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CORPORATE PRESENTATION

2016

ORAL SOLID DRUG DELIVERY

BUSINESS TO BUSINESS MODEL

DIFFERENTIATED BRANDED GENERIC

MISSION STATEMENT

Be a partner of choice for multinational and leading national pharmaceutical companies for their product needs in Pharmerging as well as Mature markets

CTD DOSSIER WITH BE & CLINICAL

HISTORY AND MILESTONES

2011 Spin Off from Ethypharm group and renamed Athena DDS

2014 Athena is EU GMP approved for ODT & Tablets

2015 5 products submitted in EU

Athena Shanghai R&D JV China open

2016 1 product registered in EU and 1 launched in Canada

1 product registered in EU and 1 product in Canada

8 products to be submitted in EU/1 in Canada/4 in Brazil

WHAT WE DO … We connect the dots

LICENSING AND SUPPLY

CO- DEVELOPMENT

CTD product to be marketed under Partner’s Brand

Supply in Semi Finished Bulk or Finished Packs

180 People (R&D/Manufacturing) dedicated to

DIFFERENTIATED BRANDED GENERIC

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)

All products supply as

Semi Finished or Finished packs

MANUFACTURING FACILITY

• EU GMP approved facility at Ambernath near Mumbai, India • State of the art equipment for Solid oral dosage forms • Conventional & Bilayer Tablets • Capsules & Sachets • Orally disintegrating tablets • Sublingual Tablets • Pellets and Granules

WHO & EU GMP for Tablet and ODT 2014

• Highest standards in manufacturing and EHS

EU & Canada Submission

2014 1. Domperidone 10 mg ODT 2. Ondansetron 4, 8 mg ODT – Canada

2015 1. Donepezil 5, 10 mg ODT 2. Meloxicam 7.5 & 15 mg ODT 3. Paracetamol Tramadol 325/37.5 mg ODT 4. Metformin SR 750 mg tablet 5. Ondansetron 4, 8 mg ODT

EU Submission 9-12 months at client request Fenofibrate 160 mg Tablets Mirtazapine 15, 30, 45 mg ODT Risperidone 1,2,3, 4 mg ODT Tramadol 50 mg ODT

2016 Q1 1. Levocetirizine 5 mg ODT 2. Zolpidem 5, 10 mg ODT 3. Fenofibrate 200 mg capsule Q2 4. Fenofibrate 267 mg capsules Q3 5. Ibuprofen 100, 200, 400 mg ODT 6. Racecadotril 10,30 mg Taste Masked Sachets 7. Zolpidem 5, 10 mg ODT SL Q4 8. Prednisolone 5 to 25 mg Soluble Tablet 9. Ketorolac 10 mg ODT 10. Desmopressin 60, 120, 240 mcg ODT SL

SR = Sustained Release ODT = Oral Dispersible Tablet TM = Taste Masked SL = Sublingual

DOMPERIDONE 10 mg ODT

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. Domperidone accelerates gastric emptying. Domperidone has better tolerance and has no significant drug interaction.

A unique opportunity

for line extension

of Domperidone

UNIQUE SELLING POINT

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

DOSSIER • CTD dossier available. • Product Registered in Europe & marketed in Emerging Markets. • Zone IV Stability data available.

BIOSTUDY • Randomized two way crossover. (Test without water Vs. Reference with water) • Ref product : Motilium Instant®10 mg, J & J, Belgium • N =36 • BE achieved

INFORMATION AT A GLANCE • Batch Size : 0.5 million doses, 1 million doses • Shelf Life : 3 years • Tablet Weight : 250 mg • Flavour : Trusil Peppermint

Registered in EU

DONEPEZIL 5/10 mg ODT

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. Unique technology of Athena

is an ideal choice for patients

with Alzheimer’s disease (AD)

UNIQUE SELLING POINT

• Effectively reduces the symptoms of mild-to-moderate dementia of Alzheimer’s disease.

• Oro-Dispersible Tablet is an ideal choice for patient with dysphagia and Alzheimer’s disease (AD).

DOSSIER • CTD dossier available. • Zone IV Stability data available.

BIOSTUDY • Randomized, three way, crossover (Test with and without water vs. Reference with

water)

• Ref Product : Aricept® 10 mg Oro-Dispersible Tablet, Eisai S.A.S, France • N = 39 • BE achieved in all conditions (with and without water)

INFORMATION AT A GLANCE • Batch Size : 5mg : 0.3 million doses, 10 mg : 0.15 million doses • Shelf Life : 3 years • Tablet Weight : 5 mg - 140 mg / 10 mg - 280 mg

Submitted in EU

LEVOCETIRIZINE 5 mg ODT

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. With the unique

technology Athena has

masked the unpalatable

taste of Levocetirizine

which is extremely bitter

UNIQUE SELLING POINT

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

• Levocetirizine is free from sedative effects.

