Post by Peter Ellis on Feb 23, 2005 9:55:58 GMT 1
22/02/2005
Mayne Group Limited (ASX:MAY) announced today that its Mayne Pharma business unit has entered into a strategic collaboration with PLIVA d.d. (PLIVA), a leading international generic and specialty pharmaceutical company, to develop and manufacture two major biogeneric products commonly used by cancer patients - erythropoietin (EPO) and granulocyte colony stimulating factor (G-CSF) - that Mayne will exclusively market and distribute in Western Europe and other selected markets around the world.
Based on IMS data, EPO and G-CSF generated sales in the countries covered by the agreement of more than $US 1.6 billion (growing at 14% per annum) in the 12 months to 30 June 2004.
Mayne's Group Managing Director and Chief Executive Officer, Mr Stuart James, said he was very pleased to be working with PLIVA, a company that was internationally respected for its world-class research and development capabilities. He also said that the agreement complements Mayne Pharma's oncology emphasis and provides a significant opportunity to establish a strong sales position in the generic market for these drugs.
"This partnership with PLIVA is consistent with our stated long-term strategy of being a significant player in the newly forming biogenerics market," Mr James said.
"As the number of patent expiries for chemically-based medicines declines over the next five to ten years, patent expiries for biological drugs will increase. So this partnership is a significant first step that will position Mayne Pharma to benefit from this very large and newly forming market opportunity," he said.
"We have been investigating biogeneric entry options for over two years and we are excited by the potential of the PLIVA relationship.
"Biological products are technically complex, requiring specialised expertise in development and manufacturing that would be expensive and risky for Mayne to develop internally. Our approach has been to focus on building a leading international hospital generic sales force and a regulatory team skilled in managing the approval of complex products.
"PLIVA's deep experience in developing and manufacturing biological products and advanced progress in the development of EPO and G-CSF ideally complement Mayne's strengths by providing us with a high quality and secure source of supply that will be necessary to maximise this significant commercial opportunity."
Speaking about the collaborative arrangement, Zeljko Covic, President of PLIVA's Management Board and CEO said: "We are especially pleased to have entered into this partnership with Mayne. We are convinced that with Mayne's strong and established hospital sales force promoting PLIVA's quality products, both companies will successfully profit from this multi billion dollar market, while at the same time providing a more affordable solution to patients."
"This partnership represents an important recognition of PLIVA's biologics program and its strong positioning on the global market. Following extensive clinical trials in Croatia, PLIVA has already developed and submitted a generic EPO for registration in Croatia, which we plan to launch this year. To the best of our knowledge, this launch will position us as one of the first companies to successfully, develop, produce, and sell a generic EPO on the commercial global market, and the first on the European continent," Mr Covic said.
Drugs exploiting modern biotechnology, generally known as biologics, are becoming increasingly used in hospitals. Biologics currently generate approximately $US 40 billion in annual sales, and represent seven of the top ten injectable hospital medicines. Nine percent of current global pharmaceutical spend is on biologics, however approximately 40% of all drugs in phase III clinical trials are biologicals, meaning biologics will continue to drive pharmaceutical spend growth at twice GDP growth. Biogenerics are thus crucial to long term affordable access to medicines.
EPO represents PLIVA's most advanced biologics program and is a generic version of Amgen's EPOGEN (epoetin-alfa) primarily indicated for the stimulation of red blood cell production in patients undergoing dialysis therapy for chronic renal failure and patients undergoing chemotherapy treatment. G-CSF is the generic version of Amgen's NEUPOGEN (filgrastim) primarily indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy induced neutropenia. These products are highly complementary to Mayne's existing portfolio of generic, injectable oncology products.
Under the terms of the agreement, €21 million will be paid to PLIVA over three years to acquire the exclusive sales, marketing and distribution rights for the two products in the above markets. PLIVA will be the exclusive supplier of finished drug product.
About Mayne
Mayne Group Limited is listed on the Australian Stock Exchange and has business in international specialty pharmaceuticals (in the manufacture of injectable and oral pharmaceuticals for distribution to more than 50 countries), diagnostic services (pathology, diagnostic imaging and medical centres), pharmacy, and health-related consumer products. Additional information is available at the company's website at www.maynegroup.com.
About PLIVA
With over 80 years of experience in the pharmaceuticals arena, PLIVA is now a global generics and specialty company, with operations in more than 30 countries in the US, CEE, and Western Europe. Building upon a strong R&D history, the company specializes in the discovery, development, production and distribution of generic and branded pharmaceutical products. Since its listing on the London Stock Exchange in 1996, PLIVA has established a fully internationalized business, with the majority of its revenues now realized on Western markets.
