Category — Biotechnology

Biocon (a Biotechnology Company with headquarters in Bangalore, India) has received the marketing authorization from the Drugs Controller general of India for  Novel Biologic Itolizumab (used for the treatment of chronic plaque Psoriasis). Itolizumab has an excellent safety profile as indicated during the 52-week clinical study conducted in India.

This approval paves the way for the launch, later in 2013, of Biocon’s Alzumab (a differentiated biologic drug) in India. It will treat moderate-to-severe Psoriasis and will be manufactured at the company’s facility in Bangalore.

According to Kiran Mazumdar-Shaw, Managing Director of Biocon, this is the company’s second novel biologic that they have developed in India after BioMab EGFR which is an anti-cancer monoclonal antibody.

Frans van Houten is the CEO of the $31 billion Dutch giant Philips.  During a visit to India recently, he said healthcare is growing rapidly in India for Philips. In fact, the company has become the number one healthcare technology provider in India. The company designs and makes its own catheterization labs at their Pune facility. The Allura cath Lab that  they make was designed in India for India, and van Houten says that it happens to be a great export product too.

Currently, there are 1.6 million hospital beds in India and  the aim of Philips is to bring better care to hospital beds in rural India through their e-ICU program. These are community hospitals that have access to trained doctors and specialists in cities remotely, through camera.

The latest healthcare technology that the company has introduced in India is called HIFU. These are highly focused ultrasound that treats cancer. The ultrasound is used as a smart beam that directly heats up the cancer tumor, and by which it disappears. According to the CEO of Philips, HIFU is currently seeing a great deal of demand in India.

Philips invests approximately more than $135 million year in the R&D department in India. Moreover, one fifth of the company’s  Indian employees work in that department.

In another twist on globalization, the responsibility for advanced workstations at Philips Healthcare, including their hardware and specialized applications have been taken over by Philips Healthcare of Haifa, Israel. These applications are developed at several Philips healthcare centers around the world, including in the US, the Netherlands, and India, and are overseen by Yair Briman, Vice president and General Manager of Philips’ healthcare, from Haifa, Israel. Philips Healthcare Israel currently has 600 employees in Haifa  the location is the company’s worldwide center for 3D scanners.

What this means

Medical device companies from the West see India not only as a market but also as a resource. Also, the path to global R&D success is not always direct from the USA or Europe to India or China, as in this example with the Haifa location taking the lead. Cross cultural expertise is crucial in being successful in such an environment. Look me up on www.amritt.com if your company needs help to be more successful in global R&D from India or China.

Dr Manu Prakash, of bioengineering faculty at Stanford Univeristy,  received a $100,000 grant from  Bill & Melinda Gates Foundation to promote the exploration of bold and innovative ways to improve global health. Prakash is a 2002 computer science graduate of the Indian Institutes of Technology.

Prakash and his team in field are testing an ultra-low-cost paper microscope designed for disease diagnostics. These lightweight, print-and-fold “Foldscopes” can be shipped in a flat configuration and assembled in minutes. Device testing will be conducted in India, Thailand and Uganda, and will allow user feedback to help refine the design for mass production.

If the pilot is successful, Prakash will have the opportunity to apply for a follow-on grant of up to $1 million.

Bolstered by  positive new data on its insulin program and growing profits, India’s Biocon also won a big financial backer for its R&D outsourcing arm as it prepares to take the unit public. GE Capital has agreed to pay $23 million for a 7.7% stake in Syngene, which handles contract research work for a number of big clients. And Biocon chief Kiran Mazumdar-Shaw says the GE deal provides Syngene with a $300 million valuation.
There’s no timeline offered on a public offering, but Mazumdar-Shaw told Dow Jones that she expects the IPO to come up in the new fiscal year starting April, 2013. And the Indian biotech chief is betting that GE Capital’s commitment can pave the way to an R&D partnership with General Electric, which has an expanding health care division that goes w into the discovery side of the business.

“This is not just a financial deal. GE will bring its vast expertise in biologics and life sciences with this deal, which will allow Syngene to look at new research opportunities,” Mazumdar-Shaw told India’s Economic Times.

Biocon reported that its development program for the insulin product Insugen met its non-inferiority goal when compared with Novo Nordisk’s Actrapid and Insulatard in a Phase III study involving 300 Type 1 diabetics. The goal was non-inferiority in HbA1c levels at 6 months. Biocon has been looking for a global partner on insulin since Pfizer dropped out of its biosimilar pact with Biocon.

Mumbai-based Piramal Enterprises is continuing research and development work in Berlin on the  PET (Positron Emission Tomography) technology it acquired from Bayer Healthcare earlier this year. The initiative wil lead to early detection of Alzheimer’s disease.

At a press briefing, Ajay Piramal, Chairman of the Piramal Group commented on the strategy, “Molecular imaging is one of the key technologies paving the way for individualized medicine. Our acquisition of a powerful pipeline in this field is an important milestone on the road to an innovative pharmaceutical portfolio.

Florbetaben, Piramal’s most advanced PET tracer, enables the detection of beta-amyloid deposits in the brain. “A phase III study to test the reliability of florbetaben in the histopathological detection of beta-amyloid has been successfully completed. Submission of the dossier for drug approval by the US Food and Drug Administration and the European Medicines Agency is expected later in 2012.