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News Breaks
February 3, 2014
05:09 EDTMYLMylan launches Hertraz, first trastuzumab biosimilar, in India
Mylan announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched the world's first trastuzumab biosimilar in India. The product, which will be marketed by Mylan under the brand name Hertraz, is a biosimilar to Roche's Herceptin. Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg. According to IPSOS, trastuzumab had sales in India of approximately $21M for the 12 months ended Dec. 31, 2012. Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.
News For MYL From The Last 14 Days
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May 28, 2015
09:24 EDTMYLJefferies sees Pharma M&A continuing, lists 22 possible targets
Jefferies analyst David Steinberg believes the M&A wave in the Pharmaceuticals space that began in 2005 can continue as the key drivers remain largely intact. In a note titled "Who is Next? The Feeding Frenzy in Specialty Pharmaceuticals," Steinberg sees deals continuing amid cheap debt, the push for lower corporate taxes and investors rewarding many acquirers for their transactions. He points out there are now around 100 publicly traded Specialty Pharmaceutical companies following the recent life sciences IPO boom. Potential takeover targets, according to Steinberg, include Valeant (VRX), Shire (SHPG), Perrigo (PRGO), Zoetis (ZTS), Mallinckrodt (MNK), Jazz Pharmaceuticals (JAZZ), United Therapeutics (UTHR), Pacira (PCRX), Indivior, Insys Therapeutics (INSY), The Medicines Co. (MDCO), Depomed (DEPO), Spectrum (SPPI), KYTHERA (KYTH), Revance (RVNC), XenoPort (XNPT), Mylan (MYL), Akorn (AKRX), Impax (IPXL), Amphastar Pharmaceuticals (AMPH), Anacor (ANAC) and BioDelivery Sciences (BDSI).
06:11 EDTMYLTeva takes 1.35% stake in Mylan, says 'ready to meet' on deal
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May 27, 2015
12:10 EDTMYLTeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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May 25, 2015
13:56 EDTMYLMylan responds to claims of EPS forecasting by Perrigo
Mylan (MYL) announced that it was asked by the Irish Takeover Panel to issue the following clarification and retraction in accordance with the Irish takeover rules, relating to its firm intention to make an offer to acquire Perrigo (PRGO). The clarification and retraction relates to certain forward-looking statements made by Mylan specifically during the "pendency of the offer" period concerning its long-stated target since 2012 of at least $6.00 in adjusted EPS by 2018. Subsequent to Mylan's May 5 earnings release, Perrigo submitted a complaint to the Irish Takeover Panel alleging that the reference to Mylan's $6.00 long-term target should be treated as a forward-looking profit forecast statement. Although Mylan's adjusted EPS goal has been a stated long-term target, and not a forecast of Mylan, at least during the offer period as it pertains to the Perrigo transaction, Mylan will no longer refer to that 2018 target or any other forward looking statements beyond 2015 that could constitute profit forecasts.
May 19, 2015
06:08 EDTMYLPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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May 18, 2015
12:07 EDTMYLPerrigo: there is price point where would engage with Mylan, Bloomberg reports
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07:22 EDTMYLUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 18 at 8 am; not all company presentations may be webcasted. Webcast Link
May 15, 2015
14:51 EDTMYLMylan ANDA for generic version of Lexapro approved by FDA
The ANDA from Mylan (MYL) for a generic version of Escitalopram Oxalate, which is sold under the trade name Lexapro by Actavis' (ACT) Forest Labs, was approved by the FDA on May 14, according to a post to the regulator's site. Reference Link
09:31 EDTMYLAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.

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