Pharmaceuticals Newsletter - November 21 to 25, 2016

India Infoline News Service | Mumbai | November 25, 2016 17:51 IST

This week, Natco Pharma got USFDA approval for generic Budesonide Capsules for USA market, Suven Life Sciences Q2 FY17 PAT was at Rs 26.5 crore. IIFL presents a weekly snapshot of all the major happenings in the pharmaceuticals industry, nationally and internationally.

Top News
 
Natco Pharma gets USFDA approval for generic Budesonide Capsules for USA market
Natco Pharma announce final approval of Abbreviated New Drug Application (ANDA) from the U S Food and Drug Administration (FDA) for generic version of Budesonide Capsules (Enteric Coated), 3 mg. NATCO and its marketing partner Alvogen plan to launch this product in the USA market immediately. Perrigo Pharma International DAC sells Budesonide Capsules under their brand ENTOCORT in the USA market. ENTOCORT EC Capsules, 3 mg, and its generic versions had U.S. sales of approximately $ 370 million for twelve months ending December 2015, according to IMS Health. Read More
 
Indian pharmaceutical companies' financial profiles stronger than global peers, but challenges on the rise
Moody's Investors Service says that Indian pharmaceutical companies, despite their smaller size, exhibit strong business profiles when compared to some of their global peers, underpinned by their good product and geographic diversity. "When compared with their global counterparts, Indian pharmaceutical companies have stronger financial profiles with low leverage and high coverage metrics," says Kaustubh Chaubal, Moody's Vice President and Senior Analyst. Read More
 
Domestic Newsmakers
 
Suven Life Sciences Q2 FY17 PAT at Rs 26.5 crore
Suven Life Sciences Ltd reported net profit increased by 6% at Rs 26.5 crore for the quarter ended September 30. The company's net profit in the corresponding quarter of the previous fiscal year was Rs 25 crore. The sales of the company during the September quarter declined by 1% to Rs 116 crore, over Rs 117 crore in the year-ago period. During the quarter under review, EBITDA Margin were at 31.9% compared with 26.7% crore. Read More
 
Sanofi Pasteur launches India’s first 6-in-1 pediatric vaccine - Hexaxim
Sanofi Pasteur, the vaccines global business unit of Sanofi, announced today the launch of India’s first innovative ready-to-use fully liquid 6-in-1 vaccine - Hexaxim. The vaccine, indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age, provides protection against 6 major childhood diseases - diphtheria, tetanus, pertussis (whooping cough), polio, Haemophilus influenza B and hepatitis B. The burden of the 6 diseases is significant, particularly in infants. Consequently, the WHO and the wide majority of countries around the world recommend vaccination against these diseases. India, under the Universal Immunization Program, also offers protection against these 6 major diseases. Read More
 
Cipla EU divests stake in Chase Pharmaceuticals to Allergan
Cipla Limited, one of India’s leading pharmaceutical companies announced that Chase Pharmaceuticals Corporation, a Delaware based corporation (Chase) (in which Cipla Limited’s UK arm, Cipla (EU) Limited (Cipla UK) has 16.7% stake) has been acquired by a subsidiary of Allergan, plc. Allergan has agreed to pay $ 125 million upfront plus potential regulatory and commercial milestones of up to $ 875 million to the shareholders of Chase. Cipla UK acquired a minority stake in Chase in May 2014 via a syndicated venture investment. Read More
 
Sun Pharma to acquire Biosintez in Russia
Sun Pharma announced the execution of definitive agreements by its wholly owned subsidiary, for the acquisition of 85.1% of JSC Biosintez, a Russian pharmaceutical company engaged in manufacture and marketing of pharmaceutical products in Russia and CIS region. The equity consideration for the 85.1% stake is US$ 24 million. Sun Pharma would also assume a debt of approximately US$ 36 million as part of this transaction. Biosintez is a Russian pharmaceutical company focusing on the hospital segment with annual revenues of approximately US$ 52 million for 2015. It has a manufacturing facility in Penza region with capabilities to manufacture a wide variety of dosage forms including pharmaceuticals for injections, blood substitutes, blood preservatives, ampoules, tablets, ointment, creams, gels, suppositories, APIs, etc. Read More
 
Lupin receives tentative approval for Generic Epzicom tablets
Pharma Major, Lupin Limited,announced today that it has received tentative approval for its Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg from the United States Food and Drug Administration (FDA) to market a generic version of ViiV Healthcare Company's Epzicom Tablets, 600 mg/300 mg. Lupin's Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg are the AB rated generic equivalent of ViiV Healthcare Company's Epzicom Tablets, 600 mg/300 mg. Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Epzicom Tablets had US sales of USD 426 million (IMS MAT September 2016). Read More
 
Wockhardt: USFDA issues warning letter to UK stepdown arm
Wockhardt Limited has informed the Exchange that U.S. Food and Drug Administration (USFDA) has issued a Warning Letter to C P Pharmaceuticals Limited, Wrexham, United Kingdom, a stepdown Subsidiary of the Company. Currently, there is no business being conducted from C P Pharmaceuticals to the US Market. C P Pharmaceuticals has already initiated required steps to address the concerns raised by USFDA and will be responding to the Agency within the prescribed time. Read More
 
Max Healthcare adopts IBM Mobility Services to optimize the patient experience
IBM announced that Max Healthcare, India’s leading hospital chain has selected IBM’s Mobile Client Care solution to transform and personalize their IT infrastructure into an intelligent, scalable and secure environment. IBM will help Max provide its patients an optimal multi-channel user experience across end user devices covering all touch points like registration, lab services, pharmacy, etc. This technological intervention is designed to help the hospital provide better patient care services, enhance employee productivity and improve customer support experience while reducing their operational costs.
 
With over 2600 beds, 2300 doctors and 13 hospitals across several states in India, Max Healthcare is one of the leading healthcare service providers in the country. In an era of changing technology, their dependence on legacy IT systems was hindering improvements in quality and efficiency of patient care. IBM’s solution will help Max move from legacy IT systems to learning systems helping Max deliver a consistent, superior user experience for its employees. Read More
 
Panacea Biotec receives receipt of EIR from USFDA
Panacea Biotec, one of India's leading research based health management companies, is pleased to announce receipt of Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and Pre­ Approval Inspection conducted by USFDA, at its Oncology Parenteral and Oral Solids Dosage formulation facilities at Malpur, Baddi in the district of Solan, Himachal Pradesh, India. Read More
 
International Round Up
 
Novartis acquires Selexys Pharmaceuticals in deal worth up to $ 665 million
Novartis has acquired U.S. based Selexys Pharmaceuticals Corp., a developer of therapeutics for blood and inflammatory disorders. The terms of the deal could amount to up to $ 665 million in upfront, acquisition and milestone payments, the company said. “With this acquisition, Novartis is able to leverage its leadership in hematology research to advance development of a potential new treatment option for patients living with this debilitating condition," said Bruno Strigini, CEO of Novartis Oncology. Read More
 
Suven Life Sciences secures two product patents in China & Mexico
Suven Life Sciences Ltd announces today that the grant of one product patent from China and one product patent from Mexico corresponding to the New Chemical Entities (NCEs)for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2032 and 2031 respectively. The granted claims of the patents are from the mechanism of action include the class of selective H3 Inverse aganist compounds and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Major Depressive disorder (MDD), Parkinson and Schizophrenia. Read More
 

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