November 2015 - PharmaCompass

November 2015
Our Mission
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
“We provide high added value
products to meet costumer
quality requirements and enhance
their market image and position.”
Our History Highlights
1979
Laboratorios LESVI acquired by Laboratorios VITA
1980
INKE chemical plant founded
1998
Start of International Expansion
2005
LESVI and INKE acquired by Invent Farma (Iceland)
2006
QUALIGEN founded to market generic products in Spain
2013
INVENT FARMA USA founded
Our Corporate Structure
INVENT FARMA SPAIN
QUALIGEN
LAB. LESVI
INKE
245
61
R&D:79, MNF:125, QC: 41
INVENT FARMA USA
Our Assets Vertical Integration
R&D Center (Barcelona)
Lesvi
manufacturing plant
10.000 m2
ISO 14001
Inke chemical plant
5.000 m2
ISO 9001:2000
ISO 14001
Our Innovation
Early market entries in those territories without product patent constraints through:
Patented alternative synthesis
New polymorphic forms
Innovative patented formulations
Chemical Development
65% Advanced Graduates
20% PhD
Pharmacological Development
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
19.058
17.097
Fully integrated automatic control system, qualified and
validated according to FDA standards
12.979
17.554
16.258
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 Environmental Contribution
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 results:
Our Service to Customers
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 results:
Our Commitment to Enhance your
Competitiveness
ENALAPRIL + HCTZ
Generics market share France
almost 10 years after launch
LISINOPRIL + HCTZ
Generics market share France
9 years after product launch
49%
25%
75%
51%
Lesvi´s customers
Other
FLUCONAZOLE SUSP
Generics Market share
8 years after launch
Lesvi´s customers
Other
ONDANSETRON ODT.
Generics Market share
8 years after launch
44%
93%
56%
7%
Our customers
Other
Our customers
Other
Our International Partners
MULTINATIONAL
ACTAVIS
ASPEN
LOCAL
ADCOCK INGRAM (RSA)
BIOGARAN (FRA)
ASTRA ZENECA
BIOSINTETICA (BRA)
BAXTER
CINFA (ESP)
DEVA (TUR)
B. BRAUN
FERRER GRUPO (ESP)
DR. REDDY’S
MYLAN
GAP (GRE)
PIERRE FABRE
KERN (ESP)
MERCK (BRA)
RANBAXY
NICHIIKO (JAP)
SANOFI-AVENTIS
SKYE PHARMA
STADA
TEVA / RATIOPHARM
SOHO GROUP (INA)
SAWAI (JAP)
TOWA (JAP)
Our International Export
Markets
USA
Brazil
European Union
Indonesia
Central America
Chile
Middle East
Mexico
Japan
Korea
Philippines
Singapore
Vietnam
South Africa
Australia
New Zealand
Our Innovative Products
Single dose unit Solutions
Otic solution
Ophtalmic solution
Acute otitis externa even when the status of the tympanic
An excellent topical use alternative
membrane is unknown
Easy to use-single dose units
Chronic suppurative otitis media, the only approved otic
Relief from dry eye symptom
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
Our Fast Dissolving Technology
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 International Results
60.000
Values in Euros (Thousands)
50.000
40.000
30.000
20.000
10.000
0
TOTAL LESVI-INKE
2002
8.300
2004
20.200
2006
31.000
2008
43.100
2010
45.411
Total company sales in 2014: 84 Mio Eur
2012
48.738
2014
52.409
Product Development Pipeline
FDF
Product
Dosage form
Indication
Dossi
er
Ophtalmics
Artificial tears carmellose InD
2 mg solution (monodose)
Dry eye
√
Artificial tears hypromellose InD
0.5 mL solution (monodose)
0.3 mg / mL (0.4 mL single
dose solution)
0.3 +5 mg / mL (0.4 mL
single dose solution)
10 mg / mL (single dose
solution)
10 mg +5 mg / mL (single
dose solution)
20 mg + 5 mg / ml (0.2 mL
single dose solution)
50 µg / ml (0.2 mL single
dose solution)
50 µg + 5 mg / ml (0.2 mL
single dose solution)
Dry eye
√
Bimatoprost
Bimatoprost + Timolol
Brinzolamide
Brinzolamide + Timolol
Dorzolamide + Timolol
Latanoprost
Latanoprost + Timolol
Generics
Intraocular pressure
2016
Intraocular pressure
2016
Intraocular pressure
R&D
Intraocular pressure
R&D
Intraocular pressure
R&D
Intraocular pressure
R&D
Intraocular pressure
R&D
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.
