COMPANY PRESENTATION

‹Nr.›

LEADER IN PEPTIDES SINCE THE 1970’s

• Dedicated to peptides

since its establishment

in 1971

• Working on a global

scale

• Public company since

1998 (Swiss Stock

Exchange)

4

OUR BUSINESS PARTNERS

% of Sales

5

OUR BUSINESS

APIs Generic peptide and

small molecule APIs,

development and

manufacturing of NCEs

Research Chemicals Custom synthesis

Catalog products

SALES REVENUES IN 2014: 183.9 MILLION CHF

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HIGHLY TRAINED EMPLOYEES

Over 790

employees

STRONG COMMITMENT TO TRAINING

GMP sites

THE BACHEM GROUP

Bachem Europe

Bubendorf, CH

Vionnaz, CH

St. Helens, UK

Weil am Rhein, DE

Bachem Americas

Torrance, US (CA)

King of Prussia, US (PA)

American Peptide

Company

Sunnyvale, US (CA)

Vista, US (CA)

BACHEM LOCATIONS

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SUNNYVALE (CA)

VISTA (CA)

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BACHEM AG BUBENDORF, SWITZERLAND

API development and manufacturing (cGMP) & production of research

chemicals (catalog products, custom synthesis) by solid-phase peptide

synthesis (SPPS) and solution phase chemistry

For SPPS

• Annual capacity of over 500 kg

• 1000L (stainless steel) and

75L / 150L (glass) reactors

For solution phase

• Annual capacity of hundreds of kg

• 100 L / 250 L / 630 L reactors and

1000 L reactor

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BACHEM IS YOUR TRUSTED PARTNER

Research & Development:

• Catalog peptides and custom synthesis services

Custom Manufacturing

• Process development and validation

• Production of peptides for preclinical and clinical phases

Commercial supply

• Supply of (multi-) kilograms to tons of cGMP API (launch

quantities, manufacturing of API for marketed drugs)

• peptide and small molecule generics

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PIONEERING THROUGH CONTINUED INNOVATION

No. of amino acids

Year

1978

Thymopentin

1993

Calcitonin

2003

Aprotinin

2013

Interferon β-1a

1989

Goserelin

BA

CH

EM

– fo

un

de

d in

19

71

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OUR PORTFOLIO OF PRODUCTS AND SERVICES

BACHEM PIONEERING PARTNER FOR PEPTIDES

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CATALOG PRODUCTS

RESEARCH INSTITUTES, UNIVERSITIES AND

INDUSTRIAL R&D

Product portfolio of over 6500 catalog peptides and biochemicals at shop.bachem.com

• Research and bulk quantities

available from stock (mg to kg)

• Peptides, amino acid derivatives,

inhibitors, substrates, resins, linkers,

reagents

Easy ordering

& fast delivery

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CUSTOM SYNTHESIS

HEALTHCARE, BIOTECH, AND PHARMACEUTICAL

COMPANIES

• Peptide synthesis from mg/g to kg

scale

• Development of synthetic routes for

scale up

• Cosmetic & diagnostic peptides

• High quality and timely delivery

Dedicated site

for Custom

Synthesis

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OUR TEAM IS EXPERIENCED IN A LARGE SELECTION OF

MODIFICATIONS

N- and C-terminal Modifications

Backbone Modifications

Non-natural Amino Acids

Glycosylation

Lipidation

Methylation

Phosphorylation and Sulfation

Cyclic Peptides

Multiple Disulfide Bond Formation

Maleimido and Clickable Peptides

Hydrocarbon-Stapled Peptides

Branched Peptides

MAP Peptides

Depsipeptides

Peptidomimetics

LABELING AND CONJUGATION

Biotinylated Peptides

Dye Labeling

Heavy Isotope Labeling

FRET or TR-FRET Peptides

Pegylated Peptides

Conjugation to Imaging Agents

Conjugation to Proteins (BSA, KLH)

Conjugation to Oligonucleotides

“We’re very pleased with Bachem’s

services. Their employees are

extremely knowledgeable.”

