INNOVATIVE DRUG DELIVERY -...

INNOVATIVE DRUG DELIVERY

ATHENA

CORPORATE PRESENTATION 2019 Drug Delivery Solutions Pvt.Ltd

HISTORY AND MILESTONES

Athena designs, develops, manufactures & commercializes oral solid lifecycle

Athena is EU GMP approved for ODT & Tablets

Athena Shanghai R&D JV China open

Products Submitted : EU 13, UK 2, SA 3, CA 2, BR 1, RUS 1 & Others4

Products Registered : EU 4, UK 2, CA 1, RUS 2, SA 1 & Others6

EU GMP approval for ODT, Tablets, Capsules & Sachets

Submissions: EU 6, UK 2, BR 1, others 10 (total 19)

Registrations: EU 2, UK 1, CA 1, Mexico 1, others 8 (total 13)

2011 Spin Off from Parent company Ethypharm and renamed AthenaDDS

2013

2014

2015

2017

2018

Drug Delivery Solutions Pvt.Ltd

ANVISA Brazil; Canada; Russia, Australia TGA Approval 2019

WHAT WE DO … We connect the dots

Licensing and Supply

Co - Development

210 People dedicated to

DIFFERENTIATED BRANDED GENERIC

Supply in Semi Finished

Bulk or Finished Packs

CTD product to

be marketed

under Partner’s Brand


ATHENA R&D

Orally disintegrating tablet


SR / EC / SLTablets

Fixed Dose CombinationSR / EC Pellets in Capsules or in Sachets

Athena facility is situated in Mumbai, INDIA with state

of the art equipment for Solid oral dosage forms.

R&D: 50 People

Our facility is WHO-GMP, EU –GMP, ANVISA, Russia GMP, Canada GMP, MCC,

INVIMA, DIGEMID, TGA Austalia approved.

Technologies

ORALLY DISINTEGRATING TABLETS

> Melts rapidly in mouth

> Taste-Masked & Flavoured

> No water needed

> Anytime & Anywhere concept

CUSTOMIZED DRUG RELEASE

TECHNOLOGY

> Modified release Tablet

> Pellets in Capsules/Sachets

> Sublingual

> Trans mucosal

FIXED DOSE COMBINATION ( FDC)


Oral Dispersible Tablets in Bulk ready for compression

DIRECT COMPRESSION TECHNOLOGY

COATING OF GRANULES FOR BITTER DRUGS (Ibuprofen , Ondansetron etc.)


All Athena Products can

also be delivered as:

Bulk Granules for Tablets

Bulk Granules for Sachets

Bulk Pellets for Capsules

Bulk Pellets for Sachets

CTD Dossiers available in 2019


CARDIO & METABOLISM

Fenofibrate 160 mg Tablets EU

Fenofibrate 200 - 267 mg Capsule EU

Metformin 750 mg SR Tablet UK

PAIN

Ketoprofen Omeprazole 200/20 mg capsule EU/Brazil

Ibuprofen 100, 200, 400 mg ODT EU

Meloxicam 7.5, 15 mg ODT Russia/Brazil/EU

Paracetamol Tramadol 325/37.5 mg Tab UK & ODT EU

Paracetamol 125, 250, 500 mg ODT EU

Prednisolone 5, 10, 15, 20, 25 mg Soluble Tablet EU

Prednisolone 1, 5 mg ODT UK

RESPIRATORY

Levocetirizine 5 mg ODT EU/Russia/Brazil

CENTRAL NERVOUS SYSTEM

Donepezil 5, 10 mg ODT Brazil

Ondansetron HCL 4, 8 mg ODT Brazil

Ondansetron Base 4, 8 mg ODT EU/Canada

Sildenafil Citrate 50, 100 mg ODT Russia

Zolpidem 5, 10 mg ODT – EU/Brazil

Zolpidem 5, 10 mg SL – Canada/Brazil

GASTRO INTESTINAL

Domperidone 10 mg ODT EU

Esomeprazole 20, 40 mg Capsule EU

Mesalazine 1g, 2g Sachet EU

Racecadotril 10, 30 mg Taste Masked Sachet EU

UROLOGY/GYNECOLOGY

Secnidazole 2 g TM pellets sachet EU

CTD Dossiers available in 2020


CARDIO & METABOLISM

Desmopressin 60, 120, 240 mcg SL Tablet EU

Vitamin D3 25- 50 K IU ODT EU

PAIN

Ketorolac 10mg ODT Brazil

Ibuprofen 200, 400 mg Taste Masked Granules Sachet EU/Brazil

Paracetamol 250, 500, 1000 mg Taste Masked Granules Sachet EU

Prednisolone 1, 5 mg ODT UK

Tramadol 50-100-150-200 mg SR pellets Capsule UK


Zolpidem MR 6.25 mg & 12.5mg Tablet Brazil/ROW

GASTRO INTESTINAL

Esomeprazole 10 mg sachet EU

Mesalazine 500 mg Tablet EU

Racecadotril 10, 30, 100 mg ODT EU

R&D/MANUFATURING STRATEGY


TERRITORIES – EU/UK/CANADA

Pharmemerging - RUSSIA/BRAZIL/MEXICO/SOUTH AFRICA….

