- Young Chemists who have just started work in industry as development chemists
- Organic Chemists/Medicinal Chemists in Research and Development who would like to gain an appreciation of development and scale up and who are perhaps contemplating moving into chemical development.
- Development and Production Chemists in industry who would like to improve their efficiency and gain an insight into alternative approaches to chemical development.
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- Managers who might benefit from a comprehensive and up to date overview of chemical development
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Glaxo……..Will help the world’s poorest people access copycat versions of its medicines at affordable prices.
Glaxo to Stop Seeking Drug Patents in Low-Income Countries
Drugmaker says move could help poor nations access cheaper copycat versions of its medicines
GlaxoSmithKline’s CEO Andrew Witty below
LONDON— GlaxoSmithKline PLC said it would stop seeking patents for its drugs in low-income countries, a move the drugmaker said could help the world’s poorest people access copycat versions of its medicines at affordable prices.
The U.K.-based company said it would take this approach in low-income and least-developed countries, a group totaling around 85 nations. In so-called lower-middle-income countries, a group of 51 nations that includes Vietnam, Cameroon and Sri Lanka, it said it would file patents but aim to grant licenses to generic manufacturers to supply low-cost versions of its drugs in those markets in return for a small royalty.
Glaxo previously filed patents in most lower-middle-income countries, and in low-income nations where a patent office exists. But that “patchwork” approach meant that generic drugmakers held back from manufacturing copycat medicines for these markets owing to the risk of being sued by pharmaceutical companies, according to Glaxo Chief Executive Andrew Witty.,,,,,,,,,continue reading
/////////Glaxo Chief Executive, Andrew Witty, filed patents, low income,poor nations, cheaper, copycat versions, medicines, GlaxoSmithKline
Zydus Chairman and Managing Director,Mr. Pankaj R. Patel won the prestigious ‘Gujarat Business Leader of the Year’ award at the CNBC Bajar, Gujarat Ratna Awards 2015-16
Zydus Chairman and Managing Director,Mr. Pankaj R. Patel won the prestigious ‘Gujarat Business Leader of the Year’ award at the CNBC Bajar, Gujarat Ratna Awards 2015-16 from Hon’ble Chief Minister of Gujarat, Smt. Anandiben Patel at a glittering ceremony held at Hyatt, Ahmedabad.
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Zydus Cadila’s, Lipaglyn (Saroglitazar) won a lot of support at the 75th Anniversary Conference of the American Diabetes Association
Lipaglyn (Saroglitazar) won a lot of support at the 75th Anniversary Conference of the American Diabetes Association. Lipaglyn is currently under Phase III clinical development for treatment of Non Alcoholic SteatoHepatitis (NASH), a serious liver disease and an unmet healthcare need, globally. There is currently no drug approved for treating NASH. Lipaglyn is already approved in India for the treatment of diabetic dyslipidemia
Speaking on the development, Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus Cadila said, “These new robust scientific data on the safety and efficacy of Lipaglyn
(Saroglitazar) being presented at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) reflect our continued commitment to millions of patients living with Diabetes, Dyslipidemia, Non-alcoholic fatty liver disease (NAFLD) and Non-alcoholic steatohepatitis (NASH).”
Zydus Cadila, a leading global healthcare provider, today announced that new scientific and clinical data on Saroglitazar will be presented at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Boston, Massachusetts, USA from 5thto 9th June, 2015. Several analyses of real-world patient data of Saroglitazar will also be presented. The abstracts are available on theADA website.
Lipaglyn – The world’s first drug for treating Diabetic Dyslipidemia combines lipid and glucose lowering effects in one single molecule.
Pankaj Patel, chairman and MD, Cadila Healthcare Ltd
Zydus is an innovation-led global healthcare provider that discovers, manufactures and markets a broad range of healthcare therapies. The group employs over 19,000 people worldwide including over 1200 scientists engaged in research and is dedicated to creating healthier communities globally.
