Our Values. Quality Intelligent efforts in everyday practice. Innovation Change that unlocks new value. Performance Passion for results

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William Cross
6 years ago
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2 Our Values 1 Innovation Change that unlocks new value Our continuous progress and growth depends on the investments we make on scientific research for new medicines and technologies. Innovation is part of our DNA and a process involving multiple aspects of dynamic activities 2 Quality Intelligent efforts in everyday practice We pay attention to detail and take decisions over the acknowledgement that our reputation depends on the empowerment of every individual to respond efficiently, perform proactively and act with care in the service of our customers 3 Performance Passion for results 4 Integrity Transparency in all we do Our employees are the driving force of our success. We embrace them with pride and trust and empower them to achieve operational excellence through knowledge sharing and continuous improvement Transparency and honesty are embedded in our DNA. Our company s code of conduct ensures that all our employees and partners make decisions that are consistent with our values, achieving the highest quality standards in our operating model 5 Leadership We walk our talk We promote a positive working environment, applying visionary leadership style to influence and achieve excellent results. Our leaders step outside the executive suit and do things that symbolize our shared vision

3 Table of Contents Ophthalmic 5 Preservative free Long Acting 9 Injectables Generic Finished 13 dosage Active 29 Pharmaceutical Ingredients Pharmathen Product list 3

5 Ophthalmic Preservative free in multi-dose vials «Approaching the market with the sophisticated, cost effective and convenient multidose preservative free products» Pharmathen Product list 5

6 Ophthalmic Preservative free in multi-dose vials PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS BIMATOPROST PRESERVATIVE FREE Eye drops solution multi dose container 0.3mg/ml Reduction of elevated intraocular pressure in chronic openangle glaucoma and ocular hypertension in adults New BIMATOPROST TIMOLOL PRESERVATIVE FREE Eye drops solution multi dose container 0.3mg/ml & 5mg/ml Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. New CHLORAMPHENICOL PRESERVATIVE FREE Eye drops solution multi dose container 5mg/ml Topical antibacterial in the treatment of superficial ocular infections New CROMOGLYCATE SODIUM PRESERVATIVE FREE Eye drops solution multi dose container 20mg/ml For the relief and treatment of the eye symptoms of hayfever Q DEXAMETHASONE PRESERVATIVE FREE Eye drops solution multi dose container 1mg/ml Treatment of non-infectious inflammatory conditions Q DORZOLAMIDE/ TIMOLOL PRESERVATIVE FREE Eye drops solution multi dose container 20mg/ml & 5mg/ml Intraocular pressure elevation treatment

7 Ophthalmic Preservative free in multi-dose vials PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS DORZOLAMIDE PRESERVATIVE FREE Eye drops solution multi dose container 20mg/ml Intraocular pressure elevation treatment HYPROMELLOSE Eye drops solution multi dose container 3.2mg/ml Used as artificial tears to prevent damage to the cornea. Also moistens hard contact lenses and lubricates artificial eyes. Q LATANOPROST PRESERVATIVE FREE Eye drops solution multi dose container 0.05mg/ml Reduction of elevated intraocular pressure Q LATANOPROST TIMOLOL PRESERVATIVE FREE Eye drops solution multi dose container 0.05mg/ml & 5mg/ml Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension Q TIMOLOL PRESERVATIVE FREE Eye drops solution multi dose container 2.5mg/ml 5mg/ml Elevated intraocular pressure decrease TRAVOPROST PRESERVATIVE FREE Eye drops solution multi dose container 40mcg/ml Elevated intraocular pressure decrease TRAVOPROST PRESERVATIVE FREE Eye drops solution multi dose container 30mcg/ml Elevated intraocular pressure decrease Q TRAVOPROST & TIMOLOL PRESERVATIVE FREE Eye drops solution multi dose container 40mcg/ml & 5mg/ml Elevated intraocular pressure decrease New Pharmathen Product list 7

9 Long Acting Injectables «We are changing the perception of conventional injectable medication, improving the effectiveness of drug therapy and enhancing patient compliance» Pharmathen Product list 9