• DOSSIER DEVELOPMENT IN INDIA

• SMALL VOLUME TO BE MANUFACTURED IN INDIA

• BULK MANUFACTURING INDIA/EUROPE

• FULL OR PARTIAL TRANSFERT TO EUROPE/BRAZIL

Actual transfer to CMO in Europe for

- Racecadotril sachets 2 M packs - full transfer

- Zolpidem ODT 0.5 to1 M Packs – partial transfer

- Secnidazole sachets 1 M packs – partial transfer

ATHENA LEAD PRODUCTS


CARDIO & METABOLISM

Fenofibrate 160/200/267 mg Tablet & Capsule EU

PAIN

Paracetamol Tramadol 325/37.5 mg Tab & ODT EU/Brazil

RESPIRATORY

Levocetirizine 5 mg ODT EU/Russia/Brazil


Ondansetron HCL/Base 4, 8 mg ODT EU/Canada/Brazil

Zolpidem 5, 10 mg ODT & SL – Canada/Brazil/EU

GASTRO INTESTINAL

Esomeprazole 20, 40 mg Capsule EU

Mesalazine 1g, 2g Sachet EU

Racecadotril 10, 30 mg Taste Masked Sachet EU

UROLOGY/GYNECOLOGY

Secnidazole 2 g TM pellets sachet EU

DOMPERIDONE 10 MG ODT

2, Domperidone improves symptoms of nausea, vomiting, bloating, and feeling of fullness

QUICKMELT® TECHNOLOGY

1, Every Single particle is coated for excellent taste masking. 2, Melts in less than 10 sec.3, Ideal anti-emetic for relief of nausea and vomiting when the patient is not willing to swallow Tablet/Capsule.

DOSSIER1, Product Registered in Europe & marketed in Emerging Markets. 2, CTD dossier available.3, Zone IV Stability data available.

BIOSTUDY (Male, Female in Healthy Volunteers)1.Randomized two way crossover. (Test without water Vs. Reference without water)2.Ref product : Motilium® Instant 10 mg, J & J, Belgium 3, N =36; BE achieved

INFORMATION AT A GLANCE

1, Commercial Batch Size : 0.5 million doses; Dossier Batch Size : 0.125 million doses 2, Shelf Life : 3 years3, Tablet Weight : 250 mg4, Flavour : Trusil Peppermint

Registered in EU

An unique opportunityfor line extension of Domperidone


UNIQUE SELLING POINT1, Domperidone Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water

DONEPEZIL 5/10 MG ODT

QUICKMELT® TECHNOLOGY1, Every Single particle is coated for excellent taste masking. 2, Melts in less than 10 sec.3, Ideal anti-emetic for relief of nausea and vomiting when the patient is not willing to swallow Tablet/Capsule.

DOSSIER1, CTD dossier available.2, Zone IV Stability data available

BIOSTUDY (Male, Female in Healthy Volunteers)1, Randomized, three way, crossover study fast (Test with and without water vs. Reference with water) 2, Ref Product : Aricept® 10 mg Oro-Dispersible Tablet, Eisai S.A.S, France3, N = 394, BE achieved in all conditions (with and without water)


1, Commercial Batch Size : 5 mg – 1 million doses 10 mg – 0.5 million doses 2, Dossier Batch Size : 0.103 million doses3, Shelf Life : 3 years4, Tablet Weight : 5 mg - 140 mg / 10 mg - 280 mg

Registered in EU

Unique technology of Athena isan ideal choice for patients withAlzheimer’s disease (AD)


UNIQUE SELLING POINT1, Donepezil Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water.2, Effectively reduces the symptoms of mild-to-moderate dementia of Alzheimer’s disease.3, Oro-Dispersible Tablet is an ideal choice for patient with dysphagia and Alzheimer’s disease (AD).

