Thu, Nov. 10, 5:15 AM
Wed, Nov. 2, 7:05 PM
- Stockholm-based Medivir AB (OTC:MVRBF)(OTC:MVRBY) inks an agreement with TetraLogic Pharmaceuticals (NASDAQ:TLOG) to acquire two clinical-stage oncology programs.
- The first, remetinostat, is an inhibitor of enzymes called histone deacetylases (HDACs) designed to be rapidly broken down in the bloodstream thereby avoiding the unwanted side effects associated with systemically administered HDAC inhibitors (e.g., nausea, vomiting, anemia, thrombocytopenia, neutropenia). It is currently in Phase 2 development for the treatment of early-stage cutaneous T-cell lymphoma. A Phase 3 study should commence in H2 2017.
- The second, birinapant, is a bivalent second mitochondrial activator of caspases (SMAC) mimetic that binds a group of proteins called cellular inhibitor of apoptosis proteins (cIAPs), thereby promoting apoptosis (programmed cell death). Medivir intends to initiate two studies: a Phase 1 assessing birinapant in combination with Merck's Keytruda (pembrolizumab) in patients with solid tumors and a Phase 2 study assessing birinapant in combination with platinum-based chemo in high-grade serous carcinomas, including ovarian cancer.
- Under the terms of the agreement, Tetralogic will receive an upfront payment of $12M, up to $96M in milestones for remetinostat, up to $130M in milestones for birinapant and sales-based tiered royalties of 13% for remetinostat and 10% for birinapant. The transaction should close by year end. Merck needs to sign off on an agreement transfer for birinapant considering its April 2015 license agreement with TetraLogic.
- Previously: Merck and TetraLogic Pharma establish clinical study collaboration (April 20, 2015)
Mon, Oct. 10, 9:17 AM
- Medivir AB (OTC:MVRBF) announces a reorganization of the company and a significant cost reduction in both early research and administrative functions. The board has decided that henceforward the company will exclusively focus on oncology, utilizing both of Medivir´s technology platforms and competences in protease inhibition and nucleotide-/nucleoside science. Partnering discussions for all remaining infectious disease assets in the R&D pipeline will be initiated by year-end, as well as for MIV-711 once the phase 2a program has been completed.
- The reorganization will result in a total cost reduction of ~110MSEK ($12.7M) per year and the elimination of ~25 research positions. The company says the smaller organization in early research will create flexibility to strengthen capabilities in clinical development and will enable broadening the pipeline with oncology projects in clinical phases.
- As a consequence of these changes, a total of around 30 positions will be cut. A charge of ~20MSEK ($2.3M) related to these actionswill be recorded in Q4.
Fri, Sep. 23, 7:31 AM
- Medivir AB (OTC:MVRBF) announces new information about its phase IIa program for the treatment of osteoarthritis. The independent Data Monitoring Committee (DMC) has recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on a review of unblinded safety data. The first patient has been enrolled into an open label phase IIa extension study, MIV-711-202.
- The objective of MIV-711-201 is to evaluate the safety, tolerability and efficacy of six months of treatment with MIV-711 in patients with moderate knee osteoarthritis.
- MIV-711, a cathepsin K inhibitor, is being developed as a DMOAD (disease-modifying osteoarthritis drug) which is a drug designed to slow or reverse the progressive joint degeneration associated with osteoarthritis. There are currently no DMOADs approved for this indication.
- Top-line data from MIV-711-201 should be available in 2H 2017 and results from the extension phase are expected in 1H2018.
Wed, Jun. 15, 7:19 AM
- Medivir AB (OTC:MVRBF) announces that the Board of Directors has tasked executive management with reviewing the possibility of dividing the company’s operations into two independent companies: an R&D organization and a commercial pharmaceutical company with a separate listing.
- The objective is to unlock the value of both the commercial operations and the pharmaceutical projects that make up the R&D portfolio. Also the split would enable the existing operations to be conducted by two clearly focused, specialized companies where both companies’ potential can be maximized.
- Update: On August 31, the company announced that it was proceeding with the separation. The action should be completed by year end.
Jul. 24, 2015, 9:01 AM
- Janssen (NYSE:JNJ) submits a supplemental New Drug Application (sNDA) to the FDA seeking new labeling for its HCV-1 drug Olysio (simprevir). The current label specifies a 12-week treatment period of Olysio, in combination with Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir), for patients without cirrhosis and 24 weeks for those with cirrhosis. The new label, if approved, will shorten the treatment periods to eight and 12 weeks, respectively. The shorter durations of treatment are supported by results from the OPTIMIST-1 and OPTIMIST-2 Phase 3 studies.
- Simprevir, an NS3/4A protease inhibitor, was jointly developed with Stockholm, Sweden-based Medivir (OTC:MVRBY) (OTC:MVRBF), which retains the marketing rights in the Nordic countries.
- Previously: Phase 3 results show HCV-1 cure rates as high as 97% for Olysio + Sovaldi (April 23)
Apr. 14, 2015, 9:06 AM
Nov. 24, 2013, 2:59 AM
- The FDA has approved Johnson & Johnson's (JNJ) and Medivir's (MVRBF) simeprevir pill for the treatment of chronic hepatitis C.
- The agency authorized that the drug, to be called Olysio, be used with other medicines.
- Olysio is part of a new wave of Hepatitis C treatments to be developed, with Gilead (GILD) and Bristol-Myers Squibb (BMY) among other companies that are working on such drugs.
- Analysts have forecast that Olysio will generate sales of almost $450M in 2016. (PR)
Mar. 4, 2013, 3:15 PM
A combination of Gilead's (GILD +0.6%) Sofosbuvir and Simeprevir, a drug being jointly developed by Medivir (MVRBF.PK) and Johnson & Johnson's (JNJ) Janssen unit, eliminates hepatitis C in all 80 patients in a Phase IIa study. The patients had failed to respond to other treatments. "We went for the most difficult to cure, with the idea if we could show good efficacy there, it could be assumed the regimen could be efficacious in other patient populations," says Gaston Picchio of Medivir partner J&J (JNJ +0.5%). (PR)| Mar. 4, 2013, 3:15 PM | 2 Comments