presentazione molteni farmaceutici...• 20 mg. + 325 mg. (red tab) • onset pain relief: 30min •...
TRANSCRIPT
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OVER A CENTURY OF HISTORY
Tradition behind experiencecompany overview
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Our vision
“To built a significant and sustainable value to
specialist physicians dealing with both pain
management and drug addiction therapeutic
areas”.
Our mission
“To grow its International commercial presence
gradually by extending worldwide our product
portfolio, building a pan European cooperation in
MMT, OST and pain management”.
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OLTRE UN SECOLO DI STORIAOver a century of history
Molteni at glance:
Molteni headquarter is located in Scandicci
(close to Florence, Italy) and it has a direct
commercial organization already established in
Italy and Poland with a portfolio of products
marketed to specialist physicians.
Molteni Farmaceutici is a privately held
pharmaceutical company founded in 1892 with
a wide spectrum of knowledge, experience and
pharmaceutical products in the field of drug
addiction and pain therapy throughout Europe.
Today Molteni counts its presence in more than 25 countries
2015
Moltenidevelops its core business in the pain treatment, becoming a well establish reality.
1972
Production moved to Scandicci area
1962
Company growth at almost 200 people employees
1920
Historical pharmacy in center of Florence
1892
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Molteni: Annual figures 2014
• Number employees = 250 people
• Production dpt. = 32 people
• Quality control dpt. = 28 people
• Regulatory dpt. = 5 people
• Medical dpt. = 6 people
84%
16%
Domestic
International (including
Polish branch)
• Total Turn Over = around € 58,6M
• Export Turn Over = around € 5,6M
33%
35%
32%
Pain
Anesthesia
Addiction
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PAIN MANAGEMENT
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ORAMORPH
(oral liquid morphine
sulphate)
10mg/5ml
30mg/5ml
2mg/ml
20mg/ml
Udv’s
Plastic unit dose vials
Syrup 100ml bottle
(child proof and doser)
Solution 20ml bottle drop
(child proof and dropper)
10, 20 and 30
udv’s
Severe chronic pain
Predictable Break through cancer pain
MORPHINE
HYDROCLHORIDE
10mg/ml
20mg/ml
50mg/5ml
Injectable forms
1 and 5 amps
Acute pain
PETHIDINE 100mg/2ml Injectable forms 1 glass amp Moderate to severe pain
DEPALGOS
(Oxycodone+Paracetamol)
5mg/325mg
10mg/325mg
20mg/325mg
Tablets
14, 28, 56
tablets
Moderate to severe chronic pain of
degenerative origin under muscle-ostearticular
illness.
PRODUCT STRENGHT PRESENTATION PACK THERAPEUTIC INDICATIONS
Pain portfolio
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MORE THAN A CENTURY OF HISTORY
Pillars of Pain Market Business
ORAMORPH
Unique Oral Liquid Morphin
Gold standard for Pain Treatment
Pediatric Indication
DEPALGOS
Fixed Combination of Paracetamol and
Oxycodone IR
Indicated both in cancer and non cancer
Pain
Therapy of Choice after NSAID’s
PECFENT
Fentanyl Pectin Nasal Spray for BTcP
Exclusive PecsysTechnology
Faster onset
Effective cover
Time after time
Over a century of history
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Oramorph ®
ORAMORPH ® (Oral Liquid Morphine)
“severe chronic cancer pain”
Syrup [2mg/ml in 100ml]
UDV Plastic Unit Dose Vials
Boxes 10, 20, 30. [10mg/5ml ]
[30mg/5ml]
[100mg/5ml]
Drops [20mg/ml in 20ml]
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Oramorph ®
ORAMORPH ® (Oral Liquid Morphine)
“severe chronic oncologic pain”
Characteristics:
• Onset 20 min.