With a strong research pipeline of NCEs, biologics and vaccines, the group became India’s first pharmaceutical company to launch its own indigenously researched therapy Lipaglyn which is also the world’s first approved therapy for diabetic dyslipidaemia. Exemptia, the world’s first biosimilar of Adalimumab is also a product of Zydus innovation. Zydus also collaborates with partners to support and make therapies affordable and accessible to communities across the world.
As a leading healthcare provider, it aims to become a global research-based pharmaceutical company by 2020.
Pankaj R. Patel (left), Chairman & Managing Director, Zybus Cadila,
Ganesh Nayak, Chief Operating Officer and Executive Director, Zydus Cadila
Zydus Cadila has announced a breakthrough in the anti-diabetic drug Lipaglyn. Lipaglyn – The world’s first drug for treating Diabetic Dyslipidemia combines lipid and glucose lowering effects in one single molecule.
The Zydus Group announced a breakthrough in its research efforts with Lipaglyn (Saroglilazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia or Hypertriglyeeridemia in Type II diabetes, not controlled by statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, Lipaglyn is the first Glitazar to be approved anywhere in the world.
“Lipaglyn provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control,” said Pankaj R. Fatel, Chairman and Managing Director, Zydus Cadila. “It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realized this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the Held of drug discovery,” Patel added,
Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the “bad” low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the “good” high-density lipoprotein (HDL) cholesterol concentration in the blood. Optimal LDL cholesterol levels ibr adults with diabetes are less than 100 mg/dh, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dLT LipaglynrM, a non-thiazoKdinedione, is the first therapy to be approved for this condition,
World over, it is estimated that 30% of all deaths occur due lo cardiovascular diseases (CVD). In India, one out of every five persons is at serious risk of developing CVD, Research has shown that diabetes is one of the major risk factors of CVD. India has a population of nearly 65 million diabetics and 77 million prc-diabctics, 85 – 97% of the diabetes patients suffer from dyslipidemia or lipid abnormalities. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD.
Discovered by the Zydus Research Centre, the dedicated NCE research arm of the Zydus group, LipaglynrM is a best-in-class innovation, designed to have a unique cellular mechanism of action following an extensive structure-activity relationship study initiated in the year 2000, Lipaglyn1M has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily. The molecule has shown beneficial effects on lipids and glyeemic control without side effects. This molecule underwent extensive pre-clinical characterisation and the I.ND was submitted in the year 2004,
As a part of the clinical development programme, extensive Phase-I, Phase-II and Phase-Ill clinical trials were conducted to evaluate the phamacokinetics, pharmacodynamics, efficacy and safety of Lipaglyn. The new drug application for Lipaglyn1 was based on a comprehensive clinical development programme spanning eight years.
Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetes patients showed that the 4 mg dose of Lipaglyn led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbAlc) thereby confirming its beneficial effects of both lipid and glyeemic control in diabetic patients,
In the second Phase III study, Lipaglyn was studied in diabetic dyslipidemic patients insufficiently controlled with statin therapy. The results from this study confirmed that Lipaglyn had a pronounced beneficial effect on both the lipid and glyeemic parameters in these subjects.
In both the studies, Lipaglyn was well tolerated and had a better safety profile than the comparators. Importantly Lipaglyn1 M has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it sale and efficacious. LipaglynIM is recommended for once daily administration as 4 mg tablets.
Zydus will offer a dedicated LipaglynIM support programme to patients and earegivers, The programme shall provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time.
About Lipaglyn
Lipaglyn[TM] (Saroglitazar) was launched in September 2013 in India, for treating Hypertriglyceridemia and Diabetic Dyslipidemia in Patients with Type 2 Diabetes not controlled by statins. Since then, more than 80,000 patients are availing this drug with a prescriber base over 3500 diabetologists, cardiologists and physicians. Lipaglyn[TM] helps in a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and has also shown a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c), thereby confirming its beneficial effects on both lipid and glycemic control in diabetic patients. Lipaglyn[TM] is a prescription medicine, and can be taken only under the advice and guidance of a registered medical practitioner.
