Your Integrated Female Health Company

Your Integrated Female Health Company

04/22/2023 2www.naari.ch

NAARI AG is a Swiss Pharmaceutical company focused on

female health with an emphasis on hormones. We are an

integrated player producing Fermentation Intermediates,

Active Pharmaceutical Ingredients and Finished Dosage

Forms supported by our in-house R&D in each domain. Our

current portfolio consists of niche generics and a robust

innovative pipeline.


VISION

NAARI aspires to be a leading

niche pharmaceutical company

which is integrated in research,

development, manufacturing and

marketing of female hormones.


• Our mission is to become a leading supplier of hormonal

products by:

o Manufacturing highest quality products in state-of-the-art

facilities, compliant with the norms laid down by

Regulatory Agencies such as WHO, USFDA (USA) and

EMEA (Europe)

o Offering innovative products in the female health space

o Competitive pricing

MISSION


NAARI’S STRENGTHS

• 100% vertically integrated–with in-house R&D and production of

Fermentation Intermediates, APIs and Finished Dosage Forms

• World-renowned result-oriented team of experts across senior

management, fermentation, synthetic chemistry and formulation

R&D, clinical development, production and marketing

• State-of-the-art infrastructure–manufacturing units and R&D labs

equipped with modern technology and equipment

• Strategic partnerships to minimize time to market and to gain access

to technologies that do not exist in-house

• Clear and dedicated focus on female health


• Maintaining highest quality standards is the cornerstone

of NAARI’s development and manufacturing philosophy

• A quality system based on very vigilant quality control

operates through the entire gamut of R&D and

production to ensure the quality, safety and efficacy in all

NAARI products

NAARI’S PHILOSOPHY: QUALITY


NAARI’S TEAM• Dr. Manfred A. May, Chairman (Widely respected as a veteran in the field of pharmaceuticals,

in recognition of his expertise has held a portfolio of senior positions in the pharmaceutical industry around the world including MD Wulfing Pharma, Global Head of the Formulation business & Board Member Merck Darmstadt , MD Gehe Pharma )

• Prof. Dr. Michael Oettel, Director (Former Head of Research - Institute of the Academy of Sciences in the G.D.R.; Head of R&D at Jenapharm and Head of the Scientific Marketing Female Healthcare at Schering AG; Inventor of Dienogest and Former Member of WHO’s Human Reproduction Program).

• Mr. Prithi S Kochhar, CEO (Fourth generation pharma entrepreneur with management experience in R&D, manufacturing (in India & China) and marketing in the CIS and India)

• Dr. Malcolm Ross, Board of Advisors (Has vast experience of 36 years in the pharmaceutical industry and has held eminent positions like Head of Pharmaceutical Analytical Research Teva Pharmaceuticals, Vice President R&D Taro Pharmaceuticals, Director Research Special Projects of Polpharma, President Generapharm)


PARTNERSHIPS At NAARI we understand that in the fast evolving and ever-changing pharmaceutical industry we cannot do everything ourselves. To capitalize opportunities and to reduce time to market, we believe it is important to have strategic and long-lasting relationships with partners that specialize in areas of development and manufacturing where NAARI does not have an in-house strength. To name a few, NAARI shares partnerships in the field of:

Finished Dosage FormsEU Partnership: In the initial two years when NAARI was executing its own manufacturing and development facilities, we entered into a strategic partnership with a company in the EU that had development and manufacturing capabilities for solid oral female hormones and was already approved by the European authorities. This enabled us to have our first product ready even before our facilities came on stream.

DiagnosticsWe have a strategic partnership with developer and manufacturer of Medical Devices with whom we have developed (and are now producing) third generation Pregnancy and Ovulation test kits. In the last couple of years these products have received the CE market and are approved for sale in almost all countries in the world.

Marketing PartnershipsNAARI is currently planning it’s own marketing set up only in Russia and the CIS. For these markets we have our own products and are also seeking partnerships to in license products in the female health space. For markets than Russia and the CIS, NAARI works with partners that have sales and marketing infrastructures and either have a presence or future interest in the female health space.


