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Wednesday, March 29, 2017
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Is There a New Approach to Drug Price Reform Brewing?

Is There a New Approach to Drug Price Reform Brewing?

"I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!" So tweeted President Trump on March 7. The reasonable assumption is that this new system involves...More...
Repatha, Amgen's PCSK9 inhibitor for high cholesterol, grabbed a lot of headlines following the release of data from a large-scale outcomes study. The trial of over 27,000 patients showed that Repatha did indeed cut adverse cardiovascular events...but maybe not as much as hoped for. This pretty much closes the debate about the benefit of these drugs—they are clearly helpful to some patients—and opens the debate about exactly who should receive them. That could put more pressure on Repatha's $14,000 annual price tag, and the similar price of Sanofi/Regeneron's Praluent.

Meanwhile, there's a PARP war a-brewing. AstraZeneca's impressive results for Lynparza in BRCA-mediated ovarian cancer is a challenge to Tesaro and its relatively new drug Niraparib. But investors like to prospects for Clovis Oncology and its recently approved PARP inhibitor Rubraca. -KT
Disappointment Hits as Amgen (AMGN)'s Repatha Prevents Heart Attacks, But Not Deaths
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AstraZeneca (AZN) Steals Tesaro (TSRO)'s PARP Thunder With Phase III Ovarian Cancer Data
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Genentech (RHHBY) New Breast Cancer Cocktail Cuts Deaths in Phase III Study, Roche (RHHBY) Stock Soars
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Kite Pharma (KITE)'s CAR-T Blood Cancer Candidate Succeeds in Major Study
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AveXis (AVXS) SMA Gene Drug Reports Positive Data
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More Bench To Clinic News
The Washington Post recently pointed out that Trump has appointed only 1 of 46 key science positions for his Administration. But he certainly got around to one important one (and, for the record, earlier than President Obama did in his Administration). Scott Gottlieb, nominated for FDA Commissioner, is a relatively popular choice with industry. The physician and venture capitalist has a long history with the agency, and he's likely to eagerly undertake reform within existing structures. But he may have a few curveballs for industry in terms of "injecting competition" on older drugs with only on manufacturer. -KT
It's Official: Trump Nominates Scott Gottlieb for Top FDA Job
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Former Celgene (CELG) Exec to Helm Cipher Pharma (DND.TO)
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Former Baxalta (BXLT) CEO to Helm Struggling Alexion (ALXN)
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GlaxoSmithKline (GSK)'s First Woman CEO Will Get a Smaller Paycheck Than (Male) Predecessor
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Surprising Departure: Celgene (CELG) President and COO "Retiring" in the Summer
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More Career Track News
Back in February, Editas Medicine won a somewhat surprising legal victory in its patent battle with the University of California and, by extension, Caribou Biosciences and Intellia. Now it's off to the races. Its first big deal with Allergan on up to five ocular programs makes perfect sense: The eye is a nice closed system, appropriate for early applications of CRISPR, and Allergan has a longstanding commercial interest in vision care. Editas gets $90 million upfront, and up to $200 million in milestones for each program. That theoretically puts the total deal amount at over $1 billion, plus royalties. -KT
Bay Area's CytomX (CTMX) Surges as Bristol-Myers (BMY) Signs Up for 8 More Projects With $200M Upfront in Deal Totaling $5B
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Turns Out Editas Medicine (EDIT)'s R&D Deal With Allergan (AGN) Could be Worth $1B
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Google (GOOG)'s Mysterious Biotech Calico Forms a Rare Deal With C4 Therapeutics
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GlaxoSmithKline (GSK), Regeneron (REGN) Join Hands to Decode the DNA of 500,000 Britons
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Alexion (ALXN), Arbutus (ABUS) Ink $80M Rare Disease mRNA Deal
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More Golden Handshakes News

Top Jobs
• Biotech Bay (Palo Alto, California)

BioInspire Tech
Vice President, Clinical Developement
Will be Responsible for the overall strategic and operational aspects of BioInspire's clinical program. Will Define development strategies including identifying clinical indications to allow for fast approvals of products.

• BioCapital (Frederick, Maryland)

Leidos Biomedical
Chief Science Officer (NCI)
The Chief Science Officer will lead the Science and Technology Group (STG) and is responsible for the programs in support of the FNLCR's mission.

• Pharm Country (Summit, New Jersey)

Celgene
VP, Head of U.S. Medical Affairs
Will manage all U.S. Hematology & Oncology Medical Affairs Hematology & Oncology functions to ensure a productive and appropriate medical partnership with the U.S. business and key stakeholders.