About Zydus
Zydus Cadila is an innovative, global pharmaceutical company that discovers, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 16,500 people worldwide including over 1200 scientists engaged in R & D and is dedicated to creating healthier communities globally. As a leading healthcare provider, it aims to become a global research based pharmaceutical company by 2020.
References
Zydus to present new scientific data on Lipaglyn in the US
New Delhi, Jun 8 (UNI) Healthcare services provider, Zydus Cadila today said the new scientific and clinical data on Lipaglyn (Saroglitazar) will be presented at the 75th annual scientific sessions of the American Diabetes Association (ADA) in Boston, Massachusetts, US from 5th to 9th June,2015.
Read more at http://www.uniindia.com/news/business-economy/zydus-to-present-new-scientific-data-on-lipaglyn-in-the-us/84440.html
READ …..https://newdrugapprovals.org/2013/06/07/cadila-banks-on-diabetes-druglipaglynsaroglitazar/
http://lipaglyn.com/downloads/Lipaglyn_Product_Monograph.pdf
http://www.ijpcs.net/sites/default/files/IJPCS_3_1_02_0.pdf
http://onlinelibrary.wiley.com/doi/10.1002/prp2.136/pdf
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Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia
Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia
Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.
Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.
Hyperlipidemia is a common genetic disorder that increases lipids and/or lipoproteins levels in the blood.
The first generic formulation approval will allow Biocon to sell Rosuvastatin Calcium 5mg, 10mg, 20mg and 40mg tablets in more than 15 European countries, starting in fiscal 2017.
“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries.”
The company plans to collaborate with regional partners to market the drug; a generic equivalent of Crestor tablets.
Biocon chairperson and managing director Kiran Mazumdar-Shaw said: “This is indeed a proud moment for Biocon’s Small Molecules business.
Biocon chairperson and managing director Kiran Mazumdar-Shaw
“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries.”
The approval will allow the company to address the $1.2bn opportunity in the EU. It will also make it easier for the company to market its products in emerging markets, where regulatory clearances are primarily based on approvals given by regulators in the US / EU.
Biocon was the first generic company to receive a certificate of suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM).
CEP certification indicates that an API is suitable for use in medicinal products in the EU.
Biocon CEO and joint managing director Dr Arun Chandavarkar said: “The European approval for Biocon’s generic version of Rosuvastatin Calcium underscores Biocon’s unique strengths in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products.
“It augurs well for this nascent business, which will be one of our growth drivers in the coming years.”
The company plans to boost its generic formulations business with a target of 20-25 filings over the next few years.
Additionally, Biocon is developing a new facility in Bengaluru, in the Indian state of Karnataka, where it will produce oral solid dosage formulations.
Biocon CEO and joint managing director Dr Arun Chandavarkar
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Alembic Pharma advances 1% on Rhizen-Novartis license agreement
India Infoline News Service | Mumbai | December 10, 2015 11:32 IST
Swiss subsidiary Rhizen Pharmaceuticals S.A. entered into an exclusive, worldwide license agreement with Novartis for the development and commercialization of Rhizen’s, inhaled dual Pl3K-delta gamma inhibitor and its closely related compounds for various indications.
read
Rhizen Pharmaceuticals Announces Exclusive Worldwide License Agreement for the Development and Commercialization of a Dual PI3K-delta gamma Inhibitor
| Source: Rhizen Pharmaceuticals SA
La Chaux-de-Fonds, Switzerland , Dec. 09, 2015 (GLOBE NEWSWIRE) — Rhizen Pharmaceuticals S.A. announced today that they have entered into an exclusive, worldwide license agreement with Novartis for the development and commercialization of Rhizen’s, inhaled dual PI3K-delta gamma inhibitor and its closely related compounds for various indications.
Under the terms of the agreement, Rhizen will receive an upfront payment and is eligible to receive development, regulatory and sales milestones payments. In addition Rhizen is also eligible to receive tiered royalties on annual nets sales.
