Merck KGaA ADR (MKGAY) - OTCPK - Current
  • 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
    | 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
  • Mon, Jan. 11, 10:09 AM
    | Mon, Jan. 11, 10:09 AM
  • Mon, Jan. 4, 8:34 AM
    • Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY), Pfizer (NYSE:PFE) and Syndax Pharmaceuticals enter into an exclusive collaboration to evaluate the combination of the anti-PD-L1 IgG1 monoclonal antibody, avelumab, and Syndax's small molecule HDAC inhibitor, entinostat, in patients with heavily pre-treated, recurrent ovarian cancer. Syndax will be responsible for conducting the Phase 1b/2 clinical trial. Financial terms of the partnership are not disclosed.
    • Avelumab is currently being investigated across a range of tumor types under the alliance between Germany's Merck and Pfizer.
    • Ovarian cancer strikes ~240K women worldwide each year. The prognosis is generally poor because the cancer is typically detected in the advanced stage. Patients who are unable to undergo treatment with platinum-based chemo have very limited treatment options.
    | Mon, Jan. 4, 8:34 AM
  • Dec. 22, 2015, 9:09 AM
    • Pfizer (NYSE:PFE) and development partner Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) announce the initiation of two Phase 3 clinical trials assessing PD-L1 inhibitor avelumab in ovarian cancer and urothelial cancer.
    • JAVELIN Ovarian 200, a 550-subject, open-label, parallel group, global study will assess the superiority of avelumab as monotherapy or in combination with pegylated liposomal doxorubicin (PLD) compared to PLD alone in patients with platinum-resistant/refractory ovarian cancer. The primary endpoint is overall survival (OS). The study will be conducted in more than 190 sites in North America, Europe and Asia. According to clinicaltrials.gov, the estimated study completion date is February 2018.
    • JAVELIN Bladder 100, a 668-subject global study, will assess avelumab as maintenance therapy in the first-line setting in patients with locally advanced or metastatic urothelial cancer. Avelumab plus best supportive care (BSC) will be compared to BSC alone. The primary endpoint is OS. According to clinicaltrials.gov, the estimated study completion date is May 2019.
    • Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. The companies inked a strategic alliance in November 2014 to co-develop and co-commercialize the product. Other studies are ongoing in non-small cell lung cancer, Merkel cell carcinoma and gastric/gastro-esophageal junction cancer.
    | Dec. 22, 2015, 9:09 AM
  • Dec. 9, 2015, 11:32 AM
    • Pfizer (PFE -0.3%) and alliance partner Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) initiate two Phase 3 clinical trials evaluating avelumab in advanced/metastatic gastric/gastro-esophageal junction (GEJ) cancers, conditions associated with poor prognoses.
    • The first study, JAVELIN Gastric 100, will compare the switch from first-line chemotherapy to maintenance therapy with avelumab versus continuation of chemo in patients with unresectable, locally advanced or metastatic gastric/GEJ cancers whose disease has not progressed with first-line platinum-based chemo. The randomized, open-label trial will enroll 629 subjects across more than 220 sites in North and South America, Europe and Asia Pacific.
    • The second study, JAVELIN Gastric 300, will assess the superiority of avelumab compared to the investigator's choice of chemo from a pre-specified list of options in patients with unresectable, recurrent or metastatic gastric/GEJ cancers. The randomized, open-label trial will enroll 330 subjects across 170 sites in the same regions as JAVELIN Gastric 100.
    • Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. The companies inked a strategic alliance in November 2014 to co-develop and co-commercialize the product. Other studies are ongoing in non-small cell lung cancer and Merkel cell carcinoma.
    | Dec. 9, 2015, 11:32 AM
  • Dec. 7, 2015, 11:17 AM
    • Nano cap Threshold Pharmaceuticals (THLD -82.7%) drops through the floor on a massive 23x surge in volume in response to its announcement that lead product candidate evofosfamide (formerly TH-302) failed two Phase 3 studies, MAESTRO and TH-CR-406/SARC021.
    • In MAESTRO, the regimen of evofosfamide plus gemcitabine failed to show a statistically valid improvement in overall survival (OS) compared to gemcitabine plus placebo in treatment-naive patients with advanced unresectable or metastatic pancreatic cancer (p=0.0589).
    • In TH-CR-406/SARC021, the regimen of evofosfamide and doxorubicin failed to show a statistically valid improvement in OS compared to doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (p value not disclosed).
    • Evofosfamide is an investigational hypoxia-activated prodrug which is activated under tumor hypoxic (low oxygen) conditions which typify many cancers. Low oxygen levels in solid tumors are due to insufficient blood supply as a result of abnormal vasculature.
    • Full results will be submitted for presentation at future scientific conferences and for publication.
