STADA Acquires Triple Combo Pump Therapy, Seeks European Approvals

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by David Melamed, PhD |

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Stada, triple combo therapy

STADA Arzneimittel has announced the acquisition of Sweden-based Lobsor Pharmaceuticals, gaining the rights to its triple-combination therapy of levodopa, carbidopa, and entacapone, delivered via modern pump technology, as a treatment for patients with late-stage Parkinson’s disease.

The triple-combo treatment has already been approved in most Nordic countries, including Sweden, Denmark, Finland, and Norway. By acquiring the therapy, STADA is aiming to have it approved throughout major European markets.

The company will assign its new therapy to its subsidiary, Britannia Pharmaceuticals, which focuses primarily on disorders of the central nervous system.

“This acquisition of Lobsor significantly expands STADA’s specialty footprint and serves as further evidence that STADA is a leading go-to-partner for specialty pharmaceuticals, generics and consumer health products,” Peter Goldschmidt,STADA CEO, said in a press release. “It also complements our portfolio and expertise in the treatment of late-stage Parkinson’s disease, where we have strong expertise via our company Britannia Pharmaceuticals.”

The triple treatment was originally under the control of Lobsor in all countries except the Americas, Japan, and Taiwan. Lobsor has been able to demonstrate the treatment’s therapeutic potential, which allowed the Sweden-based company to lead its approval in the region.

STADA’s acquisition of Lobsor will allow for the therapy to be produced and distributed on a much greater scale.

“With limited resources, we have managed to take the treatment system through proof of concept and early proof of business,” said Ulf Rosén, CEO of Lobsor.

“Now it is time to scale up, and Britannia has the relevant experience, organisation, resources and out-reach to make the therapy available internationally,” Rosén said. “Lobsor’s management is happy to stay on to support a smooth and effective transition and is looking forward with anticipation to handing over the treatment system to Britannia.”

The therapy combo includes levodopa, which is a molecular precursor for the neurotransmitter dopamine that is commonly prescribed to Parkinson’s patients. In the progression of Parkinson’s, the brain cells that produce dopamine are damaged and lost.

As the disease progresses, levodopa is typically administered in combination with other treatments to enhance its effectiveness. In this instance, the levodopa is paired with carbidopa and entacapone, which are designed to slow the breakdown of the levodopa and dopamine.

Carbidopa inhibits the activity of a certain type of enzyme, called a decarboxylase, that is known to break down dopamine in the body.

The triple therapy also includes entacapone, which is a small molecule inhibitor of another enzyme, catechol-O-methyltransferase (COMT), involved in the breakdown of dopamine.

The treatment now acquired by STADA is unique, in that it is a gel formulation delivered via an infusion directly into the small intestine. The infusion is controlled by a lightweight, wearable pump, giving patients the flexibility to administer the therapy at their convenience.

Britannia will use the combo therapy to expand its own efforts to provide care for Parkinson’s patients; the company also provides a 24-hour nurse service.

“We believe this infusion formulation will have positive clinical benefits for patients who need a device-aided, continuous form of therapy which can resolve intractable motor fluctuations and improve their quality of life,” said Robert Wood, managing director of Britannia. “We aim to broaden patient access to a device that is light, user-friendly, and discreet, enabling them to get on with their everyday lives with the full support of Britannia’s existing 24-hour Parkinson’s disease nurse service.”

Ultimately, the triple treatment is designed to improve quality of life by addressing the symptoms of Parkinson’s disease.

“Continuous improvement of the management of Parkinson’s disease, including through infusion pump therapies and deep-brain stimulation, is important,” said Dag Nyholm, MD, PhD, associate professor of neurology at Uppsala University in Sweden.

Nyholm notes that advances help both to increase therapy adherence and reducing side effects among patients.

“The field is moving forward in several areas; with exciting new approaches which try to modify the course of the disease,” he added. “However, we have to keep improving the symptomatic treatments which [give] our patients the best possible quality of life, in spite of the degenerative nature of the disease.”