MKGAY
Merck KGaA ADROTCPK - Current
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  • Thu, Dec. 1, 8:41 AM
    • Roche (OTCQX:RHHBY) builds on its distribution alliance with Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) by adding the qPCR and endpoint PCR portfolios from Kapa Biosystems, a company Roche acquired in late 2015. The deal excludes Kapa's Next-Gen Sequencing products.
    • The distribution agreement is worldwide except the U.S., Japan and Brazil.
    | Thu, Dec. 1, 8:41 AM
  • Wed, Nov. 30, 7:05 AM
    • Evotec AG (OTC:EVOTF)(OTCPK:EVTCY) and Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) life sciences unit ink a set of collaboration agreements with the aim of discovering new therapeutic targets. The partnership will leverage Merck's comprehensive lineup of genetic reagents, including CRISPR and shRNA libraries, and Evotec's versatile screening platforms and disease expertise.
    • Evotec COO Dr. Mario Polywka says, "Together with our recent licensing of the CRISPR/Cas9 gene editing technology, these agreements with Merck further strengthen Evotec's offering in the area of target identification and validation for our partners. Deploying Merck's assay-ready reagents on our cellular screening platforms and in vivo models creates powerful capabilities in the area of target ID. With this we provide more value to joint clients by a one-stop-shop solution for this innovative drug discovery segment."
    • Financial terms are not disclosed.
    | Wed, Nov. 30, 7:05 AM
  • Tue, Nov. 29, 9:16 AM
    • The FDA accepts under Priority Review the Biologics License Application (BLA) from Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) EMD Serono unit seeking approval of avelumab for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a Breakthrough Therapy, Fast Track and Orphan Drug designation.
    • MCC is a rare and aggressive type of skin cancer that affects ~2,500 Americans each year.
    • Priority Review status shortens the review clock to six months from the usual 10 months. The specific action date is not provided but should be around June 1, 2017.
    • Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer (NYSE:PFE) for the treatment of a range of cancers under a strategic alliance inked in November 2014.
    • The marketing application in Europe is currently under review.
    | Tue, Nov. 29, 9:16 AM
  • Tue, Nov. 22, 8:44 AM
    • QuintilesIMS (NYSE:Q): will lead a collaborative initiative involving Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) and Pfizer (NYSE:PFE) with the goal of providing clearer and more proactive insight into how anti-cancer treatments are used in actual practice across key European markets. Specifically, the initiative aims to bridge the information gaps and inconsistencies in knowledge related to how oncology products are used, for which types of patients and indications and in what sequences and combinations. The ultimate goal is to improve the quality of care for cancer patients and improve outcomes.
    • Financial details are not disclosed.
    | Tue, Nov. 22, 8:44 AM | 2 Comments
  • Mon, Oct. 31, 6:38 AM
    • Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) and development partner Pfizer (NYSE:PFE) announce that the European Medicines Agency (EMA) has validated Merck's Marketing Authorization Application (MAA) seeking approval of avelumab for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive skin cancer that affects ~2,500 Europeans each year. MCC, an Orphan Drug indication, is associated with a poor prognosis with a five-year survival rate less than 20%.
    • Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer for the treatment of a range of cancers under a strategic alliance inked in November 2014.
    | Mon, Oct. 31, 6:38 AM
  • Wed, Oct. 12, 11:02 AM
    • Thinly traded nano cap HTG Molecular Diagnostics (HTGM +63.3%) heads north on a whopping 440x surge in volume in response to its announcement that it has entered into an agreement with Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) to develop companion diagnostic tests for Merck's cancer candidates.
    • The initial development program, utilizing the HTG EdgeSeq DLBCL Cell of Origin Assay, will focus on Merck's M7583, an inhibitor of Bruton's Tyrosine Kinase (BTK).
    • Financial terms are not disclosed.
    | Wed, Oct. 12, 11:02 AM | 3 Comments
  • Tue, Sep. 27, 9:17 AM
    • Shire plc (NASDAQ:SHPG) terminates its collaboration agreement with Momenta Pharmaceuticals (NASDAQ:MNTA) to develop and commercialize M923, a biosimilar to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab). It made the decision after an assessment of its product portfolio following the Baxalta acquisition.
    • Under the terms of the 2011 collaboration agreement between Baxalta and Momenta, the deal will terminate 12 months following the formal notice. Shire will continue to fund the M923 program until then, although preparations to transfer all clinical, regulatory and commercialization activities to Momenta will begin immediately.
