Orchid Chemicals signs out-licensing deal with Alvogen
May 5th, 2010 - 6:02 pm ICT by IANSChennai, May 5 (IANS) City-based drug company Orchid Chemicals and Pharmaceuticals has signed an out-licensing and distribution agreement with US-based Alvogen for eight formulations having a market size of $8 billion.
As per the agreement, the Indian company will develop and manufacture eight oral non-antibiotic formulations for licensing and marketing by Alvogen in the US.
According to Alvogen, regulatory applications have already been submitted for three of the eight products under the agreement. Two of these have received tentative approvals from the US Food and Drug Administration (USFDA).
A further five products are under development. The products are expected to be launched in the US market beginning 2011.
Outside the US, Alvogen has identified 20 emerging markets in Europe, Asia and Latin America as its priorities for entry and expects to be operational in 15 countries by the year-end.
Alvogen will source the drugs only from Orchid Chemicals. It would pay certain dossier licence fees to Orchid based on development and regulatory milestones and share profits arising from marketing of these products.
Both the companies would share the legal expenses and bio-study costs.
“Orchid has created a strong base in the US generics market through its antibiotic and non-antibiotic product portfolio. Moving forward, we are progressing on further leveraging on our non-antibiotic product portfolio,” said Managing Director K. Raghavendra Rao.
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Tags: chennai, distribution agreement, emerging markets, europe asia, food and drug, food and drug administration, latin america, legal expenses, licence fees, managing director, milestones, orchid chemicals, pharmaceuticals, priorities, product portfolio, raghavendra rao, regulatory applications, share profits, us food and drug administration, year end