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CUSTOM DEVELOPMENT AND MANUFACTURING OF NCEs

BIOTECHS AND PHARMACEUTICAL COMPANIES

• Development and manufacturing of APIs

from early clinical trials to

commercialization

• Process development, optimization and

validation

• Quality by design

• Sterile fill & finish for clinical trials

(Clinalfa®)

• Production of launch quantities

Our

project team is

your proactive

partner

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OUR PIPELINE OF CUSTOMER NCE PROJECTS

DEVELOPMENT & VALIDATION

• Product characterization

• Development and validation of

analytical methods

• Stability studies

• Identification of impurities

cGMP SYNTHESIS OF APIs

• For all phases of clinical trials

• Commercial supply

Over

150 NCE

projects

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REGULATORY AFFAIRS SUPPORT

• Consultation with customers

• Compilation of CMC documentation for IMPD/IND

• Support for regulatory requests

• Global submission experience: preparation, filing, updating of DMFs

Numerous CMCs have been

submitted in support of

successful applications of our

partners

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PROJECT MANAGEMENT

• Coordinates project activities

• Monitors project objectives and progress

• Facilitates direct customer interactions with Bachem experts

• Provides regular and timely project updates

We manage your project in

close collaboration with you

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CLINALFA®

STERILE PEPTIDES FOR CLINICAL RESEARCH

Clinalfa® Basic

• Vials of sterile freeze-dried products

• Used as controls when investigating

new peptide drugs, particularly for

metabolic, neurologic, and cardiac

indications

Clinalfa® Plus

• NCEs supplied as sterile freeze-dried

or ready-to-use liquid formulation

vials for clinical trials

Clinalfa® products are released by a Qualified Person.

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GLYCOSYLATION – OUR NEW SERVICE

Advantages of Glycosylation of Peptide Drugs

• Increased half-life, providing extended

dosing duration

• Better solubility, enabling improved

formulation properties

• Improved response to therapy

• Increased drug tolerance

Human follicle-stimulating hormone, a 92 amino

acid glycopeptide.

PDB: 1FL7

Fox, K.M., Dias, J.A., Van Roey, P. (2001) “Three

dimensional structure of human follicle-stimulating

hormone”, Mol. Endocrinol.15: 378-389

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BACHEM AND GLYTECH

Two pioneers in their

respective fields

collaborating to

advance

innovation in drug

development

The complex chemical synthesis of

Interferon β-1a was adapted to cost-

effective industrial-scale

manufacturing.

Interferon β-1a is a glycosylated 166 amino acid

protein and an approved drug substance to treat

multiple sclerosis with a world market of more than

$ 4 billion. There are currently three recombinant

products on the market which are mixtures of at least

10 glycoforms.

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PIONEERING PARTNERSHIP BACHEM AND GLYTECH

The partnership between Bachem and GlyTech is focused on

the chemical development and manufacturing of glycosylated

peptides.

Bachem has the proven expertise to scale up and

manufacture kilogram scale peptides. GlyTech is capable of

producing glycans in kg amounts by a proprietary technology.

«The selective chemical glycosylation at large scale has the

potential to be applied to a variety of peptides, where we can

pioneer the concept of improving current and future drugs via

chemical glycosylation.» Dr. José de Chastonay, CMO Bachem

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GLYCOPEPTIDE APIs BY CHEMICAL SYNTHESIS

The goal is to improve physicochemical properties of peptides

through selective glycosylation

• Both chemical structure and position of glycosyl moieties can markedly

improve the biological activity of a peptide.

• A comprehensive library of glycans, containing human glycoproteins

linked to asparagine, has been created.

• Well-defined glycosylated structures can be generated through chemical

synthesis, which allows optimal choice of the glycosyl moiety and its

position.

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GENERIC APIs

BIOTECHS AND PHARMACEUTICAL COMPANIES

• Trusted supplier

• Strong reputation for sustained

quality & supply

• Long term collaborative partnerships

• Generic APIs are available from

stock in commercial quantities

Peptide

&

Small Molecule

Generics

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WE ARE YOUR TRUSTED PARTNER

LONG-TERM RELATIONS

PRODUCT SUPPLY AGREEMENT WITH

Goserelin AstraZeneca (Great Britain)

Triptorelin Debiopharm (Switzerland)

Nitisinone Swedish Orphan (Sweden)

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REGULATORY AFFAIRS SUPPORT

OVER 80 ACTIVE DMFs AND 15 CEPS WORLDWIDE

Active DMFs

worldwide*

*Please inquire for country specific information

“It has been a great experience

working with Bachem. They offer a

large collection of products with

consistent high quality and have

been a very responsive and

engaged partner.”

Big Pharma Company

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*All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.