• Quick pain control (MERITO and ORTIBER Study)
Easy to identify the minimal effective dose
• Washing receptor / avoids rotation to
inappropriate opioid dosages or combinations
analgesics
• Shelf life: 3 years
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Oramorph ®
Positioning:
• Predictable pain
• Start therapy
• Opioid rotation
• Pain in childhood
• Titration 1 drop = 1.25 mg morphine
• Daily dose: 0.2 to 0.3 mg / kg body
weight split every 4 hours
• Pediatric indication
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Oramorph ®
Oramorph ®. Morphine sulphate oral liquid presentation is the
reference drug in moderate to severe cancer pain. It is highly
recommended by all national and international guidelines
(EAPC ESMO Clinical Guidelines for the Use of Chronic Opioid
Therapy)
Oramorph® vs Competitors
1. Oramorph® is the appropriate medication for initiation of
therapy with opioid because it is the only one that allows
you to establish the lowest effective dose and to identify
the lowest interacting dose (unlike for example the Slow
Release oral medications and transdermal patches).
2. Oramorph® is the only drug that is approved for pediatric
patients (other opioids are off-label).
3. Oramorph® is commercially available in a wide range of
formulations (oral vials, drops, syrup), so as to meet the
medical needs for all patients with pain.
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OLTRE UN SECOLO DI STORIAOver a century of history
€ 1.586.169
Turnover Yr. 2014 (BU International)Marketed
Countries of interest
Oramorph®status of the international business
Contract signed. Registration to start.
Israel: launch expected Q3 2015
Jordan: registration ongoin
Russian Federation:
project under evaluation
Central American: registration to start
in: Ecuador, Panama, Costa Rica,
Caribbean.
Latin America:
project under evaluation
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DEPALGOS (tablets)
(Oxycodone + Paracetamol)
Depalgos is a fixed dose combination of Oxycodone IR (5, 10, 20 mg) and Paracetamol (325 mg).
Treatment of moderate to severe muscle-osteoarticular pain not adequately controlled
by NSAIDs and/or paracetamol alone.
Treatment of moderate to severe cancer pain
Positioning:
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Depalgosproduct profile
DEPALGOS (tablets)
(Oxycodone + Paracetamol)
• 5 mg. + 325 mg. (yellow tab)
• 10 mg. + 325 mg. (pink tab)
• 20 mg. + 325 mg. (red tab)
• Onset pain relief: 30min
• Tablets of 14s, 28s, 56s.
• Start treatment with a 5mg every 6-8h
• Shelf life: 5 years
• Storage precautions: none
• Equi-analgesia 1 to 2
(i.e 10 mg of oral OXYCODONE = 20mg oral MORPHINE)
Generic of PERCOCET (marketed in U.S.)
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Depalgoskey messages
� Synergic combination of
Oxycodone/Paracetamol that offers
improved efficacy with lower dose
� Depalgos is the only fixed oral dosage form
(IR) that is authorized and marketed in one of
the European countries (Italy)
� Depalgos has a good tolerability profile with
lower side effects than conventional
treatments
58%
32%
10%
strenghts - market share %
5 mg
10 mg
20 mg
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Pecfentproduct profile
The ideal medication for BTcP:
• Provide an effective pain relief
• Work rapidly
• Have a relatively short duration of action
• Be non invasive
• Easily be administered by physicians, patients
and their caregiver
Positioning:
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Product Summary:PecFent – Fentanyl Pectin Nasal Spray
• PecFent is an innovative fentanyl product for BTCP
• Aqueous nasal spray of fentanyl and Archimedes’ proprietary PecSys nasal
delivery system
• Two product strengths:
– 100 µg and 400 µg per spray of fentanyl in a low spray volume (100 µl)
• Nasal spray pump fitted with audible and visual dose counter and lock
• Each bottle delivers 8 sprays
– Provides a minimum of one day of treatment at highest dose
– Presented with Child Resistant Container
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ANESTHESIA
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ROPIVACAINE
(hydrochloride vials &
infusion)
2mg/ml
7,5mg/ml
10mg/ml
Amp 10ml 20ml/Bags 100,
200ml
Amp 10ml, 20ml
Amp 10ml, 20ml
Pack of 5 plastic
amp
Local and general anesthesia
(motor block)
Acute pain post-operative
KETAMINE 50mg/ml Injectable amp 2ml Pack of 1 glass
amp
Anesthetic for diagnostic and surgical
procedure
L-BUPIVACAINE 2,5mg/ml
5mg/ml
7,5mg/ml
0,625mg/ml
1,25mg/ml
Ampoules 10ml
Amp 10ml
Amp 10ml
Bag 100ml ,200ml
Bag 100ml ,200ml
Pack of 10
Local and general anesthesia
(motor block)
Acute pain post-operative
PRODUCT STRENGHT PRESENTATION PACK THERAPEUTIC INDICATIONS
Anaesthesia portfolio
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ROPIVACAINE
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OLTRE UN SECOLO DI STORIAOver a century of history
Ropivacaine®status of the international business
€ 1.274.509
Turnover Yr. 2014 (BU International)Marketed
Contract signed. Registration to start.