FENOFIBRATE CAPSULE 267 MGUNIQUE SELLING POINT1, Fenofibrate is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL,

triglycerides) and raise “good” cholesterol (HDL) in the blood

2, Fenofibrate works by increasing the natural substance (enzyme) that breaks down fats in the blood. Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancre as disease pancreatitis)..

DOSSIER1, CTD dossier available2, Zone IV Stability data available

BIOSTUDY1, Randomized, 2 way crossover, fed study2, Reference Product : Lipanthyl® Micro Capsule Abbott Healthcare UK 3, N = 254, BE Study.

INFORMATION AT A GLANCE1, Commercial Batch Size : 267 mg : 0.248 million doses 2, Dossier Batch Size: 0.105 million doses3, Shelf Life : 2 years4, Average Fill Weight : 267 mg: 400mg 5, Capsule Size 0

Submitted in EU


Micro-ionised Fenofibrate formu-lation has improved absorption characteristics compared with the standard preparation allowing a daily low dosage and once daily administration.

LEVOCETIRIZINE 5 MG ODT

UNIQUE SELLING POINT

1, Levocetirizine Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water

2, Levocetirizine is considered as a first line treatment for allergic conditions such as hay fever; year round allergies, and chronic nettle rash.

3, Levocetirizine is free from sedative effects.

DOSSIER1. CTD dossier available with non infringing formulation. 2, Zone IV Stability data available

BIOSTUDY (Male, Female in Healthy Volunteers)1, Randomized, single dose, two way crossover study (Test without water vs Reference with water) 2, Ref Product : Xyzall® , UCB France3, N = 234, BE achieved


1, Commercial Batch Size : 0.5 million doses 2, Dossier Batch Size : 0.125 million doses

Shelf Life : 3 year3, Tablet Weight : 250 mg 4, Flavour : Black Currant

Submitted in EU

With the unique technology Athena has masked the unpalat-able taste of Levocetirizine which is extremely bitter


MELOXICAM 7.5/15 MG ODT


1, Meloxicam Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water.

2, Meloxicam selectively inhibits COX-2 relative to COX-1.3, Meloxicam is equivalent to Diclofenac SR in relieving acute pain associated with osteoarthritis and has

much better tolerance

DOSSIER1, CTD dossier available.2, Zone IV Stability data available.

BIOSTUDY (Male, Female in Healthy Volunteers)1, Randomized, two way crossover. (Test without water vs. Reference with water.) 2, Ref Product : Mobic® 15 mg Tablet, Boehringer Ingelheim, France3, N = 24 (Male & Female) 4, BE achieved


1, Commercial Batch Size : 7.5 mg – 0.675 million doses, 15 mg – 0.337 million doses 2, Dossier Batch Size : 7.5 mg – 0.225 million doses, 15 mg – 0.225 million doses3, Shelf Life : 3 years4, Tablet Weight : 7.5 mg - 180 mg / 15 mg - 360 mg 5, Flavour : Orange

Submitted in EU

A unique opportunity for line extension of Meloxicam

Projected Prevalence of Arthritis in US inadults


METFORMIN 750 MG SUSTAINED RELEASE TABLET


1, Same efficacy as Immediate Release Tablets

2, SR – once a day as compared to IR – Thrice a day, thus reducing the frequency of administration

3, Better tolerability – reduces GI side effects like nausea, abdominal pain, diarrhoea

4, First line drug of choice for Type 2 diabetes

5, Suppresses glucose production by liver thus decreasing hyperglycaemia

DOSSIER1, CTD dossier available.

2, Zone IV Stability data available.

BIOSTUDY (Male, Female in Healthy Volunteers)1, Test Product: Metformin SR 750 mg Tablets

2, Ref Product: Glucophage SR 750 mg (Merck Serono, UK)

3, S1 - Single dose, fast - 54 subjects

4, S2 - Single dose, fed - 42 subjects

5, S3 - Multiple dose, fed - 36 subjects

6, BE achieved


1, Commercial Batch Size : 0.5 million doses

2, Dossier Batch Size : 0.125 million doses

3, Shelf Life : 3 years

4, Tablet Weight : 1250 mg

Registered in EU

A unique opportunity to strength-

en the anti- diabetic portfolio


ONDANSETRON 4/8 MG ODT


1, Ondansetron Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water.

2, Ondansetron is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy) and radiation therapy.

