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News Breaks
May 27, 2014
07:09 EDTINCY, BMY, MRKIncyte, Bristol-Myers enter agreement to evaluate two Immunotherapies
Bristol-Myers Squibb (BMY) and Incyte (INCY) announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 inhibitor, INCB24360, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include melanoma, non-small cell lung, ovarian, colorectal, squamous cell carcinoma of the head and neck and diffuse large B-cell lymphoma. The study, which is expected to begin in Q4 will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed. INCB24360 is currently in Phase I/II development for metastatic melanoma in combination with ipilimumab and as monotherapy for ovarian cancer. Incyte has also established a clinical agreement with Merck (MRK) to combine INCB24360 with Merck’s (MRK) anti-PD-1 immunotherapy checkpoint inhibitor in a non-small cell lung cancer study.
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July 21, 2014
07:21 EDTMRKGilead could be hurt by new HCV drugs, says Wells Fargo
Noting that data on a new Merck (MRK) HCV treatment is expected in November, Wells Fargo thinks Merck's HCV drug could be combined with Gilead's (GILD) Sovaldi to shorten the duration of treatment to four weeks. Other companies could take similar actions, and Gilead's per patient revenues would be significantly reduced if this occurs, the firm warned. However, it continues to have an upbeat outlook on Gilead heading into what it sees as a strong quarter and is still upbeat on the company's long-term HCV opportunity. It keeps an Outperform rating on Gilead.
06:43 EDTMRK, BMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 17, 2014
08:08 EDTBMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
06:26 EDTMRK, BMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTMRK, BMYPerrigo retreats after analyst sees limited potential buyers
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08:11 EDTMRKMerck looks to revive livestock drug Zilmax, WSJ says
Merck has been preparing to conduct a large-scale study this summer to evaluate the safety of its Zilmax feed additive, which the company pulled from the U.S. market last year over concerns in the beef industry that the drug made it difficult for some animals to walk, reported The Wall Street Journal. Reference Link
07:35 EDTMRK, BMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
July 10, 2014
16:12 EDTMRKMedivation names Dawn Svoronos as Chief Commercial Officer
Medivation (MDVN) announced Dawn Svoronos has been appointed as its chief commercial officer, reporting to David Hung, M.D., founder, CEO and president of Medivation. Svoronos currently is a member of Medivation's Board of Directors and is a former president of Europe and Canada for Merck & Co. (MRK), where she oversaw commercial operations in approximately 30 EU and EU accession countries. Svoronos will lead Medivation's commercial organization on an interim basis and will participate in the company's search for a permanent chief commercial officer. Cheryl Cohen, Medivation's former chief commercial officer, has left the company to pursue other opportunities.
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
July 8, 2014
07:34 EDTINCYIncyte achieves $25M milestone for approval of Jakavi in Japan
Incyte Corporation (INCY) has earned a $25M milestone payment from Novartis (NVS) in connection with the approval of Jakavi in Japan for the treatment of patients with myelofibrosis. Incyte will record this amount as contract revenue in the third quarter. Under the Incyte-Novartis Collaboration and License Agreement, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Novartis also continues to make progress in obtaining formal pricing and reimbursement approval for a third major European country and expects this to occur in the second half of 2014. Once achieved, Incyte will earn an additional $60M milestone payment.
07:20 EDTBMYBristol-Myers price target lowered to $55 from $62 at Leerink
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07:17 EDTMRK, INCY, BMYLeerink raises immuno-oncology market forecast to $36B
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