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April 21, 2014
08:18 EDTMYL, NVS, TEVA, MNTAMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
News For MNTA;NVS;MYL;TEVA From The Last 14 Days
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September 29, 2015
08:46 EDTNVSNoven reports final decisions in IPRs challenging Novartis' Exelon patch patents
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08:18 EDTTEVATeva initiated with a Neutral at Nomura
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08:02 EDTTEVAEagle Pharma receives new patent for bendamustine rapid infusion product
Eagle Pharmaceuticals (EGRX) announced that the United States Patent and Trademark Office has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride formulation administered in a 50mL bag within ten minutes. The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents, further expands and protects Eagle's bendamustine HCI intellectual property estate. The Prescription Drug User Fee Act goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia and patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle's rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture. The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. (TEVA) entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.
September 28, 2015
16:40 EDTTEVAAllergan to begin reporting Global Generics business as discontinued ops in Q3
Allergan (AGN) intends to begin reporting its Global Generics business as discontinued operations with its third quarter 2015 results. The transaction with Teva (TEVA) is expected to close in the first quarter of 2016.
16:23 EDTTEVAAllergan sees 10% branded revenue growth after divestiture of generics unit
Following the close of the divestiture of the Generics business to Teva (TEVA), New Allergan (AGN) expects to have a powerful financial profile to drive continued long-term growth: 10% branded revenue growth; Non-GAAP gross margins of 77% to 79% with additional long-term expansion anticipated; Non-GAAP SG&A as a percentage of revenue between 21-24%, declining within that range over time; Non-GAAP tax rate of ~15%; Interest expense for New Allergan will be largely dependent on capital deployment decisions following the close of the transaction; Commitment to investment grade ratings. "New Allergan will have strong double-digit revenue growth and will be a development powerhouse stacked with 70 mid-to-late stage R&D projects to address customer and patient needs," said Brent Saunders, CEO and President. "The New Allergan will be lean and nimble with an expanded margin profile driven by leading brands in seven therapeutic categories, a streamlined operating model with one of the most efficient SG&A as a percentage of sales in the industry, a non-GAAP tax rate of approximately 15 percent, and a simplified manufacturing network globally. The continued robust performance of our overall business and strong mid-to-late stage pipeline puts Allergan in a strong position to meet our growth targets for the remainder of the year and over the long-term."
12:22 EDTNVSArray says binimetinib-encorafenib combo shows differentiated tolerability
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07:58 EDTNVSNovartis to hold a conference call
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07:52 EDTTEVAIIR Holdings to hold a conference
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07:46 EDTTEVAUBS to hold a field trip
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07:31 EDTMYLMylan launches generic Invega tablets
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07:27 EDTMYLFDA and the Parental Drug Association to co-host a conference
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05:26 EDTTEVATeva announces approval of Copaxone in Japan
Teva announced the approval by the Japanese Ministry of Health, Labour and Welfare of once-daily COPAXONE 20mg injection for the prevention of relapse of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Limited. In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of the MHLW. In March, 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize COPAXONE in Japan. The Japanese approval for COPAXONE is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries.
September 27, 2015
18:48 EDTNVSNovartis reports updated Phase 3 data on Tafinlar-Mekinist for melanoma
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16:53 EDTTEVATeva reports Phase 3 data on reslizumab for asthma exacerbations
Teva Pharmaceutical presented results from a post hoc analysis of two pivotal Phase 3 clinical trials showing that treatment with reslizumab reduced clinical asthma exacerbations by 75% versus placebo in a subgroup of patients with late onset asthma with elevated blood eosinophils, who were inadequately controlled on inhaled corticosteroids. Reslizumab is a humanized anti-interleukin-5 monoclonal antibody. Results were pooled from two Phase 3 clinical trials that investigated reslizumab IV 3mg/kg in patients who had at least one asthma exacerbation within the previous year. In the subgroup with late onset asthma, reslizumab showed a 75% reduction in asthma exacerbations and improvement in lung function as measured by forced expiratory volume in one second. In the overall pooled patient population, asthma exacerbations were reduced by 54%, and in the subgroup of subjects diagnosed with asthma at less than 40 years of age, exacerbations were reduced by 42%. Common adverse events in the reslizumab treatment group were comparable to placebo.
16:16 EDTNVSNovartis reports Phase 3 reults on Afinitor for neuroendocrine tumors
Novartis announced results of a Phase 3 pivotal study showing Afinitor, or everolimus, tablets reduced the risk of progression by 52% versus placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin. Additionally, the data show everolimus, a mammalian target of rapamycin inhibitor, extended median progression free survival by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm. Overall survival was a key secondary endpoint of the trial. While the OS data are not mature, the first interim analysis showed a trend favoring the everolimus arm, according to Novartis. Additional analyses are planned. Another secondary endpoint was best overall response rate. The study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo. Adverse events were consistent with the known safety profile of everolimus. The results of the RADIANT-4 study will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET, Novartis said.
September 25, 2015
13:51 EDTMYLBMO's pharma predictions for rest of year include take on Mylan, Perrigo
BMO Capital analyst David Maris rolled out his rest of year predictions for the Specialty Pharmaceuticals space. Among them is his belief that Mylan (MYL) will be unsuccessful in acquiring Perrigo (PRGO). Perrigo will either be acquired by another company or make an acquisition itself, Maris tells investors in a research note. His other predictions include Jazz Pharmaceuticals (JAZZ) proving to be a good buying opportunity amidst the current negative sentiment and ZS Pharma (ZSPH) offering upside following the recent pullback given the potential for a near-term buyout and prospects for its "best in class drug for hyperkalemia" winning approval in 2016.
09:02 EDTTEVATeva acquires Gecko Health Innovations, terms not disclosed
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08:37 EDTTEVAAntares Pharma could benefit from drug pricing controversy, says Oppenheimer
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07:22 EDTTEVA, NVSEuropean Society for Medical Oncology to hold a conference
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05:15 EDTNVSNovartis announces CHMP adopted positive opinion for Entresto
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