DOSSIER • CTD dossier available with non infringing formulation. • Zone IV Stability data available.

BIOSTUDY • Randomized, single dose, two way crossover study • Ref Product : Xyzal® 5 mg Tablet of UCB France • N = 24 • BE achieved

INFORMATION AT A GLANCE • Batch Size : 0.5 million doses / 1 million doses • Shelf Life : 2 years • Tablet Weight : 250 mg

Submitted in EU

MELOXICAM 7.5/15 mg ODT

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.

A unique opportunity

for line extension

of Meloxicam

UNIQUE SELLING POINT

• Meloxicam selectively inhibits COX-2 relative to COX-1. • Meloxicam is equivalent to Diclofenac SR in relieving acute pain associated with

osteoarthritis and has much better tolerance.

DOSSIER • CTD dossier available. • Zone IV Stability data available.

BIOSTUDY • Randomized, two way crossover. (Test without water vs. Reference with water.) • Ref Product : Mobic® 15 mg, Boehringer Ingelheim, France • N = 24 (Male & Female) • BE achieved

INFORMATION AT A GLANCE • Batch Size : 7.5 mg - 0.7 million doses / 15 mg - 0.35 million doses • Shelf Life : 2 years • Tablet Weight : 7.5 mg - 180 mg / 15 mg - 360 mg • Flavour : Orange

MESALAMINE SR SACHET

500/1000/2000 MG

• Improves patient compliance by reducing the number of doses and easy to administer

sachet against swallowing 6-8 tablets or capsules. Site – specific delivery of

the drug ensured by

unique specially coated

Multi Particulate drug

delivery system.

UNIQUE SELLING POINT

DOSSIER • Building CTD dossier • Zone IV Stability data available.

BIOSTUDY • BE conducted on Pentasa® 2 gm • The results are lower than the accepted value • Redo BE after modifying the formula

INFORMATION AT A GLANCE • Batch Size : 5 mg : 500mg : 0.48 million doses / 1000mg : 0.24 million doses / 2000mg : 0.12 million doses • Shelf Life : 2 years • Tablet Weight : 500mg : 833.4mg / 1000mg : 1666.7mg / 2000mg : 3333.3mg

• Target release therapy for Ulcerative Colitis. • Pentasa® 4 gms Sachet launched in EU • Salofalk® 3 gms Sachet launched in EU

ONDANSETRON 4/8 mg ODT

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. A unique opportunity

for line extension

of Ondansetron

UNIQUE SELLING POINT

• Ondansetron in potent & highly selective • 5HT3 reception antagonist

DOSSIER • CTD dossier available. • Zone IV Stability data available.

BIOSTUDY • 2 studies with UK & Canadian reference • Randomized, two way crossover. (Test with water and test without water) • Ref Product : Zofran® Oro-Dispersible Tablet 8 mg, Glaxo SmithKline, UK. • N = 24 (Male & Female) • BE achieved INFORMATION AT A GLANCE • Batch Size : 4 mg - 0.75 million doses / 8 mg - 0.37 million doses • Shelf Life : 2 years • Tablet Weight : 4 mg - 0.75 million doses / 8 mg - 0.37 million doses • Flavour : Strawberry

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

• Every Single particle is coated for excellent taste masking. • Melts in less than 30 sec.

T – Ondansetron 8mg ODT (Athena) Vs R – Zofran 8mg ODT, GSK (UK)

Submitted in EU & Launched in Canada

SECNIDAZOLE TASTE MASKED

PELLETS IN 2G SACHET

• One shot treatment for bacterial vaginosis.

A unique

opportunity to

replace

Metronidazole

tablets & gel

UNIQUE SELLING POINT

DOSSIER • CTD dossier available for out of EU. • 577 patients non-inferiority clinical study • Zone IV Stability data available.

INFORMATION AT A GLANCE • Batch Size : 0.09 million doses / 0.13 million doses • Shelf Life : 2 years • Average Fill Weight : 4228 mg

• Secnidazole 2gm single dose is comparable to 7 days treatment with Metronidazole tablet.

• Sachets are ideal choice over tablet as it gives ease of administration of larger doses.

• Sachets are well accepted by patients due to ease of use.

MARKET PLACE • 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.

