Key Developments: Merck KGaA (MKGAY.PK)
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19 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Antaria Ltd Announces Supply Agreement With Merck KGaA
Antaria Ltd announced the finalisation of the supply agreement for Alusion with Merck KGaA. The term of the Merck Agreement is five years commencing with a two year take or pay arrangement. The Merck Agreement contemplates a minimum 50% increase in sales volumes during the two year period. Antaria enjoys a long working relationship with Merck KGaA and the Merck Agreement will reinforce this relationship going forward. Full Article
EU Regulators May Fine Merck KGaA-Business Standard
Business Standard reported that Merck KGaA declined to comment on the reports from Brussels that European Union anti-trust regulators may fine the domestic pharma company for allegedly blocking of entry of cheaper generic medicines in the market. Reports said that Merck KGaA was among the nine companies that are to fined for the allegedly blocking the entry of the generic medicines in the EU. Full Article
Merck KGaA Raises Low End Of Prior FY 2013 EPS Guidance-Conference Call
Merck KGaA announced that for fiscal 2013 it is narrowing the guidance on earnings per share (EPS). Before the Company guided EPS to be between $8.2 to $9.0 and now it is further refine that to the range of $8.5 to $9.0. Full Article
AEterna Zentaris Inc Announces Transfer Of Manufacturing Rights Related To Cetrotide To Merck KGaA
AEterna Zentaris Inc announced that its German subsidiary has entered into binding agreements with various partners and licensees with respect to the manufacturing rights and obligations for its Cetrotide product. The principal effect of such agreements is to transfer manufacturing rights and to grant a manufacturing license for Cetrotide to a subsidiary of Merck KGaA of Darmstadt, Germany (Merck Serono), in all jurisdictions. Subject to the satisfaction of customary closing conditions, the transaction is expected to be completed on or about October 1, 2013, at which time Aeterna Zentaris would receive a one-time payment of EUR2.5 million, or approximately $3.2 million and certain other payments. In addition, the Company has also entered into a transitional services agreement with Merck KGaA under which the Company will, during a 36-month period, provide various transition services to assist Merck KGaA in assuming responsibility for the manufacturing of Cetrotide in consideration for the payment of a monthly fee to the Company throughout such period. Full Article
Merck KGaA's EMD Serono Appeals Court Decision On Collaboration Agreement With Pfizer Inc
Merck KGaA announced that a Pennsylvania appellate court recently decided that the collaboration agreement that EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, and Pfizer Inc. entered into in July 2002 for the co-promotion of the multiple sclerosis treatment Rebif (interferon beta-1a) extends until December 31, 2015. EMD Serono, which developed Rebif, had contended that the collaboration should end on December 31, 2013, based on the provisions of the agreement governing extension of the term, and had filed a complaint seeking a court declaration to that end. A lower court ruled that the agreement extends through 2015 and the appellate court affirmed that decision. EMD Serono has asked the appellate court to reconsider ruling. Unless the court grants the request on or before June 7, it will be deemed denied. Full Article
Merck KGaA to Issue FY 2012 Dividend
Merck KGaA announced that it has proposed a dividend of EUR 1.70 per share for the fiscal year 2012, which is up 13% from the dividend for the fiscal year 2011. Full Article
Merck KGaA's EMD Serono, Inc Phase III Trial Of Cilengitide Did Not Meet Primary Endpoint In Patients With Newly Diagnosed Glioblastoma
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced that the Phase III CENTRICa trial of the investigational integrin inhibitor cilengitide did not meet primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen (temozolomide and radiotherapy). CENTRIC includes patients with newly diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter status. The trial was planned and is being conducted in partnership with the European Organization for Research and Treatment of Cancer (EORTC). Patient safety in CENTRIC was monitored frequently by an independent data monitoring committee and no new or unexpected safety concerns were noted. In prior clinical studies, the most frequently reported adverse events the investigators considered to be attributed to cilengitide included nausea and fatigue. CENTRIC is a randomized, controlled, multicenter, open-label Phase III trial. The trial evaluated the efficacy and safety of cilengitide in combination with temozolomide and radiotherapy in more than 500 patients from 23 countries worldwide with newly diagnosed glioblastoma and methylated MGMT gene promoter status. Patients whose tumors have an unmethylated MGMT gene promoter status are currently being evaluated in the Phase II, randomized, open-label, multicenter COREb trial. Full Article
EU Agency Recommends Sanofi SA, Merck KGaA Pediatric Vaccine-Reuters
Reuters reported that the European Medicines Agency recommended approval of Hexyon, a new 6-in-1 pediatric vaccine from Sanofi Pasteur MSD, a joint venture between Merck KGaA and Sanofi SA. The new vaccine protects against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. Full Article
Threshold Pharmaceuticals Inc And Merck KGaA's Merck Serono Announce Initiation Of TH-302 Phase 3 MAESTRO Study In Patients With Locally Advanced Or Metastatic Pancreatic Adenocarcinoma
Threshold Pharmaceuticals Inc announced that Threshold's partner Merck KGaA, Darmstadt, Germany, through its division Merck Serono, initiated the global Phase 3 MAESTRO study assessing the efficacy and safety of investigational hypoxia-targeted drug TH-302 in combination with gemcitabine in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma. The initiation of the Phase 3 MAESTRO study resulted in Threshold earning a $30 million payment from Merck KGaA pursuant to the terms of Threshold's license and co-development agreement with Merck KGaA, which includes an option for Threshold to co-commercialize in the U.S. MAESTRO stands for TH-302 in the treatment of MetastAtic or unrESectable pancreaTic adenocaRcinOma. MAESTRO is a randomized, placebo-controlled, international, multi-center, double-blind Phase 3 trial of TH-302 plus gemcitabine compared with placebo plus gemcitabine and is expected to enroll 660 patients. The primary efficacy endpoint is overall survival; the secondary endpoints include efficacy measured by progression-free survival (PFS), overall response rate and disease control rate, as well as assessments of safety and tolerability, pharmacokinetics and biomarkers. The study is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). Full Article
Merck KGaA's Stimuvax Misses Primary Endpoint In Phase III Trial-DJ
Dow Jones reported that Merck KGaA said a Phase III trial of Stimuvax on patients with non small cell lung cancer didn't meet the primary endpoint, or a significant improvement in overall survival. Stimuvax refers to Merck's product L-BLP25. Despite not meeting the primary endpoint, notable treatment effects were seen for L-BLP25 in certain subgroups. Further analysis is planned in the coming weeks to explore the potential benefit-risk profile of L-BLP25 in certain populations. Merck KGaA has an exclusive licensing agreement with U.S.-based Oncothyreon Inc. (ONTY) for Stimuvax. Full Article
Swiss billionaires buy Merck Serono HQ for biotech campus
* Merck to sell Geneva site to Bertarelli-backed consortium
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