More information about PLIVA can be found at www.pliva.com.
Mayne Group Limited (ASX:MAY) announced today that its Mayne Pharma business unit has entered into a strategic collaboration with PLIVA d.d. (PLIVA), a leading international generic and specialty pharmaceutical company, to develop and manufacture two major biogeneric products commonly used by cancer patients - erythropoietin (EPO) and granulocyte colony stimulating factor (G-CSF) - that Mayne will exclusively market and distribute in Western Europe and other selected markets around the world.
Based on IMS data, EPO and G-CSF generated sales in the countries covered by the agreement of more than $US 1.6 billion (growing at 14% per annum) in the 12 months to 30 June 2004.
Mayne's Group Managing Director and Chief Executive Officer, Mr Stuart James, said he was very pleased to be working with PLIVA, a company that was internationally respected for its world-class research and development capabilities. He also said that the agreement complements Mayne Pharma's oncology emphasis and provides a significant opportunity to establish a strong sales position in the generic market for these drugs.
"This partnership with PLIVA is consistent with our stated long-term strategy of being a significant player in the newly forming biogenerics market," Mr James said.
"As the number of patent expiries for chemically-based medicines declines over the next five to ten years, patent expiries for biological drugs will increase. So this partnership is a significant first step that will position Mayne Pharma to benefit from this very large and newly forming market opportunity," he said.
"We have been investigating biogeneric entry options for over two years and we are excited by the potential of the PLIVA relationship.
"Biological products are technically complex, requiring specialised expertise in development and manufacturing that would be expensive and risky for Mayne to develop internally. Our approach has been to focus on building a leading international hospital generic sales force and a regulatory team skilled in managing the approval of complex products.
"PLIVA's deep experience in developing and manufacturing biological products and advanced progress in the development of EPO and G-CSF ideally complement Mayne's strengths by providing us with a high quality and secure source of supply that will be necessary to maximise this significant commercial opportunity."
Speaking about the collaborative arrangement, Zeljko Covic, President of PLIVA's Management Board and CEO said: "We are especially pleased to have entered into this partnership with Mayne. We are convinced that with Mayne's strong and established hospital sales force promoting PLIVA's quality products, both companies will successfully profit from this multi billion dollar market, while at the same time providing a more affordable solution to patients."
"This partnership represents an important recognition of PLIVA's biologics program and its strong positioning on the global market. Following extensive clinical trials in Croatia, PLIVA has already developed and submitted a generic EPO for registration in Croatia, which we plan to launch this year. To the best of our knowledge, this launch will position us as one of the first companies to successfully, develop, produce, and sell a generic EPO on the commercial global market, and the first on the European continent," Mr Covic said.
Drugs exploiting modern biotechnology, generally known as biologics, are becoming increasingly used in hospitals. Biologics currently generate approximately $US 40 billion in annual sales, and represent seven of the top ten injectable hospital medicines. Nine percent of current global pharmaceutical spend is on biologics, however approximately 40% of all drugs in phase III clinical trials are biologicals, meaning biologics will continue to drive pharmaceutical spend growth at twice GDP growth. Biogenerics are thus crucial to long term affordable access to medicines.
EPO represents PLIVA's most advanced biologics program and is a generic version of Amgen's EPOGEN (epoetin-alfa) primarily indicated for the stimulation of red blood cell production in patients undergoing dialysis therapy for chronic renal failure and patients undergoing chemotherapy treatment. G-CSF is the generic version of Amgen's NEUPOGEN (filgrastim) primarily indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy induced neutropenia. These products are highly complementary to Mayne's existing portfolio of generic, injectable oncology products.
Under the terms of the agreement, €21 million will be paid to PLIVA over three years to acquire the exclusive sales, marketing and distribution rights for the two products in the above markets. PLIVA will be the exclusive supplier of finished drug product.
About Mayne
Mayne Group Limited is listed on the Australian Stock Exchange and has business in international specialty pharmaceuticals (in the manufacture of injectable and oral pharmaceuticals for distribution to more than 50 countries), diagnostic services (pathology, diagnostic imaging and medical centres), pharmacy, and health-related consumer products. Additional information is available at the company's website at www.maynegroup.com.
About PLIVA
With over 80 years of experience in the pharmaceuticals arena, PLIVA is now a global generics and specialty company, with operations in more than 30 countries in the US, CEE, and Western Europe. Building upon a strong R&D history, the company specializes in the discovery, development, production and distribution of generic and branded pharmaceutical products. Since its listing on the London Stock Exchange in 1996, PLIVA has established a fully internationalized business, with the majority of its revenues now realized on Western markets.
More information about PLIVA can be found at www.pliva.com.