• Total EU market for Metronidazole is Euro 113 M (IMS) and in US above USD 100 M. • Large number of territories available (US/ASIA/LATAM/MME/Some EU countries). [*] Source - www.typesofbacteria.co.uk

Launched in LATAM

SILDENAFIL 50/100 mg ODT

Sildenafil Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in

mouth and can be administered anytime anywhere with or without water. A unique opportunity

for line extension

of Sildenafil

UNIQUE SELLING POINT

• Sildenafil is an effective first-line therapy for erectile dysfunction.

DOSSIER • CTD dossier available. • Zone IV Stability data available.

BIOSTUDY • Randomized, single dose, 3 way crossover pilot study • Ref Product : Viagra® 100 mg Tablet of Pfizer France • N = 15 • BE achieved

INFORMATION AT A GLANCE • Batch Size : 50 mg - 0.5 million doses / 100 mg - 0.25 million doses • Shelf Life : 3 years • Tablet Weight : 50 mg - 600 mg / 100 mg - 1200 mg • Flavour : Peppermint

MARKET PLACE • Erectile dysfunction concerns 30 million men in the US and 36 million men in Europe[1]. • Used by more than 27 million men worldwide since it was first introduced in 1998. • Source - [1]: Minnesota Men’s Health Centre, articles

TRAMADOL 37.5 MG + PARACETAMOL 325 MG

ODT

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

Tramadol + Paracetamol

is a logical extension to

Tramadol

UNIQUE SELLING POINT

DOSSIER • CTD dossier available. • Zone IV Stability data available.

BIOSTUDY • Single dose, three way PK study under fasting conditions • Ref Product : Zaldiar® Tablets (Grunenthal SA, Germany) • N=37 • BE achieved

INFORMATION AT A GLANCE • Batch Size : 0.5 million doses • Shelf Life : 3 years • Tablet Weight : 1200 mg • Flavour : Peppermint

Registered in EU

VOGLIBOSE 0.2/0.3 MG ODT

• Voglibose scores over both Acarbose (Glucobay®) and Miglitol in terms of lesser side

effects profile. Oro-Dispersible tablet

with special technology

offers Uniform drug content

and Homogeneous product.

UNIQUE SELLING POINT

DOSSIER • CTD dossier available. • Zone IV Stability data available.

BIOSTUDY • Pharmacodynamic study available similar to Takeda product • Randomized, single dose, two way crossover study • Reference Product : Basen® Oro-Dispersible Tablet 0.3 mg • of Takeda Pharma, Japan • N = 30

INFORMATION AT A GLANCE • Batch Size : 0.2 mg : 0.53 million doses / 0.3 mg : 0.35 million doses

• Shelf Life : 2 years • Tablet Weight : 0.2 mg - 130 mg / 0.3 mg - 195 mg • Flavour : Banana

• Voglibose an Alpha glucosidase inhibitor & has no major drug interaction. • Voglibose provides effective management of high postprandial • (after meals) blood glucose level where other treatments fail.

ZOLPIDEM 5/10 MG ODT

• Zolpidem ODT is pleasant and convenient as a tablet that melts in mouth and can be

administered anytime anywhere with or without water. • Selective binding hence very strong hypnotic properties.

Unique technology of

Athena (Oro-Dispersible

Tablet) is an ideal choice

for patients with

CNS disorders.

UNIQUE SELLING POINT

DOSSIER • CTD dossier available. • Zone IV Stability data available.

• Randomized, 3 way crossover study (Test with and without water Vs. Reference with water)

• Reference Product : Stilnox® Tablets 10 mg of Sanofi Aventis, France • N = 30 • BE achieved

INFORMATION AT A GLANCE • Batch Size : 5 mg : 0.65 million doses / 10 mg : 0.33 million doses • Shelf Life : 2 years • Tablet Weight : 5 mg - 200 mg / 10 mg - 400 mg

BIOSTUDY

• Donepezil ODT

• Mirtazapine ODT

• Risperidone ODT

Metformin SR 750 mg Tablet

Bioequivalent to Glucophage® XR Merck

Full CTD Dossier ready

3 Bioequivalence Fast 56 subjects/Fed – 42 Subjects/Multiple Dose – 36 subjects

Tablet weight 1250 mg

MOQ 0.56 Million doses

NEW

• Same efficacity than Metformin IR (1)

• Simpler posology :

SR once a day vs IR 3 times a day

• Simpler administration

• Greater adherence in therapy (2)

• Greater patient satisfaction. (3)

• Better tolerability (2)

• Decrease Gastro-intestinal side effects :

• Less diarrhea, nausea and abdominal pain

RACECADOTRIL 10,30 mg

Taste Masked Granules in Sachets

Athena product is Non Infringing versus Tiorfan®

Bioequivalence versus to Tiorfan® 30 mg Bioproject Q2 2016

CTD Dossier for out of EU available

CTD Dossier for EU in Q3 2016

• Can be used in children from 1 month 3

Loperamide cannot be used below 2 years :

• Risk of Intestinal ileus (a complet intestinal obstruction)

• CNS effects : Respiratory depression, coma, slumber

• Can be used in invasive diarrhea 4,5*

Loperamide cannot be used :

• Risk of intestinal perforation, bacterial overgrowth and bacteraemia .