Duloxetine
30 and 60 mg capsules
Dutasteride+Tamsulosin
0.5/0.4 mg capsules
200 mg / 5 ml and 50 mg / 5
ml
Fluconazol oral solution
√
Dosage form
Indication
Dossier
10 mg tablets
10 and 20 mg tablets
Analgesia
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
Olmesartan
5, 10, 15 and 20 mg odt
5, 10, 20 and 40 mg tablets
Phychosis, schizophrenia
General Hypertension
√
√
Olmesartan + hctz
20/12.5, 20/25, 40/12.5 and 40/25 mg
tablets
General Hypertension
√
Nausea & vomiting
chemotherapy induced
√
Irritable bowel syndrome
Analgesia
√
√
OndansetronP
Ondansetron oral dispersableP
Ondansetron inject solutionP
Otilonium bromide
Paracetamol effervescent
4 and 8 mg tablets
4 and 8 mg odt
4 and 8 mg injection vial
40 mg tablets
1g effervescent tabs
Paracetamol / Tramadol
325/37.5 mg effervescent tabs
Analgesia
Prasugrel
5 and 10 mg tablets
Thrombosis
QuetiapineP
25, 100, 200 and 300 mg tablets
Phychosis, schizophrenia,
depression bipolar
√
2016
√
Rivaroxaban
2.5, 10, 15 and 20 mg tablets
Thrombosis. Stroke
RizatriptanP
5 and 10 mg oral dispersible tablets
Migraine
√
Solifenacin
Telmisartan
5 and 10 mg tablets
20, 40 and 80 mg tablets
Overactive bladder
General Hypertension
√
√
√
Telmisartan + hctzP
40/12.5, 80/12.5 and 80/25 mg tablets
General Hypertension
√
Analgesia
√
ZolmitriptanP
2.5 and 5 mg oral dispersible tablets
Migraine
√
Major depression, pain due to
diabetic neuropathy, anxiety
√
Benign prostatic hyperplasia
Antifungal
2018
√
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
Ketorolac
Memantine
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
2018
Product Development Pipeline
API
API
Indication
R&D Validations batches
DMF
API
Indication
R&D Validations batches
DMF
√CoS
√
√
√
√
2015
ApixabanP
Venous thromboembolism
√
2017
Nitrendipine
Hypertension
Aprepitant
Emesis
√
2017
OlanzapineP
Schizophrenia, psychosis
Arformoterol tartrateP
Asthma / COPD (Inhaled)
√
√
Olanzapine pamoate*
Schizophrenia, psychosis
√
√
Olmesartan medoxomil
Hypertension
Olodaterol*
Asthma / COPD (Inhaled)
Ondansetron baseP
Emesis
√
√
Ondansetron hydrochlorideP
Emesis
√CoS
√
PaliperidoneP
Schizophrenia & bipolar mania
Schizophrenia & bipolar mania
(injection)
Prophylaxis and therapy of thrombosis
√
Prasugrel hydrochlorideP
Prophylaxis and therapy of thrombosis
√
Prucalopride succinate*
Chronic constipation
AsenapineP
Schizophrenia and acute mania
Bilastine*
Allergy
Carvedilol
Hypertension, angina, heart failure
Cinacalcet
Hyperparathyroidism / Hypercalcaemia
ClevidipineP
Hypertension
Clomethiazole
Insomnia
Dabigatran etexilate
Thrombosis
Desloratadine
Allergy
Desvenlafaxine
Major depressive disorder
√
√
√
2015
Paliperidone palmitate
2015
2016
√
√
Prasugrel baseP
RisperidoneP
Schizophrenia, psychosis
Thrombosis. Stroke
Rizatriptan benzoateP
Migraine
Roflumilast
COPD with chronic bronchitis
2015
Salmeterol xinafoateP
Asthma and COPD
√CoS
√
Telaprevir*
Chronic Hepatitis C
Hypertension
√
√
Parkinson disease
√
(+) Tetrabenazine
Parkinson disease
√
Tolvaptan*
Hiponatremia
Umeclidinium*
COPD treatment
Vilanterol trifenatate*
COPD with chronic bronchiitis
ZolmitriptanP
Migraine
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
√
√
TelmisartanP
Granisetron HClP
Emesis
√CoS
√
Tetrabenazine
Iloperidone
Schizophrenia and other psychotic
disorders
√
2015
Imidafenacin
Urinary incontinence
√
2015
Hypertension
√
2015
IndacaterolP
Asthma / COPD (Inhaled)
√
2015
Luliconazole
Antifungal
2016
Mitiglinide
Non-insulin dependent diabetes
√
√
Montelukast sodium
Asthma, allergic & seasonal rhinitis
√
√
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.
2016
√
Rivaroxaban
DronedaroneP
Imidapril
√
Other products: Enalapril maleate, Fluconazole, Loratadine and Quetiapine.
P = Patent applications/granted patents owned by Invent Farma Group
CoS= Products with Certificate of Suitability
* = Candidates to be developed
Respiratory products
√CoS
√
√
2015
√
√
√
√