GLENMARK PHARMACEUTICALS

Glenmark Pharmaceuticals Ltd was incorporated in November 18th, 1977. The Company is actively involved in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). It is engaged in the business of development, manufacture and marketing of pharmaceutical products both formulation and active pharmaceuticals ingredients to regulated and semi-regulated markets. The company has several molecules in various stages of pre-clinical and clinical development primarily focused in the areas of Oncology, Respiratory and Dermatology. Its branded generics business has a significant presence in markets across emerging economies including India. The company has 14 manufacturing facilities across US, India, Argentina, Czech Republic and Switzerland. The generics business services the requirements of developed markets like the US and Western Europe. The API business sells products in over 80 countries including the US, various countries in the EU, South America and India. In the year 1979, the company entered dermatology market with the launch of 'Candid Cream'. In the year 1980, they started exporting their products. In the year 1983, the company commissioned their first manufacturing facility at Nasik in Maharashtra. In the year 1984, they established R&D department at Nasik Plant. In the year 1987, they launched Ascoril. In the year 1989, the company started operations in Afghanistan, Sri Lanka, Kenya and Mauritius. In the year 1982, the company expanded the Nashik plant by acquiring the adjacent plot to include the R&D Department as well as increase in installed production capacity. In the year 1996, the company incorporated a wholly owned subsidiary company namely, Glenmark Exports Pvt Ltd to consolidate their position in international business. In the year 1999, they started marketing their products in Brazil. In the year 2000, they came out with the public issue. They entered in diabetes segment. Also, they acquired three brands from Lyka Labs. In the year 2001, the company launched API manufacturing business. In the year 2002, they acquired an API manufacturing facility at Ankleshwar, Gujarat from Glaxosmithkline Pharmaceuticals Ltd. In the year 2004, the company entered their first out-licensing deal for discovery R&D with Forest Laboratories for Oglemilast, their CIPD/asthma molecule. They acquired Laboratories Klinger; Brazil together with their ANVISA approved manufacturing facility inorder to expand their operations in the Latin American markets. They commissioned their own manufacturing facility in Goa to service exports to regulated markets, namely USA. In the year 2005, the company launched commercial sales front-end in the US. They commissioned a new manufacturing facility at Baddi, Himachal Pradesh. They entered collaborative agreement on Oglemilast with Teijin Pharma for the Japan region. Also, they announced collaborative agreement with Napa Pharmaceuticals Inc, for their anti-diarrheas compound Crofelemer. The company acquired Servycal S A, a marketing company in Argentina with strengths in oncology. Also, they acquired Bouwer Bartlett Pty Ltd, a sales and marketing company in South Africa. In the year 2006, the company signed out-licensing deal in discovery R&D with Merck KGaA, Germany for their diabetes molecule, Melogliptin. Their lead molecule Oglemilast (GRC 3886) entered Phase II clinical trials. In the year 2007, the company acquired Medicamenta, a marketing and manufacturing company in the Czech Republic. Their molecule GRC 6211 for the potential treatment of pain, including osteo-arthritis pain out-licensed to Eli Lily. They received MHRA, UK approval for their semi-solid manufacturing plant at Baddi. In the year 2008, the company initiated Phase II-b for Oglemilast (GRC 3886) in Asthma. They completed pre-clinical development for initiating Phase I trials for GBR 500, a monoclonal antibody for inflammation. The company's molecule for Rheumatoid Arthritis, GRC 4039, entered Phase I trials. They re-organized their business and incorporated Glenmark Genrics Ltd as a subsidiary company. They received USFDA approval for the state-or-the-art semi-solids manufacturing plant at Baddi. In the year 2009, the company's molecule for neurophatic pain, osteoarthritis, completed the Phase I trials. During the year 2009-10, the company incorporated a subsidiary company, namely Glenmark Generics B.V., Netherlands. In the year 2010, Crofelemer, a first-in-class anti-diarrhoeal molecule completed phase 3 trials. They received the final approval for Pramipexole Dihydrochloride tablets from the USFDA. Glenmark Generics entered into an exclusive licensing agreement with Par Pharmaceuticals, USA to market Ezetimibe. The company and Sanofi-Aventis signed license agreement to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain. They launched 