    • Momenta better get busy. The FDA just approved Amgen's (NASDAQ:AMGN) version and Samsung Bioepis' version, to be marketed by Biogen (NASDAQ:BIIB), is under regulatory review in Europe. Germany's Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) is also in the mix. Indian outfit Cadila Healthcare launched its HUMIRA biosimilar in India in September 2014.
    | Tue, Sep. 27, 9:17 AM | 7 Comments
  • Mon, Jul. 18, 7:38 AM
    • The European Medicines Agency (EMA) accepts for review Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) Marketing Authorization Application (MAA) seeking approval of Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS).
    • Head of Global R&D for the Biopharma business of Merck, Luciano Rossetti says, "Although there are multiple therapies available for relapsing-remitting MS, there is still a significant unmet medical need with a focus on efficacy, dosing, durability and safety. The company believes that Cladribine Tablets, if approved, would have a first-of-its-kind dosing regimen and serve as an important therapeutic option for patients with relapsing-remitting MS."
    • The MAA submission includes data from three Phase III studies, CLARITY, CLARITY EXTENSION and ORACLE MS, and the Phase II ONWARD study.
    | Mon, Jul. 18, 7:38 AM | 1 Comment
  • Wed, Jul. 6, 9:55 AM
    • Patient recruitment is underway in a Phase 3 clinical trial, JAVELIN Ovarian 100, evaluating Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) and Pfizer's (PFE -0.6%) avelumab for the treatment, in combination with platinum-based chemo, of previously untreated patients with locally advanced or metastatic epithelial ovarian cancer. This is the first late-stage study assessing the addition of an immune checkpoint inhibitor to standard-of-care treatment for this aggressive cancer.
    • JAVELIN Ovarian 100 is an open-label study that will randomize ~950 subjects 1:1:1 to receive either avelumab with carboplatin/paclitaxel or avelumab following carboplatin/paclitaxel or carboplatin/paclitaxel alone. The primary endpoint is progression-free survival (PFS) from baseline to month 36. According to ClinicalTrials.gov, the estimated study completion date is September 2019.
    • Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer for the treatment of a range of cancers under a strategic alliance inked in November 2014.
    | Wed, Jul. 6, 9:55 AM | 1 Comment
  • Tue, Jul. 5, 8:00 AM
    • Juniper Pharmaceuticals (NASDAQ:JNP) announces that Merck KGaA (OTCPK:MKGAY) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for OneCrinone 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment.
    • This approval further expands the global Crinone progesterone gel franchise into the world's' third largest pharmaceutical market, giving women and couples struggling with infertility in Japan a new, patient-friendly therapeutic option for luteal phase support
    • The market launch should commence later this year.
    • Merck KGaA has global rights (ex-U.S.) to Crinone and OneCrinone. Allergan (NYSE:AGN) owns the U.S. rights.
    | Tue, Jul. 5, 8:00 AM
  • Mon, Apr. 18, 11:56 AM
    • Chinese biotech BeiGene (BGNE -2.9%) reports positive data from an ongoing Phase 1 clinical trial assessing product candidate BGB-283 in patients with BRAF or KRAS/NRAS-mutated cancers who have not responded adequately to prior treatments (one to six prior lines of therapies). The data were presented at the 2016 American Association for Cancer Research Annual Meeting in New Orleans, LA.
    • At the time of the data cutoff, there were 29 evaluable patients. One receiving a 40 mg starting dose had a confirmed complete response, two patients receiving a 20 mg or 30 mg starting dose had confirmed partial responses and 15 patients had stable disease (no progression), implying a disease control rate of 79% (n=23/29).
    • The most frequent mild-to-moderate (grade 1 or 2) treatment-related adverse events were fatigue (52%), thrombocytopenia (low blood platelets)(39%), decreased appetite (39%), hand-foot syndrome (redness/swelling in hands and/or feet)(35%), acne (32%) and hypertension (32%). Serious treatment-related adverse events (grade 3 or 4) observed were thrombocytopenia (13%), fatigue (10%) and liver enzyme (ALT) elevation (10%).
