november 2015 - pharmacompass · to the activities stated in art. 10.6 of the directive 2001/83/ec...
TRANSCRIPT
November 2015
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
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
Our Corporate Structure
INVENT FARMA SPAIN
QUALIGEN LAB. LESVI INKE INVENT FARMA USA
R&D:79, MNF:125, QC: 41
61 245
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
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:
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
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
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
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
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
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
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
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
Our International Export Markets
Indonesia Japan Korea
Philippines Singapore Vietnam
Australia New Zealand
USA Brazil
Central America Chile
Mexico
South Africa
European Union
Middle East
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
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
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
)
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 √
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.