The lead compound is a novel, potent, and selective dual PI3K-delta gamma inhibitor with demonstrated anti-inflammatory and immuno-modulatory activity in pre-clinical systems and models representative of respiratory diseases. With a favorable ADME and PK profile and high therapeutic index in animals, the inhaled dual PI3K-delta gamma inhibitor holds promise in the treatment of human airway disorders.
About Rhizen Pharmaceuticals S.A.:
Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer, immune and metabolic disorders. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways. Rhizen is headquartered in La-Chaux-de-Fonds, Switzerland. For additional information, please visit Rhizen’s website, www.rhizen.com.
info@rhizen.com
RP 6503
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Zydus gets USFDA nod for clinical trials of Saroglitazar
November 19, 2015
New Delhi: Zydus Cadila has received US health regulator’s nod to initiate phase II clinical trials of Saroglitazar, its new drug for treating high fat levels in body due to diabetes, obesity, and sedentary habits.
“United States Food and Drug Administration (USFDA) has endorsed company’s plan to initiate a phase II clinical trial of Saroglitazar in patients with severe hypertriglyceridemia,” Zydus Cadila said in a statement.
http://www.medicaldialogues.in/zydus-gets-usfda-nod-for-clinical-trials-of-sarolitazar/
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Process Development for Low Cost Manufacturing
-
Process Development for Low Cost Manufacturing on 23-24 nov 2015 , Hyderabad, INDIA
- 23.11.2015 – 24.11.2015
- Hotel Green Park – Hyderabad, India
- View Brochure
- or click
- https://scientificupdate.co.uk/index.php/training/scheduled-training-courses/details/213-Low-Cost-Manufacturing.html?utm_source=Scientific+Update+News&utm_campaign=d31c03d4e3-India_Courses_Hyderabad7_22_2015&utm_medium=email&utm_term=0_08c5e1fb69-d31c03d4e3-78584097
Chemical process research and development is recognised as a key function during the commercialisation of a new product particularly in the generic and contract manufacturing arms of the chemical, agrochemical and pharmaceutical industries.
The synthesis and individual processes must be economic, safe and must generate product that meets the necessary quality requirements.
This 2-day course presented by highly experienced process chemists will concentrate on the development and optimisation of efficient processes to target molecules with an emphasis on raw material cost, solvent choice, yield improvement, process efficiency and work up, and waste minimisation.
Process robustness testing and reaction optimisation via stastical methods will also be covered.
A discussion of patent issues and areas where engineering and technology can help reduce operating costs.
The use of engineering and technology solutions to reduce costs will be discussed and throughout the course the emphasis will be on minimising costs and maximising returns.
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Christopher Conway has been appointed to lead AMRI ’s discovery business strategy as SrVP of Discovery and Development and Global Commercial Sales.
Christopher Conway, Senior Vice President,
Global Sales and Marketing
Christopher Conway has been appointed to lead the company’s discovery business strategy as Senior Vice President of Discovery and Development and Global Commercial Sales.
September 3, 2015
SEE AN UPDATEFRO AMRI
QUOTE
Dear industry colleague,
As we continue to support the research and development that leads to the commercialization of pharmaceutical products, it is critical that we align our focus on R&D with the commercial demands of the market. Today, AMRI has announced an organizational change in our Discovery and Development Services (DDS) business. These changes are expected to drive top and bottom line growth for the Discovery and Development Solutions (DDS) business through strong commercial leadership; strengthen the DDS strategy and aggressively pursue the most valuable growth opportunities, externally and internally; and ensure that our service offerings are well aligned with your needs and the needs of the market.
Effective immediately, Christopher Conway has been appointed to lead the company’s discovery business strategy as Senior Vice President of Discovery and Development and Global Commercial Sales. In this role, Chris will head up the global Discovery and Development Solutions (DDS) business leading these businesses in the United States, Europe and Asia. Sales and marketing will also continue to report to him. He succeeds Michael A. Luther, Ph.D., MBA, who will be leaving AMRI to pursue other opportunities. We thank Dr. Luther for his efforts in moving the DDS business along over the last year and wish him the best in his future endeavors.