Kuwait: launch expected 2015.
Israel: registered. Not yet marketed
Lebanon: marketed
Jordan: launch expected Q4 2015.
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One concentration:
• 2 mg/ml Ropivacaine base;
Two presentations for the market
•100 ml solution in a 100 ml flexible polypropylene bag with transparent over pouch.
•200 ml solution in a 250 ml flexible polypropylene bag with transparent over pouch.
The bag is equipped with:
- 1 admixture port
- 1 administration port
Ropivacaine®Solution for infusion. Product profile
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Primary Packaging: bags
Description Primary Packaging
Ropivacaine Molteni
Flexible Bag PP
Administration Port
(insertion part of the infusion device)
PP
Admixture Port
(point for injecting pharmaceutical products into the solution)
PP
(membrane in contact with the product)
Advantage of Ropivacaine Molteni bag
Molteni bag is made of polypropylene in all parts.
This is why PVC isn’t well accepted material for pharmaceutical containers in
some countries for two main reasons::
• PVC can contain additives (such as phthalates)
• PVC is more difficult to dispose off and therefore more harmful for the
environment.
The primary packaging of both products has the following characteristics:
transparent container with a resistance to breaking and a reduced volume for storage.
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Three concentrations
- Ropivacaine hydrochloride corresponding to 2.5 mg/ml
- Ropivacaine hydrochloride corresponding to 7.5 mg/ml
- Ropivacaine hydrochloride corresponding to 10 mg/ml
Presentations
- 10 ml polypropylene ampoule,
in sterile blister packs of 5, 10 and 20
Ropivacaine®Solution for injection. Product profile
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Primary Packaging: amps
Description Primary Packaging
Levobupivacaine Molteni
Material of ampoules PP
Attack on the luer-lock syringe Complies
Advantage of Ropivacaine Molteni ampoules
The compliance with the luer-lock syringe allows the aspiration of the
solution without using needle.
This characteristic of the ampoule was developed by Molteni for
Ropivacaine generic product in order to respond to the market requests
coming from some European countries
The primary packaging has a transparent container with a resistance to breaking.
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Ketamine 50mg/ml in 2ml
KETAMINE
“surgical anaesthesia”
Injectable forms (pack of 1 glass vial)
• 100 mg/2ml
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Pharmaceuticals Forms:
• [2mg/ml amp 10ml]
• [5mg/ml amp 10ml]
• [10mg/ml amp 10ml]
• [0,625mg/ml bag 100, 200ml]
• [1,25mg/ml bag 100, 200ml]
Levo-Bupivacaine Molteniproduct profile
Positioning:
Pain management in adults by
continuous epidural infusion for the
management of post operative pain
and labor analgesia.
Marketing Advantage:
• The compliance with the luer-lock syringe
allows the aspiration of the solution without
using needle.
• Molteni’s bag is made of polypropylene. In some countries,
the PVC isn’t well accepted material for pharmaceutical
containers because it contains additives such phthalates.
