Home Active Pharmaceutical Ingredients (API)Levodopa and Entacapone STADA and Bioglan signed an Agreement to Increase Production Capacity to Meet Rising Demand for Parkinson’s Treatment.

STADA and Bioglan signed an Agreement to Increase Production Capacity to Meet Rising Demand for Parkinson’s Treatment.

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STADA, Bioglan, Signed, Agreement, Increase, Production, Capacity, Rising, Demand, Parkinsons, Treatment, Lecigon, Dopamine, Levodopa, Carbidopa, Entacapone,

KEYWORDS:

  • Bioglan, the Swedish subsidiary of the Spanish pharmaceutical company, and STADA Arzneimittel AG have signed an agreement to expand the production capacity for manufacturing Lecigon, a medicine used for the treatment of advanced Parkinson’s disease.
  • In October, STADA acquired the rights to a triple combination product with the active ingredients levodopa, carbidopa and entacapone.
  • STADA Germany head Eelco Ockers: “We are delighted to be able to offer a novel triple-combination product with modern pump technology that strategically complements our neurology portfolio and continues our commitment to treating Parkinson’s disease patients.”
STADA, Bioglan, Signed, Agreement, Increase, Production, Capacity, Rising, Demand, Parkinsons, Treatment, Lecigon, Dopamine, Levodopa, Carbidopa, Entacapone,

STADA and Bioglan signed an Agreement to Increase Production Capacity to Meet Rising Demand for Parkinson’s Treatment.

Bioglan, the Swedish subsidiary of the Spanish pharmaceutical company REIG JOFRE, (BME:RJF), and STADA Arzneimittel AG have signed an agreement to expand the production capacity for manufacturing Lecigon, a medicine used for the treatment of advanced Parkinson’s disease.

Since the launch of the pump-based combination medicine in 2020, Bioglan has already delivered around 250,000 doses via 100 batches, thereby meeting patient need for Lecigon in the initial launch countries. To meet the increasing demand for the therapy as STADA introduces Lecigon in further European countries over the coming months, the partners have agreed to build a new factory in Malmö, Sweden. Investment in this expansion that adds a sixth semi-solid production line at the site amounts to more than EUR 3 million.

Lecigon is a patented pharmaceutical gel formulation containing a combination of levodopa/carbidopa and entacapone in a 47 ml pre-filled cartridge for continuous infusion into the small intestine through a discreet, lightweight and wearable pump that weighs 134 grams. The Crono LECIG Pump is currently prescribed for patients with late-stage Parkinson’s disease who are experiencing debilitating motor symptoms that can no longer be controlled by oral medication.

Following initial launches in Nordic countries, the therapy has already been approved in several European countries and is currently marketed by STADA in Germany, Austria and Slovenia, with launches in additional European and selected international markets scheduled in the near future.

Simon Björklund, CEO of Bioglan, commented: “Lecigon is a new and highly interesting drug that shows great progress with strong patient demand. Continuous new launches in Europe require significantly increased supply. I am glad that the close and successful collaboration with STADA will enable this expansion. Bioglan anticipates over the long term manufacturing large volumes of Lecigon to a market that over time could run to millions of euros.”

Robert Wood, managing director of STADA’s Britannia Pharmaceuticals Ltd subsidiary that specializes in central nervous system disorders such as Parkinson’s disease, said the facility expansion reflected the significant potential of Lecigon to satisfy unmet patient need for this debilitating condition. “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. 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,” he stated.

Bioglan belongs to the Spanish pharmaceutical company Reig Jofre and is the center of excellence for semi-solid product development and production.

Founded in 1929 in Barcelona, Reig Jofre is a family-run pharmaceutical company, listed on the Spanish stock exchange’s continuous market, dedicated to the research, development, manufacture and marketing of pharmaceutical products and food supplements at its four plants in Toledo (2), Barcelona and Malmö (Sweden).

About Lecigon:

Lecigon is a new gel formulation of a fixed combination of levodopa, carbidopa and entacapone for continuous intestinal use in advanced PD. It combines the favourable dynamics of continuous intestinal infusion with the benefits of a dopa catechol-O-methyltransferase (COMT) inhibitor, entacapone, in an easy-to-use pump-based treatment. It is an evolution of Stalevo, a widely used oral therapeutic in earlier stages of PD. Lecigon is formulated and designed for individuals with advanced PD.

Levodopa is a precursor of dopamine
 and mediates the anti-parkinsonian effect, whereas carbidopa and entacapone modify the metabolism of levodopa to increase and prolong brain exposure to levodopa and to decrease dopamine-related side effects outside the brain. The continuous intestinal administration of Lecigon is administered with a small and accurate pump enabling a dosage within the narrowing therapeutic window in advanced PD. The delivery directly into the intestine circumvents the limitations of erratic gastric emptying and short plasma half-life of levodopa.

The addition of the COMT inhibitor entacapone increases the bioavailability of levodopa and thereby allows the use of lower doses and volumes of levodopa and carbidopa. Thus, the addition of entacapone in Lecigon enables the use of a smaller primary container as well as a smaller and lighter pump.

The lower dose of levodopa and carbidopa required in the presence of entacapone, not only enables the use of a smaller container and pump system, but is also in line with clinical concerns about potential side effects of high levodopa and carbidopa doses.

About Parkinson disease:

Parkinson’s disease (PD) is the second-leading cause of dementia and is characterized by a progressive loss of dopaminergic neurons in the substantia nigra alongside the presence of intraneuronal α-synuclein-positive inclusions. Therapies to date have been directed to the restoration of the dopaminergic system, and the prevention of dopaminergic neuronal cell death in the midbrain. This review discusses the physiological mechanisms involved in PD as well as new and prospective therapies for the disease. The current data suggest that prevention or early treatment of PD may be the most effective therapeutic strategy. New advances in the understanding of the underlying mechanisms of PD predict the development of more personalized and integral therapies in the years to come. Thus, the development of more reliable biomarkers at asymptomatic stages of the disease, and the use of genetic profiling of patients will surely permit a more effective treatment of PD.

About Bioglan:

Bioglan AB is a contract development and manufacturing organization with more than thirty years of experience in research, development, manufacturing and marketing of pharmaceuticals.

We develop, produce and market pharmaceuticals and medical devices. We also provide support for pharmaceutical, healthcare and life science companies in all aspects of development and manufacturing of semi-solid and liquid products. We collaborate with companies of all sizes, from the smallest start-up to the leading pharmaceutical companies.

Our manufacturing authorization from the Swedish Medical Products Agency allows us to produce non-sterile semi-solid and liquid products, both at pilot scale for clinical trials or at full-scale to supply a large commercial market. We can even be your QP release site for other types of products. Our quality system fulfils the EU and FDA GMP (Good Manufacturing Practice) requirements as well as the ISO 13485 standard for Medical Devices.

Bioglan is a reliable, efficient and flexible organization that delivers projects with the best quality at the right time in a cost-effective way. We are proud that we meet the quality requirements of the global markets.

About STADA Arzneimittel AG:

STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a two-pillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2019, STADA achieved adjusted Group sales of EUR 2,608.6 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 625.5 million. As of December 31, 2019, STADA employed 11,100 people worldwide. 

 

SOURCE: AUTHENTIC

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