10 LAI s PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS RISPERIDONE long-acting Injectable 12.5mg/vial 25mg/vial 37.5mg/vial 50mg/vial Acute and chronic schizophrenic psychoses treatment Q ARIPIPRAZOLE long-acting Injectable 300mg/vial 400mg/vial Treatment of schizophrenia Under development EXENATIDE long-acting Injectable 2mg/vial Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus Q LANREOTIDE long-acting Injectable 60mg/vial 90mg/vial 120mg/ vial Treatment of acromegaly Q LEUPROLIDE ACETATE long-acting Injectable 3.75mg/vial 7.5mg/vial 11.5mg/vial 22.5mg/vial 30mg/vial 45mg/vial Palliative treatment of advanced prostatic cancer and management of endometriosis Q4 2017

LAI s PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS OCTREOTIDE ACETATE long-acting Injectable 10mg/vial 20mg/vial 30mg/vial Treatment of acromegaly and control symptoms

11 LAI s PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS OCTREOTIDE ACETATE long-acting Injectable 10mg/vial 20mg/vial 30mg/vial Treatment of acromegaly and control symptoms such as diarrhea or flushing in patients with tumors Q PALIPERIDONE PALMITATE long-acting Injectable 25mg/vial 50mg/vial 75mg/vial 100mg/ vial 150mg/vial Indicated for the treatment of schizophrenia in adult patients Q Pharmathen Product list 11

13 Generic finished dosage «Research, Innovation and IP protection at the disposal of our highly competitive business model» Pharmathen Product list 13

14 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS ALENDRONATE & CHOLECALCIFEROL tablets 70mg/2800IU 70mg/5600IU Postmenopausal osteoporosis APREPITANT hard capsules 80mg, 125mg, 165mg Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults Q ARIPIPRAZOLE orodispersible tablets 10mg, 15mg, 30mg Schizophrenia, manic episode treatment ARIPIPRAZOLE tablets 5mg, 10mg 15mg, 30mg Schizophrenia, manic episode treatment ATOMOXETINE hard capsules 10mg, 18mg 25mg, 40mg 60mg, 80mg & 100mg Treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD) New ATORVASTATIN f.c. tablets 10mg, 20mg 40mg, 80mg Hypercholesterolaemia treatment, cardiovascular disease prevention BIMATOPROST eye drops, solution 0.1mg/ml 0.3mg/ml Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension

15 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS BRINZOLAMIDE eye drop suspension 10mg/ml Intraocular Pressure Elevation Treatment & Open-angle Glaucoma CASPOFUNGIN powder for concentrate for solution for infusion 50 mg, 70mg Invasive candidiasis, invasive aspergillosis treatment New CEFUROXIME AXETIL f.c. tablets 125mg, 250mg 500mg Mild to severe infections treatment CIPROFLOXACIN solution for infusion 100mg/50ml 200mg/100ml 400mg/200ml Infections treatment CIPROFLOXACIN f.c. tablets 250mg, 500mg 750mg Infections treatment CISATRACURIUM BESYLATE solution for injection / infusion 2mg/ml, 5mg/ml Adjunct to general anaesthesia CLOPIDOGREL f.c. tablets 75mg Prevention of Atherothrombotic & Thomboembolic Events DARUNAVIR f.c tablets 75mg, 150mg, 300mg, 400mg, 600mg & 800mg Treatment of patients with human immunodeficiency virus (HIV-1) infection Q Pharmathen Product list 15

16 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS DIMENHYDRINATE Sublingual tablets 50mg Prevention and treatment of motion sickness. Symptomatic treatment of short duration of nausea and vomiting not accompanied with fever. DIMETHYL FUMARATE Gastro resistant hard capsules 120mg, 240mg Treatment of adult patients with relapsing remitting multiple sclerosis Q DORZOLAMIDE Eye drops solution 20mg/ml Intraocular pressure elevation treatment DORZOLAMIDE / TIMOLOL Eye drops solution 20mg/ml & 5mg/ml Intraocular pressure elevation treatment DULOXETINE hard gastro-resistant capsules 30mg, 60mg Treatment of depression and generalized anxiety disorder. Treatment of diabetic peripheral neuropathic pain ENOXAPARIN solution for injection 20mg/0.2ml 40mg/0.4ml 60mg/0.6ml 80mg/0.8ml 100mg/1ml Antithrombotic ENTECAVIR f.c tablets 0.5mg, 1mg Indicated for the treatment of chronic hepatitis B virus (HBV) infection Q2 2016

