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This week, SpeakPharma interviews Alexandre Williams, owner and director of Athena Pharmaceutiques, which is a trusted partner of choice to source differentiated branded generics in the pharmaceutical sector. Williams discusses the importance of research and development (R&D) to deliver cutting edge medical solutions to the international market, and the strategy behind choosing India to expand its R&D operations.
🔑 HIGHLIGHTS// branded generics/ innovation/ forward thinking/ CDMO/ France/ India
Athena Pharma has come a long way since it was first spun off from its parent company — Ethypharm — in 2011. The growth has been particularly remarkable over the last three years. Tell us how the company has managed to scale new heights during and post the Covid-19 pandemic?
We’ve been expanding operations in emerging markets since 2012, while also not ignoring developed markets. In 2017, we launched products in Europe, Canada, and the UK among other markets. So, we’ve been on a roll.
Covid had, in fact, a small impact on our activity. It did slow down some R&D and expansion projects. However, given our broad portfolio with allergy, anti-emetic and pain relief products, we saw an increase in sales during the pandemic.
In fact, 2020 was a big year for us. We acquired our first European factory in France — Athena IPS, set up our first office in Canada, and bought an effervescent technology. In 2022, we acquired the brand Secnol (secnidazole) and launched a new R&D facility in India.
Compared to Covid, we saw the European energy inflation crisis as a bigger threat, given the continent’s reliance on Russia for energy. Russia’s invasion of Ukraine and the expected sanctions on Russian imports meant that energy costs were going to skyrocket and create a massive turmoil in the supply chain. Those repercussions were felt by the market and our clients.
Our growth is fueled by our extensive portfolio of products. We have a huge number of launches planned in Brazil and pretty much every emerging market. Indeed, we will see over 100 new launches in the next two years.
🔑 HIGHLIGHTS// EU/ UK/ factory in France/ new office in Canada/ new R&D unit in India/ effervescent tech/Secnol acquisition
How is the market for branded generics growing? How is Athena creating a differentiation within this market to prolong the life of well-established products through improved drug delivery systems?
As mentioned, the pandemic was a booster for the branded generics market. As healthcare systems the world over scrambled to meet needs, accessibility and affordability that come with branded generics made them even more crucial. Furthermore, global supply chain disruptions led to a shift toward manufacturing locally and regionally produced branded generics. India has emerged as the largest generic supplier in the world. And with its growing population, the demand for affordable medication has also grown.
Branded generics are best supported with improved formulations. By offering a better, different or new product, our partners can market differentiated products that are set apart from competition. The differentiation must really bring an improvement in terms of delivery, compliance, taste or dosing. Only real lifecycle advantages make a difference, but it also must be cost effective to allow our partners to push sales of these new brand generics.
🔑 HIGHLIGHTS// pandemic boosted branded generics market/ India emerged as largest generic supplier
How important has R&D been to the company’s objective of delivering cutting-edge drugs? What steps have to be undertaken to ensure Athena’s commitment and dedication to R&D?
Innovation has always been central to Athena’s DNA, right from our humble beginnings. The mission was to leverage great research and development (R&D) to deliver cutting edge medical solutions to the international market.
We have invested steadily since our inception, including an investment in 2021 that led to opening up of our French R&D center. A year later, our new R&D center came up in Mumbai, adjacent to our Indian factory.
Personnel is key and I must say that I am highly proud of our R&D team. Building a good team takes time and effort. No R&D department can function without the right people.
🔑 HIGHLIGHTS// innovation/ team work/ right people
Athena has expanded its global presence (in markets like Brazil, Canada and China) in recent years. How have these expansions contributed to growth?
Different geographies come with different situations, needs, demographies, and healthcare challenges. This forces us to adapt our technology to create products of interest in each of those territories. When we successfully pull off a product lifecycle in one market, we can take what we learned and make that product a huge success in other markets.
For instance, in Canada we developed a generic zolpidem tablet for insomnia that disintegrates under the tongue. We then adapted it and positioned it as branded generic for Latin America and Europe and saw great success.
🔑 HIGHLIGHTS// different geographies — different needs
How have dosage forms like oro-dispersible and modified release formulations performed? Have you added more drugs to these dosage forms?
Oro-dispersible tablets (ODTs) are like conventional tablets with super disintegrants that dissolve in the mouth within minutes. ODTs have made it easy to administer medication, especially in pediatric, geriatric, and mental illness populations. This makes them a very popular dosage form. Improved patient compliance, rapid onset of action, and improved stability are some of the advantages we’ve seen. Athena’s Fastmelt technology has rendered it a leader in the ODT space.