• Fewer adverse events compared to Loperamide – Imodium®

No constipation and abdominal cramps

High therapeutic index 6 (20 times the therapeutic dose was given to healthy adult with no ill effects)

It doesn’t cross the blood-brain barrier :

• Does not induce CNS toxicity 1

• Does not impair mental performance

• Has no potential for abuse or physical dependance 7

NEW

PREDNISOLONE 5,10,15,20,25 mg

SOLUBLE TABLET

Similar product as Amdipharm product marketed in UK

Athena product is Non Infringing

Biowaiver

Full CTD Dossier in Q4 2016

Pediatric use for Moderate & Severe Asthma crisis

NEW

ZOLPIDEM 5,10mg SUBLINGUAL

Zolpidem SL (5 mg and 10 mg) Sublinox® /Edluar ® received FDA

approval in 2009 for short-term treatment of insomnia characterized by

difficulties with sleep initiation.

Athena product is Non Infringing versus Sublinox® /Edluar ®

Bioequivalence versus to Sublinox® Meda Valeant Canada

CTD Dossier in Q3 2016

• Less inter-individual variability : 3

NEW

DESMOPRESSIN SUBLINGUAL

60,120, 240 mcg

Similar product to Minirin melt ®/DDPAV melt® product marketed by Ferring

Athena product is Non Infringing

CTD Dossier in Q4 2016

NEW

CTD DOSSIERS in 2015 & 2016

CARDIO & METABOLISM • Desmopressin 60, 120, 240 mcg ODT SL • Fenofibrate 200 mg capsules • Fenofibrate 267 mg capsules • Metformin 750 mg SR tablet • Voglibose 0.2, 0.3 mg ODT (non EU)

PAIN • Ibuprofen 100, 200, 400 mg ODT • Ketorolac 10 mg SL ODT • Meloxicam 7.5, 15 mg ODT • Paracetamol Tramadol 325/37.5 mg Tab • Paracetamol Tramadol 325/37.5 mg ODT • Prednisolone 5 to 25 mg Soluble Tablet

UROLOGY/GYNECOLOGY • Secnidazole 2 g TM pellets sachets (non EU)

CENTRAL NERVOUS SYSTEM • Donepezil 5, 10 mg ODT • Ondansetron 4, 8 mg ODT • Sildenafil Citrate 50, 100 mg ODT • Zolpidem 5,10 mg ODT • Zolpidem 5,10 mg SL ODT

GASTRO INTESTINAL • Racecadotril 10,30 mg Taste Masked Sachets • Domperidone 10 mg ODT RESPIRATORY • Levoceterizine 5 mg ODT CTD Dossier at client request (9 months) Fenofibrate 160 mg tablets & capsules Mirtazapine 15, 30, 45 mg ODT Risperidone 0.5, 1,2,3,4 mg ODT Tramadol 50 mg ODT Tramadol SR capsules

SR = Sustained Release ODT = Oral Dispersible Tablet TM = Taste Masked SL = Sublingual

GASTRO INTESTINAL • Esomeprazole DiHyMg 20, 40 mg EC caps – Generic Nexium® • Esomeprazole DiHyMg 20, 40 mg ODT –Lifecycle Nexium® • Esomeprazole DiHyMg 10 mg Sachets – Generic Inexium® sachets France • Racecadotril 10,30 mg ODT – Lifecycle Tiorfan ®

PAIN • Prednisolone Sodium Phosphate 5, 20 mg ODT – Generic Orapred® • Tramadol 100, 150, 200 mg SR capsules – Generic Zydol® Tablet CNS • Di Methyl Fumarate 120, 240 mg EC Capsules – Generic Tecfidera® Biogen

CHRONIC IRON OVERLOAD • Deferasirox 125,250,500 mg Soluble Tablet– Generic Exjade®

Pipeline Products SR = Sustained Release ODT = Oral Dispersible Tablet TM = Taste Masked SL = Sublingual

OUR PARTNERS… EUROPE / CANADA

LATAM

www.athenadds.com

ASIA/INDIA

MIDDLE EAST / AFRICA