Biocon ties up with Mylan to sell monoclonals, biogenerics in US, Europe

Mylan will have commercialization rights of Biocon’s products in US, Canada, Japan, Australia, New Zealand and EU.

India’s leading biotech firm Biocon Ltd has reached an agreement with Mylan to tap the emerging opportunity for high value biogeneric drugs in US and European markets.

As per the pact, Biocon will collaborate with the US-based global generic maker Mylan Inc on developing, manufacturing and commercialization of multiple generic biologic compounds for the global marketplace.

The partnership with Mylan, which claims to have operation in over 140 countries in the world, would catapult Biocon into the highly competitive arena of monoclonal anti-bodies and other biogeneric products in the world, Biocon said.

“Biocon is extremely pleased to have found a partner as strong as Mylan to accelerate our work in generic biologics and take it to the next level around the world, especially in regulated markets,’’ said Biocon Chairman and Managing Director, Kiran Mazumdar-Shaw.

Biocon’s partnership with Mylan is largely focused, largely, on monoclonal antibodies.

Monoclonal antibodies are emerging as the most dominant class in biologics. Monoclonal antibodies are used to treat cancer and autoimmune diseases such as rheumatoid arthritis.

Through this partnership Biocon hoped to deliver high quality, affordable bio-generic antibodies and biologics in both the developed and emerging economies.

Biocon’s link up with Mylan is the latest in a series of similar pacts by Biocon with overseas companies to develop generic versions of biologic drugs for overseas markets.

“This unique collaboration combines Biocon’s scientific expertise; excellent product development track record; scalable biologics manufacturing with Mylan’s one-of-a-kind global commercial footprint and our regulatory expertise around the world, ‘’ stated Mylan’s Chairman and CEO, Robert J. Coury in a company release.

Generic biologics, especially monoclonal antibodies, are expected to become the next great bolus of growth in the generic pharmaceutical industry, and through this alliance, Mylan and Biocon have covered all four corners of what any organization would want or need to have secured to offer a highly competitive and distinct generic biologics product portfolio with tremendous growth potential for the coming decade, Mr Coury added

Mylan and Biocon will share development, capital and certain other costs to bring products to market. Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries through a profit sharing arrangement with Biocon.

Also, Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world.

Other financial aspects of the deal or product details are not disclosed.

The generics segment in the pharmaceutical industry is currently based almost entirely on chemically synthesized drugs. The pressure to lower health care costs is galvanizing governmental efforts globally to facilitate the entry of generic bio-tech or protein derived drugs, as well. An estimated $25 billion worth of biologics will have lost patent protection by 2016, creating a significant market opportunity for protein therapeutics like insulin and its analogs, erythropoietin, human growth hormone, monoclonal antibodies and many others.

However, the marketplace is expected to see only a few players in the field, at least in the beginning, because of the complexity and costs involved in developing generic biologics.

Bio-generics in the emerging markets are expected to grow from the current estimate of $1.5 billion at a projected rate of over 20% per annum over the next 5 years.

The biogenerics opportunities are further accentuated by the oncoming regulatory guideline to accept follow-on biologics or biosimilars on par with chemical based drugs in US.

Bio-similars, bio-generics, follow-on biologics are products derived from biotechnology have been a hot topic in the US recently. Democratic House rep Henry Waxman proposed legislation that would give biotech drugs just five years of exclusivity. Another rep, Republican Anna Eshoo, put forward a proposal offering 12 years. The proposal is currently stuck at the proposal for 7 years of exclusivity for biotech products as “a generous compromise’’ by Obama.

Biologic drugs should face the same generic competition as standard pharmaceuticals after seven years. Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs, Obama aides stated.

However, Biotechnology Industry Organization President feels that the seven years of data exclusivity called for by the administration as a risky short cut to biosimilars.

The generic versions of expensive biotechnology drugs would reduce the amount of money spent on healthcare in the United States

Currently, some of the high-profile biotech products used to treat cancer like Avastin and Herceptin cost  $100,000 and  $48,000/year for treatment.

Bio-generics in the emerging markets are expected to grow from the current estimate of $1.5 billion at a projected rate of over 20% per annum over the next 5 years.

Biocon is well positioned to capitalize on these opportunities through its early investments in research, development and manufacturing of high quality protein therapeutics, including both novel biologics and bio-generics. Combining this with Mylan’s regulatory and commercialization capabilities in US and Europe creates a cost effective model to address a large, emerging opportunity for generic biologics, the releases stated.

Based in Canonsburg, PA, Mylan Inc is the third largest generic company in the world. Mylan supplies over 570 products to customers in more than 140 countries and territories. Mylan owns a controlling interest in the world’s third largest active pharmaceutical ingredient manufacturer Matrix Labs. Mylan operates a specialty business focused on respiratory and allergy therapies.

Established in 1978, Biocon Limited is one of India’s premier biotechnology companies. Biocon’s group companies specializing in biopharmaceuticals, custom research and clinical research which deliver products and solutions to partners and customers across the globe. Biocon launched the world’s first recombinant human insulin, Insugen in November 2004 using Pichia expression and India’s first indigenously produced monoclonal antibody BIOMAb-EGFRTM.

A leading US trade publication, Med Ad News, in its 2007/08 listings has ranked Biocon 20th amongst the leading biotechnology companies in the world and the 7th largest Biotech employer in the world.

Based in Bangalore, southern India, Biocon has a portfolio of biopharmaceutical drugs that include insulin, erythropoietin and monoclonal antibodies.

In 2007, Biocon licensed to U.S.-based Abraxis BioScience Inc. (ABBI) the right to develop its generic version of G-CSF in the U.S. and the European Union. G-CSF, or granulocyte-colony stimulating factor, is a class of drugs used to help cancer patients maintain levels of infection-fighting white blood cells.

In the same year, the company signed a pact with another U.S.-based company, Invitrogen Corp. (IVGN), to market insulin to the global cell culture market.