Teva Considering Bond Offering- Teva Pharmaceutical (TEVA) is looking to raise between $20 billion and $25 billion as early as next week to finance its acquisition of Allergan’s (AGN) generic business. This is according to a report by Globes. The planned bond offering will be aimed at foreign investors, the report noted.
Provectus Biopharma Forms Australian Subsidiary- Provectus Biopharmaceuticals (PVCT) announced that it has formed an Australian subsidiary, Provectus Biopharmaceuticals Australia Pty Ltd. that included opening a Sydney office in New South Wales. Interim CEO Peter Culpepper noted that the creation of an Australian entity is a fundamental part of company's plans for extended global reach in conjunction with planned partnering for commercialization of PV-10. The new unit should make it easier to work with Australian regulatory authorities and having an office in the region may facilitate our work in Asian markets as Sydney is just two hours ahead of Beijing, Hong Kong and Singapore.
Inotek Pharma Commences Mid-Stage Study of Glaucoma Combe Drug- Inotek Pharma (ITEK) announced that it has commenced a Phase 2 dose-ranging study of a fixed-dose combination of trabodenoson and latanoprost in an eye-drop formulation for the treatment of glaucoma. The primary endpoint is mean IOP at month 2. Trabodenoson, Inotek's lead product candidate, is a selective adenosine mimetic that augments the natural function of the eye's trabecular meshwork, the main passageway to transport aqueous humor (fluid) out of the eye.
Revance Completes Meeting with FDA- Revance Therapeutics (RVNC) shares edged lower in after-hours trading on Thursday after the company announced hat it completed its Type B/pre-IND/pre-Phase 3 meeting with the FDA regarding the advancement of RT002 (daxibotulinumtoxinA for injection) for the treatment of glabellar (frown) lines. Clinical trials should commence in H2. The Phase 3 program will include two placebo-controlled pivotal studies in the U.S. and Canada. The primary endpoint will be a composite of the proportion of patients who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity at maximum contraction at week 4.
Ultragenyx’s rhGUS Succeeds in Late-Stage Study- Ultragenyx Pharmaceuticals (RARE) announced positive results in a Phase 3 clinical trial evaluating enzyme replacement therapy, Fast Track-tagged recombinant human beta-glucuronidase (rhGUS), for the treatment of mucopolysaccharidosis 7 (MPS 7), known as Sly syndrome. The study met its primary endpoint of a statistically valid reduction of 64.8% from baseline in urinary GAG (dermatan sulfate) excretion after 24 weeks of therapy (p<0.0001). The data are being presented at the 14th International Symposium on MPS and Related Diseases in Bonn, Germany.