BOBCAPS ELIXIR Pharmaceuticals and Healthcare Investment Banking Newsletter Inaugural Edition April – September 2018
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BOBCAPS ELIXIR Pharmaceuticals and Healthcare Investment Banking Newsletter Inaugural Edition April – September 2018 BOB CAPITAL MARKETS LTD. A wholly owned subsidiary of Bank of Baroda President’s Note Inside this Edition Dear Reader, 3 Company News It gives me immense pleasure to share the inaugural edition of BOBCAPS ELIXIR, Investment Banking Newsletter covering Pharmaceuticals and Healthcare sectors. Our endeavour is to 6 Industry News publish ELIXIR as a quarterly newsletter covering the industry deal dynamics, trends and events that has shaped the industry in recent times. 7 Key Transactions We have covered the following key subsectors – Pharmaceuticals, Biotechnology & Life Sciences, Healthcare & Diagnostics and Medical Devices & Consumables. 8 Select Deals – Case Study We hope you find this newsletter interesting and we look forward to receiving your feedback to help us improvise on our future editions. Public Market Data 10 Please get in touch with us: [email protected] Warm Regards, 13 Team Avdhoot Deshpande President, Investment Banking – Equity Company News Product & Regulatory (1/2) Product Launch Glenmark launches Akynzeo in India under licensing pact with Helsinn Glenmark receives US FDA approval for generic Vagifem 10 mcg Glenmark Pharmaceuticals launched Akynzeo, a drug used for prevention of Glenmark Pharmaceuticals Inc, USA (Glenmark) has announced that USFDA has chemotherapy-induced nausea and vomiting, in India and Nepal under an granted final approval for Estradiol Vaginal Inserts USP, 10 mcg, the generic version exclusive licensing pact with Swiss pharma group Helsinn. Akynzeo is an oral fixed of Vagifem, 10 mcg, of Novo Nordisk which is used for providing relief from combination of netupitant (300 mg) and palonosetron (0.5 mg). menopause symptoms. Sanofi Pasteur launches quadrivalent influenza vaccine, FluQuadri in India Glenmark receives marketing approval for generic Seretide Accuhaler Sanofi Pasteur announced the launch of its 4-strain influenza vaccine FluQuadri in Glenmark’s subsidiary Glenmark Arzneimittel GmbH has secured marketing India – this will be India’s first quadrivalent vaccine to provide broader protection authorization in Germany for fluticasone/salmeterol dry powder inhaler (DPI), a against influenza to population above 3 years of age. generic version of GlaxoSmithKline’s Seretide Accuhaler. It is use for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Glenmark will sell the Sanofi launches multiple sclerosis drug, Aubagio in India product in Germany under the name “Salflutin”. Sanofi Genzyme, the specialty care global business unit of Sanofi, has launched US FDA nod to Sun Pharma’s glaucoma drug Aubagio from its international Multiple Sclerosis (MS) portfolio. A chronic and debilitating disease of the nervous system, Multiple Sclerosis has varied symptoms Sun Pharma has received the USFDA approval for its new drug application of like weakness in the limbs, poor vision, fatigue or slurred speech XELPROS, which is used to reduce open-angle glaucoma or ocular hypertension. Dr Reddy's Labs launches generic Bloxiverz injection in US market Expansion and Diversification Dr Reddy’s Laboratories has launched the US FDA approved neostigmine methylsulfate injection, USP, a therapeutic equivalent generic version of Bloxiverz China’s medical devices company Lepu Medical to foray into Indian market injection. Dr Reddy’s neostigmine methylsulfate injection, USP is available in 5 Lepu Medical Technology, the leading manufacturer and innovator is all set to make mg/10 mL and 10 mg/10 mL multi-dose vials. its foray into Indian medical devices and equipment market through an overseas Regulatory Approvals subsidiary company. Lepu will set up a fully functional operation organization with 95% Indian employees and will be soon launching the whole range of PCI products. Zydus gets US FDA marketing approval for Nystatin ointment, omeprazole and sodium bicarbonate capsules Wockhardt sets up its first manufacturing facility in the Middle East Zydus Cadila has received the final approval from the US FDA to market Nystatin Drug firm Wockhardt has set up its first facility in the Middle East in Dubai to ointment USP, 100,000 units per gram. It will be manufactured at its topical manufacture new chemical entities (NCEs) for catering to global markets. The manufacturing facility at Ahmedabad. The Company has also received the final facility is spread over 10,000 sq. meters. approval to market omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg Glenmark to market generic tiotropium bromide powder inhaler in West Europe and 40 mg/1100 mg. Glenmark Pharmaceuticals Europe has entered into a