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Fe3 Medical, an InCube Labs company says the state of Texas has invested $3.5 million as part of an extension to the company’s Series B round to be used for product development, clinical trials and regulatory submissions required to obtain FDA approval for the transdermal patch for patients with iron-deficiency anemia. The company adds that the Fe3 patch offers an alternative to oral iron for the nearly half of patients who cannot tolerate gastrointestinal side effects of iron pills such as constipation, diarrhea, nausea and bloating.
Scintilla Pharmaceuticals, a subsidiary of Sorrento Therapeutics has entered into a binding term sheet to acquire Malvern, PA-based Scilex Pharmaceuticals, Inc. Scintilla says its lead product RTX, for treating opiate refractory cancer pain, has undergone a successful Phase 1 – 2 clinical trial, and is scheduled to begin Phase 2 clinical trials in early 2017. Scilex’'s lead product candidate, ZTlido (lidocaine patch 1.8%), is a branded lidocaine patch formulation being developed for treating postherpetic neuralgia. The company says it filed an NDA with FDA 7/2015 for Ztlido and is meeting with the agency this month to prepare a planned NDA re-submission for a potential FDA action date in mid-2017.
WuXi AppTec, an open-access R&D capability and technology platform company serving and its small-molecule process development and manufacturing subsidiary, Shanghai SynTheAll Pharmaceutical Co. are opening operations in San Diego, CA, which provides process research and development and API manufacturing services for early phase clinical studies.
Valeant Pharmaceuticals has entered into a licensing agreement with Norgine B.V. under which Valeant has obtained the rights to develop and commercialize NER1006 Powder for Oral Solution in the U.S. and Canada. According to the company, NER1006 is a novel, low-volume (1L) polyethylene glycol-based bowel preparation for cleansing of the colon in preparation of colonoscopy. It expects to file an application for approval with FDA this year. It says NER1006 has been developed to provide overall bowel cleansing, with an additional focus on the ascending colon in adults.
Pfenex Inc. says it will regain the full rights to PF582, a biosimilar candidate to Lucentis, following its partner's strategic review of its biosimilar pipeline. The company says Phase 1/2 safety and efficacy data in a trial enrolling a total of 25 VEGF-inhibitor naïve patients with neovascular age-related macular degeneration showed that with respect to safety, there were no meaningful differences in intra-ocular pressure between PF582 and Lucentis at any of the timepoints and the efficacy and pharmacodynamic results indicated that there were no meaningful differences in best corrected visual acuity and the decreases in central retinal thickness between PF582 and Lucentis at any of the timepoints were also similar.