17 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS EPLERENONE f.c. tablets 25mg, 50mg Beta-blockers therapy ESCITALOPRAM f.c. tablets 5mg, 10mg 15mg, 20mg Major depressive episodes, Panic disorder, social anxiety disorder, generalized anxiety disorder & obsessive-compulsive disorder treatment ESOMEPRAZOLE powder for solution for injection/infusion 40mg Gastric antisecretory treatment for adults and children FEBUXOSTAT f.c tablets 80mg, 120mg Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred Q FINASTERIDE f.c. tablets 5mg Benign prostatic hyperplasia (BPH) treatment and control FINGOLIMOD hard capsules 0.5mg Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis Q FLUCONAZOLE solution for infusion 50mg/25ml 100mg/50ml 200mg/100ml 400mg/200ml Anti-infective therapy Pharmathen Product list 17

18 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS FLUVASTATIN XL prolonged release tablets 80mg Dyslipidaemia adjunct to diet & Secondary prevention in coronary heart disease GALANTAMINE f.c. tablets 4mg, 8mg, 12mg Dementia of the Alzheimer type symptomatic treatment GALANTAMINE SR prolonged-release hard capsules 8mg, 16mg 24mg Dementia of the Alzheimer type symptomatic treatment IBANDRONATE concentrate for solution for infusion 1mg/1ml 2mg/2ml 6mg/6ml Prevention of Skeletal Events & Treatment of Hypercalcaemia IBANDRONATE f.c. tablets ONCE A MONTH 150mg Postmenopausal osteoporosis treatment IBANDRONATE f.c. tablets 50mg Prevention of Skeletal Events in Patients with Cancer IRBESARTAN f.c. tablets 75mg, 150mg 300mg Essential hypertension treatment IVABRADINE f.c tablets 5mg, 7.5mg Treatment of coronary artery disease New

19 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS ISOTRETINOIN soft gel. capsules 5mg, 10mg 20mg Severe forms of acne treatment LEFLUNOMIDE f.c. tablets 10mg, 20mg 100mg Active rheumatoid arthritis treatment psoriatic arthritis treatment LEVETIRACETAM concetrate for solution for infusion 100mg/ml Epilepsy treatment LEVETIRACETAM oral solution 100mg/ml Epilepsy treatment LEVETIRACETAM f.c. tablets 250mg, 500mg 750mg, 1000mg Epilepsy treatment LEVOFLOXACIN solution for infusion 5mg/ml Infections treatment LEVOFLOXACIN f.c. tablets 250mg, 500mg Infections treatment LINEZOLID f.c. tablets 600mg LINEZOLID solution for infusion 600mg/300ml Nosocomial & community acquired pneumonia treatment Nosocomial & community acquired pneumonia treatment Pharmathen Product list 19

20 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS LOSARTAN f.c. tablets 12.5mg, 25mg 50mg, 100mg Essential hypertension treatment LOSARTAN +HCTZ f.c. tablets 50/12.5mg 100/25mg Essential hypertension treatment MEMANTINE f.c.tablets 10mg, 20mg Moderate to Severe Alzheimer s Disease Treatment MEROPENEM powder for solution for injection or infusion 500mg, 1g Infections treatment MONTELUKAST f.c.tablets 10mg Asthma treatment MONTELUKAST chewable tablets 4mg, 5mg Asthma treatment MOXIFLOXACIN Eye drops solution 5 mg/ml Bacterial infections treatment MOXIFLOXACIN f.c. tablets 400mg Bacterial infections treatment

21 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS MOXIFLOXACIN solution for infusion 400mg/250ml Bacterial infections treatment OLANZAPINE orodispersible tablets 5mg, 10mg 15mg, 20mg Treatment of Schizophrenia or Manic Episode bipolar disorder recurrence prevention (manic episode patients responding to therapy) OLANZAPINE f.c. tablets 2.5mg, 5mg 7.5mg, 10mg 15mg, 20mg Treatment of Schizophrenia or Manic Episode bipolar disorder recurrence prevention (manic episode patients responding to therapy) OLANZAPINE powder for solution for injection 10mg/vial Treatment of Schizophrenia or Manic Episode bipolar disorder recurrence prevention (manic episode patients responding to therapy) ONDANSETRON solution for Injection 4mg/2ml 8mg/4ml Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting. Pharmathen Product list 21