Atosiban DMF

Aviptadil DMF

Bivalirudin* DMF

Buserelin DMF

Calcitonin (salmon) CEP, DMF

CRF Trifluoroacetate (human, rat) DMF

Desmopressin Acetate CEP, DMF

Exenatide* DMF

Glucagon DMF

Gonadorelin Acetate CEP, DMF

Goserelin Acetate CEP, DMF

GRF Acetate (human) DMF

Histrelin Acetate DMF

Leuprolide Acetate CEP, DMF

Octreotide Acetate DMF

Teriparatide Acetate,

pTH (1-34) (human) DMF

Secretin Hydrochloride (porcine) DMF

Somatostatin CEP, DMF

Tetracosactide DMF

Triptorelin Acetate DMF

Triptorelin Pamoate DMF

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PEPTIDE GENERIC APIs

*All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.

COMING SOON

Products under

development &

potential candidates

• Lanreotide*

• Liraglutide*

• Lixisenatide*

• Pasireotide

Acetate*

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SMALL MOLECULE GENERICS

*All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.

Antazoline Hydrochloride DMF

Antazoline Phosphate DMF

Antazoline Sulfate DMF

Carbidopa CEP, DMF

L-Cysteine Hydrochloride Monohydrate

Econazole Sulfosalicylate

Etomidate CEP, DMF

L-Ornithine α-Ketoglutarate Monohydrate DMF

Pergolide Mesylate CEP, DMF

Perindopril Erbumine CEP, DMF

Propofol CEP, DMF

Trimetazidine Dihydrochloride CEP

Xipamide DMF

Zolpidem Tartrate CEP coming soon

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LARGE SCALE MANUFACTURING AT BACHEM

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LARGE SCALE

1000 L SPPS reactor

Scale: 8-35 Mol SPPS

MEDIUM SCALE

75 / 150 L SPPS reactor

Scale: 0.75 - 7 Mol SPPS

MANUFACTURING CAPABILITIES SOLID PHASE PEPTIDE SYNTHESIS

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Three story cleavage unit, especially designed for peptide resin cleavage

MANUFACTURING CAPABILITIES CLEAVAGE (I)

250 L vessels for cleavage Filters to filter off

polystyrene resin

1000 L precipitation

vessel

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MANUFACTURING CAPABILITIES CLEAVAGE (II)

CLOSED & CONTAINED PEPTIDE ISOLATION

• Fully contained operation

• Improved filtration

Inverting filter centrifuge Heinkel HF600.1

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PREPARATIVE HPLC

• Columns 5, 20, 30, 59 cm (diameter)

• Scalable processes

MANUFACTURING CAPABILITIES PURIFICATION (I)

20cm Ø HPLC 59cm Ø HPLC

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MANUFACTURING CAPABILITIES PURIFICATION (II)

• ELUENT BUFFER TANK

FARM

• Equipped with weighing cells for

automated buffer preparation

• Jacketed for temperature control

• Control unit guarantees optimal

operation: expiration date,

minimal volume, etc.

2000 L stainless steel tanks

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MANUFACTURING CAPABILITIES PRODUCT ISOLATION

BATCH LYOPHILIZATION

• 6 freeze dryers with

‒ 4.6 m2 (49.5 ft2) shelf area

‒ 150 kg (39.6 gal) ice condenser

capacity

• 9 freeze dryers with

‒ 2.3 m2 (24.8 ft2) shelf area

‒ 100 kg (26.4 gal) ice condenser

capacity

• Located in clean rooms

• All equipment qualified (cGMP)

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MANUFACTURING CAPABILITIES ANALYTICAL TECHNIQUES

Ultra-High-Performance Liquid Chromatography (rapid HPLC, UHPLC) is

used as the standard analytical LC method for IPC and release testing

TECHNIQUES

AVAILABLE

• Amino Acid Analysis

• Bioburden

• Endotoxins

• Ion Exchange HPLC

• Mass Spec

• RP-(U)-HPLC

• SCX-HPLC

….and much more

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BACHEM PIONEERING PARTNER FOR PEPTIDES SINCE 1971

• Independent CMO with >40 years proven track record of peptide

innovation and manufacturing expertise

• Our products and services support our partners through all stages of

drug development

• Highest industry standard for quality assurance, control, and regulatory

compliance

• Excellent project management record with the world’s leading

pharmaceutical and biotechnology companies

• Sustainable long-term partnership with all stakeholders

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Thank you for

your attention