'Prasugrel', a revolutionary new anti-platelet drug for the management of Acure Coronary Syndrome with PCT (Precutaneous Coronary Intervention) for the first time in India. During the year 2010-11, the company has incorporated a subsidiary company namely, Glenmark Arzneimittel GmbH, Germany. In October 2010, the company won the Frost and Sullivan Award for 'Indian Innovator Pharmaceutical Company of the year' in October 2010. The company was chosen as the 'Best Company Across Emerging Markets' 2011, and recognized for the 'Best Overall Pipeline' 2011 by SCRIP, the largest selling and most respected pharmaceutical magazine in the world. In 2012, Forest Laboratories and Glenmark Signed Development Agreement for Worldwide Collaboration on Novel Agents to treat Chronic Inflammatory Conditions. Glenmark Generics announces the settlement of Paragraph IV litigation with Janssen Pharmaceuticals, Inc. Glenmark Generics receives tentative approval for zolmitriptan orally disintegrating tablets. The International Centre for Dispute Resolution ruled in favor of Glenmark on arbitration claim against Napo. In 2013, Glenmark announces launch of Hydrocortisone Butyrate cream in the US. Glenmark announces a new Discovery and the Initiation of IND enabling studies of a novel monoclonal antibody targeting OX40. The USFDA approves the companies Crofelemer 125 mg delayed-release tablets for the symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART). Glenmark Generics receives ANDA approval for Mupirocin Calcium Cream USP 2%. Atovaquone Prognanil (Malarone) patent revoked & Glenmark launches first UK generic. Glenmark discovers IND enabling studies of a novel monoclonal antibody. In 2014, Glenmark merge its subsidiaries i.e. Glenmark Generics Ltd. ('GGL') and Glenmark Access Ltd. ('GAL') with GPL. Glenmark enters Oncology with the Discovery and the Initiation of IND enabling studies of an innovative bi-specific antibody. Glenmark Pharmaceuticals inaugurates new Antibody Manufacturing Facility in La Chaux-de-Fonds, Switzerland. US Food & Drug Administration (USFDA) has granted Glenmark its final acceptance for abbreviated new drug approval (ANDA) to the company. Glenmark Pharma receives $5 mn from Sanofi as milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta l) integrin monoclonal antibody. Glenmark Generics gets USFDA nod for skin infection cream. In 2015, Glenmark Pharmaceuticals Ltd announces approval and launch of Ashlyna TM Extended - Cycle Oral Contraceptive Tablets in the US. Glenmark Pharmaceuticals Ltd announces approval and launch of Trandolapril & Verapamil Hydrochloride (HCI). Glenmark Pharma gets US FDA nod for Salmecort MDI Inhaler in Russia. The Cabinet Committee on Economic Affairs (CCEA) headed by PM approves the foreign investment proposals of two pharma majors Glenmark Pharmaceuticals and Aurobindo Pharma worth Rs 4,187 crore. Glenmark Pharmaceuticals Ltd. has certified approving the Scheme of Arrangement of Glenmark Generics Ltd. and Glenmark Access Ltd. with Glenmark Pharmaceuticals Ltd. Glenmark announces Strategic Development & Licensing Agreement with Celon, Poland for generic Seretide Accuhaler in Europe. Glenmark Pharmaceuticals receives tentative ANDA approval for Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Glenmark Pharmaceuticals receives ANDA approval for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%: 0.05%. Glenmark Pharmaceuticals has entered into a settlement agreement with Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd., and Royalty Pharma. During the year, the company received approval for generic Seretide in Russia. On 19 September 2016, Glenmark Pharmaceuticals, Inc., USA announced that it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene's ABRAXANE product - paclitaxel protein (albumin)-bound particles for injectable suspension. As per the terms of the agreement, Glenmark has obtained Global Exclusive Marketing and Distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product's development from Glenmark, including royalties on sales. On 12 December 2016, Glenmark Pharmaceuticals Inc., USA announced the availability of ezetimibe, the first and only generic version of ZETIA (Merck) in the United States for the treatment of high cholesterol. The availability of ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company, with whom Glenmark will share profits. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe as provided for under Section 505 (j) (5) (B) (iv) of the FD&C Act. On 19 December 2016, Glenmark Pharmaceuticals announced its strategic blueprint to transition into an innovation-led global pharmaceutical organization over the next decade. The Blueprint conveys the company's greater business alignment expanding generics to prioritizing research and development efforts in three key therapeutic areas: oncology, respiratory and dermatology. The innovative oncology pipeline, with candidates targeting multiple tumors, is the top priority with the greater promise to deliver novel, first-in-class molecules and help Glenmark evolve into a fully commercialized, innovation-led pharmaceutical company. The strategic blueprint also outlines aggressive plans to increase Glenmark's presence worldwide by strengthening focus on complex generics including injectables and expanding its manufacturing footprint. On 2 March 2017, Glenmark Pharmaceuticals announced that its US subsidiary Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck's & Co.'s NuvaRing product - etonogestrel/ethinyl estradiol vaginal ring - designed to allow women access to a more affordable birth control option. Development on the vaginal ring product is currently under way and the two companies expect to file an Abbreviated New Drug Application (ANDA) in fiscal 2019. Evestra will develop this product exclusively for Glenmark for the US market, and will receive certain milestone payments during various stages of the product's development, including royalties on net sales. Glenmark has secured exclusive marketing and distribution rights for the product, including an option to commercialize two additional Evestra vaginal ring products, for the US market. On 30 March 2017, Glenmark Pharmaceuticals announced positive results for GSP 301, an investigational fixed-dose combination of mometasone furoate (25 mcg) and olopatadine hydrochloride (665 mcg) administered twice daily as a nasal spray being studied for the treatment of seasonal allergic rhinitis. These results are from a recently completed Phase 3 trial assessing the efficacy and safety of GSP 301 combination therapy versus mometasone, olopatadine or placebo. On 14 December 2017, Glenmark Pharmaceuticals announced that it met its primary clinical endpoint in a Phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR). Ryaltris has conditionally accepted as the brand name for GSP 301 Nasal Spray by the US Food & Drug Administration (FDA). Glenmark plans to submit the company's first new drug application (NDA) to the FDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of CY 2018. On 22 February 2018, Glenmark Pharmaceuticals announced that it has entered into an exclusive agreement with South Korea's Sam Chun Dang Pharm. Co. Ltd. (SCD), to develop, manufacture and market a portfolio of ophthalmic products in the US and Canada. Under this agreement, these products will be developed and manufactured by SCD in South Korea. Glenmark will seek all market authorizations and commercialize the products in North America. On 4 April 2018, Glenmark Pharmaceuticals and Helsinn Group (Helsinn), a Swiss pharmaceutical group focused on building quality cancer care products, announced that they have entered into an exclusive licensing agreement to introduce AKYNZEO in India and Nepal. AKYNZEO, an oral fixed combination of netupitant 300mg and palonosetron 0.5mg in capsule form, is used for prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The licensing agreement with Glenmark for AKYNZEO represents Helsinn's first such agreement in India. Glenmark will have exclusive marketing rights for AKYNZEO in India and Nepal. On 22 May 2018, Glenmark Pharmaceuticals announced that the company has submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name. On 19 June 2018, Glenmark Pharmaceuticals announced that the US Food & Drug Administration provided its first supplemental Abbreviated New Drug Applications (ANDA) approval for the company's manufacturing facility in Monroe, North Carolina. The approval covers: Atovaquone and Proguanil Hydrochloride Tablets, 250 MG/100 MG and 62.5 MG/25 MG, a generic version of GlaxoSmithKline's Malarone (atovaquone and proguanil hydrochloride) Tablets. The Monroe, North Carolina facility is Glenmark's first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations. Glenmark has invested more than $100 million into the facility with plans for further expansion in the coming years. At peak capacity, the site is anticipated to produce 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes and 25-30 million ampoules for inhaled formulations. During the F.Y. 2017-18 Glenmark Pharmaceuticals Singapore Pte. Ltd. was formed as the wholly owned subsidiary of the company In FY18, Glenmark was granted approval of 21 Abbreviated New Drug Applications (ANDA), comprising 18 final approvals and three tentative approvals. Notable approvals include Aprepitant Capsules USP, Atomoxetine Capsules USP, Nitroglycerin Sublingual Tablets and Propafenone Hydrochloride Extended-Release Capsules USP. The Company filed a total of 16 ANDA applications with the US FDA throughout the fiscal year. During the year 2018, Glenmark launched