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News Breaks
April 3, 2014
14:28 EDTTEVA, MYLMylan says USPTO rejects Teva '808 patent reissue application on Copaxone
News For MYL;TEVA From The Last 14 Days
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December 12, 2014
07:06 EDTTEVATeva upgraded to Buy from Neutral at Sterne Agee
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December 11, 2014
09:39 EDTTEVATeva FY15 outlook appears strong, reasonable, says BMO Capital
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07:32 EDTMYLMylan launches generic version of Hikma Maple's Robaxin injection
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07:24 EDTTEVATeva to host conference call
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07:12 EDTTEVATeva sees FY15 Copaxone sales $3.5B-$3.7B
Sees FY15 Treanda sales $670M-$750M. Sees FY15 ProAir family sales $470M-$580M, Azilect sales $350M-$400M and Nuvigil sales $300M-$330M. Erez Vigodman, President & CEO of Teva, said, "Generics remain at the heart of our business, both as the cornerstone of the Company, but also as an area that has great impact on society. At the same time, we anticipate four specialty product approvals and five submissions in 2015 – which we believe will improve treatment options for patients, and add value for all of our stakeholders." The company expects 2015 generic revenues in the United States to be $4.2B-$4.6B, $2.6B-$3.0B in Europe and $2.0B-$2.3B in its ROW markets. Results of its specialty segment are expected to be impacted by the introduction of two AB-rated generic competitors to Copaxone in the U.S. beginning in September 2015, which is a modeling assumption only, as well as by increased competition from oral products for the treatment of multiple sclerosis. In addition, the company is expecting to invest in a significant number of product launches and in its specialty pipeline. "All of these will result in lower profit and profitability, as we focus on generating growth over the next few years," Teva said.
07:08 EDTTEVATeva sees FY15 gross profit 59.5%-61.5%
Teva sees FY15 cash flow from operations $4.3B-$4.7B and free cash flow $3.5B-$3.7B.
07:07 EDTTEVATeva sees spending $1B-$1.2B on share buybacks in 2015
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07:06 EDTMYLMylan launches generic version of Orapred ODT
Mylan announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions. Prednisolone Sodium Phosphate Orally Disintegrating Tablets had U.S. sales of approximately $19.9M for the 12 months ending September 30.
07:02 EDTTEVATeva sees FY15 EPS $5.00-$5.30, consensus $5.06
Sees FY15 revenue $19B-$19.4B, consensus $20.07B.
December 10, 2014
08:31 EDTTEVATeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTMYLMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
07:44 EDTTEVAAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
11:30 EDTTEVA, MYLLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:21 EDTTEVAMerck says looked at all risks, including patent litgation, before Cubist deal
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06:47 EDTTEVAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
December 5, 2014
10:05 EDTMYLBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
07:54 EDTTEVALannett names Michael Bogda as president, effective December 1
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December 4, 2014
10:32 EDTTEVATeva receives positive outcomes in Europe for three-times-a-week COPAXONE
Teva Pharmaceutical Industries announced that it has received a positive outcome in the decentralized procedure for its new, three-times-a-week COPAXONE 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis RMS. The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State’s Medicines and Healthcare Products Regulatory Agency, and all Concerned Member States in Europe who were involved in the procedure. Granting of national authorizations will happen in the near future. The three-times-a-week COPAXONE 40 mg/ml formulation will allow for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60%, while maintaining the known benefits of once daily COPAXONE 20 mg/ml. “We welcome the opportunity to make COPAXONE 40 mg/ml available to patients with RMS in Europe,” said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. “Three-times-a-week COPAXONE 40 mg/ml will be available in Europe as early as the first quarter of 2015 with expected launches in Germany, Netherlands and Denmark. Launches in other EU countries are expected throughout 2015.”
10:03 EDTMYLMylan receives tentative FDA approval for abacavir/lamivudine NDAs
Mylan announced that its subsidiary Mylan Laboratories has received tentative approval from the FDA for its New Drug Applications for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored, Mylan said. The FDA's tentative approval through the President's Emergency Plan for AIDS Relief program means the formulations meet all of the agency's quality, safety and efficacy standards, it stated. The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation to a total of 115 resource limited countries including all low-middle income, least developed countries and sub-Saharan Africa. Mylan's products are expected to be eligible for purchase in early 2015.
05:30 EDTTEVACTI BioPharma receives $15M payment from Teva for TRISENOX
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