Related to this announcement, we would like to take the opportunity to announce the hiring of Rory Curtis, Ph.D., who has joined AMRI as Vice President of Discovery Biology and Pharmacology. Rory will also serve as site head with responsibility for scientific operations at AMRI’s Buffalo, N.Y. location. Rory was most recently Senior Director of Human Diseases in Discovery at Cubist Pharmaceuticals, where he developed Cubist’s antibacterial drug discovery into new disease areas such as pain, inflammation and gastro-intestinal disease. Before this, he held positions of increasing responsibility at Elixir Pharmaceuticals, Millennium Pharmaceuticals and Regeneron Pharmaceuticals.
Rory Curtis
Vice President of Discovery Biology and Pharmacology, Site Head AMRI Buffalo
In addition to Chris’ current direct reports and Rory, he will have a scientific leadership team reporting into him, which includes Michael P. Trova, Ph.D., Senior Vice President of Chemistry; Raj Shenoy, Senior Director of Global Chemical Development; and Pete Michels, Ph.D., Senior Director of Metabolism and Biotransformations.
Michael P. Trova, Ph.D.
Pete C. Michels, Ph.D., Senior Director, Chemical Development, Fermentation and Biocatalysis, AMRI
We are very excited about the future of AMRI Drug Discovery and Development and are pleased to welcome Rory to the AMRI discovery team. Market demand for our DDS services continues to grow and these changes will help us increase our market share and strengthen AMRI’s global position in Discovery and Development.
As we approach the second half of 2015, we are looking forward to working with you on a great number of new opportunities in 2016 and beyond. We appreciate your loyalty and support, and continue to remain dedicated to enhancing your pharmaceutical services experience from early discovery through to the commercialization and delivery of drug product. If you have any questions, please feel free to read today’s related press release at www.amriglobal.com, or contact us here.
Sincerely,
William S. Marth
President and CEO
Albany Molecular Research Inc. (AMRI)
www.amriglobal.com
William S. Marth. President and Chief Executive Officer Albany Molecular Research, Inc.
Albany Molecular Research Inc. (AMRI)
26 Corporate Circle
Albany, NY 12203
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Our services include Drug Discovery, such as medicinal chemistry, discovery biology and in vitro ADME; Development, such as pre-formulation, formulation and validation; and Manufacturing, such as cGMP API manufacturing.
SINGAPORE RESEARCH CENTRE
AMRI’s Singapore Research Centre, Pte. Ltd. provides chemistry and biology services to support drug discovery and development programs. AMRI is one of the first drug discovery R&D companies to establish operations in Singapore. Fully integrated with AMRI’s locations in the United States, Asia, and Europe, the Singapore centre offers medicinal chemistry services such as hit-to-lead andlead optimization as well as focused library synthesis / custom synthesis. In the area of biology / in vitro pharmacology, the Singapore Research Centre provides target validation; assay development; HTS; rapid production of SAR quality data; and in vitro ADMET support, including CYP inhibition, metabolic stability (liver microsome assays), and aqueous solubility. As a signatory to the World Patent Treaty, Singapore provides an environment that protects intellectual property, enabling our scientists to conduct proprietary and cutting-edge research on behalf of our customers.
Areas of Expertise: Discovery Services
Contact Information:
61 Science Park Road
#05-01 The Galen
Singapore Science Park II
Singapore 117525
Phone: +65-6398-5500
Fax: +65-6398-5511
HYDERABAD RESEARCH CENTRE
The Hyderabad Research Centre, Pvt. Ltd. (AMRHRC) is located in Hyderabad, India, an emerging technology metropolis located in South Central India.
All fully integrated with AMRI’s U.S.-based resources, this Centre’s core area of expertise is in the areas of medicinal chemistrysupport, chemical development, custom synthesis of scaffolds and building blocks, process development, GMP analytical services,scale-up and preparation of reference standards.