22 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS ONDANSETRON f.c. tablets 4mg, 8mg Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting. PALIPERIDONE prolonged-release tablets 1.5mg, 3mg, 6mg, 9mg, 12mg Schizophrenia treatment Q PARICALCITOL solution for injection 5mcg/ml, 10mcg/2ml, 2mcg/ml, 4mcg/2ml Prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing aemodialysis. PRAMIPEXOLE tablets 0.088mg, 0.18mg, 0.35mg, 0.7mg, 1.1mg Parkinson's disease treatment. Treatment of moderate to severe idiopathic Restless Legs Syndrome PRASUGREL f.c tablets 5mg, 10mg Prevention of atherothrombotic events in adult patients with acute coronary syndrome Q1 2017

23 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS PREGABALIN capsules, hard 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Neuropathic pain, epilepsy and generalised anxiety disorder treatment QUETIAPINE SR prolonged-release tablets 50mg, 150mg, 200mg, 300mg, 400mg Schizophrenia and bipolar disorder treatment RALOXIFENE f.c. tablets 60mg Postmenopausal osteoporosis treatment and prevention REPAGLINIDE tablets 0.5mg, 1mg, 2mg Type 2 diabetes adjunct to diet RISEDRONATE f.c. tablets 5mg, 30mg, 35mg Postmenopausal Osteoporosis Treatment & Paget's disease (30mg). Treatment of osteoporosis in men at high risk of fractures (35mg) RISPERIDONE f.c. tablets 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg Acute and chronic schizophrenic psychoses treatment Pharmathen Product list 23

24 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS RIVASTIGMINE oral solution 2mg/ml Dementia of the Alzheimer type symptomatic treatment. Treatment of dementia in patients with idiopathic Parkinson's disease. RIVASTIGMINE hard capsules 1.5mg, 3mg, 4.5mg, 6mg Dementia of the Alzheimer type symptomatic treatment. Treatment of dementia in patients with idiopathic Parkinson's disease. RIZATRIPTAN orodispersible tablets 5mg, 10mg RIZATRIPTAN tablets 5mg, 10mg Headache phase of migraine attacks acute treatment Headache phase of migraine attacks acute treatment ROPINIROLE f.c. tablets 0.25mg, 0.5mg 1mg, 2mg, 5mg Parkinson's disease treatment ROPINIROLE SR prolonged-release tablets 2mg, 3mg, 4mg 8mg Parkinson's disease treatment ROPIVACAINE solution for infusion in bags 100ml, 200ml 2 mg/ml Surgical anaesthesia & acute pain management

25 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS ROPIVACAINE solution for injection In vials 10ml, 20ml 2 mg/ml, 5.0 mg/ml, 7.5 mg/ml, 10 mg/ml Surgical anaesthesia & acute pain management SEVELAMER CARBONATE f.c. tablets 800mg Hyperphosphataemia control SEVELAMER HCL f.c. tablets 800mg Hyperphosphataemia control SILDENAFIL f.c. tablets 25mg, 50mg, 100mg Erectile dysfunction in adult males treatment TEICOPLANIN powder & solvent for solution for injection 100mg, 200mg, 400mg Infections treatment TOLTERODINE f.c. tablets 1mg, 2mg Urge incontinence Symptomatic treatment TOLTERODINE SR prolonged-release hard capsules 2mg, 4mg Urge incontinence Symptomatic treatment TOPIRAMATE f.c. tablets 25mg, 50mg, 100mg, 200mg Epilepsy treatment Pharmathen Product list 25

26 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS TRANDOLAPRIL capsules 0.5mg, 1mg 2mg, 4mg Mild or moderate hypertension TRAVOPROST eye drops solution 40mcg/ml TRAVOPROST eye drops solution 30mcg/ml Elevated intraocular pressure decrease Elevated intraocular pressure decrease Q TRAVOPROST & TIMOLOL eye drops solution 40 mcg/ml & 5 mg/ml Elevated intraocular pressure decrease New TRIFUSAL powder for oral suspension 600mg Secondary prophylaxis after a first coronary or cerebrovascular ischaemic event New VALACICLOVIR f.c. tablets 500mg Herpes zoster, herpes simplex therapy & CMV infection prophylaxis VALGANCICLOVIR f.c. tablets 450mg Cytomegalovirus (CMV) retinitis in patients with AIDS treatment New VENLAFAXINE IR tablets 37.5mg, 50mg 75mg Treatment & recurrence prevention for major depressive episodes generalized anxiety disorder, social anxiety disorder & panic disorder treatment