Modified drug release protracts the drug’s release into the bloodstream or to a specific target and this means they can be taken at less frequent intervals. We’ve seen an increase in patient convenience, compliance, and thereby improved efficacy. Sustained release (SR) products sustain the level of a drug in the bloodstream and reduce adverse effects.
Indeed, we had developed many ODTs, taste masked and SR products. But what amazes me is that every time you are afraid that those matured technologies will become outdated, they don’t, and we have endless new developments to be carried out.
🔑 HIGHLIGHTS// ODTs for pediatric, geriatric, and mental illness/ SR drugs sustain level in bloodstream, reduce side effects
What are some of the fastest growing drug release mechanisms? How is effervescent technology performing?
As I mentioned, we are seeing speedy growth in drug delivery technologies. Fixed dose combinations are products of two or more drugs in a single dose. The simpler dosing schedule leads to excellent patient compliance, and it is among the fastest growing drug release mechanisms.
Effervescent technology is widely used in Europe, and worldwide it is used to deliver vitamins. The technology is of particular interest when it comes to products that need to be solubilized and drugs that absolutely need to be taken with water. However, effervescent technology is underdeveloped in emerging markets and only used for over-the-counter (OTC) or food supplement products. There are many new formulations that can use effervescent technology, so we can easily expand.
🔑 HIGHLIGHTS// effervescent tech for vitamins/ yet to pick up in emerging markets
What are some growth plans of Athena? Where do you see the company in the next five years?
Our new target markets for the coming years are China and the US, where we aren’t as active at present. As far as growth goes, the most critical aspect is identifying the product that is to be developed. So, our goal in the coming years is to enrich our portfolio of products that bring real value to people and their quality of life. Ideas are welcome!
🔑 HIGHLIGHTS// China/ USA/ expand portfolio
In terms of drug delivery technologies, Athena has come up with some groundbreaking solutions. Could you please tell us how these may be game-changers in the lives of patients?
These days, there is a lot of talk about revolutionary biotechnologies like ARNm (advances in radiotherapy and nuclear medicine) and CAR-T therapies, which specifically target and eliminate cancer cells more effectively. But we should not underestimate the crucial role our drug delivery technologies play, particularly in enhancing medication acceptance and compliance. They hold immense potential and remain an integral part of the healthcare landscape because we offer cost-effective and impactful solutions that improve patient outcomes.
🔑 HIGHLIGHTS// enhancing medication acceptance and compliance/ cost-effective and impactful solutions
Can artificial intelligence (AI) and machine learning help in discovering new drug delivery technologies? If so, then how?
They can certainly help in pharmacodynamics (effects of drugs and the mechanism of their action). In the in vivo vitro correlation, which is the predictive mathematical model that describes the relationship between the in vitro property of an oral dosage form and the corresponding in vivo response, Al can help gain a better understanding of the drug’s release or dissolution and the amount absorbed.
AI can help optimize and perhaps even individualize timing and dosage. It can analyze patient data, health records, geographical locations, medical literature, and patient demographics to match patients for clinical trials and monitor the trials for adverse events. Such real-time analysis can increase patient safety and help researchers assess how individual patients respond. It can help design formulations and select which technology serves the patient best. The use of AI will be massive, and we are just starting to use it.
🔑 HIGHLIGHTS// pharmacodynamics/ optimize and perhaps even individualize timing and dosage/ patient safety
What were the factors that helped Athena choose India for its expansion, particularly for R&D?
R&D power is really what makes Athena different, and it is thanks to our Indian staff who are experienced and well trained in pharmaceutical development. So, we chose India mainly for excellence in drug delivery and knowledge of pharmaceutical development. And not just for cost-effectiveness.
The Indian skill and competence are enhanced by the fact that Athena is active in so many markets from Europe and Canada to Brazil, Russia, and Asia. So, competence and experience required in those pharmaceutical markets is being acquired by our Indian personnel. The country is also doing a lot to ease foreign entry into its pharmaceutical industry like reducing timelines for facility approval.
🔑 HIGHLIGHTS// India: Excellence in pharma knowledge for DDS development
Impressions: 84
https://www.pharmacompass.com/speak-pharma/athena-s-r-d-prowess-is-its-key-differentiator-with-our-india-unit-bringing-in-excellent-knowledge
#SpeakPharma with Athena
19 Apr 2024
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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.
Impressions: 3250
https://www.pharmacompass.com/speak-pharma/companies-are-looking-for-differentiated-branded-generics-speakpharma-with-athena-dds
#SpeakPharma with Athena DDS
12 Sep 2019
