Glenmark gets USFDA approval to sell Rufinamide

Glenmark Pharmaceuticals on Thursday said it has been granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.

Lennox-Gastaut syndrome is a form of childhood-onset epilepsy.

"Glenmark...has been granted tentative approval last week by the United States Food and Drug Administration (USFDA) for its Rufinamide tablets," the company said in a Bombay Stock Exchange (BSE) filing.

The approval has been granted for the tablets in 200 mg and 400 mg strengths. Rufinamide is a therapeutic equivalent of Banzel tablets of Eisai.

Glenmark further said: "Under the terms of a settlement agreement between Glenmark and Eisai, Glenmark will be permitted to market this product in the US on May 30, 2022 or potentially earlier under certain circumstances."

Citing IMS Health sales data, the pharma firm said that "for the 12 month period ending March, the Banzel market achieved annual sales of approximately $ 121.8 million."

Glenmark's current portfolio consists of 96 products authorised for distribution in the US marketplace and 68 ANDAs (Abbreviated New Drug Application) pending approval with the FDA.

"In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio," the company added.

Shares of Glenmark Pharmaceuticals were trading at Rs 902.65 apiece in the morning trade, down 0.48 per cent on the BSE.

Govt plans to provide essential medicines at 60% lower rates

The Centre is planning to provide essential medicines at 40-60 per cent lower rates through its 'Jan-Aushdi' medical stores, Union Minister Ananth Kumar said on Friday.

"In the last one year, more than 300 life saving medicines which are used to treat diseases such as cancer, AIDS and other, the Modi government has brought them under drug price control," the Minister of Chemicals and Fertiliser said.

There are also plans to reduce the prices of medicines, the Minister said. The department of pharmaceuticals comes under his ministry.

"We are planning to increase the total number of Jan-Aushdi stores to 3,000, and at these stores essential medicines will be provided at 40 per cent, 50 per cent and 60 per cent lower rates," Kumar said at an event organised by news channel Aaj Tak.

The minister also said that urea prices have not been increased and there will not be any hike in next four years.

"In the coming four years, there will not be any increase in urea prices. And keeping the prices at Rs 5,360 per tonne, we will increase the domestic production of fertilisers," he said.

Novartis drug Afinitor® extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors

THURSDAY, 21 MAY 2015

Novartis

Novartis announced today that the Phase III study of Afinitor® (everolimus) tablets plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin met its primary endpoint: significant extension of progression-free survival (PFS) compared to placebo plus best supportive care[1]. The RADIANT-4 study is part of one of the largest clinical trial programs in NET[1].

Afinitor is already approved in more than 95 countries for patients with advanced pancreatic NET, a rare form of cancer[1-3].

NET are a rare type of cancer that originate in neuroendocrine cells found throughout the body, and are most often found in the GI tract, lungs or pancreas[4]. NET can be functional or nonfunctional: functional NET produce symptoms caused by the secretion of hormones and other substances; nonfunctional NET do not secrete hormones, and may only produce symptoms caused by the tumor's growth, such as intestinal blockage, pain and bleeding[5-7]. At time of diagnosis, up to 44% of patients with GI NET and 28% of patients with lung NET have advanced disease, meaning the cancer has spread to other parts of the body and is more difficult to treat[2-4]. There are limited treatment options for patients with advanced GI or lung NET[4].

"We look forward to presenting the findings from the RADIANT-4 trial of everolimus, which has the potential to become an important treatment option for patients with advanced nonfunctional GI or lung NET," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "The results will serve as the basis of planned worldwide regulatory filings for everolimus in these two types of NET, bringing us closer to our goal of offering Afinitor for these patients."

Full results from the RADIANT-4 study will be submitted to a major medical meeting. Worldwide regulatory filings are planned for 2015.

About RADIANT-4
RADIANT-4 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care versus placebo plus best supportive care in 302 patients with well differentiated advanced NET of GI or lung origin, and no history or active symptoms of carcinoid syndrome, who had documented disease progression within the previous 6 months. Patients were randomized 2:1 to receive either daily everolimus 10 mg or daily placebo orally.

The primary endpoint of RADIANT-4 was PFS. Secondary endpoints included safety, objective response rate and overall survival.

About Afinitor® (everolimus) tablets
Afinitor® (everolimus) is approved in more than 95 countries, including the United States and throughout the European Union, for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin. It is also approved in 119 countries including the United States and European Union for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy.

Afinitor is approved in the European Union for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor (NSAI). In the United States, Afinitor is approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative (advanced HR+/HER2-) breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.

Everolimus is also available from Novartis for use in certain non-oncology patient populations under the brand names Afinitor® or Votubia®, Certican® and Zortress® and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Indications vary by country and not all indications are available in every country. The safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world.

1. Novartis data on file.
2. National Library of Medicine and the National Institutes of Health. Pancreatic islet cell tumor. Available at http://www.nlm.nih.gov/medlineplus/ency/article/000393.htm. Accessed May 2015.
3. Halfdanarson, et al. Pancreatic neuroendocrine tumors (PNETs): incidence, prognosis and recent trend toward improved survival. Annals of Onc. 2008; 19: 1727-1733.
4. Yao, et al. One Hundred Years After "Carcinoid:" Epidemiology of and Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United States. J Clin Oncol. 2008; 26: 3063-72.
5. Akerstrom, et al. Timing and extent of surgery in symptomatic and asymptomatic neuroendocrine tumors of the pancreas in MEN 1. Langenbecks Arch Surg. 2002; 386:558-69.
6. Modlin, et al. Priorities for Improving the Management of Gasteroenteropancreatic Neuroendocrine Tumors. J Natl Cancer Inst 2008;100: 1282-1289.
7. Oberg K, Kvols L, Caplin M, et al. Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol. 2004: 966-976.

