Administration challenges: Innovative solutions in IV ...

© 2018 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company.© 2018 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company.

Administration challenges:Innovative solutions in IV applications

Dragana CVIJANOVIC

28/08/2018

© 2018 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company.

The Small Molecules market is a large and fragmented market covering a broad spectrum of medical indications

Large drug market with ~38bn doses and generating $120bn revenue to the Pharma industry

Fragmented drug market spread over ~100 Anatomical Therapeutic Classes (ATC2)

Drugs mainly used at Hospitals

70% of this drug market is sold to the Hospital channel

Low drug AUSP ~$3 /dose

81% of this market is made by drugs with AUSP lower than $2

24%

18%

11%8%

5%

4%

4%

4%

4%

3%

3%

12%

9%

16%

6%

2%

2%

7%

5%5%1%

5%

9%

33%

Small Molecules sales in 2016Breakdown by medical indications

Other Hospital Solutions

Antibacterials

Analgesics & Anaesthetics

Other Vitamins & Minerals

Gastro-intestinal DisordersdrugsHormones non-biologics

Other Therapeutic Products

Cardiovascular System Non-biologic DrugsResp & Pulmonary non-biologicsCardiac Therapy

Other Nervous System Drugs

Other Therapeutic Classes

Units ~38bn (int)Revenue $120bn (ext)

AUSP: Average Unit Selling Price

Source: IQVIA/IMS based sales (Raw data 2016)- Drug market demand


Drugs presented in a ready-to-administer format represent ~1% of thistotal market in volume but 10% in value

Ampoules46%

Vials43%

Bags9%

Others1%

RTA 1%+/-350 MU

Pens<1%

Small Molecules drug market –Volume Breakdown by presentation

Ampoules : -0.4%Vials : +2%Bags: +7%Others : -20%RTA : +4%Pens : -2%

CAGR14-16

2016 Total market: 38bn units

RTA => Ready-To-Administer ( ie PFS + Ready-To-Administer devices (Hospira Carpuject™…)


Ampoules19%

Vials52%

Bags18%

Others1%

RTA 10%$11 bn

Pens0%

Small Molecules drug market –Revenue Breakdown by presentation (USD)

2016 Total market: $ 110bn

Included : PFS, Disposable Auto InjectorsExcluded : Cartridge


Pfizer Hospira is the major player in ready-to-administer form on small moleculemarket. Largest revenue is generated in North America & Europe.

40%

10%5%4%

3%

3%

3%

3…

2%

2%

Other players (n=290), 25%

Top Drug Pharma players in 2016

RTA presentations~350Mu

*on the small molecule market


All other trademarks are property of their respective owner.

AFRICA & MIDDLE EAST

0%

ASIA14%

EUROPE20%

LATIN AMERICA

2%

NORTH AMERICA64%

Small Molecules drug market in RTA –Regional Breakdown (US$)


Based on past growth & current trends, injectables in PFS are expected to grow by 10%, driven by increased usage in critical care

SODIUM17%

MORPHINE17%

HYDROMORPHONE15%

EPINEPHRINEHYDROXOCOBALAMIN

ESTRADIOL

BETAMETHASONE

LIDOCAINECYANOCOBALAMIN

BROMINE

SUMATRIPTAN

MEDROXYPROGESTERONE

PROPOFOL

THYMOPENTIN Other molecules

140 156

170 188

208 230

254

281

311

345

382

423

-

50

100

150

200

250

300

350

400

450

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

Drug demand in PFS

10% CAGR18-21


RTA presentations~350Mu

Top 15 molecules in Ready-To-Administer presentation

Source: BD Internal projection model


Ready-to-administer marketed drugs in the small molecules space

Hospira Carpuject ™

Sagent Pharma

Fresenius Simplist™

Sagent/Mylan Sumatriptan

Astra Zeneca Lidocaine

Martindale/Aurum Range



Investing in prefilled syringes for acute drugs in hospital enhances patient outcomes & clinician’s efficiencies

• Patient safety risks associated with conventional preparation (vial/ampoule + syringe):

• Medication errors

• Risk of contamination

• Reuse of consumables

• Requires many time consuming steps

Challenges Today

• Improved patient safety through reduction in:

• Risk of medication errors

• Reuse

• Risk of contamination

• Convenience & improved ease of administration

Prefill Benefits

• Anesthetics

• Cardiovascular

• Emergency

• Intensive Care

Applicable therapeutic areas/drugs

Benefits of Prefilled Syringes – Global Value Dossier, January 2017


BD observations

Some criteria to identify candidates for vial to prefill conversion drivers

DRUG

PREPARATION

• Must :

• Limited range of concentrations/doses covers most patient situations

• Additional Criteria

• Complex or time consuming preparation prone to errors

• Drug is a controlled substance

• Drug is an hazardous substance

DRUG

STORAGE

• Must :

• Drug is stable in solution

• Drug is not known to interact with material used in PFS (eg elastomer, silicon, glue…)


• Drug is stored at ambient temperature

• Drug is known to have a short shelf life when compounded in standard disposable plastic syringe (interaction), a container

