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News Breaks
March 24, 2014
13:30 EDTTEVA, MYLDistrict Court upholds Mylan's patents on performist inhalation solution
Mylan announced the United States District Court for the Northern District of West Virginia issued a decision upholding the validity of all patents asserted by Mylan, protecting Perforomist Inhalation Solution. Mylan previously sued Teva alleging that Teva's Abbreviated New Drug Application for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva's defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva's ANDA. The Court's decision also prevents Teva's ANDA, which has yet to receive a tentative approval from the FDA, from receiving final approval prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.
News For MYL;TEVA From The Last 14 Days
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September 28, 2015
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
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.
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 EDTTEVAEuropean Society for Medical Oncology to hold a conference
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September 24, 2015
15:24 EDTMYLMylan says Perrigo lawsuit 'without merit'
Mylan (MYL) believes that the Perrigo (PRGO) suit filed in Israel is entirely without merit and that Mylan's offer in Israel is valid and proper in all respects. With that said, Perrigo's efforts are entirely futile, as all Perrigo shareholders-institutional and retail, including those in Israel-have always been free to switch their holdings at any time from the Tel Aviv Stock Exchange to the New York Stock Exchange, through a simple, fully automated, well-established system by notifying their broker. As a result, shareholders can participate fully in Mylan's compelling offer without regard to any lawsuits in Israel or any other frustrating actions pursued by Perrigo in Israel. Further, as Mylan has previously stated publicly, it has been its intent and desire to list Mylan's shares on the TASE to maintain liquidity in Israel for the convenience of those shareholders in Israel who prefer to trade on the TASE, and Mylan is already well-advanced in the process of submitting its application to the TASE and the Israel Securities Authority, and is committed to continuing to work closely with these parties to complete this process.
14:17 EDTMYLAppeals court affirms Shire Vyvanse patents valid until 2023
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07:26 EDTTEVATeva stock performance can improve into year-end, says Deutsche Bank
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07:12 EDTTEVATeva added to short-term buy list at Deutsche Bank
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September 23, 2015
08:24 EDTMYLWeakness in drug stocks creates buying opportunities, says RBC Capital
After Hillary Clinton unveiled a plan to lower drug prices, RBC Capital does not expect the plan to be passed by Congress. The firm adds that the plan is positive for generic drug makers and could pressure the FDA to more quickly approve generic drug applications. RBC identifies Insys Therapeutics (IINSY), Endo (ENDP), and Sagent Pharma (SGNT) as three stocks it likes that have suffered "disproportionate selloffs over the last two days." The firm identifies Sagent, Emdo and Mylan (MYL) as three companies with high generic exposure that have sold off.
06:16 EDTMYLMylan countersues Perrigo, cites tender offer 'misstatements,' Reuters reports
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September 22, 2015
08:23 EDTTEVAWith Pharma in 'hot seat,' Citi still likes Allergan, Teva
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07:43 EDTTEVADrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:35 EDTMYLMylan to cancel 'stichting' takeover defense
Mylan N.V. yesterday confirmed that on September 19, 2015 the Stichting Preferred Shares Mylan, an independent foundation incorporated under the laws of the Netherlands, requested cancellation of the preferred Mylan shares issued to the Foundation on July 23, 2015. The Foundation informed Mylan it was satisfied that influences that might adversely affect the strategy, mission and other interests of Mylan, its business and its stakeholders to be protected by the Foundation as described in the Foundation's articles of association have been sufficiently addressed. Cancellation of the preferred shares requires Mylan shareholder approval. The Mylan Board of Directors will announce the shareholders meeting to approve the cancellation of the preferred shares in due course.
06:20 EDTTEVALeerink reiterates Outperform on Neurocrine after call with neurologists
Leerink analyst Paul Matteis reiterates an Outperform rating on Neurocrine (NBIX) after speaking with two neurologists on the clinical potential of the company's NBI-98854 and Teva's (TEVA) SD-809 for the treatment of Tardive Dyskinesia, Tourette's Syndrome and Huntington's Chorea. Matteis left the call "increasingly optimistic" on the likelihood of NBI-98854 showing Phase III success for Tardive Dyskinesia. The analyst has a $67 price target for shares.
September 21, 2015
05:46 EDTMYLMylan reinstated with an Equal Weight at Barclays
Barclays analyst Douglas Tsao reinstated Mylan (MYL) with an Equal Weight rating and $57 price target. The analyst expects uncertainty around the company's tender offer for Perrigo (PRGO) to weigh on the shares over the near term.
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