Grünenthal has bought Thar Pharmaceuticals to add another complex regional pain syndrome (CRPS) candidate to its late-phase pipeline. The takeover means Grünenthal now owns two of the leading pipeline prospects in CRPS, a recently minted orphan disease for which no drugs are approved in the U.S. or Europe.
Aachen, Germany-based Grünenthal has paid an undisclosed sum to take out a rival for the untapped CRPS market while giving itself a second shot on goal should its current candidate stumble.
Thar’s drug, T121, is an oral formulation of zoledronic acid, an intravenous version of which is sold by Novartis as Zometa. The oral formulation delivered comparable safety results to the intravenous version in an early-phase trial, prompting Thar to work toward an early-2017 start date for a Phase III study. Thar had planned to bankroll the Phase III trial by going public, but has canned the IPO in favor of accepting the buyout bid from Grünenthal.
Grünenthal will now take responsibility for worldwide development of T121. Work on the trial will ramp up as a study of Grünenthal’s other CRPS candidate, neridronate, winds down. Neridronate beat placebo in an 82-person study in 2012. On the back of that result, Grünenthal and Abiogen Pharma—the company that licensed neridronate to the German drugmaker—initiated more trials in CRPS. Grünenthal recently updated the status of its Phase III trial to “completed.”
If neridronate and T121 both succeed in the clinic, Grünenthal has a shot at cornering the virgin CRPR market by introducing intravenous and oral products in quick succession, although others are going after the indication, too.
"With the successful development of our expanded portfolio, oral T121 and IV neridronate, Grünenthal seeks to offer CRPS patients new hope for the future,” Grünenthal CSO Klaus-Dieter Langner said in a statement. “Our teams are highly motivated and will use all of their knowledge, experience and resources to bring these promising treatments to market for patients as soon as possible."
The need for speed is partly driven by the competitive landscape. Axsome Therapeutics has its own oral formulation of zoledronic acid that could pip T121 to market. In its IPO filing, Thar acknowledged Axsome’s drug “may be available in the market and used as an off-label therapy for the treatment of pain associated with CRPS before we can commercialize T121.”