strategic, exclusive licensing Cipla receives US FDA approval for generic Albenza agreement for marketing generic tiotropium bromide dry powder inhaler (DPI) in Cipla has received final approval for its ANDA for albendazole tablets (200 mg) Western Europe. The product is used in the treatment of chronic obstructive from the US FDA. Cipla’s albendazole tablets (200 mg) is AB-rated generic pulmonary disease (COPD). therapeutic equivalent version of Impax Laboratories Inc.’s, Albenza. Albendazole is AstraZeneca open GMD Centre in India an anthelmintic drug indicated for use in treatment of parenchymal neurocysticercosis. AstraZeneca opened its new Global Medicines Development (GMD) Centre in Bengaluru – the unit is one of its 9 GMD centers globally that transforms Zydus receives US FDA approval for generic Atelvia delayed-release tablets breakthrough molecules into medicines and monitor its use and safety. Zydus Cadila has received the final approval from the US FDA to market Risedronate sodium delayed-release tablets (US RLD – Atelvia delayed-release tablets), 35 mg. This medicine is used to treat osteoporosis in women, caused by menopause. 3 Source: Industry websites, Deal Databases Company News Product & Regulatory (2/2) ...Expansion and Diversification Manipal-backed iGenetic to branch out into B2C mass diagnostics vertical Hetero Labs recalls over 1.59 mn bottles of hypertension drug from US iGenetic Diagnostics, a healthcare diagnostics firm with a focus on specialized and Indian drug firm Hetero Labs is recalling over 1.59 mn bottles of Valsartan Tablets differentiated tests will soon offer routine assessments for consumers under a used for treatment of hypertension from the US market due to deviations from the different brand. good manufacturing norms. The Company is recalling Valsartan Tablets USP in the Novartis to pay as much as USD 1 bn for skin drug rights strengths of 40 mg, 80 mg, 160 mg and 320 mg, manufactured by the company for Camber Pharmaceuticals. Novartis AG agreed to buy the rights to a skin-disease drug from developers Galapagos NV and MorphoSys AG for ~USD 1 bn. Novartis will pay EUR 95 mn Sun Pharma again faces FDA heat on Halol plant (USD 111 mn) upfront and deferred payments of up to EUR 850 mn based on the drug reaching certain regulatory, commercial and sales goals. Drug major Sun Pharmaceutical Industries has come under the US Food and Drug Mitra Biotech, Glenmark partner for advancing immuno-oncology drug pipeline Administration (FDA) scanner with the regulator issuing six observations related to utilizing CANscript platform deficient procedures at its Halol manufacturing facility. The facility in Gujarat received its first approval in four years from the FDA for a product used to treat Mitra Biotech, a Massachusetts-based global leader in advancing personalized cancer only in June. The Halol plant had been under FDA scanner since September oncology treatment has entered into a partnership with Glenmark Pharmaceuticals 2014. focused on advancing Glenmark's proprietary immuno-oncology drug pipeline utilizing Mitra’s CANscript platform. CANscript is a human, immune-relevant ex vivo platform that allows drug developers to understand drug performance in human Fundraise/ IPO tissue, which in turn allows for an informed approach to clinical development and patient response. Carlyle-backed pathology firm Metropolis Healthcare files for IPO Lupin, Japan’s Nichi-Iko tie up to distribute biosimilar drug Metropolis Healthcare one of the leading diagnostics companies in India, has filed a Lupin, India’s third-largest drug maker has tied up with Japan’s Nichi-Iko for the DRHP for an IPO comprising 15.16 mn shares consisting of an offer for sale of up to distribution, promotion and sale of Lupin’s recently filed biosimilar Etanercept in 5.01 mn shares by the Promoter Dr. Sushil Shah and upto 10.25 mn shares by Japan. Etanercept is used for the treatment of several auto immune diseases. Carlyle. The company reported consolidated revenue of ~INR 6.5 bn and PAT of ~INR 1.1 bn for the year ended 31 March 2018. Recalls / Exits / Regulatory Radar Abbott discontinues Xience Alpine stents in India PE fund Jacob Ballas to exit Inventia Healthcare through INR 4,500 mn IPO National Pharmaceutical Pricing Authority (NPPA) has permitted Abbott Healthcare Inventia Healthcare backed by private equity fund Jacob Ballas, filed DRHP for an to discontinue selling its premium metallic stent Xience Alpine Premium from the IPO. Inventia focuses on developing oral solid dosage formations (OSDFs), The share Indian market. Due to the regulatory intervention on stent prices, Abbott had sale will see Jacob Ballas exit Inventia by selling its entire 23.4% stake. The firm applied for withdrawal of its high-end stents last year. plans to raise fresh capital of INR 1250 mn which will be used to retire