Dermikelp, VWash Plus, Tacroz and Tacroz F in Zambia; Tacroz and Telma H in Tanzania; Ascoril D, Teneligliptin and its combination with Metformin in Mauritius, Momate F in Uganda and Sertaconazole (Onabet) in Sudan. During the year 2018, Glenmark launched Tacroz, Dosetil and Momate NS in Philippines; Momate NS, Dermikelp and VWash in Malaysia and Konzert in Cambodia in the Asia region. As on March 31 2018, the Company has filed over 370 Global DMFs in various markets, including 103 USDMFs, 28 CEPs, 40 EU- DMFs, 22 Canadian DMFs, 12 Japan DMFs, 13 Australian DMFs and other DMFs in various Rest-of-the-World (ROW) countries. During the year 2018, NebZmart, NebZsol and Vocety were launched in Brazil. In Colombia, the Company strengthened its dermatology portfolio and introduced Glenpalene, Glenpalene C, Dermotil S, Glencort, Butemax and Clotridid. Momate AZ nasal spray was launched in the Caribbean region and Glenmark is the first generic alternative in the market offering this unique combination. In FY18, Momate Rhino Advance, a unique combination of mometasone + azelastine nasal spray on the local market, was launched in Uzbekistan and is indicated for the treatment of patients with seasonal allergic rhinitis. Momat Rino 60 and 120 doses nasal sprays were also launched in Uzbekistan. During the year, Glenmark launched Glenspray (mometasone) 50 mcg/120 doses and Glenspray (mometasone) 50 mcg/60 doses in Ukraine. During the year 2018, Glenmark also successfully concluded the US FDA audit of the API plant at Mohol and is awaiting the EIR from the agency. During the year 2018-19, the Company acquired 100% stake in Zorg Laboratories Private Limited (Zorg) for an aggregate consideration of 5 lacs before adjustments and subject to legal and financial due diligence. Subsequently, name of Zorg was changed to Glenmark Life Sciences Limited (GLS). The shareholders of the Company approved the transfer of its Active Pharmaceuticals Business (API) to GLS by passing a resolution through postal ballot. During the FY2019, the Company had entered into a collaboration with leading, home-grown private equity firm True North Enterprise Private Limited (True North') and transferred its Orthopaedic and Pain management business valued at Rs 635 crore to Integrace Private Limited, a subsidiary of True North. Integrace will market the product portfolio in India and Nepal. As on 31 March 2019,the company has 42 subsidiary companies under its roof. The Company filed a total of 13 ANDAs with the USFDA during the financial year. In FY 2018-19, Glenmark was granted approval for 25 Abbreviated New Drug Applications (ANDA), comprising of 20 final approvals and 5 tentative approvals. During the year, the company bagged CII Safety Health and Environmental Excellence and Innovation Award 2018 for the Indore facility. During the FY2020,the Company had entered into Business Transfer Agreement with Integrace Private Limited for transfer Company's Gynaecology business, valued at Rs 115 crore. During the year, the Company entered into definitive agreement with Hindustan Unilever Limited for divestment of VWash franchise comprising VWash Plus Intimate Hygiene Wash, VWash WOW, VWash Plus Bikini Line, VWash Plus wipes and other such assets globally including the associated trademarks, brand names and certain business contracts. It launched a globally researched innovator molecule, Remogliflozin in FY 2019. As on 31 March 2020, the company has 44 subsidiary companies under roof. It introduced a fixed-dose combination of Remogliflozin Etabonate and Vildagliptin in 2020. It also launched a fixed-dose combination of Remogliflozin+Metformin under the brand names Remo-M and Remo-Zen M. Glenmark Life Sciences Limited, a wholly owned subsidiary of the Company on 16th April 2021 has filed a draft red herring prospectus with the Securities and Exchange Board of India for an initial public offer, comprising of a fresh issue of up to Rs. 11,600 million and an offer for sale of up to 7,305,245 equity shares of Rs. 2 each of Glenmark Life Sciences Limited, by Glenmark Pharmaceuticals Limited. The !PO will be subject to market conditions, receipt of applicable approvals and other considerations. In the fiscal year 2020-21, Glenmark was granted approval of 14 ANDAs comprised of 10 final approvals and 4 tentative approvals. Additionally, it was granted approval on a Prior Approval Supplement (PAS) for the 0.25 mg strength for Fingnolimod Capsules. Notable approvals include: Sirolimus Tablets, Tacrolimus Capsules USP, Topiramate Extended-Release Capsules USP, Chlorpromazine Hydrochloride Tablets USP and Diltiazem Hydrochloride Extended-Release Capsules USP. The Company filed a total of 7 ANDAs with the USFDA in FY21 and plan to file 18-20 ANDAs in FY22 including 5-6 filings which got delayed in FY21 due to the