A Trusted Partner for Pharmaceutical Industry Leaders Corporate - - PowerPoint PPT Presentation
A Trusted Partner for Pharmaceutical Industry Leaders Corporate - - PowerPoint PPT Presentation
A Trusted Partner for Pharmaceutical Industry Leaders Corporate Presentation An Independent API Company You Can Trust A world-class developer and manufacturer of differentiated Active Pharmaceutical Ingredients Global Presence - More than 250
An Independent API Company You Can Trust
A world-class developer and manufacturer of differentiated Active Pharmaceutical Ingredients Global Presence - More than 250 customers in over 50 countries Customer oriented – We are on the same wavelength, always in tune with the results required to support your needs 32 years of exceptional regulatory track record with leading global regulatory authorities (USFDA, EU-EMA, PMDA, TGA, KFDA, ANVISA and COFEPRIS) Scale – More than 250 metric tons of API produced every year Strong expertise in complex chemistry, innovative process development, crystalline forms and particle design Leading R&D capabilities and strong regulatory expertise – 198 DMFs worldwide API CDMO services from pre-clinical grams to multi ton commercial scale Customized solutions to meet individual customer requirements Creative business models to get to market, including co-development partnerships Long heritage of excellence, and global leadership in select molecules
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Over 30 Years of Service
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1987 2005 2013 2017
Founded in Israel Perrigo acquires Agis Acquired by SK Capital Renamed Wavelength Pharmaceuticals Renamed Perrigo API
A New York based transformational private investment firm with a disciplined focus on the pharmaceuticals and specialty chemicals sectors $4.6B portfolio, 12 companies generating aggregate annual revenues of $9B, employing +10,000 people globally, with 86 plants operating across 24 countries, selling to customers in 115 countries Vast industry and operating experience, augmenting leadership teams with strong talent to transform businesses into higher performing standalone customer-centric organizations Building strong and growing businesses that create substantial long-term value with improved strategic positioning as well as lower operating risk
New Ownership – Renewed Focus
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Leadership Team
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Management Team
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CEO Iftach Seri
CFO
Tami Cohen
Head of BD Marketing & IP
Ilan Avni
Head of R&D
Benzion Dolitzky
Head of Quality, Regulatory & Compliance
Sarah Isaacs
Head of HR
Liat Mayan
Head of Operations
Amit Kalimi
Board of Directors
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Chairman Aaron Davenport Arik Yaari Meron Mann Barry Penney Stephen d’Incelli Itzhak Krinsky Iftach Seri
Working with Us is Always an Advantage
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Committed to Quality
Strict compliance with the most stringent cGMP standards of all key global regulatory bodies Highly experienced team of over 80 quality assurance and quality control personnel Consistent supply of high quality APIs since 1987 Over 100 successful customer and health authorities audits in the past 5 years Israeli MoH audit in Feb 2019 - mutually recognized by the EU as EU GMP (no observations) USFDA audit in Jul 2018 (no 483s)
Wavelength Pharmaceuticals - A Partner You Can Trust
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Global Presence - More than 250 customers in over 50 countries
Market Presence Wavelength Sites NJ USA NA Sales Office India R&D Israel Head Office Production R&D 11
>80% of sales in US, EU & Japan
Spain EU Sales Office
API Contract Development and Manufacturing Services
Technology Transfer Process Development Analytical Methods Development Synthesis of Impurities and Standards Potential Genotoxic Impurities Evaluation including High Sensitivity Analytical Methods Suppliers Qualification Solid State / Polymorphism Research Characterization of Physical Properties Particle Design Process Optimization cGMP scale Up Process Validation Stability Studies Full cGMP Documentation & DMF Compilation cGMP Manufacturing - Grams to Multi Ton Scale
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People Are Key To Our Success
350 FTE
175 80 70 15 10
Operation Quality R&D Sales and Marketing G&A
23 35 42
PhD MSc Chemical Engineers
Leading R&D Capabilities and Strong Regulatory Expertise
70 R&D scientists and 10 regulatory experts in Israel and India Strong expertise in complex chemistry, innovative process development, crystalline forms and particle design Quality by design and complete regulatory support throughout the product lifecycle Extensive knowhow and experience in filing Drug Master Files with many different agencies, enables us to provide best-in-class regulatory support for our customers in various markets
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32 USDMF United States 13 CEP 28 EDMF Europe 11 JDMF Japan 7 KDMF Korea 120 Rest of World 198 DMFs Total
World-Class Manufacturing Facility
Located in the Neot Hovav Eco Industrial Park in Israel Wide range of multi-purpose production capabilities from grams scale to multi-ton commercial quantities Complex chemical reactions and advanced pharmaceutical technologies Highly potent compounds, steroids and cytotoxics manufacturing capabilities complying with the strictest containment requirements (OEB 4, <1µg/m3) Ability to quickly and efficiently meet our customers’ production needs translates into lower risk, faster turnaround, and unparalleled quality