    • BGB-283 is called a RAF dimer inhibitor which has shown activity against the RAF family of kinases, including ARAF, BRAF, CRAF and BRAF V600E. It can potentially address resistance to first-generation BRAF inhibitors. For example, vemurafenib, discovered b Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) and marketed by Roche (OTCQX:RHHBY +1.4%) under the brand name Zelboraf, achieves only a 5% response rate in BRAF V600E-positive colorectal cancer.
    • BeiGene is currently conducting all clinical development for BGB-283. It retains all rights to the candidate in China while Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) has exclusive rights ex-China.
    • Previously: BeiGene on deck for IPO (Jan. 20)
    | Mon, Apr. 18, 11:56 AM | 1 Comment
  • Tue, Apr. 5, 11:36 AM
    • The first patient has been treated in a Phase 3 clinical trial evaluating the combination of avelumab, an anti-PD-L1 monoclonal antibody, and Pfizer's (PFE +1.3%) INLYTA (axitinib), a tyrosine kinase inhibitor, for the treatment of advanced renal cell carcinoma (RCC). It is the only late-stage trial assessing this novel combination in the RCC setting.
    • The 583-subject study, called JAVELIN Renal 101, is a randomized (1:1) open-label trial evaluating avelumab + INLYTA compared to Pfizer's SUTENT (sunitinib malate). The primary endpoint is progression-free survival (PFS) from randomization up to 30 months. According to clinicaltrials.gov, the estimated study completion date is February 2018.
    • Pfizer and Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) are co-developing and will co-commercialize avelumab under a strategic alliance inked in November 2014.
    • Read now Pfizer's Road To Leadership In Oncology
    | Tue, Apr. 5, 11:36 AM
  • Tue, Mar. 8, 8:54 AM
    • Merck KGaA ADR (OTCPK:MKGAY): Q4 EPS of €1.13.
    • Revenue of €3.46B (+15.5% Y/Y).
    | Tue, Mar. 8, 8:54 AM
  • Thu, Mar. 3, 8:11 AM
    • Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY), Pfizer (NYSE:PFE) and Verastem (NASDAQ:VSTM) ink an agreement to evaluate the combination avelumab and Verastem's lead product candidate VS-6063 in patients with advanced ovarian cancer. A Phase 1/1b study should commence in H2. Financial terms are not disclosed.
    • Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer for the treatment of a range of cancers. VS-6063 inhibits an enzyme called focal adhesion kinase (FAK) which plays a key role in the development and survival of cancer stem cells. FAK is frequently overexpressed in tumors, enabling cancer cells to evade attack by the immune system.
    • Recent research showed that combining FAK inhibitors with immuno-oncology agents may be clinically beneficial.
    | Thu, Mar. 3, 8:11 AM
  • Wed, Mar. 2, 6:54 AM
    • Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) commences a Phase 3 clinical trial assessing MSB11022, a biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab), for the treatment of moderate-to-severe plaque psoriasis. The 400-subject study, called AURIEL-Psoriasis, will compare MSB11022 to Humira at sites in Europe, Asia, North Central America. The primary endpoint is number of patients achieving a 75% improvement in symptoms (PASI 75) at Week 16.
    • According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is September 2017.
    • Amgen's (NASDAQ:AMGN) Humira biosimilar, ABP 501, is currently under FDA and EMA review.
    • Previously: Amgen submits MAA in Europe for Humira biosimilar ABP 501 (Dec. 4, 2015)
    • Previously: FDA accepts Amgen's BLA for Humira biosimilar (Jan. 25)
    | Wed, Mar. 2, 6:54 AM
  • Fri, Feb. 12, 12:25 PM
    • In its first pay-for-delay decision, the U.K.'s Competition and Markets Authority (CMA) dings GlaxoSmithKline (GSK +0.7%) for ₤37.6M ($54.4M) for its activities to delay generic competition to its antidepressant Seroxat (paroxetine) during the period 2001 - 2004.
    • According to the Authority, the company paid more than ₤50M to certain firms to delay the launch of their versions, thereby depriving the National Health Service of significantly better pricing. When generics finally hit the market at the end of 2003, prices were 70% below branded Seroxat.
    • Despite claims that it did nothing wrong, the company has agreed to the settlement in order to avoid costly litigation.
    • The CMA also fined Generics UK (now part of Mylan (MYL -1%)) and its former parent Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) ₤5.8M and Actavis (AGN +0.1%) ₤1.5M as the successor to Alpharma.
    | Fri, Feb. 12, 12:25 PM