INTELLECTUAL PROPERTY

NAARI has a pipeline of patents to protect its products

Our patents span across• Fermentation• Chemical Synthesis• Formulation Manufacturing


OUR INFRASTRUCTURE• Basel, Switzerlando Corporate Headquarter and Marketing Office

• Indiao Noida

Fermentation R&D Synthesis R&D Analytical R&D Regulatory Affairs

o Kashipur Fermentation Production Intermediates and API Manufacturing

o Rudrapur Formulation R&D Formulation Analytical R&D Formulation manufacturing


NOIDALab Area : 4600 sq ft Number of Scientists: 25

• Synthesis R&Do Dedicated to steroid and hormone research

with a special section for only estrogens• Analytical R&D

o Developing, standardizing and validating analytical methods

o Conducting stability studies of APIs


KASHIPUR• Total Area: 48,000 Sq. meters

• Built-Up Area:o 80 Sq. meters for Fermentation Block

o 220 Sq. meters for intermediates Block.

o 100 Sq. meters for API manufacturing Block I

o 240 Sq. meters for API manufacturing Block II

o 790 Sq. meters for Warehouse Block.

o 125 Sq. meters for Admin/QA/QC Block.

o 1240 Sq. meters for Utility Block

• Capacity: 25-30 tons of steroid and steroid

intermediates per annum

• Reactors capacity: o Intermediates – 14700 Liters

o APIs – 2500 Liters


RUDRAPURWHO GMP certified manufacturing unit (Gearing up for USFDA , ANVISA, WHO – Geneva, MHRA, BfArM Germany inspections

• Total Area: 45, 000 Sq. meters

• Built-Up Area:o 2450 Sq. meters for Non –Hormone facility

o 500 Sq. meters Hormone facility

o 500 Sq. meters Administration & QA/QC facility

o 150 Sq. meters Utility facility

o 830 Sq. meters ware house main pharma block

o 130 Sq. meters Ware house hormone block

• Equipments: All modern equipment suitable for manufacturing of hormonal products and packaging facility

• Capacity: General Pharma Block Hormone Block

o Capsules: 5.4 Billion/Year o 1.4 billion tablets/year

o Tablets: 2.3 Billion/year


FORMULATION R&D, RUDRAPUR• Capacity: The equipment are suitable to produce 0.5 kg to 5.0 kg of

batch size

• Equipments Available:

o Vibro sifter & Multimill

o Rapid mixer granulator

o Fluid bed equipment

o Octagonal blender

o Auto coater

o Friability, dissolution and hardness tester

o Induction seal machine

o Remi stirrer

o Resch dryer


MARKET PRESENCE(of Intermediates, APIs & Drug Products)

• APIs – In-house consumption and customers worldwide including Europe and North America

• Intermediates – In-house consumption and supply contracts with innovative companies in Europe that are forerunners in the female hormone space

• Finished Dosage Forms –o Supply contracts with major Donor agencies and Institutional buyers like DKT, National

Ministries of Health

o EU, North America & Brazil: Agreements with big pharma and generics companies for licensing and supply of the products we are developing

o Developing markets: partnerships with major regional companies in some markets and own infrastructure in other markets


OUR BUSINESS MODEL• CIS: Our business model here is to set up our own niche

branded female health company supported by our own sales force promoting specialized generics & innovative products.

• We started filings in Q1 2011 and already have 5 approvals and numerous others in the pipeline

• A sales force of over 100 medical representatives is planned in the next 36 months

• In Q4 2011 Naari completed the acquisition of it’s first brand from Bayer for an Endometriosis product

• Apart from our own portfolio, we (NAARI) are licensing a number of products to expand our portfolio. Currently we license a contraceptive from the EU and a GnRH antagonist for Endometriosis

CIS


OUR PRODUCT PORTFOLIO

• Our product portfolio includes:o Intermediateso Active Pharmaceutical Ingredients (APIs)o Finished Dosage Forms (FDFs)o Nutraceuticalso Diagnostics


OUR APIs CATEGORIES PRODUCTS CAS NO.

