Privately-held Swedish pharmaceutical company Lobsor Pharmaceuticals AB is eying the U.S. market for a potential treatment for neurodegenerative diseases such as Parkinson’s disease.
Privately-held Swedish pharmaceutical company Lobsor Pharmaceuticals AB is eying the U.S. market for a potential treatment for neurodegenerative diseases such as Parkinson’s disease.
Uppsala-based Lobsor was granted a U.S. patent for its lead Parkinson’s treatment Lecigon. In October, the company received market authorization from the Swedish Medical Products Agency for Lecigon, a new gel therapy for symptomatic treatment of advanced Parkinson’s disease.
Lecigon is a combination of levodopa, carbidopa and entacapone. The combination treatment is continuously infused into a patient’s small intestine through a newly developed lightweight pump. Lobsor said the U.S. patent award reinforces the path for introducing a similar treatment in the United States through the company’s U.S.-based partner Intrance Medical Systems Inc.
Ulf Rosén, chief executive officer of Intrance Medical Systems, told BioSpace that the granting of the patent provides Intrance the tool to an exclusive therapy platform and grow from there.
“The approved patent captures an important factor of product differentiation – allowing a decrease in overall dosing while maintaining clinical outcome. I think this feature will significantly increase in importance when choosing advanced therapy and COMT-inhibition is key in this scenario,” Rosén said.
While Rosén said he could not provide a forecast for when Lecigon could enter the U.S. market space, he said the company has been in discussion with different sections of the U.S. Food and Drug Administration.
“To obtain NDA clearance our intention is to use the 505(b)(2) pathway, which I see as the fastest route to market,” Rosén said.
The 505(b)(2) pathway provides a potential pathway to regulatory approval in the United States by allowing some information required for a New Drug Application, such as safety and efficacy information on the active ingredient, to come from previously performed studies.
Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s disease. As the disease progresses, patients eventually reach the stage of advanced Parkinson’s. About 10 percent of Parkinson’s patients are estimated to be in the advanced stage. Of those, between 10 and 30 percent of patients receive adequate treatment. With advancing disease, it becomes increasingly difficult to counteract PD symptoms and one of three options for advanced PD come into play in which the goal is to provide continuous or continuous-like dopaminergic stimulation.
If it receives approval in the U.S., Lecigon could go head-to-head against AbbVie’s advanced Parkinson’s disease treatment Duopa. The AbbVie therapeutics is a combination of carbidopa and levodopa. It was approved by the FDA in 2015.
In its announcement, Lobsor noted that Levodopa (dopamine replacement agent) in combination with carbidopa has been the primary choice for continuous treatment of advanced Parkinson’s. That combination treatment though can have some problems. Primarily, Lobsor noted, high loads of levodopa, which can have long-term side effects. In order to overcome that issue, Lobsor’s therapy is a novel combination of three active substances that are already in use. The combination therapy comprises a dopamine replacement agent, a DD inhibitor (DD=dopamine decarboxylate) and a COMT inhibitor (COMT=catechol-O-methyltransferase). This combination is covered by the new patent in the U.S. The patent also includes a method of preparing the suspension and a method of treating a patient using the suspension. The patent is not limited to any amounts or ratios of the three components, which allows Lobsor to vary and tailor the concentration depending on regulatory demands, patient groups and cost, the company said.
Lobsor Chief Executive Officer Roger Bolsöy said the company is excited about receiving the new patent that will provide additional protection for the Lobsor treatment technology.
“With the new formulation and lightweight delivery pump, we believe Lecigon will significantly improve convenience and quality of life for Parkinson’s patients. Improving bioavailability and achieving a similar clinical outcome with significantly lower levodopa doses means we can also report significant reductions in 3-OMD, a metabolite in a metabolic complex associated with long term side effects of levodopa,” Bolsöy said in a statement.
The US patent expires in September 2035 and a corresponding patent is also granted in Sweden. Lobsor have co-pending applications for the same invention in Europe, Australia, Canada, China and Japan.
