Alvogen inks pact with Indian pharma majors for contract manufacture and licensing deals
Alvogen Inc. the US-based generic pharmaceuticals company, has unveiled its concrete business efforts to enter India through joint ventures. In this regard, it has already signed agreements with several pharma companies including the Chennai-based Orchid and Shashun Chemicals, Bangalore-based Strides Arcolab, and Mumbai-based Marksans Pharma. The company intends to seal a total of 20 deals in the country. The company is also identifying companies to manufacture bio-similars.
With Orchid Chemicals Alvogen will market eight high potential oral products from Orchid in the US market, with total current annual branded sales of approximately $8-9 billion.
We look at India for its chemical expertise, presence of highest number USFDA plants, sustained quality and cost advantage. There has been also a spare production capacity in India and companies here have further augmented the technical capability to develop a comprehensive range of drugs, Robert Wessman, executive chairman, Alvogen Inc said at a press conclave.
Indian companies will produce both generics and APIs. The range will be shipped from here to its customers globally.
Partnerships would allow us to have the first-to-market opportunity, besides economize on cost of product by 40 percent if these were produced in the US. We will save $100 million as production costs, he added.
Orchid’s products, are complex generics with multiple development, manufacturing and IP challenges, will be sold by Alvogen’s experienced US sales team. Regulatory applications have already been submitted for three of the eight products under the agreement, two of which have already received tentative approvals from the FDA. Further, five products are under development. The products are expected to be launched in the US market, beginning in 2011.
Alvogen has 220 molecules in its global product pipeline and by the end of 2010 the company aims to file 50 ANDAs in the US. It will source 150 products out of the 220 from India and retain the complex high value drugs to be produced from its US plants. It will gear up generate of $1 billion by 2010 of which $500 million will be products from Indian plants.
The global trend is to take a quick advantage impending patent expiry of drugs in 2013, which will further increase the competition. This is where Alvogen was aggressive to tap the expertise of Indian pharma through strategic partnerships. We are looking for the development of therapeutics from cardiology, central nervous system to oncology.
Although its core market is the US it is looking to expand its presence in Eastern Europe, Asia and Latin America, he said.
The company has invested $5 million to set up its own clinical research facility in Bangalore which will be headed by Dr. Saral Thangam and Sudhir Pai as directors. In addition, an API sourcing office is also opened here to identify the suppliers for the range of bulk drugs.