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.
Thursday, September 27, 2018
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.
Novartis strikes deal with Chinese firm to make Kymriah gene cancer med
Novartis has enlisted Chinese manufacturer Cellular Biomedicine (CBMG) to make its $475,000 (362,663 pounds) gene-modifying cancer treatment Kymriah as the Swiss drugmaker intends to win approval for the therapy in the world’s most populous country.
Local regulations require that Novartis manufactures Kymriah in China if it wants to treat the country’s patients with the drug.
The Chinese company’s shares rose more than 16 percent in pre-market trading after the deal was announced on Thursday. Novartis shares closed 0.9 percent higher.
Basel-based Novartis is paying $40 million to buy 9 percent of CBMG’s shares, the Chinese company said. Novartis also gets rights to develop and sell products using CBMG technology in the deal.
The deal fits Novartis’ push to expand its global manufacturing footprint for Kymriah, a one-time, personalised CAR-T therapy in which doctors remove disease fighting T-cells from individual patients to be modified to attack cancer before being re-infused into patients.
Novartis recently announced production pacts in France, Germany and Switzerland, where it is building its own Kymriah factory. Novartis would lead distribution, commercialisation and approval efforts within China, it said, but declined to give the status of Kymriah’s progress with Chinese drug regulators.
“For proprietary reasons, we cannot disclose our strategy in China,” a spokeswoman said in an e-mail. “However, our collaboration with CBMG is a step towards our efforts to bring Kymriah to patients in China.”
The treatment, aimed at patients who have failed to respond to other drugs, has already been approved in Europe and the United States to treat gravely ill children with acute lymphoblastic leukemia (ALL), as well as adults with diffuse large B-cell lymphoma (DLBCL).
Novartis is initially rolling out the treatment in Europe just for young patients with ALL, after encountering problems with the quality of batches for DLBCL patients. The company has said the treatment for DLBCL patients requires additional work to meet commercial specifications.
A similar CAR-T therapy, Gilead Sciences Yescarta, has also been approved for DLBCL patients in the United States and Europe. Last year, Yescarta’s maker began manufacturing Yescarta in China, part of its bid for eventual approval there.
China’s GenScript Hit on Report Critical of Unit’s Gene-Therapy Tests
GenScript Biotech Corp.’s stock tumbled nearly 27% on Thursday following a research report alleging safety violations by the Chinese company’s subsidiary that has partnered with Johnson & Johnson.
The report alleged that Nanjing Legend Biotechnology Co. bypassed standard safety procedures while testing an experimental gene therapy on Chinese patients. It accused the parent company, GenScript, of cherry picking results disclosed to investors. GenScript, which suspended trading in Hong Kong after its shares slipped to 11.86 Hong Kong dollars, and Legend deny any wrongdoing.
Little is known about Flaming Research, the compilers of the report. The group’s website describes it as a “a team of seasoned equity investors who are sickened by the inability of Hong Kong regulators” to crack down on corporate fraud and who “will be exposing fraudulent companies to protect the interest of minority shareholders.”
The website doesn’t list a corporate address or a telephone number. Flaming couldn’t be reached for comment.
Still, the accusations made in its 14-page report spooked investors.
In December, impressed with early results from patient tests in China, J&J’s drug unit paid $350 million for the global rights to co-develop and market Legend’s experimental therapy. The companies are testing it on patients in the U.S. A J&J spokesman said the company is looking into the report.
Legend’s progress is closely watched because it is the first Chinese company to get approval to test a gene therapy in the U.S. It is also one of the few companies testing a CAR-T candidate.
CAR-T therapy involves extracting patients’ disease-fighting white blood cells, genetically modifying them to more vigorously attack cancer, then re-injecting them into their bodies.
The first CAR-T therapy, Novartis AG’s Kymriah to treat aggressive forms of leukemia, was approved last year. The treatment costs hundreds of thousands of dollars for its potential to cure patients. Legend’s targets multiple myeloma.
Among the safety issues that Flaming alleges is an instance where a patient’s relative transported cells hundreds of miles from Xi’an, where they were collected at a hospital participating in Legend’s research, to Nanjing, where the company is based and conducts the cell modifications.
Legend Chief Executive Frank Fan said doctors extracted and sealed the sample, suggesting there was no risk of contamination, and that the relative volunteered to take it because at the time Legend lacked a reliable way to transport samples. Samples are tested for quality before being modified, he said.
China didn’t have rules for gene-therapy experiments until a few months ago.
Flaming also slammed the company for administering its therapy through regular syringes instead of the intravenous infusions Novartis uses. Dr. Fan said the doses were small enough to be administered through regular syringes and that doing so is safe.
Flaming further said that Legend’s early results may be fraudulent because, on follow-up visits, patients were evaluated with blood tests instead of a more accurate bone-marrow biopsy. Dr. Fan said biopsies were done, but not on every visit. The procedure, he said, “is painful and stressful and cannot, and does not, need to be done each time.”
Flaming accused GenScript of cherry picking what it disclosed to investors, and when, in an attempt to keep its stock price high. In one instance, it said the company delayed publicly announcing a trial death until after posting promising early results. GenScript said it would respond with a statement later Thursday.
Even after Thursday’s drop, its stock was three times what it was in June last year, when Legend unveiled its experimental therapy at a cancer conference in the U.S.
Theravance financial flexibility, assets underappreciated, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren says recent meetings with Theravance Biopharma management support his Overweight rating on the shares. The Trelegy royalty stream could potentially be monetized in the near-term as a source of non-dilutive financing, which would alleviate concerns regarding the need for cash, a significant portion of the current bear thesis, Van Buren tells investors in a research note. Further, he notes that management remains confident in a Yupelri approval on November 13. The analyst continues to recommend that investors own Theravance shares as he believes both its financial flexibility and current assets are underappreciated.
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