Companies are looking for differentiated branded generics

"Companies are looking for differentiated branded generics"

#SpeakPharma with Athena DDS

2019-09-12

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This week, SpeakPharma spoke to Alexandre Williams, founder and managing director of Athena, an international company with an Indian manufacturing base that specializes in lifecycle products. Williams tells us about Athena’s products and also gives us an insight into the lifecycle management of oral dosage products. Athena’s India office is situated in Mumbai, with a manufacturing facility in Ambernath in the Mumbai Metropolitan Region.

Can you briefly tell us about the origins of Athena?

In 2006, a private equity firm invested in Ethypharm, a Europe-based speciality pharmaceutical company with a global reach. It wanted to shift the company’s focus from business-to-business (B2B) to business-to-consumer (B2C) and divest some assets, including the Indian operations.

Athena Drug Delivery System (Athena DDS) is a spin-off of Ethypharm India’s operations. The company spun off from its parent — Ethypharm — in 2011.

Like Ethypharm, Athena also deals in specialized oral solid DDS products. Some of the shareholders, management and staff of Athena have been with us since our Ethypharm days. However, we have shifted from Ethypharm’s B2C model to a B2B business model.

Our beginnings were not easy, as we had to build a new, standalone company. This meant developing and registering a new product portfolio in a variety of markets.

Much like the other formulation manufacturers, we were also affected by the rapidly increasing regulatory pressure. Therefore, we had to make significant investments in our India plant over the last few years.

What type of dosage forms does Athena manufacture?

We are only into oral solid dosage forms such as capsules, tablets and sachets. However, each of these have a special delivery system — such as taste masked granules/pellets, sustained release, extended release, enteric coated, oro-dispersible tablets, sublingual tablets, modified release tablets and so on.

What is oral dosage product lifecycle management and how does it benefit companies?

Companies are looking for differentiated branded generics. These are generic molecules with a lifecycle that does not exist yet or that is still very rare in the global market. Athena focuses on well-established products that can be improved through ‘oral solid drug delivery systems’. These drug delivery systems allow for a longer life in the market and help create a differentiation within the mainstream generic market.

Although currently the branded generic market is not the same as the generic one, it is catching pace gradually.

Tell us about Athena’s modified release formulations as well as oro-dispersible dosage forms? What are these products, and how are they beneficial to the end-user?

Oro-dispersible tablets can be taken any time and anywhere, and without water. These features of oro-dispersible tablets benefit the geriatric and pediatric populations.

Oro-dispersible tablets are well established in certain prescription segments such as central nervous system drugs, painkillers, drugs to treat nausea, vomiting and allergy, as well as OTC (over-the-counter) segments.

Take the example of Donepezil oro-dispersible tablet, which is taken by patients of dysphagia and Alzheimer’s disease. Donepezil oro-dispersible tablet melts in mouth and can be administered anytime, anywhere, and with or without water. It is an ideal choice for patients with Alzheimer’s since it effectively reduces the symptoms of mild-to-moderate dementia in such patients.

Athena has already developed many oral lifecycle products. These include Esomeprazole 20, 40 mg EC Capsule, Levocetirizine 5 mg ODT, Meloxicam 7.5, 15 mg ODT, Mesalasine 1 and 2 grams sachets, Ondansetron 4, 8 mg ODT, Secnidazole 2 grams Sachet High Dose, Racecadotril sachets 10, 30 mg, Tramadol Paracetamol 37,5/325 mg ODT, Zolpidem 5, 10 mg ODT and SL. These products are already marketed by leading companies across geographies or are under registration.

Can you update us on Athena’s latest activities?

On the one hand, we are upgrading our portfolio of products with very interesting new ideas, on the other hand, we have upgraded our quality level to match mature and emerging markets.

We have recently bagged approvals in markets like Brazil, Canada and Russia. We are looking forward to entering these markets quite aggressively with our drug delivery portfolio.

Following our regulatory approval in Brazil, we have opened an office in Sao Paulo along with a dedicated pipeline for the country.

What are some of your future plans?

We are actively looking to establish a second factory in order to pursue our expansion plans, and meet the requirements of an upcoming, rich pipeline of launches in many markets.

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