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News Breaks
May 8, 2014
06:39 EDTACUR, PFE, RBXLYAcura Pharma announces settlement of patent litigation with Ranbaxy
Acura Pharmaceuticals (ACUR) announced that it has entered into a Settlement Agreement with Ranbaxy (RBXLY) to dismiss, without prejudice, its patent infringement action pending against Ranbaxy in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc. (PFE) under its brand name OXECTA, for which Ranbaxy is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application, or ANDA, filing with the FDA infringes U.S. patents owned by Acura. The Settlement Agreement provides that Ranbaxy's current product that is the subject of its ANDA does not infringe Acura's Orange Book listed patents with the FDA. Acura has not provided Ranbaxy with a license to Acura's patents and Acura may re-commence patent infringement litigation against Ranbaxy if Ranbaxy changes the formulation of its generic to the AVERSION oxycodone product.
News For ACUR;RBXLY;PFE From The Last 14 Days
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April 15, 2015
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
April 9, 2015
16:18 EDTACURAcura Pharma to develop abuse deterrent hydrocodone
Acura Pharmaceuticals is initiating development of an immediate-release hydrocodone bitartrate with acetaminophen tablet incorporating Acura's novel LIMITXâ„¢ abuse deterrent technology. Hydrocodone/APAP is the largest prescribed opioid to treat moderate to severe pain. It also is the single most abused prescription opioid, predominately by swallowing multiple tablets. LIMITX is designed specifically to address this route of abuse. Development of the company's LIMITX technology is currently being supported by a grant from the National Institute on Drug Abuse of the National Institutes of Health to develop an immediate-release hydromorphone tablet.
09:51 EDTPFEPerrigo did not expect Mylan takeover letter, CNBC's Faber reports
Perrigo (PRGO) did not expect the takeover letter it received from Mylan (MYL), CNBC's David Faber reports, citing sources. Perrigo will take its time in deciding what its next steps are, Faber added. Shares of Mylan are up 3% in early trading, which is being attributed, at least in part, to speculation the company could be a takeover target itself. Analysts this morning mentioned Teva (TEVA) as a potential acquirer of Mylan. Chatter this morning has Pfizer (PFE) also potentially interested in the EpiPen maker
09:25 EDTPFEPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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08:04 EDTPFEPfizer launches PCSK9 competitive grants program
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April 7, 2015
08:20 EDTACUREgalet risk from patent lawsuit looks low, says JMP Securities
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08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:14 EDTPFEEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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April 6, 2015
17:17 EDTACURAcura Pharma says aware of Purdue patent infringement suit over Oxaydo
In a regulatory filing, Acura stated, "On April 3, 2015, we became aware that Purdue Pharma L.P., Purdue Pharmaceuticals L.P. and The P.F. Laboratories, commenced a lawsuit against us and our Oxaydo product licensee Egalet US, Inc. and its parent Egalet Corporation in the United States District Court for the District of Delaware. The complaint alleges patent infringement involving the OXAYDO product, and seeks injunctive relief as well as awards of damages and attorneys’ fees. As of the date of filing of this Current Report on Form 8-K, Purdue has not served the complaint on us. We deny the allegations in the complaint, believe they are without merit and intend to defend the action vigorously."
10:37 EDTPFETargacept says Pfizer terminates research & license agreement with Catalyst
In a regulatory filing from earlier, Targacept (TRGT) said: "As previously reported, on March 5, Targacept, Talos Merger Sub, a Delaware corporation and a wholly owned subsidiary of Targacept and Catalyst Biosciences, entered into an Agreement and Plan of Merger, pursuant to which, among other things, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Merger Sub will merge with and into Catalyst, with Catalyst becoming a wholly owned subsidiary of Targacept and the surviving corporation of the merger. On April 1, Catalyst notified Targacept that Pfizer (PFE) would be exercising its right to terminate in its entirety the June 29, 2009, research and license agreement between Catalyst and Wyeth, which governs the development and commercialization of Catalyst’s leading human Factor VIIa product candidate for the treatment of hemophilia and surgical bleeding indications. On April 2, Pfizer provided Catalyst with its formal written notice of termination of the research and license agreement. Upon the June 1, effective date of the termination, the license and certain rights under the research and license agreement will terminate and revert to Catalyst. Catalyst has informed Targacept that Pfizer is committed to an orderly transfer of data, regulatory documentation and related technology under the agreement to Catalyst to enable Catalyst to continue the clinical development of this product candidate. Targacept is currently reviewing the implications of this event on the proposed Merger. In morning trading shares of Targacept are down almost 12% to $2.51.

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