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April 1, 2014
05:38 EDTHSP, MDCOThe Medicines Co. provides update on Angiomax patent litigation
On March 31, Judge Andrews in the U.S. District Court of Delaware issued his Trial Opinion in The Medicines Company v. Hospira, Inc. The case involves Hospira's (HSP) Abbreviated New Drug Applications, or ANDAs, seeking approval to commercially manufacture, use or sell a generic version of The Medicines Company's (MDCO) Angiomax bivalirudin drug product before the expiration of the patents covering this product. The Delaware Decision follows a September 23-25, 2013 bench trial. With respect to patent validity, the Court held that the two patents in the case, U.S. Patent Nos. 7,582,727 and 7,598,343 were valid on all grounds. Specifically, the Court found that Hospira had failed to prove that the patents were either anticipated and/or obvious. The Court further held that the patents satisfied the written description requirement, were enabled and were not indefinite. With respect to infringement, based on its July 2013 Markman Decision, the Court found that Hospira's ANDAs did not meet the "efficient mixing" claim limitation and thus did not infringe the asserted claims of the '727 and '343 patents. The Court found that the other claim limitations in dispute were present in Hospira's ANDA products. The Court has not yet entered a final judgment. Any appeal to the Court of Appeals for the Federal Circuit would need to be filed within 30 days of such entry. The '727 and '343 patents expire in 2028.
News For MDCO;HSP From The Last 14 Days
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October 9, 2015
08:30 EDTMDCOBioNJ to hold a summit
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October 6, 2015
17:16 EDTMDCOThe Medicines Co., SymBio Pharmaceuticals enter strategic partnership in Japan
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October 5, 2015
07:31 EDTMDCOThe Medicines Co. ALN-PCSsc 'a potential game changer,' says RBC Capital
After examining surveys and speaking with experts, RBC Capital says that the uptake of The Medicines Co's ALN-PCSsc treatment has been strong among anti-PCSK9 patients, reaching 20%-30%. The firm estimates that the company could conservatively generate $9B-$18B in revenue from the drug. It believes that the product is "a potential game changer and valuation driver" for the company. RBC keeps a $46 price target and Outperform rating on the shares.
October 1, 2015
07:05 EDTMDCOMedicines Company says BARDA exercises option on Carbavance pact
The Medicines Company announced that Rempex Pharmaceuticals, a wholly owned subsidiary, has been awarded the next option on a contract by the Biomedical Advanced Research and Development Authority, or BARDA, to support the development of CARBAVANCE. CARBAVANCE is the combination of a carbapenem antibiotic with a novel beta-lactamase inhibitor that is targeted for treatment of multi-drug resistant gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae. The cost-share contract with BARDA was initiated in 2014 and extends over 5 years. The award of this third option brings the total commitment from BARDA to $53.8M. If all options are exercised in the contract, it would bring the total value of the award to approximately $90M.
September 28, 2015
07:27 EDTHSPFDA and the Parental Drug Association to co-host a conference
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September 25, 2015
09:01 EDTMDCOThe Medicines Co. receives CHMP positive opinion for Ionsys
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