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Page 1: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

November 2015

Page 2: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Mission

“We provide high added value products to meet costumer

quality requirements and enhance their market image and position.”

Development and manufacture of APIs with complex synthesis process

Development, manufacturing and registration of pharmaceutical specialties

Distribution of our products through global partner alliances. Continuous international expansion

since 1998

Page 3: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our History Highlights

Laboratorios LESVI acquired by Laboratorios VITA INKE chemical plant founded Start of International Expansion LESVI and INKE acquired by Invent Farma (Iceland) QUALIGEN founded to market generic products in Spain INVENT FARMA USA founded

1979

1998

2013

1980

2005

2006

Page 4: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Corporate Structure

INVENT FARMA SPAIN

QUALIGEN LAB. LESVI INKE INVENT FARMA USA

R&D:79, MNF:125, QC: 41

61 245

Page 5: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Assets Vertical Integration

R&D Center (Barcelona)

Inke chemical plant

5.000 m2

ISO 9001:2000 ISO 14001

Lesvi manufacturing plant

10.000 m2

ISO 14001

Page 6: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Innovation

Patented alternative synthesis

New polymorphic forms

Innovative patented formulations

65% Advanced Graduates

20% PhD

Chemical Development Pharmacological Development

Early market entries in those territories without product patent constraints through:

Page 7: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Results

More than 100 patents granted in most important countries worldwide

Independent expert reports validating our strong patent position

220 dossiers (FDF) submitted to Regulatory agencies of different territories and around 120 Marketing authorizations granted

Invent Farma Group is among the top 10 European manufacturer companies with “the highest number of European patent filings”

Source: EPO-14

Page 8: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Manufacturing Value API

Multipurpose plant designed for stringent standards required for

parenteral grade and respiratory products

Pharmaceutical grade (class 10000 compliance) in last synthesis steps

and packaging

Critical in-process controls and cleaning process validation in the whole

process to assure the highest quality standards

Full testing of our products under aseptic conditions

Page 9: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Manufacturing Value Finished Product

Latest technology sterile plant, prepared and approved

for aseptic process

Fully integrated automatic control system, qualified and

validated according to FDA standards

17.554 16.258

12.979

17.097 19.058

Page 10: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our Quality Contribution

Quality Assurance

FDA inspected facilities (last inspection in 2013, Inke; in 2015 Lesvi)

GMP certification by Health Authorities

ISO 9001:2008 (Inke)

Quality driven organization

37% of employees directly involved in quality

Preparation of Technical documentation:

DMF’s, EU dossiers, CoS’s

Full implementation of GMP

Our results

High quality products, low impurity levels

Successful internal/external audits

High regulatory performance - several MA’s

including France without Deficiency Letter

Page 11: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our results:

Total commitment to protection of environment

Employee's training is essential to achieve higher

level of environmental awareness and care

Environmental management system

Environmental fully equipped laboratory (TOC,

Respirometer, Microtox...)

Environmental UNE EN ISO 14001:2011

Our Environmental Contribution

Page 12: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our results:

Support to our customers on:

Submission of dossiers

Deficiency letters

Patent issues

Technical issues

Country specific requirements

You can expect from us:

Quality and personal service

Flexibility and remarkable adaptation to

customer needs

Speed of response

Our Service to Customers

Page 13: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

51%

49%

Lesvi´s customersOther

ENALAPRIL + HCTZ Generics market share France almost 10 years after launch

56%

44%

Our customersOther

ONDANSETRON ODT. Generics Market share 8 years after launch

FLUCONAZOLE SUSP Generics Market share

8 years after launch

Our Commitment to Enhance your Competitiveness

93%

7%

Our customersOther

75% 25%

Lesvi´s customersOther

LISINOPRIL + HCTZ Generics market share France 9 years after product launch

Page 14: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our International Partners

ADCOCK INGRAM (RSA)

KERN (ESP)

SAWAI (JAP)

SOHO GROUP (INA)

FERRER GRUPO (ESP)

TOWA (JAP)

CINFA (ESP)

BIOGARAN (FRA)

BIOSINTETICA (BRA)

DEVA (TUR)

GAP (GRE)

MERCK (BRA)

NICHIIKO (JAP)

MULTINATIONAL LOCAL

B. BRAUN

ACTAVIS

ASPEN

DR. REDDY’S

PIERRE FABRE

STADA

TEVA / RATIOPHARM

BAXTER

ASTRA ZENECA

RANBAXY

SANOFI-AVENTIS

SKYE PHARMA

MYLAN

Page 16: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Otic solution

Acute otitis externa even when the status of the tympanic

membrane is unknown

Chronic suppurative otitis media, the only approved otic

solution for this indication; represents 85% of otitis of 1.5% of

adult population

Indicated also in paediatrics use (no systemic absorption)

