Presentazione Molteni Farmaceutici...• 20 mg. + 325 mg. (red tab) • Onset pain relief: 30min •...

OVER A CENTURY OF HISTORY

Tradition behind experiencecompany overview

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”.

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

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

PAIN MANAGEMENT

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

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

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]

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

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

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.


€ 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:


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:

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.)

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

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:

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

ANESTHESIA

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


Anaesthesia portfolio

ROPIVACAINE


Ropivacaine®status of the international business

€ 1.274.509


Contract signed. Registration to start.

Kuwait: launch expected 2015.

Israel: registered. Not yet marketed

Lebanon: marketed

Jordan: launch expected Q4 2015.

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

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.

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

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.

Ketamine 50mg/ml in 2ml

KETAMINE

“surgical anaesthesia”

Injectable forms (pack of 1 glass vial)

• 100 mg/2ml

Pharmaceuticals Forms:

• [2mg/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.

ADDICTION

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.


Addiction portfolio

METHADONE

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

• 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.

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.


Methadone®status of the international business

€ 968.737


Countries of interest Contract signed. Registration to start.

Costa Rica: registration to start

Latin America:


Canada:


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

NETWORK

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.

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.



(since 2014)



(since 2014)

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

Presentazione Molteni Farmaceutici...• 20 mg. + 325 mg. (red tab) • Onset pain relief: 30min •...

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