Estrogens Estradiol Benzoate 50-50-0

Progestins

Allylestrenol 432-60-0Dienogest 65928 – 58 - 7Lynestrenol 52-76-6Norethisterone 68-22-4

Norethisterone Acetate 51-98-9

Norethisterone Enanthate 3836-23-5

Levonorgestrel 797 - 63 - 7

Anabolics

Boldenone Undecylenate 13103-34-9

Nandrolone Decanoate 360-70-3

Nandrolone Phenylpropionate 62-90-8

Anti - Progestins Mifepristone 84371-65-3

Male Hormones Testosterone Enanthate 315-37-7


OUR UPCOMING APIs

CATEGORIES PRODUCTS CAS NO.

2013

Male Hormones

Testosterone Propionate 57-85-2

Testosterone Phenylpropionate 1255-49-8

Testosterone Decanoate 5721-91-5

Testosterone Isocaproate 15262-86-9 2014

Estrogens Estradiol Valerate 979 – 32 – 8


OUR INTERMEDIATES

NAME CHEMICAL STRUCTURE CAS NO.

Estradiene Dione (4,9 Diene) 5173-46-6

Nandrolone Base 434-22-0

Norandrostenedione (19 NOR) 734-32-7

4,9 Diene Ketal 5571-36 - 8

O

O

O

OH

H

H H

H

O

H

H H

H

O

OCH3

O

O


NAME CHEMICAL STRUCTURE CAS NO.

Estrone 53-16-7

OH

O

OUR UPCOMING INTERMEDIATE


OUR FORMULATIONS (1)

PRODUCT CATEGORY INNOVATOR INDICATIONS

Dienogest 2mg Visanne Endometriosis

Dienogest 2mg + Ethinyl Estradiol 0.03mg Valette Oral Contraceptive

Levonorgestrel 0.03 mg Microlut Oral Contraceptive (For nursing mothers)

Levonorgestrel 0.75mg Next Choice Emergency Contraceptive (Progestin only Pill)

Levonorgestrel 1.5mg Plan B One-Step Emergency Contraceptive (Progestin only Pill)

Mifepristone 200mg Mifeprex, Mifegyne Termination of Pregnancy till 63 days

Misoprostol 200mcg CytotecPrevention of NSAID-induced gastric ulcers, treatment of missed miscarriage, and induction of labor

Mifepristone & Misoprostol Combipack

Mifeprex, Cytotec Termination of pregnancy till 63 days

Lynestrenol 0.5 mg Exluton Oral Contraceptive (Progesterone only Pills)


OUR FORMULATIONS (2) PRODUCT CATEGORY INNOVATOR INDICATIONS

Levonorgestrel 0.15mg + Ethinyl Estradiol 0.03mg

Seasonale, Microgynon Combined Oral Contraceptive

Levonorgestrel 0.10 mg + Ethinyl Estradiol 0.02 mg Loette Combined Oral Contraceptive

Levonorgestrel 0.125 mg + Ethinyl Estradiol 0.03 mg Minisistone Combined Oral Contraceptive

Cyproterone Acetate 2 mg + Ethinyl Estradiol 0.035 mg Diane 35 Combined Oral Contraceptive

Norethisterone Enanthate 200 mg/ml Noristerat Parenteral Progestogen-Only Contraceptive

Depo-medroxyprogesterone acetate (DMPA) Depo-Provera Parenteral Long-Acting Contraceptive

Disulfiram 250 mg/500 mg Antabuse Alcoholism

Ivermectin 3 mg Stromectol Anti-parasitic


OUR DIAGNOSTICS

NAME INDICATION PICTURE

U - Chek HCG Pregnancy Test Kit Midstream

Ova - Chek Ovulation Kit Midstream


OUR NUTRACEUTICALS

• Along with Diindolylmethane, which has come to market recently, Naari has another nutraceutical coming up very soon:

Name Indication

Paraffin wax laxative Mild laxative for pregnant women


OUR INNOVATIVE PIPELINE• We have a robust pipeline of innovative products at various

stages of development each of which has different regulatory strategies based on the target market

Product Categories Stage

Endometriosis

Product 1

Product 2

Contraception [only 505(b)2]


For further information contact us @

THANK YOU

Arnold Bocklin - Strasse 114051 Basel, Switzerland

TEL: +41 615880242FAX: +41 615684352 Email: [email protected]

mailto:[email protected]

Documents

Your Integrated Female Health Company