AstraZeneca provides update on brodalumab development programme

Amgen today announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab, an investigational IL-17 receptor inhibitor in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The announcement follows Amgen's decision to concentrate on other portfolio priorities after observing suicidal ideation and behaviour events in the brodalumab programme which may result in restrictive labelling.

AstraZeneca will confirm its decision on the future development of brodalumab as soon as possible, based on further review of the data.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "Data from the three AMAGINE Phase III pivotal studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit. We will fully evaluate the data and assess all options before we make our independent decision about the future of this potential medicine."

About Brodalumab (AMG 827)
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.

About the Amgen and AstraZeneca Collaboration
In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialise five monoclonal antibodies from Amgen's clinical inflammation portfolio. With oversight from joint governing bodies, Amgen leads clinical development and commercialisation for brodalumab and AMG 557/MEDI5872 (Phase Ib for autoimmune disease, such as systemic lupus erythematosus). AstraZeneca, through its biologics arm MedImmune, leads clinical development and commercialisation for MEDI7183/AMG181 (Phase II for ulcerative colitis and Crohn’s disease), MEDI2070/AMG139 (Phase II for Crohn's disease) and MEDI9929/AMG157 (Phase II for asthma).

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Ranbaxy announces launch of Atorvastatin, generic Lipitor®, in the U.S.

FRIDAY, 02 DECEMBER 2011

Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) ("Ranbaxy"), today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the U.S. market. Atorvastatin is a cholesterol-reducing medicine, the generic equivalent of the brand Lipitor®, which generated total annual sales of $7.89 billion in the United States through September 2011.(1)

Mr. Arun Sawhney, CEO & Managing Director, Ranbaxy, stated, "Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received U.S. FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor. We are committed to continuing to expand our portfolio of products offered in the U.S. market for the benefit of patients, prescribers and the U.S. healthcare system."

Pursuant to an agreement between Ranbaxy and Teva Pharmaceuticals USA, Inc. ("Teva"), a portion of the profits from sales of Atorvastatin during Ranbaxy's 180-day first-to-file exclusivity period will be paid to Teva. Terms of the agreement will not be disclosed.

*Lipitor® is a registered trademark of Pfizer.

1. Source: IMS-MAT Sept. 2011

About Ranbaxy Pharmaceuticals Inc.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida USA, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe.

Cadila Healthcare near deal to buy smaller rival Claris - paper

Cadila Healthcare Ltd(CADI.NS), among India's top ten drugmakers, is in late-stage talks to buy smaller rival Claris Lifesciences Ltd(CLAI.BO) for about 34 billion rupees ($534 million), the Economic Times newspaper reported on Thursday, citing sources aware of the talks.

Both companies are engaged in last-minute due diligence negotiations, and the deal is expected to be announced next month, the daily reported.

Claris, which has a market capitalisation of about $240.5 million, makes specialty generic drugs including blood products and anti-infectives, as well as the delivery systems for such products, such as vials, ampoules and intravenous bags.

About half of the company's sales come from 70 emerging markets, including Brazil and Russia.

Media reports in February said several global and domestic drugmakers were in a race to buy Claris's injectable products business, but Claris denied having any intention to sell.

A spokeswoman for Cadila and a spokesman for Claris did not immediately respond to a request for comment on Thursday.

Cadila shares were down 0.5 percent, while those of Claris were up 10 percent in early trade on Thursday, while the broader Nifty was down 0.03 percent.

($1 = 63.7100 rupees)

(Reporting by Zeba Siddiqui; Editing by Biju Dwarakanath)

Indian Pharma Indutry

The pharmaceutical industry in India is the world's third-largest in terms of volume.^[1][2] According to the Department of Pharmaceuticals of the Indian Ministry of Chemicals and Fertilizers, the total turnover of India's pharmaceuticals industry between 2008 and September 2009 was US$21.04 billion.^[3] The domestic market was worth US$12.26 billion. The industry has a market share of $14 billion in the United States.^[4]

According to the India Brand Equity Foundation, the Indian pharmaceutical market is likely to grow at a compound annual growth rate (CAGR) of 14-17 per cent in between 2012-16.^{[citation needed]} India is now among the top five pharmaceutical emerging markets of the world.^{[citation needed]}

Exports of pharmaceutical products from India increased from US$6.23 billion in 2006–07 to $10.1bn in 2013(according to ibef india) a combined annual growth rate of 21.25%.^[3]According to PricewaterhouseCoopers (PWC) in 2010, India joined the top 10 global pharmaceutical markets in 2020 with turnovers reaching US$50 billion.^[5]

The government began encouraging the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.^[6] This patent act removed composition patents from foods and drugs, and though it kept process patents, these were shortened to a period of five to seven years.

The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market and as they left, Indian companies carved a niche in both the Indian and world markets by reverse-engineering new processes for manufacturing low-cost drugs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has not changed its business model.^[7]

In 2009-10, India's biopharmaceutical industry grew at 17 percent, with revenues of Rs. 137 billion ($3 billion). Bio-pharma was the biggest contributor, generating 60 percent of the industry's growth at Rs. 88.29 billion, followed by bio-services at Rs. 26.39 billion and bio-agri at Rs. 19.36 billion.^[8]

In 2013, there were 4,655 pharmaceutical manufacturing plants in India, employing over 345 thousand workers.^[9]