Wide anti-bacterial spectrum with high efficacy for

Pseudomonas and Staphylos

European patent number EP 806206

Our Innovative Products Single dose unit Solutions

Ophtalmic solution

An excellent topical use alternative

Easy to use-single dose units

Relief from dry eye symptom

Page 17: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Orodispersable tablets for:

Olanzapine

Zolmitriptan

Rizatriptan

Ondansetron

Desloratadine

Designed for conventional manufacturing and packaging technology

Rapid disintegration (5-10 seconds), high mechanical strength and good taste Patent application filed: appl. Nº PCT/EP2008/063068

on October 1, 2007

Our Innovative Products Our Fast Dissolving Technology

Page 18: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Our International Results

Total company sales in 2014: 84 Mio Eur

0

10.000

20.000

30.000

40.000

50.000

60.000

2002 2004 2006 2008 2010 2012 2014TOTAL LESVI-INKE 8.300 20.200 31.000 43.100 45.411 48.738 52.409

Valu

es in

Eur

os (T

hous

ands

)

Page 19: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Other products already in the market: enalapril, enalapril+HCTZ, Lisinopril, Lisinopril+HCTZ, Fluconazol tablets, Irbesartan, Irbesartan + HCTZ, Loratadine (tablets and syrup), Risperidone, Valsartan and Valsartan + HCTZ P = Patent applications/granted patents owned by Invent Farma Group InD = Industrial designs owned by Invent Farma Group

Products protected by valid patents are developed with no commercial purposes. These products are under development for uses related to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. Products protected by valid patents in Spain are not offered out of the scope of the activities stated at Art. 52.1, b) of the Spanish Patent Act, i.e. activities carried out to obtain a Marketing Authorization in Spain or out of Spain. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents. © LESVI Laboratorios / Inke. All rights reserved.

Product Development Pipeline FDF

Product Dosage form Indication Dossier

Ophtalmics Artificial tears carmellose InD 2 mg solution (monodose) Dry eye √ Artificial tears hypromellose InD 0.5 mL solution (monodose) Dry eye √

Bimatoprost 0.3 mg / mL (0.4 mL single dose solution) Intraocular pressure 2016

Bimatoprost + Timolol 0.3 +5 mg / mL (0.4 mL single dose solution) Intraocular pressure 2016

Brinzolamide 10 mg / mL (single dose solution) Intraocular pressure R&D

Brinzolamide + Timolol 10 mg +5 mg / mL (single dose solution) Intraocular pressure R&D

Dorzolamide + Timolol 20 mg + 5 mg / ml (0.2 mL single dose solution) Intraocular pressure R&D

Latanoprost 50 µg / ml (0.2 mL single dose solution) Intraocular pressure R&D

Latanoprost + Timolol 50 µg + 5 mg / ml (0.2 mL single dose solution) Intraocular pressure R&D

Generics

Aripiprazole 5, 10, 15 and 30 mg tablets Schizophrenia, bipolar disorder √

AsenapineP 5 and 10 mg sublingual t Schizophrenia, bipolar 2017

Azithromycin 500 mg tablets and 200 mg / 5 ml susp. Macrolide antibacterial √

Ciprofloxacin otic solutionP 1 mg ear solution (monodose) Otitis √

ClopidogrelP 75 mg tablets Atherothrombosis √ DesloratadineP 5 mg tablets Allergy √

DexketoprofenP 12.5 and 25 mg tablets and 50 mg / 2 ml inject sol. Analgesia √

Duloxetine 30 and 60 mg capsules Major depression, pain due to diabetic neuropathy, anxiety √

Dutasteride+Tamsulosin 0.5/0.4 mg capsules Benign prostatic hyperplasia 2018

Fluconazol oral solution 200 mg / 5 ml and 50 mg / 5 ml Antifungal √

Product Dosage form Indication Dossier Ketorolac 10 mg tablets Analgesia √ Memantine 10 and 20 mg tablets Alzheimer’s disease √

Montelukast 4 and 5 mg chewable tabs 10 mg tablets Asthma, allergy √

OlanzapineP 2.5, 5, 7.5, 10, 15 and 20 mg tablets Phychosis, schizophrenia √

Olanzapine oral dispersableP 5, 10, 15 and 20 mg odt Phychosis, schizophrenia √ Olmesartan 5, 10, 20 and 40 mg tablets General Hypertension √

Olmesartan + hctz 20/12.5, 20/25, 40/12.5 and 40/25 mg tablets General Hypertension √

