AstraZeneca opens $15-m PR&D lab in Bangalore

Pharma major AstraZeneca inaugurated its $15-million state-of-the-art Global Process Research & Development Laboratory (PR&D Lab) in Bangalore on March 21, 2007. This is the company's fourth PR&D facility and the only one outside of Europe.

Declared operational by AstraZeneca CEO, David Brennan, the facility will strengthen the existing global PR&D programs and provide support to the company's existing drug discovery program at Bangalore, engaged in finding a cure for tuberculosis (TB). The co-location of drug discovery and PR&D scientists will help AstraZeneca maximize scientific interactions and enable shared use of infrastructure.

"The facility will leverage India's strength in process chemistry," said Brennan. The PR&D lab can accommodate up to 75 process scientists and according to Brennan, it is more than likely to be fitted-out to its capacity by 2009. Currently, it houses 35 scientists.

While one of the key objectives of the PR&D lab is to focus on New Chemical Entities (NCEs), the facility is dedicated to tuberculosis, a disease that is present in latent form in at least one-third of the population. "The growing resistance to the existing TB drugs, coupled with lack of patient compliance results in relapse. The objective is to shorten the therapy duration and improve patient compliance," said Brennan. The facility is expected to handle potential TB drug candidates by 2010.

"By 2010 AstraZeneca is likely to identify drug candidates for TB, we are pretty close," said Dr Jan Lundberg, executive vice president for the global discovery research at AstraZeneca.

AstraZeneca declared Best Safe Industry

AstraZeneca has secured the first place in "Best Safe Industry" in medium scale category at the 36th National Safety Day on March 4, 2007 at Bellary, Karnataka.

Bhasker Iyer, managing director, AstraZeneca Pharma India Ltd, said, "We are delighted to be recognized for our safety, health and environment (SHE) standards. To demonstrate our commitment towards SHE, we have had no fatal accidents since the inception of the plant in 1981. AstraZeneca has invested significantly on safety systems in the plant and all employees are well trained on the safety aspects of the machines."

The award is towards the recognition of safety, health and environment systems available in the plant and the good work done towards the society under corporate social responsibility. The award was presented by the labour minister, Iqbal Ansari, at the 36th National Safety Day organized by the Directorate of Industries and Boilers, Government of Karnataka in collaboration with the Karnataka chapter of the National Safety Council.

UN Misra, vice president-operations, AstraZeneca Pharma India Ltd, said, "At AstraZeneca we are very concerned about protecting the environment. Our manufacturing facility is equipped with state-of-the-art technology to treat all effluents and the discharge is used to maintain our greenery spread over 40 acres. The credit goes to all the employees at the facility."

"Government is keen to promote rapid biotech industrial growth"

The government is keen to promote rapid biotech industrial growth, which is already of $ 1.5 billion in terms of revenue and is growing at 40 percent, Dr MK Bhan, secretary, department of biotechnology, has said.

Dr Bhan informed that the department would be implementing several new programs next year such as new institutions for translation health science and research, stem cell biology, animal biotechnology, marine sciences and applications, food and nutrition. Time bound, multi-institutional grand challenge programs are planned in food and nutrition, vaccines and diagnostics, medical devices, molecular breeding of crops for improved yield and quality and microbial bioprospecting. There are also plans for establishment of agri-food parks in the agri-food cluster in Punjab, which would host start-up companies. The department will establish the proposed the Agri Food Biotechnology Institute and a Central Food Bioprocessing Unit in this Punjab agri cluster.

"To promote small and medium industrial R&D activities and effective functioning of biotechnology parks, a biotechnology industry, research assistance center (BIRAC), and program for collaboration with large industries, technology management system for biotechnology with technology transfer units will also be set up," he said.

He also noted that the department has launched Small Business Innovative Research Initiative (SBIRI) aiming at public-private partnership and forging effective links between academia and industry in up scaling and validation of laboratory research to commercialization. The overwhelming response from small and medium industries resulted in 200 applications and 34 proposals have been supported in areas of product development in agriculture, health care, aquaculture and animal sconces.

Zenotech signs pact with Ranbaxy for global entry into biosimilars

Zenotech Laboratories Limited (ZLL), a specialty generic injectables company with strong expertise in the area of biotechnology, has signed a global clinical development and marketing agreement with Ranbaxy Laboratories Ltd for its first biosimilar product, G-CSF (filgrastim).

The agreement involves upfront licensing fees and profit sharing after launch. The financial part of the agreement was not disclosed. Under the agreement, Ranbaxy has committed resources to introduce the G-CSF product for global marketing beginning with markets in the EU where regulations for biosimilars are in place.

Dr Jayaram Chigurupati, CEO, Zenotech Labs said, "No Indian biosimilar product so far has been launched in the EU due to the substantial investments involved in clinical trials and the regulatory expertise required. Both these aspects pose significant barriers to entry. We are proud to associate with Ranbaxy for development of G-CSF for the European Union and eventually for the US market. G-CSF will lead the way for the development of other biosimilar molecules within the Zenotech portfolio. These products will be manufactured in Zenotech's US FDA/EU approvable biologics facility in Hyderabad".

Malvinder Mohan Singh, CEO and managing director of Ranbaxy Laboratories Ltd, said, "This agreement signals Ranbaxy's foray into biosimilars by pooling in Ranbaxy's significant regulatory and front-end infrastructure with Zenotech's expertise in the development and manufacture of biosimilar products. This also strengthens our existing alliance with Zenotech for oncology products given our strategic stake in the company."

Ranbaxy launches Atorvastatin in Denmark

Ranbaxy Laboratories has launched the generic Atorvastatin, a cholesterol-lowering drug that is marketed by Pfizer as Lipitor in Denmark.

PPD licenses statin from Ranbaxy Laboratories

Ranbaxy Laboratories and PPD made an announcement that PPD has acquired an exclusive worldwide license to develop, manufacture and market Ranbaxy's novel statin for the treatment of dyslipidemia.

Under the terms of the agreement, Ranbaxy will be entitled to receive milestone payments upon the occurrence of specified clinical events. In the event of approval to market a drug product, Ranbaxy will be entitled to receive royalties on sales of the drug and sales-based milestones. PPD will be responsible for all costs and expenses associated with the development and commercialization of the compound, including preclinical and clinical studies. Ranbaxy has retained co-marketing rights to the compound in India.

India, Croatia sign joint declaration to strengthen cooperation in S&T

India and Croatia have signed a joint declaration for strengthening scientific and technological cooperation between the two countries. The union minister for science and technology and earth sciences, Kapil Sibal and the Croatian minister of science, education and sports, Dragan Primorac, signed the declaration in Zagreb.

The joint declaration pursues the Programme of Cooperation in science and technology for the period 2005-08 being implemented by the department of science and technology on the Indian side and ministry of science, education and sports on the Croatian side. It aims at further expanding and intensifying two-way exchanges between the scientific R&D communities of India and Croatia.

With a view to effectively pursuing the above objective, the parties agreed to establish a joint fund of €1 million, for which each party will make an equal contribution. The next meeting of the joint committee shall be organized within three months to develop modalities and identify projects under this fund. Both parties agreed to work out joint projects for FP7 Programme of EU.