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Tesaro’s Zejula; Mylan on EpiPen; Ohio sues drugmakers; ATUM, Horizon Discovery Announce deal

Tesaro’s Zejula; Mylan on EpiPen; Ohio sues drugmakers; ATUM, Horizon Discovery Announce deal

Jun 02, 2017

Tesaro and its new med Zejula are on the block, but bidders aren’t rushing in

Just ahead of the year’s biggest download of cancer data, the maker of a closely watched drug has put itself up for sale, according to The Wall Street Journal. That’s Tesaro, whose PARP inhibitor Zejula won FDA approval in March. That med launched soon after at a price of $118,000 per year, which Tesaro touted as lower than its head-to-head rivals in ovarian cancer, AstraZeneca’s Lynparza and Clovis Oncology’s Rubraca. Analysts have pegged Zejula, or niraparib, as one of 2017’s biggest launches, with 2022 sales of $1.9 billion. That’s an enticing prospect for bigger companies looking to beef up their oncology businesses, but that very fact could make it an expensive prospect, too. Thanks to a big stock runup since Tesaro rolled out top-line Zejula data last July, the company’s market value as of Thursday morning was $8 billion. Tesaro has requested offers from a variety of potential bidders over the past few weeks—but they also say potential acquirers aren’t exactly falling over themselves to pursue a deal. Price is potentially one reason, obviously. Another? Would-be buyers might be waiting for the American Society of Clinical Oncology meeting this weekend, where AstraZeneca will present data on Lynparza and Tesaro will post data on a Zejula combination with Merck’s blockbuster PD-1 therapy Keytruda. Still another reason for the supposedly lukewarm interest: Pfizer’s $14 billion deal for Medivation—and its PARP med talazoparib—has come in for criticism lately.

Mylan lowballed Medicaid on EpiPen by $1.27B

Mylan quickly agreed to a $465 million settlement with the U.S. government last fall in a move to put some of its EpiPen problems in the past. Now, it appears that figure is far short of taxpayer harm resulting from the injector’s misclassification on Medicaid, news that comes as the deal has yet to be finalized. The Department of Health and Human Services’ Office of Inspector General reports that EpiPen’s Medicaid misclassification cost taxpayers $1.27 billion from 2006 to 2016, far exceeding the U.S. government’s settlement agreement with the drugmaker. Under heavy scrutiny for years of price hikes on the lifesaving epinephrine injection, Mylan struck a deal with the government to resolve fresh allegations of Medicaid misclassifications back in October. Pushing to learn more about the misclassification, Sen. Grassley on Wednesday said Mylan still isn’t cooperating with the investigation. Mylan is withholding communications between it and the Centers for Medicare and Medicaid Services, which notified the company several times about the misclassification, according to the senator.

Ohio sues drugmakers for marketing fraud

After seeing drug overdoses become the state’s leading cause of accidental deaths, officials in Ohio have had enough. In a new lawsuit filed on Wednesday, Ohio Attorney General Mike DeWine is going after Teva, Allergan, Johnson & Johnson, Purdue and Endo for alleged “fraudulent marketing practices” on powerful opioid painkillers. Ohio’s 101-page lawsuit says the pharma companies, individually and together, broke pharma marketing rules and “helped unleash” an opioid epidemic that has had “far-reaching financial, social, and deadly consequences” in the state. The companies did that, according to the suit, by spending millions to widely market the meds while downplaying risks. Similar to a host of other lawsuits filed against opioid makers, Ohio’s suit says that to push their painkillers, the companies borrowed a page from the “Big Tobacco playbook.” They worked to convince “key opinion leaders” and professional societies of the benefits of opioids in treating chronic pain. For its part, Teva said it’s reviewing the complaint and can’t comment until that review is complete. Endo said it couldn’t comment on ongoing litigation; Allergan also declined to comment.

ATUM, Horizon Discovery Announce cross-license agreement

ATUM and Horizon Discovery have announced that they have signed a cross-license agreement for Horizon’s CHO SOURCE platform and ATUM’s vector technology to speed development of highly productive stable cell lines for drug development. ATUM has licensed Horizon’s CHO SOURCE platform, including the Glutamine Synthetase (GS) Knock-Out CHO K1 (Chinese hamster ovary) line, and will use its proprietary Leap-In® Transposase Technology to offer cell line development services.  Horizon has exclusively licensed a vector suite developed by ATUM for the CHO SOURCE platform, to provide a complete cell line solution to its customers. Together, these technologies enable expression of complex biologics for customers of both ATUM and Horizon. ATUM is also offering Horizon customers a no-fee evaluation license for the transposase system.

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