Actualización posterior a la patente: el oleoducto genérico es una potencial ganancia inesperada

A medida que los precios del glifosato continúan tambaleándose a niveles récord, muchos productores técnicos y formuladores están aislando sus ganancias explorando nuevos activos y productos patentados posteriores a la patente.

Few have suffered along with glyphosate’s demise like Australia’s Nufarm, which in July dropped its full-year profit forecast range by half. The company is undertaking a strategic business review that involves reallocating resources away from its key product, glyphosate.

Together with Japan’s Sumitomo Chemical, which is a one-fifth owner of the Australian generics giant, the company is developing a more effective weed management system for genetically-modified crops. One such product, most likely based on candidate compounds from Sumitomo’s pipeline, is a new herbicide that differs in mode of action from existing active ingredients (ais). Uses for Sumitomo’s flumioxazin and Nufarm’s phenoxy-type herbicides and glyphosate premixes are also in the works.

Top 10 Off-Patent Companies    
    Ventas en US$ Millones
Rango Empresa 2008  2009 
Makhteshim Agan  2,335  2,042 
Nufarm  2,287  1,821 
Fósforo unido  937  1,000 
Cheminova  990  933 
Sipcam  451  431 
Atanor  370  N / A 
Gowan  281  325 
AMVAC  238  209 
Rotam  213  N / A 
10  Rallis  203  189 

Fuente: Phillips McDougall y FCI Research

More of the industry’s top suppliers are reducing the impact of glyphosate. Cheminova is planning “to substantially reduce the glyphosate share of total revenues,” says the company’s Marketing Director Kurt Pedersen Kaalund.

Y Gowan también está invirtiendo en su cartera para crear más diversidad de ingresos.

“We are working toward US registration of two new actives, and we also will launch novel formulations that allow new uses and new premixes in Europe,” says Gowan CEO Juli Jessen. “In all markets, we are bringing soft chemicals that are registered organic to complement our conventional chemistry. By offering these, our conventional line can be used in programs that are constrained by food chain requirements or more restricted labels.”

Companies likely will need to diversify their portfolios significantly to replace lost revenue from the world’s widest used active, as it is unlikely there will be another blockbuster such as glyphosate, especially amid the use of residual chemistries to thwart glyphosate resistance issues.

“Pest control will increasingly be approached from multiple angles, so the chance of a cure-all chemical is not great,” Jessen says.

Although there’s probably no “big product” that will have the global reach — or profits — of glyphosate, there are plenty of new ais coming off patent. But the transition might not be easy as companies try to transition technical expertise to smaller lines with greater sophistication.

• Active Substances With Patent Expiring

“There are many companies not in glyphosate but into other generics, and they have the relevant technologies and equipment,” says Nigel Uttley of Enigma Marketing. “It is very difficult to move from such a large tonnage product (like glyphosate) to some of the very small tonnage products such as sulfonylureas.”

Ojo para comprar

Makhteshim Agan Industries (MAI) está aumentando agresivamente toda su cartera de productos a través del desarrollo, pero más notablemente, productos de adquisición, tecnología y capacidad de fabricación.

El año pasado, MAI introdujo 19 ingredientes activos en más de 100 formulaciones, dice Yoav Zeif, vicepresidente de productos y marketing de MAI. La compañía tiene más de 110 activos en su portafolio.

“We’ve expanded our business over the last few years through both acquisitions and an array of product introductions,” Zeif says. “We acquired access to 2,4-D which is a strategic global herbicide that has shown consistent growth in demand in recent years.”

Dado que los fabricantes de semillas planean introducir cultivos resistentes al 2,4-D el próximo año, se espera que el crecimiento de ese producto aumente.

“In addition, we launched the new product Galil (imidacloprid and bifentherin) in Latin America, which successfully replaces old chemistries such as endosulfan,” Zeif says.

MAI also entered into a long term agreement with Cibus, a US-based company focused on developing non-GM traits for crop enhancements. The company’s North American division is in the process of finalizing its acquisition of Albaugh, which comes with a glyphosate plant in the US.

Gaining access to other chemicals, through either acquisitions or agreements, is strengthening the portfolios of many post-patent suppliers. Rallis India Ltd. recently entered an agreement to source azoxystrobin from Syngenta for marketing in India — with exclusive rights to specified combination products to work with the fungicide — while Syngenta will continue to get another fungicide, hexaconazole, from Rallis. Rallis recently posted huge gains with a first-quarter profit of approximately $3.2 million, up 58% from $2 million in the first quarter 2009. The company’s first quarter net sales grew 20% to $42 million compared with $35 million in the same period last fiscal year. Rallis also expects its new facility at Dahej, with capacity of 5,000 tonnes per year, to go into commercial production during this year’s second quarter. The Dahej plant has a $107.3 million revenue potential over a three-year period.

Cheminova’s Kaalund also noted the importance of acquisitions. “It is part of our strategic development to make acquisitions of crop protection products, companies and activities to increase sales and improve results,” he says. “We have made such acquisitions in the past, including Stähler and the dimethoate business of Isagro SpA.”

Estructura y función

Además de agregar nuevos productos, algunos proveedores de genéricos están realizando cambios en su estructura corporativa. Gowan, por ejemplo, ha establecido divisiones en Estados Unidos y Francia.

“The focus that comes with a dedicated US company provides a mechanism to work with our partners from the foundation of the company,” Jessen says. “We also expect to add other platforms, though these will start very small; two are under consideration for 2011.”

MAI también ha creado dos nuevas regiones: América y Asia, Pacífico y África.

“On the operations side, we increased our synthesis and formulation capacity mainly in Israel and Europe,” Zeif says. “We have diversified our manufacturing footprint and added our own manufacturing and formulation capacity in Poland and the US. In parallel, we have progressed with major environmental upgrades in our plants in Israel.”

Una perspectiva positiva

The refocus of many companies to a world with lower glyphosate profits has proved positive. Cheminova’s global sales have increased “through the continued introduction of new products, which we expect shall continue in the coming years,” Kaalund says. “We see continued growth in the global post-patent market.”

Enigma’s Uttley’s marketing research shows the generic sector will increase as more patents expire, “but the original patent holders will maintain a large share of the market through the creation of off-patent proprietary products — especially mixture products and new formulations,” he says. “The growth of mixture products is highly significant. It segments the market and often extends the IPR portfolio and is one of the main post-patent strategies employed by the multi-nationals. Some of the mixture patents have dubious validity.”

MAI planea capitalizar este crecimiento global general con sus estrategias de expansión en Europa, Brasil y América del Norte.

“There are analysts who forecast that some $9 billion of product will be coming off patent over the next 10 years,” Zeif says. “This represents a major market opportunity for us. Similarly, as resistant strains emerge, we continue to look to new formulations to meet the requirements of the market.”

But there is some caution amid opportunity. Companies are entering new markets and product niches with established competition and technical hurdles they will need to overcome. Additionally, the global regulatory environment isn’t getting any easier, especially in Europe and the US. And expanding a business requires funding that might be difficult to secure in today’s lending markets.

“Since research concentrates on biotech, and the costs per chemical is growing, it is unlikely for new products to come on at the same rate that patents expire,” Gowan’s Jessen says.