Updates on Drug License Approvals and ANDA Applications - Research Report on Mylan, Actavis, Warner Chilcott, Astex, and Avanir
NEW YORK, July 16, 2013 /PRNewswire/ --
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Today, Wall Street Reports announced new research reports highlighting Mylan Inc. (NASDAQ: MYL), Actavis, Inc. (NYSE: ACT), Warner Chilcott Plc (NASDAQ: WCRX), Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), and Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Mylan Inc. Research Report
On July 11, 2013, Mylan Inc. (Mylan) confirmed that the Company has been sued by Aptalis in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Mesalamine Rectal Suppositories (the generic version of CANASA), 1000 mg. Mylan has filed a substantially complete ANDA containing a Paragraph IV certification for the suppositories and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the US District Court for the District of New Jersey. The Full Research Report on Mylan Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/5c2f_MYL]
Actavis, Inc. Research Report
On June 28, 2013, Actavis, Inc. (Actavis) announced that it will release its Q2 2013 financial results on July 25, 2013, before the US financial markets open. The Company will host a conference call and webcast on the same day at 8:30 a.m. ET to discuss the financial results. Actavis had reported a 24% YoY increase in net revenues to $1.9 billion in Q1 2013. The increase led the Company to raise its full-year 2013 guidance, estimating total net revenue of approximately $8.1 billion. The Full Research Report on Actavis, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/4b90_ACT]
Warner Chilcott Plc Research Report
On July 11, 2013, Warner Chilcott Plc (Warner Chilcott) and Actavis announced the receipt of a request for additional information from the Federal Trade Commission (FDC) in connection with Actavis' pending acquisition of Warner Chilcott. The information request was issued under notification requirements of the hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended. The effect of the second request is to extend the waiting period imposed by the HSR Act until 30 days after the Companies have substantially complied with the request. Actavis and Warner Chilcott intend to cooperate fully with the FTC's review and expect the transaction to close in H2 2013. The Full Research Report on Warner Chilcott Plc - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/35c8_WCRX]
Astex Pharmaceuticals, Inc. Research Report
On July 8, 2013, Astex Pharmaceuticals, Inc. (Astex) announced its intention to submit an Investigational New Drug (IND) application to the FDA for ASTX727, a novel hypomethylating agent (HMA) in Q4 2013. Later in 2013, preclinical data on ASTX727 will be submitted for presentation at a scientific meeting. "We are pleased to announce that ASTX727, in the late preclinical stage of development, becomes the third product in our epigenetic franchise that began with DACOGEN (decitabine) for Injection," said James S.J. Manuso, Ph.D., CEO and Chairman of Astex. "This franchise includes SGI-110, expected to enter Phase III clinical trials in 2014." The Full Research Report on Astex Pharmaceuticals, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/eadc_ASTX]
Avanir Pharmaceuticals, Inc. Research Report
On July 2, 2013, Avanir Pharmaceuticals, Inc. (Avanir) and OptiNose AS (OptiNose) announced that the Companies have entered into an exclusive North American license agreement for the development and commercialization of OptiNose's novel Breath Powered intranasal delivery system containing low-dose sumatriptan powder for the treatment of acute migraine. If approved, this product would be the first and only fast-acting, dry-powered nasal delivery form of sumatriptan. Pursuant to the agreement, OptiNose has received an upfront cash payment of $20 million and is eligible to receive certain shared development costs and up to an additional $90 million in total linked to the achievement of future clinical, regulatory, and commercial milestones. Further, if approved, Avanir will make tiered royalty payments based on net sales in North America. Avanir will also assume responsibility for regulatory, manufacturing, supply-chain, and commercialization activities for the investigational product, now named AVP-825. The Company expects to file the application with the FDA by early 2014. The Full Research Report on Avanir Pharmaceuticals, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.wsreports.com/r/full_research_report/22e9_AVNR]
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