Areas of Expertise: Chemical Development and Small Scale Manufacturing
Contact Information:
Hyderabad Research Centre Pvt. Ltd.
Plot # 9, Alexandria Knowledge Park, Turkapally, Shameerpet
Genome Valley, RR District, Hyderabad – 500 078, India
Tel : +91 – 40 – 6687 6666 (Board)
Fax : +91 – 40 – 6687 6600
http://www.amrismartsourcing.com/meet-the-bloggers/
GRANT CARR, PH.D. 
SENIOR DIRECTOR, LEAD DISCOVERY, AMRI
ROBERT B. KARGBO, PH.D.
SENIOR RESEARCH SCIENTIST I, AMRI
Sandoz, Pfizer closing Mumbai API plant
Sandoz closing Mumbai API plant but says it remains committed to India
Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region.
From online sources
Drug major Sandoz will discontinue operations at its Turbhe site (Maharashtra) by end December 2016, as part of global plans to optimise its manufacturing network.
The Turbhe sites employs 170 people and manufactures antibiotics and active pharmaceutical ingredients (API), a note from the company said. Sandoz is the generic drugs arm of pharmaceutical company Novartis.
“Sandoz will refocus its manufacturing set up in India as part of its strategy to optimise its global manufacturing network, while continuing to serve patients in India,” the company said. As part of the plan, Sandoz will focus its manufacturing at other sites which employ over 1,300 employees and produce over three billion tablets and 180 tonnes of API annually, it added. The company has two manufacturing facilities at Kalwe and Mahad.
“We made the announcement today to ensure our associates are informed as soon as possible about our decisions and to ensure a transparent process,” Vivek Devaraj, Sandoz Country Head in India, said in the statement. “We are committed to managing the process with care, sensitivity and respect for all impacted associates at Turbhe, to supporting our customers through the transition and to meeting patient needs for access to important medicines,” he added.
In 2012, the company had shut down its formulations and API development centres, respectively. Drug companies have in the past shut down plants in India as a fallout of global strategies, mergers and acquisitions. At present, Pfizer’s plant in Thane faces an uncertain future.
……………………
ABOUT PFIZER
There has been practically no production at Pfizer’s Thane plant (pic above) since 2013.
Sandoz India’s Turbhe plant to down shutters by December 2016
Less than a week after Sandoz, the generic division of Novartis, announced that it would discontinue operations at its Turbhe site by end December 2016, another MNC, Pfizer India announced the closure of its manufacturing facility at Thane, two months from today, from September 16, 2015.
According to Pfizer India spokesperson, the Thane plant was commissioned in the 1960s, manufacturing medicines for both domestic and international markets but there has been ‘practically been no production activity at this plant since 2013′. Hence closure of the site would not impact supply of Pfizer India’s medicines.
Both plant closures are a consolidation of manufacturing facilities, with the shutting down of older facilities and re-direction to more modern facilities, with Pfizer India’s statement attributing the decision to ‘an assessment of its long term viability and its ability to achieve the needed production.’
132 of the 212 Pfizer India workmen at the Thane plant had already taken up the voluntary retirement scheme (VRS) offered by the company and the statement indicated that the remaining 80 workmen who continued to receive full wages despite plant inactivity, would also receive requisite compensation as mandated by law.
While the close down process is in the final stages at Pfizer India’s Thane facility, Sandoz’ July 10 announcement is the beginning of the process at its Turbhe plant, which employs 170 associates and manufactures antibiotics and APIs.
“We made the announcement (on July 10) to ensure our associates are informed as soon as possible about our decisions and to ensure a transparent process,” said Vivek Devaraj, Sandoz Country Head in India. He said the company was “committed to managing the process with the utmost care, sensitivity and respect for all impacted associates at Turbhe, to supporting our customers through the transition and to meeting patient needs for access to important medicines.” Manufacturing would now focus at its other sites which employ over 1,300 associates and produce over three billion tablets and 180 tonnes of API annually.”