pandemic. During 2021, its subsidiary, Ichnos Sciences signed a licensing agreement with Almirall SA for the IL-1RAP antagonist ISB 880 for an upfront payment of EUR 20.8 Million. It received approval for 14 ANDAs that comprised 10 final approvals and 4 tentative approvals. It launched 10 new products in FY 2020-21. On 30th April, 2021, the Company made a strategic investment of Rs. 400 million in ABCD Technologies LLP . During the year 2022, Company received US FDA's NDA approval for novel Ryaltris-AZ as a novel fixed dose with a steroid of Mometasone Furoate and Azelastine for the treatment of allergic rhinitis in adults and paediatric patients 12 years of age and older. It launched Tiotropium Bromide Dry Powder Inhaler (DPI) in UK. It launched Tavulus in Spain and Tiotropium in Germany. It also launched Beclometasone to provide asthma patients access to a high-quality, cost-effective inhaler. It launched Glendes in Malaysia for treatment of minor cases of allergy. In Brazil, it launched Salbutamol to relieve symptoms of asthma and chronic obstructive pulmonary disease (COPD) such as coughing, wheezing and feeling breathless. It launched Canditral- SB in India to treat fungal infections of the mouth, throat, toenails, fingernails or lungs. To treat the symptoms of LennoxGastaut Syndrome (seizures), it launched Rufinamide tablets in the USA. It collaborated with Canadian biotech firm SaNOtize Research & Development Corp. to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam. It launched NONS under the brand name FabiSpray in February 2022, after receiving manufacturing and marketing approval from the Drugs Controller General of India (DCGI) as part of the accelerated approval process. Ichnos Sciences Inc., a subsidiary of Glenmark completed a EUR ~21 Million exclusive licensing agreement for the IL-1RAP antagonist ISB 880. Remogliflozin, Vildagliptin, Metformin, a Fixed Dose Combination (FDC) was launched during the year to enhance patient access to SGLT2 and DPP4 inhibitors for effective treatment of diabetes. FabiSpray was also launched in Singapore and Hong Kong under the brand name VirX. It introduced India's first Probiotic based product across its dermatology portfolio, such as Elovera Pro Cream and Elovera Pro Lotion. It launched 10 new products in the US taking total marketing portfolio in US 174 generic products authorized for distribution in the U.S. market. It entered into an agreement with AstraZeneca to commercialize its product, Pulmicort Respules in Colombia. Besides this, it entered into exclusive licensing agreement with Lotus International Pte. Ltd. for commercializing Ryaltris in Singapore, Hong Kong and Vietnam. Three new pharmaceutical modules became fully operational at its Ankleshwar facility. During the year 2022-23, in the Respiratory segment, Glenmark became the first company in India to market Indamet - an innovative fixed drug combination of Indaceterol, a long-acting beta-agonist and mometasone, an inhaled corticosteroid, for the treatment of uncontrolled asthma. In the Diabetes segment, it launched sitagliptin under the brand name SITAZIT and its fixed dose combinations with metformin and dapagliflozin respectively; teneligliptin + pioglitazone Fixed-Dose Combination drug for Type 2 Diabetes under the brand name Zita Plus Pio; lobeglitazone 0.5mg, under the brand name LOBG; Fixed-Dose Combination (FDC) of Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) SR under the brand name Zita-PioMet; Lobeglitazone + Metformin under the brand name LOBG-M. In the Cardio-Vascular segment, it launched Sacubitril + Valsartan under the brand name, Sacu V for the treatment of heart failure. New products such as La Shield Pollution Protect, La Shield Probiotic Moisturizer and Scalpe Pro Shampoo contributed to business growth in FY23. Thereafter, in FY23, Glenmark launched 8 new products during the fiscal year 2022-23, consisting of a mix of immediate-release oral solids and an injectable. Notable launches include Ezetimibe Tablets USP; Abiraterone Acetate Tablets USP, 500 mg; Fingolimod Capsules, 0.5 mg; Sodium Phenylbutyrate Tablets USP, 500 mg; Nicardipine Hydrochloride Capsules; Bumetanide Injection, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials; and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials, and Teriflunomide Tablets. It launched first generics, Teriflunomide (Aubagio) Tablets. It got into a distribution agreement with Cediprof for USFDA approved Mixed Amphetamines Immediate-Release Tablets. As of March 31, 2023, Glenmark's marketing portfolio included 183 generic products authorized for distribution in the U.S. market. 4 new products were introduced in the market, including Fenismart(dimetindene) gel and Phelisans (phenasone + lidocaine) ear drops. It launched RYALTRIS in the Malaysian market in 4Q of FY23.