    • Co-developer Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) has canceled its commercialization plans for the product.
    | Dec. 7, 2015, 11:17 AM | 5 Comments
  • Nov. 25, 2015, 7:24 AM
    • The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) issues a positive opinion backing Orphan Drug designation for avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer that strikes 2,500 Europeans each year.
    • Pfizer (NYSE:PFE) and alliance partner Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) are currently conducting a Phase 2 trial, JAVELIN Merkel 200, assessing avelumab in patients with metastatic MCC whose disease has progressed after at least one prior line of chemotherapy. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint (confirmed best overall response) is January 2016. The estimated study completion date is January 2017.
    • The companies inked a deal in November 2014 to co-develop and co-commercialize the product.
    • Among the benefits of Orphan Drug status in the EU is a 10-year period of market exclusivity for the indication, if approved.
    • Previously: Pfizer and Merck KGaA's avelumab a Breakthrough Therapy for rare skin cancer (Nov. 18)
    | Nov. 25, 2015, 7:24 AM | 1 Comment
  • Nov. 18, 2015, 7:56 AM
    • The FDA designates Pfizer (NYSE:PFE) and alliance partner Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) Orphan Drug- and Fast Track-tagged avelumab a Breakthrough Therapy for the treatment of Merkel cell carcinoma, a rare type of skin cancer also known as neuroendocrine carcinoma of the skin. It strikes ~1,500 Americans each year.
    • Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
    • The data supporting the designation was generated in a Phase 2 study called JAVELIN Merkel 200. Additional data from the trial will be presented at a medical conference in 2016.
    • Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. The companies inked a strategic alliance in November 2014 to co-develop and co-commercialize the product.
    | Nov. 18, 2015, 7:56 AM
  • Nov. 4, 2015, 9:12 AM
    • Darmstadt, Germany's Merck KGaA (OTCPK:MKGAF) (OTCPK:MKGAY) and development partner Pfizer (NYSE:PFE) announce the initiation of an international Phase 3 clinical trial evaluating PD-L1 inhibitor avelumab (MSB0010718C) versus platinum-based doublet chemotherapy in treatment-naive advanced non-small cell lung cancer (NSCLC).
    • The open-label, randomized study will enroll ~420 subjects with recurrent or Stage IV PD-L1+ NSCLC across 240 sites around the world. Participants will receive either avelumab or the investigator's choice of platinum-based chemo based on the patient's histology (squamous or non-squamous) as first-line treatment. The primary endpoint is progression-free survival. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is February 2018. The estimated study completion date is June 2023.
    • This is the second Phase 3 trial assessing avelumab in NSCLC. The first, initiated in April of this year, is evaluating the PD-L1 inhibitor in patients whose disease has progressed after receiving platinum-based doublet chemo compared to docetaxel. According to clinicaltrials.gov, the estimated study completion date is October 2021.
    • The companies inked a strategic alliance in November 2014 to co-develop and co-commercialize avelumab.
    | Nov. 4, 2015, 9:12 AM | 1 Comment
  • Oct. 7, 2015, 7:55 AM
    • The FDA designates Orphan Drug-tagged avelumab for Fast Track review for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. Avelumab, currently in Phase 2 development for MCC, is a fully human anti-PD-L1 IgG1 monoclonal antibody. It is being co-developed and co-commercialized by Merck KGaA (OTCPK:MKGAF) (OTCPK:MKGAY) and Pfizer (NYSE:PFE) under their November 2014 strategic alliance.
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the NDA.
    | Oct. 7, 2015, 7:55 AM | 4 Comments
  • May 12, 2015, 7:53 AM
    • Threshold Pharmaceuticals (NASDAQ:THLD) announces that the FDA has designated evofosfamide, in combination with gemcitabine, for Fast Track review for treatment-naive patients with metastatic or locally advanced unresectable pancreatic cancer. This is the second Fast Track tag for the drug candidate. In November 2014 the FDA granted it for the treatment, in combination with doxorubicin, of advanced soft tissue sarcoma.
    • Evofosfamide (TH-302) is an investigational hypoxia-activated prodrug which is activated under tumor hypoxic (low oxygen) conditions which typify many cancers. Low oxygen levels in solid tumors are due to insufficient blood supply as a result of abnormal vasculature.
    • Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA (OTCPK:MKGAF) (OTCPK:MKGAY), which includes an option for Threshold to co-commercialize it in the U.S.
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    • THLD is up 17% premarket on robust volume.
    | May 12, 2015, 7:53 AM
Company Description
Merck KGaA is a global pharmaceutical, chemical and life science company with a history that began in 1668 and a future shaped by approximately 40,000 employees in 67 countries. Merck KGaA's subsidiaries in North America operate using the umbrella brand "EMD".
Sector: Healthcare
Industry: Drug Related Products
Country: Germany