The Grünenthal Group has acquired Thar Pharmaceuticals for an undisclosed price, in a deal that adds a late-stage drug candidate to the buyer’s portfolio of pain treatments.
The acquisition, disclosed yesterday, adds to Grünenthal’s pipeline worldwide development and commercialization rights to T121, Thar’s Phase III-ready lead candidate for management of pain associated with complex regional pain syndrome (CRPS).
T121 is a novel composition-of-matter patented oral zoledronic acid drug that has received the FDA’s orphan drug designation. The intravenous (IV) form of zoledronic acid, marketed by Novartis as Reclast®, is already approved for postmenopausal osteoporosis in women, increase of bone mass in male osteoporosis, glucocorticoid-induced osteoporosis, and Paget’s disease in men and women.
Grünenthal says T121 complements and broadens its CRPS portfolio, which includes the Phase III candidate IV neridronate.
“This acquisition fully supports our strategy to become a leading player in CRPS,” Grünenthal CEO Gabriel Baertschi said in a statement.
Grünenthal plans to conduct pivotal studies intended to show the efficacy and safety of T121 in CRPS. According to the company, preclinical and pilot clinical results have suggested that zoledronic acid could significantly reduce pain and other debilitating symptoms of CRPS, a debilitating condition for which no treatments have been approved by the FDA or European Medicines Agency.
The acquisition of Thar comes some 3 months after the Pittsburgh-based company filed for a $50 million initial public offering that was never carried out. In that IPO, Thar detailed its pivotal-stage plans for T121.
“We plan to conduct two double-blind, placebo-controlled, multisite Phase III clinical trials with approximately 150 patients each,” Thar stated in its S-1 filing, dated August 19. “We anticipate initiating the first pivotal clinical trial in the first quarter of 2017.”
Headquartered in Aachen, Germany, Grünenthal focuses on transforming IV-only drugs into oral drugs for existing and new indications using its proprietary technology EnhanceTM development platform.