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ADDICTION
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METHADONE
(oral liquid solution)
1mg/ml
5mg/ml
10mg/ml
100ml, 500ml, 1000ml
bottle
Treatment of heroin drug addiction
dependence
LEVO-METHADONE
(oral liquid solution)
5mg/ml 100ml, 500ml bottle Treatment of heroin drug addiction
dependence
BUPRENORPHINE 2mg
8mg
Sublingual tablets 7 or 14 tablets Treatment of heroin drug addiction
dependence
NALTREXONE 50mg Oral tables 14 or 28 tablets Treatment of alcohol dependence and
detoxification
NALOXONE
0,4mg/ml
0,04 mg/2ml
Injectable amp
1 glass amps Used to counteract life-threatening depression
of the central nervous system and respiratory
system.
PRODUCT STRENGHT PRESENTATION PACK THERAPEUTIC INDICATIONS
Addiction portfolio
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METHADONE
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Eptadone®/Methadone Molteni
1 mg/ml syrup• 20, 40, 60 ml. Singledose
5 mg/ml syrup• 20 ml. Singledose
1 mg/ml syrup•100, 500, 1000 ml. multi dose
5 mg/ml syrup•100, 500, 1000 ml. multi dose
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• Methadone (Eptadone®)
“Oral Solution - Contains Methadone Hydrochloride”
COLORED & SUGAR FREE
Methadone Molteniproducts profile
Stability:12 months(when bottle opened)
Multidose:
1 mg/ml syrup•100, 500, 1000 ml.
5 mg/ml syrup•100, 500, 1000 ml.
10 mg/ml syrup•100, 500, 1000 ml.
Shelf life: 3 years
blue
amber
green
Guide lines: average daily dose to be effective 60-120 mg.
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Brand Image 2014
Positioning
Eptadone is the gold standard
treatment for all patients suffering
of Heroin Addiction due to is
unsurpassed efficacy
It is more effective in retention.
It is more effective in reducing heroin.
It is less expensive.
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OLTRE UN SECOLO DI STORIAOver a century of history
Methadone®status of the international business
€ 968.737
Turnover Yr. 2014 (BU International)Marketed
Countries of interest Contract signed. Registration to start.
Costa Rica: registration to start
Latin America:
project under evaluation
Canada:
project under evaluation
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Molteni’s franchise in Drug Addictionproducts available
• Naloxone (Naloxone Molteni)
injectable vial 0,4mg/ml (adults)
injectable vial 0,04mg/2ml (neonatal)
pack of 1 or 5
• Naltrexone (Naltrexone Molteni)tablets 50 mg
pack of 14 or 28.
Therapeutics indication: Detoxification and Alcohol abuse
Available in:
ALBANIA
HONG KONG
Tender market in:
NEW ZELAND
On the market (compassion use):
SWEDEN
Registration ongoing:
SWEDEN
CANADA
CHINA
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NETWORK
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Molteni network:
Qualified and one of authorized and selected regular product’s supplier for
implementation and maintenance of local national program
Unicef (since 2009)
Group of specialists involved and working deeply in the addiction treatment programs at
mainly but not only at European level.
The aim is to create word of mouth and awareness on MMT so that people from developing
countries can acquire more knowledge in this therapeutic field.(Independent association)
International financing organization that aims to attract and disburse additional
resources to prevent and treat HIV and AIDS, tuberculosis and malaria.
Monitoring Methadone programm in Ukraine, distributed by Allianz.
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Molteni network:
Médecins Sans Frontieres (MSF) is an international humanitarian non-
profit organization that provides emergency and long-term medical care
to vulnerable populations while advocating for equal access to
healthcare worldwide.
Molteni has been awarded as «preferable supplie» for 2 years in a row.
Qualified and one of authorized and selected regular product’s supplier for
implementation and maintenance of local national program
(since 2014)
Qualified and one of authorized and selected regular product’s supplier for
implementation and maintenance of local national program
(since 2014)
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Thank youL.Molteni & C dei Fratelli Alitti S.p.A.
Strada Statale 67 Frazione Granatieri, 50018 Scandicci Firenze .Italy
Telephone: +39 055 7361226 Fax: +39 0557361354
www.moltenifarma.it