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.
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.
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.
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)
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, 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.
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)
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.
Mon, Jan. 11, 10:09 AM
- As expected, Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) returns all rights to evofosfamide back to discoverer Threshold Pharmaceuticals (THLD -4%). Last month, Threshold shares plunged over 80% on the news that two Phase 2 clinical trials assessing the product candidate in pancreatic cancer failed to achieve their primary endpoints. The disappointing results prompted Merck to cancel its commercialization plans.
- Previously: Threshold's lead product candidate flunks two late-stage trials; shares plummet 83% (Dec. 7, 2015)
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.
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. 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. 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.
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. 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.
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".
Industry: Drug Related Products