• 12 April 2012
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Marken launches new branches

Marken continued its expansion of services in India by augmenting its existing Mumbai facility with four additional branches to support the growing demand in clinical trial logistics within India. The expansion in New Delhi, Hyderabad, Pune and Bangalore will support the growing need for temperature controlled logistics of sensitive drugs and cold chain specimens.

Marken is currently developing a new purpose-built good manufacturing practice (GMP) compliant depot in Bangalore that is due to be completed by the end of 2012. The depot will join Marken's already operational Argentina, Mexico and Singapore depots, offering the full range of temperature controlled storage capabilities, including controlled, ambient, refrigerated and frozen as pharmaceuticals and medical devices.

Ranbaxy's Atorvastatin now in Europe
Ranbaxy Laboratories launched the generic versions of Atorvastatin tablets, 10 mg, 20 mg, 40 mg and 80 mg in Italy and Sweden; and 10 mg, 20 mg and 40 mg in the Netherlands, after receiving approval from the respective local regulatory authorities. In accordance with its settlement agreement with Pfizer, Ranbaxy introduced the product ahead of the applicable patent expiries. Pfizer's patent expires in Italy on May 8, 2012, and in the Netherlands and Sweden on May 6, 2012. Atorvastatin, which is a cholesterol reducing drug, is the largest selling pharmaceutical product in Italy with sales of 1885 crore ($377 million) (according to IMS MAT Dec, 2011). The market size for Atorvastatin in the Netherlands is 822 crore ($164.4 million) and in Sweden is 275 crore ($55 million), according to IMS MAT Dec, 2011.

Health ministry to monitor TB cases
Union Minister for Health and Family Welfare, Mr Ghulam Nabi Azad, highlighted the government's emphasis on early diagnosis and complete treatment of drug-sensitive tuberculosis (TB) cases under the Revised National Tuberculosis Control Programme (RNTCP) in order to prevent the emergence of drug-resistant TB. Mr Azad said that the 12 cases recently reported in Mumbai were all extensively drug-resistant TB (XDR-TB) cases. In the terminology of the Word Health Organization (WHO), the phrase 'totally drug-resistant tuberculosis (TDR-TB)' does not exist.

A cumulative total of 6,994 drug-resistant TB cases have been put on treatment in the country under RNTCP. All states and union territories have introduced services with variable access across 260 districts in the country, with continuous monitoring of services by the ministry. The diagnosis and treatment protocols for all forms of drug-resistant TB, including XDR-TB, have been developed and disseminated in the country. As per the health ministry's figures, there are 37 accredited quality-assured culture and drug susceptibility testing laboratories to diagnose drug-resistant TB cases in the country.

Dr Reddy's launch of Ziprasidone
Dr Reddy's Laboratories recently launched Ziprasidone Hydrochloride capsules, a bioequivalent generic version of Geodon in the US market, following the approval by the US Food and Drug Administration.

The Geodon brand had US sales of approximately $1.34 billion for the most recent 12 months ending December 2011, according to IMS Health. Dr Reddy's Ziprasidone Hydrochloride capsules, in 20 mg, 40 mg, 60 mg and 80 mg strengths, are available in 60 count bottle size.

Center for climate research launched
The International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) and the Department of Science and Technology (DST-Climate Change Program), Ministry of Science and Technology, Government of India, launched the Center of Excellence on Climate Change Research for Plant Protection (CoE-CCRPP) at the ICRISAT headquarters near Hyderabad.

The project, funded by the DST-Climate Change Program, is for a three-year period with an overall goal to establish facilities and provide opportunities for the ICRISAT and partner institutes to conduct research-for-development initiatives on climate change and its impact on diseases and pests on legumes in the semi-arid tropics.

Dr Akhilesh Gupta, advisor, DST Climate Change Program (CCP) noted the merits of the CoE-CCRPP as being the only project among the 147 qualified projects under the program that received full support after a long and stringent process of approval.

Abexome, Bioneeds collaborate
Abexome Biosciences, an analytical solution provider to the biopharma industry, and Bioneeds, a leading OECD GLP certified pre-clinical service provider in India, are collaborating to provide pre-clinical and core biology services to pharmaceutical and biopharmaceutical companies in India using their complementary capabilities.

Under this agreement, Abexome and Bioneeds will provide end-to-end solutions including custom antibody and ELISA method development, pharmacokinetic studies, regulatory toxicity studies and in vivo and in vitro efficacy assays for drug screening. Dr Vinay Babu, MD, Bioneeds, said that the collaboration will enable both organizations to access each other's complementary capabilities and offer a wider spectrum of services to pharma and biotech companies.

Biogen's MS device gets DCGI nod
Biogen Idec Biotech India received approval of the first, single-use, intramuscular autoinjector for interferon beta-1a, which are to be used by patients with multiple sclerosis (MS) in India. Approved by the Drug Controller General of India (DCGI), the new autoinjector, Avonex Pen, is designed to enable easier, more convenient interferon beta-1a administration, improving the treatment experience for MS patients. It was approved based on data from a specific clinical study supporting its effectiveness as a new treatment administration option.

Biogen Idec recently received approval in the US and European Union for the autoinjector. Thousands of patients with MS in India are administered interferon beta-1a therapy.

Once-weekly interferon beta-1a (intramuscular) is one of the most commonly prescribed treatments for the relapsing forms of MS worldwide. It has been shown to slow down the progress of physical disability and reduce relapses. It has been available for use in the US for more than 15 years and in India for the past five years.

Panacea launches polio vaccine in Nigeria
Panacea Biotec launched Polprotec, an enhanced potency, inactivated poliovirus vaccine, in Nigeria in collaboration with Emzor Pharma, Nigeria. On this occasion, Panacea Biotec and Emzor announced a joint 'Planet Polio-Free Mission' statement. The two firms pledged to contribute towards achieving the goal of global polio eradication.

They also pledged that no child will ever again be paralyzed by the wild polio virus (WPV) or vaccine-derived polio virus (VDPV) by providing complete portfolio of oral polio vaccines (OPV) and inactivated polio vaccine (IPV) and IPV-based combination vaccine at an affordable price. Dr Dorothy Esangbedo, president, Pediatric Association of Nigeria (PAN), pointed out that this was the first time IPV was launched in Nigeria.

Sun to supply Lipidox to the US
The US FDA allowed the import of Lipodox, which will be supplied by Sun Pharmaceuticals, as a part of a series of steps to increase the supply of critically needed cancer drugs. This move is in response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection), which is used in multiple treatment regimens. Lipodox (doxorubicin hydrochloride liposome injection) will be temporarily imported as a replacement drug for Doxil.

This drug is expected to end the shortage and fully meet patient needs in the coming weeks. The FDA's exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorized distributor Caraco Pharmaceutical Laboratories.

Swedish firm ties up with Cadila
Bactiguard, a Swedish company offering solutions for preventing hospital acquired infections, signed an exclusive cooperation agreement with Cadila Pharmaceuticals. Under the agreement, Cadila Pharmaceuticals will sell the entire line of Bactiguard´s products throughout India.

Dr Rajiv I Modi, managing director, Cadila Pharmaceuticals, explained why Cadila has chosen to work with Bactiguard. He said that hospital-acquired infections are a big problem for patients in India and Bactiguard has a unique solution targeted at preventing healthcare associated infections. He said that he was confident that hospitals in the country will embrace Bactiguard's clinically proven solution in order to help save lives in India.

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