5vv corporate presentation 2016 - pharmacompass...eu & canada submission 2014 q1 1. domperidone 10...
TRANSCRIPT
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5vv
CORPORATE PRESENTATION
2016
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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
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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
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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
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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)
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All products supply as
Semi Finished or Finished packs
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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OUR PARTNERS… EUROPE / CANADA
LATAM
www.athenadds.com
ASIA/INDIA
MIDDLE EAST / AFRICA