OndansetronP 4 and 8 mg tablets Nausea & vomiting chemotherapy induced √ Ondansetron oral dispersableP 4 and 8 mg odt

Ondansetron inject solutionP 4 and 8 mg injection vial Otilonium bromide 40 mg tablets Irritable bowel syndrome √ Paracetamol effervescent 1g effervescent tabs Analgesia √

Paracetamol / Tramadol 325/37.5 mg effervescent tabs Analgesia √

Prasugrel 5 and 10 mg tablets Thrombosis 2016

QuetiapineP 25, 100, 200 and 300 mg tablets Phychosis, schizophrenia, depression bipolar √

Rivaroxaban 2.5, 10, 15 and 20 mg tablets Thrombosis. Stroke 2018

RizatriptanP 5 and 10 mg oral dispersible tablets Migraine √

Solifenacin 5 and 10 mg tablets Overactive bladder √ Telmisartan 20, 40 and 80 mg tablets General Hypertension √

Telmisartan + hctzP 40/12.5, 80/12.5 and 80/25 mg tablets General Hypertension √

ZolmitriptanP 2.5 and 5 mg oral dispersible tablets Migraine √

Page 20: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of

Products protected by valid patents are developed with no commercial purposes. These products are under development for uses related to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. No activity will be performed with the products protected by a patent in force beyond the scope of the bolar provision in the respective countries. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.

Product Development Pipeline API

P = Patent applications/granted patents owned by Invent Farma Group

CoS= Products with Certificate of Suitability

* = Candidates to be developed

Respiratory products

API Indication R&D Validations batches DMF

ApixabanP Venous thromboembolism √ 2017 Aprepitant Emesis √ 2017 Arformoterol tartrateP Asthma / COPD (Inhaled) √ √ AsenapineP Schizophrenia and acute mania √ √ Bilastine* Allergy Carvedilol Hypertension, angina, heart failure √ √

Cinacalcet Hyperparathyroidism / Hypercalcaemia √ 2015

ClevidipineP Hypertension Clomethiazole Insomnia Dabigatran etexilate Thrombosis 2015 2016 Desloratadine Allergy √ √ Desvenlafaxine Major depressive disorder DronedaroneP Atrial fibrillation & general arrhythmia √ √ Eletriptan HBr Migraine √ 2015 Formoterol Asthma and COPD √CoS √

Fosaprepitant dimeglumide Emesis 2015 2016

Glycopyrrolate Br COPD with chronic bronchiitis √ 2015 Granisetron baseP Emesis √ √ Granisetron HClP Emesis √CoS √

Iloperidone Schizophrenia and other psychotic disorders √ 2015

Imidafenacin Urinary incontinence √ 2015 Imidapril Hypertension √ 2015 IndacaterolP Asthma / COPD (Inhaled) √ 2015 Luliconazole Antifungal 2016 Mitiglinide Non-insulin dependent diabetes √ √ Montelukast sodium Asthma, allergic & seasonal rhinitis √ √

API Indication R&D Validations batches DMF

Nitrendipine Hypertension √CoS √ OlanzapineP Schizophrenia, psychosis √ √ Olanzapine pamoate* Schizophrenia, psychosis Olmesartan medoxomil Hypertension √ 2015 Olodaterol* Asthma / COPD (Inhaled) Ondansetron baseP Emesis √ √ Ondansetron hydrochlorideP Emesis √CoS √ PaliperidoneP Schizophrenia & bipolar mania √

Paliperidone palmitate Schizophrenia & bipolar mania (injection) √ 2016

Prasugrel baseP Prophylaxis and therapy of thrombosis √ Prasugrel hydrochlorideP Prophylaxis and therapy of thrombosis √ Prucalopride succinate* Chronic constipation RisperidoneP Schizophrenia, psychosis √CoS √ Rivaroxaban Thrombosis. Stroke √ 2015 Rizatriptan benzoateP Migraine √ √ Roflumilast COPD with chronic bronchitis 2015 Salmeterol xinafoateP Asthma and COPD √CoS √ Telaprevir* Chronic Hepatitis C TelmisartanP Hypertension √ √ Tetrabenazine Parkinson disease √ (+) Tetrabenazine Parkinson disease √ Tolvaptan* Hiponatremia Umeclidinium* COPD treatment Vilanterol trifenatate* COPD with chronic bronchiitis ZolmitriptanP Migraine √ √

Other products: Enalapril maleate, Fluconazole, Loratadine and Quetiapine.

Page 21: November 2015 - PharmaCompass · to the activities stated in Art. 10.6 of the Directive 2001/83/EC amended by Directive 2004/27/EC of the European Parliament and of the Council of