Shares of GW Pharmaceuticals jumped in late morning trading after the company said Epidiolex will be now classified as a Schedule V controlled substance, the lowest ranked class, instead of a Schedule I drug, which had been widely expected. DEA RESCHEDULES EPIDIOLEX: GW Pharmaceuticals announced this morning, along with its U.S. subsidiary Greenwich Biosciences, that the U.S. Drug Enforcement Administration has rescheduled the company’s Epidiolex oral solution. Instead of a Schedule I drug, the DEA will classify the cannabis-derived drug as a Schedule V controlled substance, the lowest restriction classification. WHAT’S NOTABLE: Epidiolex was approved in June by the U.S. Food and Drug Administration to treat patients two years and older with Dravet Syndrome and Lennox-Gastaut Syndrome, two rare forms of epilepsy that emerge during childhood. Epidiolex is derived from cannabidiol, or CBD, a molecule contained in the marijuana plant. Marijuana is considered a Schedule I drug, which are drugs seen to have high abuse potential, no medical use and severe safety concerns. Schedule V drugs, meanwhile, including some cough medicines containing codeine, have a currently accepted medical use in treatment. EXECUTIVE COMMENTARY: In a statement, GW Pharmaceuticals CEO Justin Gover said he is “pleased” that the DEA has placed Epidiolex in the lowest restriction schedule, “because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians.” Gover said the company will “work hard” to make Epidiolex available within the next six weeks. ANALYST COMMENTARY: Cantor Fitzgerald analyst Elemer Piros said the DEA’s rescheduling of Epidiolex is the “best possible outcome” for GW Pharmaceuticals, as the company has now checked off the last box to prepare for U.S launch of the drug within the next six weeks. The analyst reiterated an Overweight rating and $211 price target.
Thursday, September 27, 2018
Mirati Therapeutics weakness a buying opportunity, says Cowen
Cowen analyst Chris said he sees the pullback in Mirati Therapeutics shares as an attractive buying opportunity and reiterates his Outperform rating on the stock. There was never a reason to expect that Mirati’s data was under consideration for a late-breaking abstract presentation at ESMO, Sibutani tells investors. He expects management to share their plans for the sitravatinib + nivolumab pivotal study program at the ESMO meeting after data is presented on Monday, October 22. The analyst maintains an Outperform rating on Mirati shares.
Cigna announces enterprise leadership team for combined company
Cigna (CI) announced the enterprise leadership team for the combined Cigna and Express Scripts Holding (ESRX) business following the close of their proposed transaction. “This team is uniquely qualified to drive the improvements in affordability, choice and quality for our customers and clients, as well as the sustained attractive return for our shareholders, that this combination will deliver,” said David M. Cordani, President and CEO of Cigna. “I look forward to working with these highly-accomplished and experienced leaders. Together, we will achieve significant growth and accelerate the pace of change in health care in ways that continue to improve lives.” Upon closing, the combined company will offer multiple growth platforms: A commercial business, including employer-sponsored medical coverage, A government business, including Medicare offerings to seniors, An international business, including global supplemental benefits and A health services business, including Express Scripts. As previously announced, David Cordani will serve as President and CEO of the combined company. Express Scripts President and CEO Tim Wentworth will head the health services business as President, Express Scripts and Cigna Services. Additionally, the following executives will be members of the combined company’s enterprise leadership team, reporting to David Cordani: Lisa Bacus, Chief Marketing Officer, Mark Boxer, Chief Information Officer, Brian Evanko, President, U.S. Government Business, Nicole Jones, General Counsel.
FDA OKs Pfizer Vizimpro for non-small cell lung cancer
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
“Improving outcomes for patients is the central focus of why we develop and deliver new medicines. VIZIMPRO is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” said Andy Schmeltz, Global President, Pfizer Oncology. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”
Athenahealth fields multiple bids, none much higher than current stock price
Athenahealth has received multiple takeover bids, sources tell CNBC.
The bids are not seen as being far above the stock price of $131 before the latest news, but the Athenahealth board is motivated to get a deal done, the sources said. Interest is coming from two private equity firms and one strategic buyer, the sources said.
Paul Singer’s Elliott Management previously had bid $160 a share for the health-care software maker in an all-cash unsolicited offer. That put pressure on the company to consider strategic options. Jonathan Bush stepped down as CEO in June.
Athenahealth initiated a strategic review in June and said it would consider a sale or merger or remaining as an independent company.
Aetna, seeking antitrust nod, sells Medicare drug business to WellCare
Health insurer Aetna Inc (AET.N) said on Thursday it will sell its standalone Medicare prescription drug plan business to WellCare Health Plans Inc (WCG.N) as it seeks U.S. antitrust approval for a planned acquisition by CVS Health Corp (CVS.N).
The $69 billion CVS-Aetna deal would be the second large deal this year between insurers and pharmacy benefit managers, a consolidation the companies say will help rein in rising U.S. healthcare costs.
CVS said separately that it expects the Aetna acquisition to close in the early part of the fourth quarter of this year.
Rival insurer Cigna Corp’s (CI.N) $52 billion acquisition of Express Scripts Holding Co (ESRX.O), the largest U.S. pharmacy benefit manager, which was announced after the CVS-Aetna transaction, has already passed U.S. Justice Department scrutiny.
Aetna did not disclose the terms of the sale to WellCare but said that the Medicare pharmacy prescription plans, known as Part D plans, covered more than 2.2 million members.
The sale price is likely between $1 billion and $1.5 billion based on the number of members, BMO Capital Markets analyst Matt Borsch estimated in a research note. He forecast the acquisition would add $3 billion to WellCare’s annual revenue and 50 cents to $1 per share to earnings starting in 2020.
Wall Street analysts expected Aetna to sell all or some of its Medicare prescription drug business ahead of its combination with CVS, the largest manager of pharmacy drug plans for the Medicare program for the elderly and disabled.
The sale to WellCare aims to avoid an antitrust lawsuit over the amount of control it would have over the Medicare prescription drug market. Aetna said the asset sale is a “significant step” in the U.S. Justice Department review and that its closing is contingent on that antitrust approval.
Aetna Inc202.68
AET.NNEW YORK STOCK EXCHANGE
+0.92(+0.46%)
Leerink analyst Ana Gupte said that the sale of the entire business “almost certainly ensures approval by the DOJ,” or Justice Department. Selling the entire business also ensures a more seamless handover to WellCare, she said.
WellCare, which specializes in government Medicare and Medicaid insurance plans, has only a small Medicare prescription drug plan business with about 4 percent market share, according to a recent research note from Barclays.
CVS has a 24 percent market share and Aetna has 8.7 percent, according to Barclays.
WellCare said it does not expect to recognize revenue from the deal until 2020 because the terms call for Aetna to provide administrative services and retain the financial risk related to the government plans through 2019.
WellCare shares rose 4 percent to $319.76, Aetna added 0.7 percent to $203.13, and CVS was up 0.6 percent to $78.93.
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