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News For PFE;PFE;PFE;PFE;BMY;BMY;BMY;BMY;NVS;NVS;NVS;NVS;LLY;LLY;LLY;LLY From The Last 14 Days
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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.
06:34 EDTLLYEli Lilly CEO states company is not for sale, Financial Times says
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February 23, 2015
15:00 EDTNVSFDA approves Farydak for treatment of multiple myeloma
The FDA approved Farydak for the treatment of patients with multiple myeloma, a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. It is intended for patients who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. Farydak is to be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication. Farydak is marketed by Novartis.
13:40 EDTNVSAnalysts clash on Spectrum outlook after patent suit setback
Two research firms had divergent views on Spectrum Pharmaceuticals (SPPI) after a judge ruled that a drug which could compete with the company's Fusilev treatment does not infringe on the company's intellectual property. BACKGROUND: Late Friday, a federal judge ruled that Novartis' (NVS) levoleucovorin, a generic version of Spectrum's Fusilev, does not infringe on Spectrum's intellectual property. Fusilev is indicated after high-dose methotrexate therapy in osteosarcoma, a type of cancer that starts in the bones. It is also used to treat patients with advanced metastatic colorectal cancer. BEARISH TAKE: Roth Capital analyst Joseph Pantginis downgraded Spectrum to Neutral from Buy following the ruling, as he believes the risk to the company's revenue has risen. The company is meaningfully less likely to become profitable again, wrote Pantginis, noting that Fusilev accounted for about 50% of the company's product revenue. According to the analyst, Spectrum is becoming increasingly focused on developing its earlier stage drugs, and he expects those drugs to grow slowly. Pantginis slashed his price target on the shares to $7 from $15. BULLISH TAKE: In a note to investors earlier today, Reni Benjamin, an analyst at research firm H.C. Wainwright, wrote that the stock's plunge after the judge's ruling "creates a table-pounding buying opportunity," noting that Fusilev has been granted exclusivity as a colorectal treatment until 2018. Benjamin does not expect the company's revenue from Fusilev to decline at all until 2018, as a citizen's petition submitted by Spectrum to the FDA, along with an appeal the company is mounting to Friday's ruling, and the difficulty that Novartis will have launching its version of the drug while the appeal is ongoing, will help prevent Spectrum's revenue from dropping. Also likely to protect Spectrum's revenue are the strong relationships that the company has developed with hospitals and community doctors, the analyst stated. He kept a $15 price target and Buy rating on the shares. PRICE ACTION: In mid-afternoon trading, Spectrum tumbled $1.44, or 19.3% to $6.02.
12:21 EDTNVS, BMYOn The Fly: Midday Wrap
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11:17 EDTNVSFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
08:31 EDTLLYEli Lilly announces delay in submission of basal insulin peglispro beyond Q1
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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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07:14 EDTNVSSpectrum says plans to appeal patent suit loss to Novartis unit
Spectrum Pharmaceuticals (SPPI) confirmed in a regulatory filing that on February 20, the U.S. District Court for the District of Nevada ordered that judgment be entered in favor of defendant Sandoz in the matter entitled Spectrum Pharmaceuticals, Inc. et al v. Sandoz Inc. "Spectrum Pharmaceuticals Inc. intends to appeal this decision and the ultimate outcome of this litigation remains uncertain," the company stated. Sandoz is the generic pharmaceuticals division of Novartis (NVS).
07:06 EDTLLYEli Lilly and Incyte announces positive results for baricitinib
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February 20, 2015
10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTPFE, BMYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTNVSAmerican 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
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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08:04 EDTLLYEli Lilly extends Evacetrapib Phase 3 trial by six months
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07:12 EDTPFE, NVSWharton Health Care Club to hold a conference
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