/////////Sandoz, shutter, Indian API facility, Pfizer
Zydus Cadila Healthcare Ltd, WO 2015102017, lorcaserin
Processes for the preparation of lorcaserin
Zydus Cadila Healthcare Ltd
| Applicants: | CADILA HEALTHCARE LIMITED [IN/IN]; Zydus Tower, Satellite Cross Roads Ahmedabad – 380 015 Gujarat (IN) |
| Inventors: | DWIVEDI, Shriprakash Dhar; (IN). SHAH, Alpeshkumar Pravinchandra; (IN). GAJJAR, Samir Rameshbhai; (IN). KHERA, Brij; (IN) |
On 10 May 2012, after a new round of studies submitted by Arena, an FDA panel voted to recommend lorcaserin with certain restrictions and patient monitoring. The restrictions include patients with a BMI of over 30, or with a BMI over 27 and a comorbidity such as high blood pressure or type 2 diabetes.
On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for adults with a BMI equal to or greater than 30 or adults with a BMI of 27 or greater who “have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol
Useful for treating obesity.
The present invention relates to stable crystalline Form I of Iorcaserin hydrochloride of Formula (IA) and processes for its preparation. The invention also relates to processes for the preparation of lorcaserin and pharmaceutically acceptable salts, solvates and hydrates thereof.
Stable crystalline form I of lorcaserin hydrochloride and its process of preparation are claimed. Represents the first patenting from Cadila on lorcaserin, which was developed and launched by Arena Pharma and Eisai.
In July 2015, Newport Premium™ reported that Cadila is potentially interested in lorcaserin.
Lorcaserin hydrochloride is an agonist of the 5-HT2c receptor and shows effectiveness at reducing obesity in animal models and humans developed by Arena Pharmaceuticals. It is chemically represented as (R)-8-chloro-l -methyl -2,3,4,5-tetrahydro-lH-3-benzazepine hydrochloride having Formula (I) as depicted herein below.
(IA)
U.S. Patent No. 6,953,787 B2 discloses compound of Formula (I) and pharmaceutically acceptable salt, solvates or hydrates thereof and process for preparation thereof.
U.S. Patent No. 8,168,624 B2 discloses (R)-8-chloro-l-methyl-2,3,4,5-tetrahydro-lH-3-benzazepine hydrochloride hemihydrate and process for its preparation. The patent also discloses crystalline Form I, Form II and Form III of (R)-8-chloro-l-methyl-2,3,4,5-tetrahydro-lH-3-benzazepine hydrochloride. The crystalline Form
I and Form II are reported as anhydrous, non-solvated crystal forms. The crystalline Form III displays a dehydration feature calculated as a 3.7% weight loss which is consistent with the theoretical weight loss of 3.7% for a hemihydrate.
The patent discloses that anhydrous Form I and Form II readily converts to a hemihydrate, upon exposure to moisture. The dynamic vapor sorption (DVS) data for each of the three crystal forms reveals the hygroscopic nature of both Forms I and II, which readily adsorb moisture at relative humidity (RH) greater than about 40-60%. In addition, both Forms I and II were calculated to adsorb about 3.8% moisture between about 40 and about 80% RH which is consistent with conversion to the hemihydrate (Form III). X-ray powder diffraction (XRPD) carried out on both Forms I and II after the DVS cycle confirmed this conversion. In contrast, the DVS data in connection with Form III shows that it is substantially non-hygroscopic, adsorbing less than 0.5% water at 90% RH and the XRPD pattern showed no change in crystalline form after the DVS cycle.
International (PCT) Publication Nos. WO 2003/086306 Al, WO 2005/019179 Al, WO 2006/069363 Al, WO 2007/120517 Al, WO 2008/07011 1 Al and WO 2009/1 1 1004 Al disclose various synthetic approaches for the preparation of (R)-8-chloro-l-methyl-2,3,4,5-tetrahydro-lH-3-benzazepine, its related salts, enantiomers, crystalline forms and intermediates.
