Wednesday, December 19, 2018
AstraZeneca, Merck: FDA OKs Lynparza as 1st line maintenance therapy
AstraZeneca (AZN) and Merck (MRK) announced that the US Food and Drug Administration has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test. This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCAm advanced ovarian cancer. The approval was based on positive results from the pivotal Phase III SOLO-1 trial in which Lynparza reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared to placebo following platinum-based chemotherapy. The safety profile of Lynparza was consistent with previous trials.
https://thefly.com/landingPageNews.php?id=2839461
Vertex will submit CF treatment Orkambi and Symkevi combination in Scotland
Vertex Pharmaceuticals announced that, following constructive discussions with the Scottish Government, it will submit ORKAMBI, lumacaftor/ivacaftor, as well as SYMKEVI, tezacaftor/ivacaftor, to be used in combination with ivacaftor, to the Scottish Medicines Consortium, SMC, for appraisal. If accepted by the SMC for use on the NHS in Scotland, eligible patients with cystic fibrosis in Scotland could have access to these precision medicines in 2019. “Our recent conversations with the Scottish Government, and the SMC’s orphan medicines process have provided important flexibility for evaluating precision medicines, such as cystic fibrosis transmembrane conductance regulator modulators. Their methods reflect the innovative nature of medicines that have the potential to extend life for patients with rare diseases, like CF,” said Ludovic Fenaux, Senior Vice President, Vertex International. “We are hopeful that, through this process, all eligible patients in Scotland could have access to our medicines soon.” While the SMC reviews the submissions, clinicians could apply for access to lumacaftor/ivacaftor as well as tezacaftor/ivacaftor in combination with ivacaftor for individual patients based on clinical need via the Peer Approved Clinical SystemTier 2 process for ‘individual access to medicines not yet generally available on the NHS’. Vertex and the Scottish Government have also agreed to a confidential discount which will be applied to applications to the PACS Tier 2 process.
Allergan selloff today a buying opportunity, says Leerink
Leerink analyst Marc Goodman views today’s 7% selloff in shares of Allergan based on the breast implant news as a buying opportunity. While the suspension of sales is an incremental negative and likely to bring down consensus numbers, 2019 should bring increasingly visibility for Botox durability and the company’s the pipeline, Goodman tells investors in a research note. He keeps an Outperform rating on Allergan, which is down $11.01 to $135.82 in afternoon trading.
https://thefly.com/landingPageNews.php?id=2839433
J&J pressured again after losing appeal to reverse $4.7B baby powder verdict
Shares of Johnson & Johnson (JNJ) are slipping following media reports saying the company has lost its appeal to overturn a jury verdict that awarded $4.69B to 22 women who blamed their ovarian cancer on asbestos in the company’s baby powder and talc products.
J&J LOSES APPEAL: Johnson & Johnson has lost its appeal to overturn a jury verdict that awarded $4.69B to 22 women who blamed their ovarian cancer on asbestos in the company’s baby powder and talc products, according to The New York Times. The verdict, one of the largest personal injury awards on record, was upheld by Judge Rex Burlison in a Missouri circuit court. Late last week, Reuters reported that the company was aware that its raw talc and finished powders sometimes tested positive for small amounts of asbestos and that they “fretted” over the problem and how to address it while failing to disclose it to regulators or the public. Citing documents and deposition and trial testimony, the publication said Johnson & Johnson failed to tell the U.S. Food and Drug Administration that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc, levels of which were “rather high” in one reported case. The documents also showed successful efforts to influence U.S. regulators’ plans to limit asbestos in cosmetic talc products and scientific research on the health effects of talc, Reuters said. In response to the report, J&J issued a statement saying the article was “one-sided, false, and inflammatory.” The company also claimed in the statement that its baby powder is “safe and asbestos-free.”
TALC LAWSUITS: Johnson & Johnson has faced a slew of lawsuits alleging its talc products contain asbestos and have caused ovarian and other cancers. In July, J&J was ordered by a Missouri jury to pay $4.9B in a case involving 22 women and their families. In July, J&J Chairman and CEO Alex Gorsky told analysts that he was confident that the company’s products do not contain asbestos. According to the company’s August 2 quarterly report, talc cases make up fewer than 10% of all personal injury lawsuits that are pending against it. Reuters noted in a report that asbestos has a long latency period, with cancer diagnosis usually coming years after initial exposure. 20 years or longer for mesothelioma.
WHAT’S NOTABLE: India drug authorities went to some Johnson & Johnson facilities and got “tests and samples” of the company’s talcum powder after regulators in the country began an investigation into the powder following a report saying J&J knew the product contained cancer-causing asbestos, according to Reuters, citing a company statement. “Today, a few of our facilities were visited by the CDSCO and local FDA authorities and we are fully co-operating with them by providing tests and samples. The characterization of these visits as ‘raids’ or ‘seizures’ is incorrect as has been reported in some instances. The tests have been conducted in the regular way that the FDA collects samples,” Johnson & Johnson said, adding the safety of its talc was based on a history of safe use and decades of research.
Eli Lilly sees FY19 adjusted EPS $5.90-$6.00, consensus $5.82
Eli Lilly sees FY19 adjusted EPS $5.90-$6.00, consensus $5.82 Sees FY19 revenue $25.3B-$, consensus $24.77B, representing mid-single-digit growth driven by volume from newer medicines, including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant and Lartruvo, as well as the recent launch of Emgality. Having launched 10 new medicines over the past five years, the company expects continued pipeline progress in 2019, including U.S. regulatory action for nasal glucagon for hypoglycemia and lasmiditan for acute migraine, as well as new indications for several medicines. The company has revised its 2020 minimum financial expectations and now expects at least 6 percent compound annual revenue growth from 2015 to 2020 for the full company, and at least 7 percent compound annual revenue growth for its human pharmaceutical business.
Galapagos NV initiated at Cantor Fitzgerald
Galapagos NV initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Eliana Merle started Galapagos NV with an Overweight rating and $130 price target. 2019 will be the year that filgotinib could differentiate itself among the JAK inhibitors, Merle tells investors in a research note. The analyst thinks filgotinib’s potential is underappreciated and that upside could come from Phase 3 readouts that will show its profile.
Gilead price target raised to $92 from $88 at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young raised her price target for Gilead Sciences (GILD) to $92 after her firm increased its peak 2027 filgotinib sales estimate from $2.75B to $4.0B. Gilead books revenues in the U.S. and ~20% of sales are outside the U.S., so filgotinib is a key pipeline product not only for Galapagos NV (GLPG), but also for Gilead, Young tells investors in a research note. She reiterates an Overweight rating on the shares.
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