India’s Indoco in supply pact with Aspen on generic ophthalmic drugs for emerging markets

Indian generic firm Indoco Remedies has entered into a supply arrangement with South Africa’s Aspen on ophthalmic products for emerging markets.

Indoco has licensed out intellectual property (dossiers) of a number of ophthalmic products to South Africa’s largest pharmaceutical company, Aspen (Pharmacare Limited).

The deal will extend to 30 countries from emerging markets.

Indoco will offer these products for registration and supply them from the company’s USFDA and EU approved manufacturing facilities.

Aspen will market and distribute these products immediately on obtaining the regulatory approval, Indoco said in a press release.

“The Indoco-Aspen tie-up will bolster our International foothold thereby catapulting Indoco to a level critical to be recognized as a significant International player. Indoco is all set, with its R&D and manufacturing capabilities, to gain ground on newer and larger International territories,” stated Suresh G. Kare, chairman & managing director, Indoco.

This deal is expected to be significant in view of the large market size & availability of the products in the short term thus opening vast markets for Indoco, where the Aspen group has a strong marketing set-up.

Aspen enjoys a market share of over 30% of the generics market in South Africa and going by this success rate, we anticipate a substantial market share in different territories, including Brazil, Venezuela, Mexico,South Africa and Russia.

Indoco will get a steady stream of revenues even during the process of product registration in the form of milestone payments and the sale proceeds are expected to commence from Q1 2011.

The agreement will be broadened on an ongoing basis by adding new products and territories from time to time, thus giving Indoco’s products farther reach across geographies.

In February, Indoco Remedies Ltd., a Mumbai-based generic company, announced a technology licensing agreement
to produce generics with   Watson Pharmaceuticals, Inc.

Under the agreement Indoco will develop and manufacture a number of sterile products to Watson for the United States market.

Indoco will provide API manufacturing, formulation development and manufacturing of the generic formulations for the selected products. Watson will prepare and file the Abbreviated New Drug Applications (ANDAs) for US FDA approval and will have rights to market, sell and distribute these products in the US pharmaceutical market.

Further details of the deal have not been disclosed.

Development costs, including bio-study / clinical trials costs, legal fees and net profits from the sale of these products will be shared by Watson and Indoco in the agreed proportion, as mutually agreed by both Watson and Indoco,

Indoco will work together with Watson to explore the option of adding new products and territories to this initial arrangement.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.

Indoco has a well-built brand portfolio of 135 products in various therapeutic segments, including high growth life style segments such as anti-diabetics, cardiovascular, central nervous system, musculo-skeletal, nutrition and dental care.

Indoco has built a presence across the markets in Europe, USA, Asia, Africa, Latin America and other CIS countries. A number of its products have emerged as brand leaders in the Indian and in International markets. Indoco has made significant investments to build capabilities in API manufacturing and R & D services to enhance its visibility.

Indoco operates in over 35 countries globally for formulations and APIs. With approval of its finished dosage facilities by the US – FDA, Darmstadt – Germany, TGA Australia, MCC-South Africa and UK – MHRA, Indoco is a prtner of choice and provider of Contract Research and Manufacturing Services (CRAMS) to its customers globally.

Indoco-Watson deal ie the latest among the series of such generic-innovator alliances which has been happening since last year.

In January, Pfizer entered into a collaboration with India’s Strides Arcolab on the supply of 40 generic products.

Pfizer’s new deal with Strides Arcolab follows two similar alliances last year with Aurobindo and Claris LifeSciences of India.

Under the new collaboration Pfizer will commercialize Stride’s off-patent sterile injectable and oral products in the United States through its Established Products Business Unit.

These finished dosage form products will be licensed and supplied by Strides and Onco Laboratories Limited and Onco Therapies Limited, two joint ventures between Strides and Aspen, South Africa, in which each has a 50% ownership interest.

In May last year, Pfizer, the world’s largest drug maker, acquired rights to 55 generic  pills and 20 injectables for more than 70 emerging and developed markets through new deals.

Pfizer Inc, also entered into a licensing pact with Indian generic injectables producer Claris Lifesciences besides expanding it present alliance with Aurobindo.

Pfizer has expanded the existing collaboration with the Hyderabad, South India-based Aurobindo Pharma Ltd reached earlier this year to sell 60 off-patent drugs. Meanwhile Pfizer’s agreement with Claris Lifesciences Ltd is to market 15 off-patent injectable drugs.

Pfizer has prioritized making licensing deals to expand its injectables business, in which it believes there are relatively few rivals and maintains it has a competitive cost structure.

Under the terms of the agreement, Pfizer has acquired rights to 55 solid oral dose products and 20 sterile injectable products for patients in more than 70 emerging market countries in Latin America, Eastern Europe, Asia, Africa and the Middle East.