Under the terms of the option agreement, Bristol- Myers Squibb will have the right to exercise an option to obtain an exclusive worldwide licence to the programme
New Delhi: Biotechnology major Biocon today said it has entered into an agreement with Bristol-Myers Squibb for it’s oral insulin new drug candidate IN-105, reports PTI.
Under the terms of the option agreement, Bristol- Myers Squibb will have the right to exercise an option to obtain an exclusive worldwide licence to the programme.
It will, however, conduct the clinical trials according to a pre-agreed development programme up to the completion of Phase II, as per the agreement, Biocon said.
If the US-based company exercises the option to licence IN-105, following the successful completion of Phase II trial, the domestic firm will receive a licence fee in addition to potential regulatory and commercial milestone payments and royalties on commercial sales outside India, it added.
Biocon said it will retain the exclusive rights to IN-105 in India.
Bristol-Myers Squibb will assume full responsibility for the development programme, including all development and commercialisation activities outside India, it added.
Commenting on the development, Biocon MD and chairman Kiran-Mazumdar Shaw said: “This agreement is one huge step closer to realising the dream of bringing oral insulin to market”.
Diabetes is a chronic disease that affects about 350 million people worldwide and it is estimated that direct and indirect costs of the disease to overall healthcare system amounts to over $650 billion worldwide, Biocon said.
Dr Reddy’s currently holds an irrevocable commitment from shareholders representing over 50% of OctoPlus’ issued and outstanding shares
The investigations are being conducted to probe allegations that Wal-Mart put money into the domestic multi-brand retail chain despite a ban on foreign direct investment in the sector
New Delhi” The Enforcement Directorate (ED) will soon issue notices to American retail giant Wal-Mart as part of its probe against the company’s investment in an Indian firm for alleged violations of forex laws, reports PTI.
“The agency has received a communication from the Reserve Bank of India (RBI) to probe the investments in this regard. Notices for want of documents with regard to financial investments and remittances will be issued by the Bangalore office of the agency,” a source privy to the development said.
The agency, which has registered a case under the Foreign Exchange Management Act (FEMA), will also ask the commerce and industry ministry to furnish it with clearances that were given to the company to route the investment in 2010 in a subsidiary of Bharti ventures via a Mauritian arm, the source said.
The investigations are being conducted to probe allegations that Wal-Mart put money into the domestic multi-brand retail chain despite a ban on foreign direct investment in the sector.
Bharti Enterprises has, however, rejected the allegations that it had violated any rule in this regard. The company had said all the procedures were as per the “law of the land”.
The Rs455.8 crore investment by Wal-Mart in Cedar Support Services, a subsidiary of Bharti Ventures, had come under attack from CPI Rajya Sabha member MP Achuthan, who wrote to Indian prime minister Manmohan Singh earlier, saying it was ‘illegal’ and flouted FDI rules.
The ED, a central investigative agency mandated to probe violations under the FEMA and Prevention of Money Laundering Act (PMLA), was asked by the RBI to check the alleged violations made by the US-based retail giant in an official communication earlier this month.
In a letter dated 30th October, the Department of Industrial Policy and Promotion (DIPP) had asked that RBI may take action as appropriate as per provisions of FEMA rules and regulations.
The DIPP deals with all the FDI related matters.
“...there is a need to examine/investigate as to whether illegal investments have been made by Wal-Mart/Cedar in FDI prohibited sectors. Accordingly, the matter is being referred to the ED for further investigation and appropriate action, if necessary, in consultation with the government in accordance with the provisions of FEMA upon noticing violations if any,” a source said.
In a letter to the prime minister, Mr Achuthan, who is also a member of the Standing Committee of Parliament on IT, earlier this year had alleged that “the entire FDI has been diverted and illegally invested by Cedar in its 100% subsidiary Bharti Retail, which is carrying out multi-brand retail operations.”