• Biotech Bay (Novato, California)

Ultragenyx Pharma
VP, Regulatory Affairs, CMC
Will be responsible for leading the Regulatory Affairs CMC group and developing, implementing, and advising on global CMC regulatory strategies for new and late stage programs.

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The long saga of Valeant isn't over, but hedge fund manager Bill Ackman's part in it is. He will take a loss of nearly $3 billion in closing out his final stake and will leave the board. His overall losses in Valeant may reach $5 billion. An activist who took an aggressive role in trying to push Valeant's takeover of Allergan, he remained a staunch defender of the company even as allegations against it mounted and the share price tanked. Indeed, while Ackman may be done with Valeant, he can't quite put it behind him—he is still facing insider trading charges over his investment in Allergan around the time he was pushing for a deal with Valeant. -KT
Ex-Google (GOOG) Rock Star Decides to Raise $100M Biotech Venture Fund After All
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Ackman Is Finally Done With Valeant (VRX), Takes $2.8B Loss and Will Step Down From Board
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San Diego's Tocagen Goes for $86M IPO
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Backed by Amazon (AMZN) and Big Names Like Bristol-Myers (BMY), Celgene (CELG) and Merck (MRK), Bay Area's GRAIL Banks $900M
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Aurinia (AUPH) Closes US$173.1M Public Offering Of Common Shares And Full Exercise Of Underwriters' Option To Purchase Additional Common Shares
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More Money Talk News

Investors have been driving shares of Seattle Genetics steadily higher for the past year, and the market has been particularly enthusiastic about its licensing deal with Immunomedics on antibody-drug conjugate IMMU-132. But Immunomedics investor venBio felt that IMMU-132 was being vastly undervalued. As the result of a lawsuit, closing of the deal has been delayed at least 30 days while a battle over control of the board settles out. With accusations of voting interference and more, resolution is still a way off.

Biogen, meanwhile, scored a big victory over hedge fund manager Kyle Bass, who was seeking to invalidate a key patent on multiple sclerosis drug Tecfidera. With that threat out of the way (pending potential appeal), Tecfidera could have exclusivity to 2028. -KT
Biogen (BIIB)'s Victory Over $4B MS Patent Spat Makes Company an Even More Attractive M&A Target
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Trump Budget Would Double FDA Product Review Fees, Leading to Faster Drug Approvals
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Fired U.S. Attorney Preet Bharara Was Investigating New HHS Chief Tom Price
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Major Reorganization to Hit the NIH, Deep Cuts to Affect Thousands Under Trump Budget Plan
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A Win for venBio as Judge Hits Pause on Immunomedics (IMMU)'s $2B Deal With Seattle Genetics (SGEN)
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More Legal Briefs News
We're up to eight new chemical entities approved so far in 2017. Bavencio becomes the fourth checkpoint inhibitor on the market, and the first-ever approved treatment for metastatic Merkel cell carcinoma, a rare skin cancer. But it could have significant markets for other diseases. Kisqali has been approved for HR+/HER-2 negative breast cancer and could reach $1.6 billion in sales, according to estimates. Perhaps the most interesting thing is that Novartis is rolling it out with a flexible pricing scheme, and at a discount to Pfizer's competitive drug Ibrance. That's probably partly about scrutiny over drug prices, and partly about recommendations that patients on Kisqali receive ECG monitoring when first receiving treatment. Newron Pharmaceuticals' Xadago is the first new Parkinson's drug approved in over a decade, but it has been noted that it is very closely related to drugs that have been available for nearly 30 years. Lexicon Pharma's Xermelo, for carcinoid syndrome diarrhea (found in some patients with gastrointestinal tumors) is estimated to have peak sales around $540 million. -KT
EMD Serono Release: FDA Grants Approval For BAVENCIO (Avelumab), The First Immunotherapy Approved For Metastatic Merkel Cell Carcinoma
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BioLogics Release: KISQALI (Ribociclib) Approved For The Treatment Of HR+/HER2- Advanced Breast Cancer
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Newron Pharma (NWRN) Release: FDA Approves Xadago (Safinamide) For Parkinson's Disease (PD) Patients
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BioLogics Release: XERMELO (Telotristat Ethyl) Approved For The Treatment Of Carcinoid Syndrome
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FDA Deals Another Blow to AstraZeneca (AZN)'s Blood 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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