DRUG

INJECTION


• Drugs are used in emergency settings (e.g. Intensive Care Unit or Operating Room)

• Precise dosing is required – over dosage can be lethal e.g. pediatric dosage

• Drug may be used in situations at risk of contaminations (Home, emergency case)

Meet hospital care needs

Create value

Focus on high runner or create your niche

BD recommendations for success


Case study : Morphine-Pain management

PATIENT INTERFACE SYRINGE SYSTEM REQUIREMENTS

Challenge Design solution

Oxygen sensitive

Centerpost Breakage

Syringe clogging with NLAD

Glass container

Luer Lock Enlarged Channel

(LLEC)

DRUG PREPARATION

• Preparation is not patient dependent

• Presentation in a single dose container is already available

• Full dose is used

• No dilution is required

DRUG INJECTION

• Used in ER/ICU settings: IV with NLAD

•User Error : High impact of labelling/concentration errors

DRUG

STORAGE

• Potential interactions with plastic

• No known interactions with glass

• The drug is stored at ambient temperature

Constraints managed by process/packaging solutions: • Filling under nitrogen + scavenger to address oxygen sensitivity• Blister to address Light & heat sensitivity

DRUG REQUIREMENTS


ER: Emergency Room - ICU: Intensive Care Unit – IV: Intravenous – NLAD: Needleless Luer Access Devices


Case study : Naloxone–Antidote to opioid overdose

PATIENT INTERFACE

DRUG PREPARATION

• 0,4ml IM dose, not patient dependent

• No dilution is required

DRUG

INJECTION

• Used initially IV in medical settings (hospitals, first respondants…)

• Moving to non medical settings and potentially injected by non professionals (family, friends…)

DRUG STORAGE

• Potential interactions with plastic

• No known interactions with glass

• The drug is stored at ambient temperature

DRUG REQUIREMENTS

SYRINGE SYSTEM REQUIREMENTS

Challenge Design solution

Oxygen sensitive

Administration is done by a non professional

Glass container

Eliminiates mosttechnical steps for

injections

Multiple components to assemble 3 components to assemble 2 components to assemble

Note: BD/Pharma partner need to jointly assess medical risks when emergency drugs are in scope.



In order to answer the specific needs of this market BD has developed 2 new product lines

BD Hylok™ Glass prefillable syringe for IV injected drugs

BD Sterifill Advance™ The next generation high performance polymer syringe

Reduced risk of needle/ connectors spontaneous disconnection1.New LLA thread design.

Reduced risk of syringe clogging. LLEC (Luer LokEnlarged Channel)

Reduced risk of LLA disconnection/rotation2.New bonding technology.

1. IV connectors and needle compatibility test [internal report]. Pont-de-Claix, FR: Becton, Dickinson and Company; 2016.2. Design verification results. Pont-de-Claix, FR: Becton, Dickinson and Company; 2016. 3 .STP01 BD Clinical Study on performance, safety and acceptance of BD Sterifill™ 50 mL for infusion with electric pump.4. Usability of BD Sterifill Advance 50 mL [internal study]. Pont-de-Claix, FR: Becton, Dickinson and Company; 2014. 5. Performance, safety and acceptance of BD Sterifill 50 mL for infusion with electric pump [internal study]. Pont-de-Claix, FR: Becton, Dickinson and Company; 2013.

Validated for pump compatibility5

20 & 50 ml

A reliable connection with extension lines, thanks to BD Luer-Lok™ snapped on design3

Intuitive, ergonomic, and robust tip closure, reducing risk to drug integrity4

BD S-Lok™


The value BD brings to its customer goes beyond its extensive product offerings A wide range of services have been created to help develop container/device strategy and life cycle management plan for drugs

Medical Support

• Pre Clinical data• Clinical data• Human Factors support• Health Risk

assessment

Regulatory Support

• Worldwide registration service• Timely and accurate Regulatory Affairs package• Consultative / training services • Life cycle management strategy

Supply Chain Integration

• Ability to cope with demand variability(safety stock)

• Surge capacity allocation on request

Formulation and Analytics

• Extractable / leachable data set

Distribution and Sales

• Logistics services deliveries• Certificate of Analysis

Filling, Assembly, Labeling and Packaging

• Technical support (machine and fill-finish)

Container / Device Selection and Customization

• Early sample deliveries through BD Accelerate Program• Compatibility with drug from mechanical and chemical standpoint• Co-development partnering for customization and rapid prototyping• Functional test services• Samples’ filling (Not For Human Use)

© 2018 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.

• Analytical services


Wrap up

• Small molecule market is huge & mostly not converted to prefilled syringes, enjoying a double digit growth in prefills

• The opportunity to increase patient safety and bring differentiated solutions withready-to-administer devices is particulary relevant for drugs used in critical ICU/ER

• New BD products to support specifically challenges in the IV injection space exist

• Questions to be answered by our pharma partners: • Fit with your strategy ?• Focus on high runners or create your own niche to make the business case viable ?

ICU: Intensive Care Unit – ER: Emergency Room


Thank You!

Administration challenges: Innovative solutions in IV ...

Documents

Transcript of Administration challenges: Innovative solutions in IV ...