QUICKMELT® TECHNOLOGYIdeal anti-emetic for relief of nausea and vomiting when the patient is not willing to swallow Tablet/Capsule


BIOSTUDY (Male, Female in Healthy Volunteers)1, Randomized, two way crossover fast. (Test with water and test without water) 2, Ref Product : Zofran® Oro-Dispersible Tablet 8 mg, Glaxo SmithKline, UK.3, N = 24 , BE achieved


1, Commercial Batch Size : 4 mg – 0.75 million doses / 8 mg – 0.375 million doses 2, Dossier Batch Size : 4 mg – 0.225 million doses / 8 mg – 0.225 million doses3, Shelf Life : 3 years4, Tablet Weight : 4 mg – 200mg / 8 mg – 400mg 5, Flavour : Strawberry

Submitted in EU & Launched in Canada

A unique opportunity for line extension of Ondansetron


PREDNISOLONE SODIUM PHOSPHATE 5 & 10 MG SOLUBLE TABLETS

UNIQUE SELLING POINTCompletely soluble, fizzing tablet when dissolved in water giving a clear solution.

Pediatric use for Moderate & Severe Asthma.Also used for various conditions such as Arthritis, Blood and Immune Disorders, Eye and Skinconditions,Breathing problem, Cancer and severe allergies

DOSSIERCTD dossier

BIOSTUDYBio Waiver applied


Commercial Batch Size : 5 mg – 1 million doses / 10 mg – 0.5 million doses

Dossier Batch Size : 5 mg – 0.11 million doses / 10 mg – 0.11 million doses

Shelf Life : 2 years

Tablet Weight : 5 mg – 145mg, 10 mg – 290mg

MARKET PLACE

IMS data from 2011-2015 suggests that 5 mg Strength is widely used in UK market.

Similar product by Amdipharm is marketed in UK.

Soluble Prednisolone sodium phosphate can be easily given to the paediatric population due to its solubility and taste as compared to prednisolone alone.

Submitted in EU

A unique opportunity for line extension of prednisolone


RACECADOTRIL SACHET 10/30 MG


1, Can be administered to children of 1 month1.2, Fewer side effects in comparison toLoperamide2,Imodium® 3, Can be used in Invasive Diarrhoea3

4, Reduces secretion of water and electrolytes into the intestine

DOSSIER1, CTD dossier2, Zone II & IV Stability

BIOSTUDY (Male, Female in Healthy Volunteers)

1, Randomized, single dose, fasting, 2-way crossover (Test and reference taken with water) 2, Ref Product: Tiorfan® 30 mg, Bioprojet, France3, N = 48


1, Commercial & Dossier Batch Size : 10mg : 0.33 million doses 30mg: 0.11 million doses

2, Shelf Life : 3 years3, Average Fill Weight : 10 mg - 1000 mg / 30 mg - 3000 mg

Sources:Traitement médicamenteux des diarrhées aiguës infectieuses du nourrisson et de l’enfant J.P Cézard, J.P Chouraqui, J.P Girardet, F Gottrand* et le Groupe francophone d’hépatologie, gastroentérologie et nutrition pédiatriques** 2002.

Y. Duval-Iflah et al, Alimentary Pharmacology , 1999; ( suppl. 6) 9-142.3 Bergmann JF et al, Alimentary Pharmacology and Therapeutics, 1992; 6:305-313. Item no 194=Diarrhée aiguë et déshydrattaion chez le nourrisson, enfant et adulte. ECN pilly 2014

Submitted in EU

Taste Masking of the drug ensured by unique Specially coated Multi Particulate drug


SECNIDAZOLE TASTE MASKED PELLETS IN 2G SACHET


1, One shot treatment for bacterial vaginosis.

2, Secnidazole 2gm single dose is comparable to 7 days treatment with Metronidazole tablet. 3, Sachets are ideal choice over tablet as it gives ease of administration of larger doses.4, Sachets are well accepted by patients due to ease of use

DOSSIER1, CTD dossier available.2, 577 patients non-inferiority clinical study versus Metronidazole. 3, Zone IV Stability data available.


1, Randomized 2 way crossover study, single dose 2, Ref Product : Secnol® 2 g Sachet, IPRAD, France 3, N = 30


1, Commercial Batch Size : 0.062 million doses2, Dossier Batch Size : 0.01 million dosesShelf Life : 3 years 3, Average Fill Weight : 4228 mg

MARKET PLACE1, Bacterial Vaginosis is a problem that affects 15 to 20% of the women. In addition, there appears to be a

large incidence of Bacterial Vaginosis in women suffering from sexually transmitted diseases including those HIV positive.

2, Total EU market for Metronidazole is Euro 113 M (IMS) and in US above USD 100 M.

Launched in Middle East

A unique opportunity to replace Metronidazole tablets & gel


TRAMADOL 37.5 MG + PARACETAMOL 325 MG ODT


1, With the unique technology Athena has masked the unpalatable taste of Tramadol and Paracetamol, both ingredients of the FDC are extremely bitter.

