LEXINGTON, Ky., April 30, 2018 /PRNewswire/ -- NX Development Corp (NXDC), a privately-held life sciences company, today announced a Merger Acquisition as a result of which NXDC has become a wholly-owned subsidiary of photonamic GmbH & Co. KG (Head office: Wedel, Germany; "PHN"). PHN is the licensor of GleolanTM (aminolevulinic acid HCl (ALA)) to NXDC. The companies share an eight-year working relationship.
PHN is engaged in the development of drugs that use 5-aminolevulinic acid (5-ALA) in Europe, Japan, Korea, Australia, and the United States of America. In 2016, SBI Holdings, Inc. (Tokyo, Japan) (SBIH) acquired 100% equity interest in PHN as part of its world-wide development strategy for 5-ALA through SBIH's subsidiary, SBI ALApharma Co. Ltd., a Hong Kong company (SBI ALA). NXDC will operate as a subsidiary of PHN within SBI ALA ALApharma group of life sciences companies focused upon commercialization of 5-ALA for healthcare.
NXDC obtained U.S. Food and Drug Administration approval for the use of GleolanTM as an intraoperative imaging agent. GleolanTM is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.
"We were pleased to complete this strategic transaction with PHN, enabling our vision to bring this real–time imaging agent to the neurosurgical community. SBI ALApharma, PHN and the neurosurgical community have been critical partners throughout this journey. That NXDC is now a member of the SBI life sciences group is a vote of confidence in our achievements,"' said Alan Ezrin, Ph.D., co-founder, chairman and CEO of NXDC.
"The U.S. approval has made 5-ALA a global product in neurosurgery for PHN as well as SBI ALApharma. We are pleased to further expand our international network to also include the U.S. through this merger with NXDC. We intend to invest in additional research and development projects for 5-ALA for potential use in many other new oncology indications," said Ulrich Kosciessa, Ph.D., CEO of PHN and COO of SBI ALApharma. "Over the last ten years, 5-ALA has been used in more than 60,000 neurosurgery patients worldwide."
"Working with both companies to introduce 5-ALA to the surgical community has been a highlight of my career," said Dr. Walter Stummer (University of Muenster, Germany). "It is a culmination of my mission to see 5-ALA approved in the U.S. and to have these teams come together to change the way we manage patients with Grades III or IV glioma."
GleolanTM is an FDA-approved optical imaging agent indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. GleolanTM helps neurosurgeons see malignant tissue in real time during surgery and is provided orally prior to glioma surgery. During operation, the surgeon utilizes a modified surgical microscope with a specific blue light filter for the visualization of red-violet fluorescence.
About NX Development Corp. (NXDC)
NXDC is a privately held life science company dedicated to the commercial launch of Gleolan in the U.S.
About PHN GmbH & Co. KG
PHN is a life science company engaged in research and development of drugs that use 5-ALA, primarily in Europe, as an intra-operative diagnostic drug, marketed under the name Gliolan®. Gliolan® was launched for the visualization of brain tumors and approved by the European Medicines Agency (EMA) in 2007. Today, Gliolan® is sold in over 40 countries. PHN also distributes Gliolan® through its business partners around the world.
SOURCE NX Development Corp