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Environmental and Social Responsibility
Committed to the highest Environment Protection, Health and Safety standards Implementing Best Available Technologies across the following field of operations: Participating in multiple voluntary community programs with focus on education and health Waste treatment Gas Emission Reduction Energy Efficiency
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A Wide Range of Products
A Wide Range of API Products
New Products
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API Therapeutic Use Available DMFs
Efinaconazole Onychomycosis of the toenail or fingernail USDMF Fluticasone Furoate Seasonal and perennial allergic rhinitis , COPD USDMF Ibrutinib Mantle cell lymphoma, Chronic lymphocytic leukemia USDMF Rotigotine Parkinson’s disease USDMF Sugammdex Antidote for Vecuronium and Rocuronium USDMF under preparation Tavabarole Onychomycosis of the toenail or fingernail USDMF Tiotropium Bromide Monohydrate COPD USDMF, CEP, CDMF
API Therapeutic Use Available DMFs
Ammonium Lactate Ichthyosis and Xerosis USDMF Anastrozole Breast cancer CEP, KDMF Cetirizine Dihydrochloride Seasonal and perennial allergic rhinitis USDMF, CEP, JDMF, CADMF Cilostazol Reduction of symptoms of intermittent claudication USDMF, JDMF, KDMF, BRDMF Cisatracurium Besylate Neuromuscular blocking agent USDMF, CEP, CADMF, BRDMF, AUDMF Donepezil Base Alzheimer’s-type dementia USDMF, CEP, KDMF Donepezil Hydrochloride Alzheimer’s-type dementia USDMF, CEP, JDMF
Commercial Products
A Wide Range of API Products
API Therapeutic Use Available DMFs
Fenofibrate Hyperlipidemia; Hypertriglyceridemia USDMF, CEP, CADMF Fexofenadine Hydrochloride Allergy symptoms USDMF Flumazenil Reversal of sedative effects of benzodiazepines USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF Fluticasone Propionate Asthma, COPD USDMF, CEP, JDMF, KDMF, CADMF, BRDMF Fulvestrant Breast Cancer USDMF, CEP Granisetron Base Chemotherapy-induced nausea and vomiting USDMF Granisetron Hydrochloride Chemotherapy-induced nausea and vomiting USDMF, CEP, JDMF, KDMF, CADMF Halobetasol Propionate Topical anti-inflammatory and antipruritic conditions USDMF Imiquimod Actinic keratoses (AK); Superficial basal cell carcinoma; Genital and perianal warts/condyloma USDMF Midazolam Sedation; Amnesia; Anesthesia USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF Modafinil Excessive sleepiness associated with narcolepsy,
- bstructive sleep apnea, and shift work disorder
USDMF, CEP, BRDMF, AUDMF Mometasone Furoate anhydrous Asthma USDMF
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Commercial Products (continued)
A Wide Range of API Products
API Therapeutic Use Available DMFs Mometasone Furoate monohydrate Allergic Rhinitis USDMF, EDMF, CADMF, BRDMF, CDMF Moxonidine Hypertension CEP Omeprazole Magnesium Duodenal and gastric ulcer; Gastroesophageal reflux disease (GERD) USDMF Palonosetron Hydrochloride Chemotherapy-induced nausea and vomiting; Post-operative nausea and vomiting USDMF, EDMF, JDMF Permethrin Treatment for scabies USDMF, CEP Pramipexole Base Parkinson’s disease USDMF Pramipexole Dihydrochloride Parkinson’s disease USDMF, BRDMF Rocuronium Bromide Adjunct to general anesthesia USDMF, KDMF, CADMF Temozolomide Glioblastoma multiforme (GBM) USDMF, EDMF, CADMF, BRDMF Terbinafine Hydrochloride Onychomycosis of the toenail or fingernail JDMF, BRDMF Tramadol Hydrochloride Management of moderate to moderately severe pain USDMF, CEP, JDMF, KDMF, CADMF, BRDMF, AUDMF
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Commercial Products (continued)
A Wide Range of API Products
Under Development
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API Therapeutic Use Calscoterone Acne / Alopecia Glycopyronuim Bromide Chronic obstructive pulmonary disease (COPD) Remimazolam Sedation, Anesthesia Sitagliptin Phosphate Type II Diabetes Vilanterol Trifenatate Chronic obstructive pulmonary disease (COPD)
Under Evaluation
API Therapeutic Use Brexanolone Postpartum Depression Entinostat Breast Cancer Ganaxolone Epilepsy, Postpartum Depression Indacaterol Maleate Chronic obstructive pulmonary disease (COPD) Istradefyline Parkinson’s Disease Lumateperone Schizophrenia Roluperidone Schizophrenia Sarizotan Rett Syndrome Umeclidinium Bromide Chronic obstructive pulmonary disease (COPD)
Select Finished Dosage Form Products
As part of our legacy portfolio we continue to support our customers with select FDF dossiers Working with leading contract developers and manufacturers to provide professional regulatory support and supply chain assurance
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FDF Therapeutic Use Marketed in
Anastrozole tablets 1 mg Breast cancer Europe, Mexico Cetirizine dihydrochloride 10 mg tablets Cetirizine dihydrochloride 10 mg/ml, oral drops Cetirizine dihydrochloride 1 mg/ml, oral solution Allergic rhinitis Europe Granisetron HCl ampoules 1 mg/ml 1 ml, 3 ml Chemotherapy induced nausea Europe Granisetron HCl tablets 1, 2 mg Chemotherapy induced nausea Europe Moxonidine tablets 0.2, 0.3, 0.4 mg Hypertension Europe, Russia, Australia Temozolomide hard gelatin capsules 5, 20, 100, 140, 180, 250 mg Brain cancer US, Europe, Russia, Australia, Brazil, Israel