27 Generic finished dosage PRODUCT PHARMACEUTICAL FORM STRENGTHS THERAPEUTIC CATEGORY DOSSIER STATUS VENLAFAXINE Prolonged release hard capsules 37.5mg, 75mg 150mg Treatment & recurrence prevention for major depressive episodes generalized anxiety disorder, social anxiety disorder & panic disorder treatment VORICONAZOLE f.c. tablets 50mg, 200mg Broad spectrum antifungal VORICONAZOLE powder for solution for infusion 200mg Broad spectrum antifungal Pharmathen Product list 27

29 Active Pharmaceutical Ingredients «We transform new knowledge to innovative synthetic processes, designed to ensure quality, efficiency and sustainability» Pharmathen Product list 29

30 APIs Commercially PRODUCT INDICATION DMF STATUS Aprepitant Prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and for prevention of postoperative nausea and vomiting Q Aripiprazole Treatment of Schizophrenia Brinzolamide Ocular hypertension / Open angle Glucoma Duloxetine HCl Depressive disorder Febuxostat Chronic management of Hyperuricemia Q Fluvastatin Na Cholesterol Lowering Ibandronate Na H2O Treatment & Prevention of Postmenopausal Osteoporosis Ivabradine HCl Angina Q Linezolid Infection treatment Paliperidone Treatment of Schizophrenia Q Pregabalin Management of neuropathic pain and treatment of epilepsy

31 APIs Commercially PRODUCT INDICATION DMF STATUS Polyquaternium-1 Ophthalmic solution preservative Technical package Ropinirole HCl Parkinson s Ropivacaine Anesthesia Tolterodine Tartrate Treatment of Over active bladder Valganciclovir HCl Treatment of Cytomegalovirus (CMV) Retinitis Venlafaxine HCl Depressive disorder Voriconazole Treatment of Inasive Aspergillosis fungal infection Pharmathen Product list 31

32 APIs R&D PRODUCT INDICATION SAMPLES STABILITY DATA FROM LAB TECHNICAL PACK Agomelatine Antidepressant Clopidogrel Acute Coronary Syndrome Dimethyl fumarate Immunomodulator Entecavir Hepatitis B infection Ezetimibe Cholesterol Lowering Fingolimod HCl Treatment of multiple sclerosis Mirabegron Treatment of overactive bladder ODV succinate Antidepressant, non-hormonal treatment for menopause Paliperidone palmitate Treatment of Schizophrenia

33 APIs R&D PRODUCT INDICATION SAMPLES STABILITY DATA FROM LAB TECHNICAL PACK Rivaroxaban Reduce the risk of stroke and systemic embolism. Treatment of Deep Vein Thrombosis. Treatment of Pulmonary Embolism Rizatriptan benzoate Headache phase of Migraine Attacks Acute Treatment Rosuvastatin Ca Cholesterol Lowering Solifenacin succinate Treatment of overactive bladder Strontium ranelate Tadalafil Treatment & Prevention of Postmenopausal Osteoporosis Erectile Dysfunction & Benign Prostatic Hyperplasia Pharmathen Product list 33

34 APIs Pipeline PRODUCTS UNDER EVALUATION INDICATION Ambrisentan Dabigatran Deferasirox Dronedarone Fesoterodine Lacosamide Perampanel Raltegravir Rilpivirine Roflumilast Sitagliptin Ticagrelor Topiroxostat Antihypertensive Antithrombotic Chelating agent Antiarrhythmic Antimuscarinic Anticonvulsant, Analgesic Antiepileptic Antiviral Antiviral Antiasthmatic Antidiabetic Platelet aggregation inhibitor Anti-gout Vildagliptin Antidiabetic

35 Pharmathen Product list 35

36 Pharmathen S.A., Headquarters 44, Kifissias Avenue Marousi Athens-Greece T: F: Pharmathen UK Ground Floor South Wing 10 Bricket Road St Albans AL1 3JX United Kingdom T: +44 (0)

We embrace science and innovation

Product Catalogue We embrace science and innovation TABLE of CONTENTS 8 Long Acting Injectables 12 Differentiated Products Preservative Free Ophthalmics in Multi-Dose Vials 16 Differentiated Products Oral