BioSpace Global Roundup, Aug. 8

Global Connection

AstraZeneca – U.K.-based AstraZeneca announced the European Commission has approved an update to the marketing authorization for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease. In the Phase III DECLARE-TIMI 58 trial, Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalization for heart failure or CV death versus placebo, one of the two primary efficacy endpoints. There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however, this did not reach statistical significance. The Phase III DECLARE-TIMI 58 trial confirmed the well-established safety profile of Forxiga. The trial showed no significant imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier’s gangrene. Inclusion of the DECLARE-TIMI 58 trial data to the medicine’s label is currently under regulatory review in the US and China.

Cytena GmbH -- Germany-based Cytena will be sold to Cellink AB for €30.2 million. Cellink said it sees “great synergies” that will support and accelerate future growth of Cytena, Cellink said. Through this strategic acquisition, Cellink said it “expands its technology portfolio, supporting further expansion into the pharmaceutical industry.” Cytena’s single-cell dispensing platform enables pharmaceutical companies to develop antibodies and cell lines and offers a great complement to Cellink’s 3D bioprinting technologies. The companies’ synergies enable greater market opportunities for Cytena’s and Cellink’s product portfolio and global sales forces. The products are well-suited to be sold together to Cytena’s and Cellink’s existing customer base. Cytena will remain under current entity and management post-transaction, the company said.

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TTP LabTech – U.K.-based TTP Labtech Ltd. announced the introduction of chameleon, an industry-enabling sample-preparation system for cryo-electron microscopy (cryo-EM). The new system has been designed to enable consistent application of samples to high-quality foil grids for cryo-EM analysis, automating the current standard approach, which is a technically-demanding, largely manual process, TTP said in a statement. Chameleon will allow researchers in the rapidly growing field to more easily and accurately determine the structure of biomolecules, supporting protein research and drug discovery. The new chameleon system will bring significant improvements to current sample-prep workflows, including, high-speed blot-free plunging, automated grid handling and grid screening based on ice thickness.

Expedeon – Canada-based Expedeon AG signed an agreement with Germany-based Sona Nanotech Inc. to address limitations in development of complex, multiplex point-of-care (POC) lateral flow assay (LFA) diagnostic tests. Under the terms of the agreement, Expedeon will provide gold nanoparticle, bioconjugation technologies and expertise, and Sona will offer its lateral flow assay development services. The collaboration will enable the rapid development of more complex / multiplex immunoassays into LFAs, from proof of principle, through scale-up and transfer to manufacturing.

Acerus Pharma– Based in Toronto, Acerus announced it will take an expanded role in the commercialization of Natesto in the United States through a licensing agreement with Ayuto Bioscience. When the deal closes, the partnership between the two companies will move from an out-license model to a co-promotion arrangement that the companies believe will leverage their collective product, marketplace to capture a significant share of the U.S. market for Natesto, a testosterone gel. Under the terms of the new agreement, Colorado-based Ayuto returns the NDA for Natesto in the U.S. back to Acerus. Going forward Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. Acerus will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy as part of the companies’ joint commercialization committee, and will launch a specialist sales force focused on urologists and endocrinologists. Ayuto will retain its primary care sales force and will continue to book all product net revenue while serving as the exclusive U.S. supplier of Natesto to wholesalers, pharmacies and other customers that receive a direct shipment.

SpringWorks Therapeutics – Springworks was granted Orphan Drug Designation from the European Commission for mirdametinib, an oral, small-molecule inhibitor of MEK1 and MEK2, for the treatment of neurofibromatosis type 1 (NF1). NF1 is a rare genetic disorder characterized by mutations in the MAPK pathway. There are currently no therapies approved for the treatment of NF1-PN. Mirdametinib previously received Orphan Drug Designation from the FDA for the treatment of neurofibromatosis type 1 and Fast Track Designation from the FDA for the treatment of patients over two years of age with neurofibromatosis type 1-associated inoperable plexiform neurofibromas that are progressing or causing significant morbidity. SpringWorks expects to initiate the ReNeu trial, a Phase 2b open-label, single-arm trial with mirdametinib that will enroll both pediatric and adult NF1-PN patients, in the third quarter of 2019.

Synaptive Medical – Toronto-based Synaptive Medical announced the launch of Modus Plan in the United States. Modus Plan, previously referred to as BrightMatter Plan, will supplement Synaptive’s fully integrated suite of surgical technologies, including its robotically controlled microscope, Modus V. This release provides the additional capability of automated tractography segmentation into patient-specific bundles of interest, Synaptive said in its announcement. Synaptive’s Modus Plan software automatically generates dynamic whole-brain tractography. This new capability takes it one step further by visually segmenting these tracts into patient-specific bundles, thereby providing surgeons valuable information about areas of the brain during surgical procedures.

MC2 Therapeutics – Denmark-based MC2 announced the completion of enrollment for its EU Phase 3 study assessing the safety and efficacy of MC2-01 PAD Cream (calcipotriene and betamethasone dipropionate) in adult patients with plaque psoriasis compared to Daivobet gel. The study is a Phase III, randomized, multicenter, parallel-group study evaluating the efficacy and safety of MC2-01 PAD Cream in subjects with plaque psoriasis compared to MC2-01 vehicle and Daivobet gel. The primary objective is to show therapeutic superiority of MC2-01 PAD Cream to the active comparator, as well as to characterize the safety profile of MC2-01 PAD Cream in subjects with plaque psoriasis. The primary efficacy endpoint is percentage change from baseline in mPASI on the body at eight weeks.

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