11.9B for This SoCal CAR-T Biopharma
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Amazon just closed on its acquisition of Whole Foods, entering into a new phase of its business evolution. But is it now aiming for a big stake in healthcare, starting with the $560 billion prescription drug market? Yes, argues Goldman Sachs. The company is exploring options, including working with or becoming a pharmacy benefit manager. That certainly makes sense, since one of the most profitable parts of the PBM business is in home delivery, right in Amazon's wheelhouse. Moreover, by integrating this right down to the level of the Amazon Echo, the company could get a foot in the door for telemedicine, where more services could be done using Amazon apps from home. -KT
Ionis Pharma (IONS) Urges Investors to Reject the Below-the-Market Offer By TRC Capital
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Amazon's (AMZN) Possible Strategy for Breaking Into the $560B Pharma Market
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Former Pfizer (PFE) Scientist-Led Startup Zai Lab Taps Banks for $150M IPO
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MyoKardia Announces Closing Of Public Offering Of Common Stock Including Full Exercise Of Option To Purchase Additional Shares
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Elon Musk's Biotech Quietly Nabs $27M to Stick Machines Into People's Brains
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More Money Talk News

Martin Shkreli faces up to 20 years in prison, but how much time will he really get? He believes zero, and his lawyer thinks a max of six months would be appropriate. So far, nothing has wiped the smirk off his face, which could actually be a problem for him—the judge is less likely to be lenient with someone who has shown the exact opposite of contrition. As yet, no sentencing date has been set. -KT
This is What Happens When the FDA Approves Cancer Drugs Too Quickly
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How Eli Lilly (LLY) Allegedly Used a Fake Rule and Fake News to Protect Bad Patents
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Warning for Scientists: Scammers are Giving Away NIH Grants
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Notorious 'Pharma Bro' Martin Shkreli Found Guilty, Faces Up to 20 Years in Prison
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Pharma Scores Big Win: Trump to Ink FDA User Fee Bill, Saving 5,000 Jobs
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Former Biotech CEO Accused of Defrauding Investors
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More Legal Briefs News
There have been three new chemical entity approvals since our last issue. AbbVie's Mavyret, for all forms of hepatitis C, means more pain for Gilead Sciences. While it probably won't become the dominant drug, it will certainly take some market share—although you could argue that this is already priced in (or more than priced in) to the share value of both AbbVie and Gilead. Celgene and Agios won approval Idhifa in acute myeloid leukemia patients with an IDH2 mutation. Celgene estimates that 8% to 19% of AML patients have this mutation and expect peak sales of around $500 million. Agios, in addition to milestones, gets just a low double-digit royalty, but it is coming along with another IDH drug of its own. Finally, Pfizer's CD22-targeted antibody-drug conjugate Besponsa was approved in acute lymphoblastic leukemia. Sales could eventually top $2 billion. -KT
FDA Green Lights Pfizer (PFE) Drug for Rare, Fast-Killing Type of Leukemia
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Heads Up Tesaro (TSRO): AstraZeneca (AZN), Merck's (MRK) Ovarian Cancer Drug Just Got Expanded Use From the FDA
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AbbVie (ABBV) Wins FDA Approval for the First-Ever Drug to Treat All Forms of Hep C
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FDA Advisory Panel Votes Against Approval Of J&J's (JNJ) Sirukumab
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Agios (AGIO), Celgene (CELG) Win Early FDA Approval for New Cancer Drug
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More Rockville Files News

Karl Thiel is an analyst for The Motley Fool and a longtime follower of the biotech industry. He lives in Austin, Texas.

You may contact Karl Thiel at news@biospace.com.

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