2, Combination of Tramadol and Paracetamol provide faster onset of action and longer duration of action 3, Provide better plan management than single agent



1, Single dose, 3 way crossover study, fast (Test with & without water vs Reference with water) 2, Ref Product : Zaldiar® Tablets (Grunenthal SA, Germany)3, N=37


1, Commercial Batch Size : 0.5 million doses2, Dossier Batch Size : 0.5 and 0.125 million doses 3, Shelf Life : 3 years4, Tablet Weight : 1200 mg 5, Flavour : Peppermint

Registered in EU

Tramadol + Paracetamol is a logical extension to Tramadol


ZOLPIDEM 5/10 MG ODT

UNIQUE SELLING POINT1, Zolpidem ODT is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water

2, Selective binding hence very strong hypnotic properties


BIOSTUDY1, Randomized, 2 way crossover study (Test without water Vs. Reference with water) 2, Reference Product : Stilnox® Tablets 10 mg of Sanofi Aventis, France3, N = 38

INFORMATION AT A GLANCE1, Commercial Batch Size : 5 mg - 1.0 million doses, 10 mg - 0.5 million doses 2, Dossier Batch Size : 5 mg - 0.2 million doses, 10 mg - 0.125 million doses 3, Shelf Life : 3 years4, Tablet Weight : 5 mg - 150 mg / 10 mg - 300 mg 5, Flavour: Black Currant

Registered in EU

Stilnox®

Unique technology of Athena (Oro-Dispersible Tablet) is an ideal choice for patients with CNS disorders.


ZOLPIDEM 5/10 MG SUBLINGUAL ODT


1, Zolpidem ODT is pleasant and convenient as a tablet and can be administered anytime anywhere with or without water.

2, Initial rate of absorption is faster 1

3, Initial systematic exposure is greater 1


BIOSTUDY (Male, Female in Healthy Volunteers)1, Randomized, 2 way crossover study, single dose (Test and Reference without water) 2, Reference Product : Sublinox® Tablets, Meda Valeant , Canada3, N = 274, BE achieved (As per CA and EU requirements)

INFORMATION AT A GLANCE1, Commercial Batch Size : 5 mg - 1 million doses, 10 mg - 0.5 million doses2, Dossier Batch Size : 5 mg - 0.2 million doses, 10 mg - 0.125 million doses3, Shelf Life : 3 years4, Tablet Weight : 5 mg - 150 mg / 10 mg - 300 mg 5, Flavour: Black Current

Sources:1. Comparison of pharmacokinetic profiles of zolpidem buffered sublingual tablet and zolpidem oral immediate-release tablet: Greenblatt DJ , Harmatz JS , Roth T , Singh NN , Moline ML , Harris SC , Kapil RP Clinical Therapeutics March 6,2013; Published Online: April 01,2013.

Sublinox® Edluar™

Unique technology of Athena(Sublingual Tablet) is an idealchoice for patients withCNS disorders.


OUR PARTNERS…


CONTACT US


Manufacturing Site and R & D Center

Athena Drug Delivery Solutions Pvt Ltd.

Plot No. A1-A5, M.I.D.C.,

Chemical Zone, Near Ion Exchange,

Ambernath (W) – 421 501, India

+91 744 7461 662/3/4/5, +91 960 794 8231/2/3/4

+91 226 7370 701

India Office

Athena Drug Delivery Solutions Pvt Ltd.

602, Star Hub, Tower II, Sahar,

Andheri (East), Mumbai – 400 099. INDIA.

+91 022 67370700

+91 2267370701

[email protected]

Brazil Office

Athena Pharmaceutiques SAS

New Century Building – 11th Floor,

Leopoldo Couto de Magalhaes,

Junior Str. – 758 – Itaim Bibi,

Sao Paulo 04542 – 000 Brazil

+ 55 11 96645 1184

[email protected]

China Office

Athena-JSI Pharmatech (Shanghai) Ltd.

Suite 302, Building 6A, 590,

Ruiquing Road, Pudong District,

Shanghai 201201. China.

[email protected]

[email protected]

France Office

Athena Pharmaceutiques SAS

Espace Arnold de

Ville, 12 rue Georges Blandon,

78430 Louveciennes, France.

Cell +33 6 77 69 41 40

[email protected]

Canada & USA

Hafid Touam

Phildalphia -PA 19106 USA

Tel +1(267) 358-6250

Cell: +1(484) 832-0404

[email protected]

mailto:[email protected]




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