International (PCT) Publication No. WO 2006/071740 Al discloses combination of (R)-8-chloro-l-methyl-2,3,4,5-tetrahydro-lH-3-benzazepine with other agents. International (PCT) Publication No. WO 2012/030938 Al discloses various salts of lorcaserin with optically active acids.
U.S. PG-Pub No. US 2014/0187538 Al discloses amorphous lorcaserin hydrochloride and amorphous solid dispersion comprising lorcaserin hydrochloride and one or more pharmaceutically acceptable carriers and processes for their preparation.
International (PCT) Publication No. WO 2014/135545 Al discloses solid dispersion comprising amorphous lorcaserin hydrochloride and one or more pharmaceutically acceptable water soluble polymers.
Example-7: Preparation of crystalline Form I of lorcaserin hydrochloride. In a round bottom flask, 560g of methyl ethyl ketone and 40 ml water were taken and 100 g of 8-chloro-l-methyl-2,3,4,5-tetrahydro-lH-3-benzazepine was added and stirred for 10 minutes. The reaction mass heated to 55 to 60°C and 19.3 g of. L-(+)-tartaric acid was added slowly and stirred for one to two hours. The reaction mass was further stirred at 10-15°C for an hour and the product was filtered and washed with a mixture of methyl ethyl ketone and water. The wet cake and 150 ml methyl ethyl ketone were taken in another flask and heated to 75-80°C. 20-25 ml water was, added and stirred for an hour. Further, the reaction mass was stirred for an hour at 0-5°C. The product was filtered and washed with methyl ethyl ketone.
100 g tartrate salt of 8-chloro-l-methyl-2,3,4,5-tetrahydro-lH-3-benzazepine and 300 mL water were taken in another round bottom flask. 200 mL methylene dichloride was added and the reaction mass was cooled to 10-20°C. 17.2 g sodium hydroxide dissolved in 89 ml water was added into the reaction mass at 10-20°C. The reaction mass was stirred for an hour at 25-30°C and the layers were separated. The solvent was removed from the organic layer under vacuum and then 100 mL ethyl acetate was added into that and distilled out. Further, 100 mL ethyl acetate was added and stirred for 15 minutes. The reaction mass was filtered through a hyflow bed and the filtrate was treated with dry HC1 gas till a pH of 1.5 to 2.5 was obtained at 0-10°C and it was stirred for about 30 minutes to an hour. The product was then filtered and washed with ethyl acetate and then dried in a vacuum oven at 50°C to 55°C for 2 hours. The product was further dried at 90°C to 110°C for 20 hours to obtain crystalline Form I of lorcaserin hydrochloride. Yield: 87.5-98.6 %.
Example-8: Preparation of crystalline Form I of lorcaserin hydrochloride
In a round bottom flask, 2.20 g lorcaserin, 30 mL methylene chloride, 17.4 mL of 1M HCI in ether were added and the mixture was stirred for 5-15 minutes at room temperature. The solvent was removed under reduced pressure to give a white solid. This solid was again dissolved in 30 ml methylene chloride, 17.4 mL of 1M HCI solution and stirred for 5-15 minutes at room temperature. The solvent was removed under reduced pressure to give lorcaserin hydrochloride. The product was dried in a vacuum oven at 50°C to 55°C for 2 hours. The product was further dried at 90°C to 110°C for 20 hours to obtain crystalline Form I of lorcaserin hydrochloride.
Example-9: Preparation of crystalline Form I lorcaserin hydrochloride
50 g of lorcaserin hydrochloride hemihydrate and 50 g of hydroxypropylmethyl cellulose (HPMC) 3CPC were mixed in a blender at 25°C to 35°C. The mixture was mixed for 30 minutes and unloaded. The solid thus obtained was dried in a vacuum oven at 50°C to 55°C for 2 hours. The product was further dried at 90°C to 110°C for 20 hours to obtain crystalline Form I of lorcaserin hydrochloride.
Pankaj R. Patel (right), Chairman and Managing Director,
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