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News Breaks
March 26, 2014
06:27 EDTMRK, AZN, BMY, INCYCitigroup expects Bristol-Myers to report positive Yervoy data
Citigroup expects data for Bristol-Myers' (BMY) Yervoy in high risk stage III melanoma will increase relapse free survival by 30%-40% versus the placebo. Citi thinks peak sales for this indication will be at least $3B per year and thinks positive data from Bristol could "materially diminish" the outlook in metastatic melanoma for Merck (MRK), Incyte (INCY) and AstraZeneca (AZN). The firm keeps a Buy rating on Bristol-Myers with a $60 price target saying it does not expect Yervoy to face significant competition until 2019.
News For BMY;MRK;INCY;AZN From The Last 14 Days
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February 25, 2015
08:36 EDTBMYBristol-Myers announces data from Phase IIb BMS-663068 trial
Bristol-Myers Squibb Company announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor, virologic response rates and immunologic reconstitution were similar across the BMS-663068 and Reyataz/ritonavir arms of the trial through 48 weeks. Specifically, 61-82% of BMS-663068 patients had HIV-1 RNA levels <50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48. HIV-1 RNA levels <50 c/mL typically indicate virus replication is undetectable. Treatment with BMS-663068 resulted in no dose response safety signals, no treatment discontinuations related to adverse events, and no treatment-related serious adverse events over the course of the trial. The most common AEs were headache and abdominal pain. Due to the positive results seen thus far, a Phase III clinical trial of the attachment inhibitor among heavily treatment-experienced patients began on Monday, February 23, 2015. For the purposes of the Phase III trial, heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications. The Phase IIb study results, presented yesterday at the 22nd Conference on Retroviruses and Opportunistic Infections, highlight the novel mechanism of action of the investigational prodrug BMS-663068, which when converted into its active moiety BMS-626529, is designed to bind directly to the HIV gp120 protein, and prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2ºP studies
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February 24, 2015
07:46 EDTBMYJacobs Engineering awarded contract from Bristol-Myers
Jacobs Engineering Group (JEC) announced that it received a contract from Bristol-Myers Squibb Company (BMY) to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. The facility is being designed to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
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February 23, 2015
12:53 EDTAZNAnalysts debate potential for competing Salix takeover bid
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12:21 EDTBMYOn The Fly: Midday Wrap
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08:27 EDTMRKNGM Biopharmaceuticals to hold a teleconference
NGM Biopharm discusses the strategic collaboration with Merck to discover, develop and commercialize novel biologic therapeutics on a teleconference to be held on February 23 at 9:30 am. Webcast Link
08:15 EDTBMYRigel Pharmaceuticals and Bristol-Myers announces R&D collaboration agreement
Rigel Pharmaceuticals (RIGL) and Bristol-Myers (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel's extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system's activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb's Opdivo and Yervoy. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel's TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:06 EDTBMYBristol-Myers, Rigel enter R&D agreement for TGF beta receptor kinase inhibitors
Rigel Pharmaceuticals (RIGL) and Bristol-Myers Squibb (BMY) announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb’s Opdivo, or nivolumab, and Yervoy, or ipilimumab. Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel’s TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30M upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309M for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
08:01 EDTBMYBristol-Myers to acquire Flexus, potential total consideration may be $1.25B
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07:55 EDTAZNJefferies says other bidders may emerge for Salix
Jefferies says it could envision other bidders emerging for Salix (SLXP) and points out recent media reports have suggested Shire (SHPG) and Endo (ENDP) have considered making a bid for the company. It lists AstraZeneca (AZN) and Takeda as others who could have possible interest in Salix. The firm believes Valeant (VRX) could afford to pay more for Salix should other bidders emerge.
07:30 EDTINCYIncyte price target raised to $89 from $75 at Oppenheimer
Oppenheimer increased its price target on Incyte after the company reported that sales of its flagship Jakafi drug had jumped 46% year-over-year in Q4. The firm continues to be upbeat on Jakafi's revenue outlook and the company's pipeline. It keeps an Outperform rating on the shares.
07:06 EDTINCYEli Lilly and Incyte announces positive results for baricitinib
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07:04 EDTMRKMerck, NGM Biopharmaceuticals announce multi-year collaboration
NGM Biopharmaceuticals and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck will make an upfront payment to NGM of $94M and will purchase a 15 percent equity stake in NGM for $106M at a price per share that represents a 20% premium to NGM’s most recent financing. Merck will commit up to $250M to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.
February 20, 2015
07:23 EDTAZN, BMYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTAZN, MRKAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.
February 18, 2015
08:13 EDTINCYIncyte shares poised to rise further, says Argus
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February 17, 2015
17:16 EDTAZNActavis confirms temporary injunction related to generic Pulmicort RESPULES
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08:01 EDTINCYIncyte price target raised to $90 from $80 at Leerink
Leerink raised its price target for Incyte shares to $90 citing the company's growing oncology pipeline following its Q4 results. The firm keeps an Outperform rating on the name.
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