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Tuesday, 29 May 2007 13:37 GMT
Sandoz aims for strong place in French growth hormone market for Omnitrope
PARIS, May 29 (APM) - Sandoz France (Novartis group) wants its biosimilar drug Omnitrope (somatropin) to be the third or fourth-biggest growth hormone in France within five years, hospital-biotech operations director Kaïs Tahiri said on Tuesday at a press conference.
Omnitrope was included on the French reimbursement list on May 15, at a price 20% lower than that of other growth hormones.
It is the eighth growth hormone - and the sixth lyophilised one - to be launched in the 140 million-euro French market.
Tahiri did not say how many sales reps would be involved in promoting Omnitrope but he said that Sandoz would be investing about the same amount as competing companies in its promotion.
Press conference participants highlighted three advantages of Omnitrope, a biosimilar of Pfizer's Genotonorm which was approved by the European Commission in April 2006.
Tahiri spoke of the savings potential for the French health insurance, which could reach 28 million euros in the unlikely case of Omnitrope conquering the whole market.
But he acknowledged to APM that doctors are not very sensitive to economic arguments, and that this was something the group would have to work on.
Prof Jean-Louis Chaussin, a paediatrician and endocrinologist at Paris' Saint-Vincent de Paul hospital, said that until the appearance of synthetic growth hormone in the 1990s, growth hormone had been quite rare, resulting in limits on dosing and indications.
Despite the arrival of biotech products, "nothing has changed for two reasons: companies have kept prices high and the social security has continued to control prescriptions", he said. Growth hormones are classed as "exceptional" drugs and need special prescriptions..
With the arrival of cheaper biosimilar products, he hopes that "the savings will be reinvested," allowing growth hormone to "become a product like any other, with more varied doses and extended indications".
Sandoz's second argument is the "technological advantage" provided by a product designed more than 10 years after its originator.
Jean-Yves Le Cotonnec, founder-director of Swiss pharmaceutical consulting group Triskel Integrated Services spoke of products which are of "better quality, more consistent" and have gone through " better purification" processes.
SLIGHT ADVANTAGE IN TERMS OF ADVERSE EFFECTS
However, Phase III data have shown that these characteristics have no impact on Omnitrope's clinical efficacy or immunogenicity compared to those of its competitor. In terms of tolerance, Sandoz's product has a slight advantage with an average 0.45 to 0.46 secondary effects per patient per year compared to 1.09 with Genotonorm.
The third argument concerns the ongoing development of Omnitrope. On April 20, Sandoz obtained a variation to its European marketing authorisation for a liquid version which is more likely to provide competition for the latest arrivals in the market, Novo Nordisk's Norditropin SimpleXx and Ipsen's Nutropin AQ.
Sandoz intends to launch liquid Omnitrope in the first half of 2008.
Tahiri considers this version to be a "new product" for which the company will be able to negotiate a different price with the French economic committee on health products (CEPS). Other liquid growth hormones have however obtained the same prices as lyophilised versions.
Sandoz also hopes to eventually be present in the other three potential biosimilar markets - insulin, haematopoietic growth factors and erythropoietin, which have overall sales of over 1.1 billion euros in France.
Sandoz was unable to give dates for launches of new biosimilars.
eh/cb/clg/rw
[6855] 29/05/2007 13:37 GMT - DIABETE
Omnitrope was included on the French reimbursement list on May 15, at a price 20% lower than that of other growth hormones.
It is the eighth growth hormone - and the sixth lyophilised one - to be launched in the 140 million-euro French market.
Tahiri did not say how many sales reps would be involved in promoting Omnitrope but he said that Sandoz would be investing about the same amount as competing companies in its promotion.
Press conference participants highlighted three advantages of Omnitrope, a biosimilar of Pfizer's Genotonorm which was approved by the European Commission in April 2006.
Tahiri spoke of the savings potential for the French health insurance, which could reach 28 million euros in the unlikely case of Omnitrope conquering the whole market.
But he acknowledged to APM that doctors are not very sensitive to economic arguments, and that this was something the group would have to work on.
Prof Jean-Louis Chaussin, a paediatrician and endocrinologist at Paris' Saint-Vincent de Paul hospital, said that until the appearance of synthetic growth hormone in the 1990s, growth hormone had been quite rare, resulting in limits on dosing and indications.
Despite the arrival of biotech products, "nothing has changed for two reasons: companies have kept prices high and the social security has continued to control prescriptions", he said. Growth hormones are classed as "exceptional" drugs and need special prescriptions..
With the arrival of cheaper biosimilar products, he hopes that "the savings will be reinvested," allowing growth hormone to "become a product like any other, with more varied doses and extended indications".
Sandoz's second argument is the "technological advantage" provided by a product designed more than 10 years after its originator.
Jean-Yves Le Cotonnec, founder-director of Swiss pharmaceutical consulting group Triskel Integrated Services spoke of products which are of "better quality, more consistent" and have gone through " better purification" processes.
SLIGHT ADVANTAGE IN TERMS OF ADVERSE EFFECTS
However, Phase III data have shown that these characteristics have no impact on Omnitrope's clinical efficacy or immunogenicity compared to those of its competitor. In terms of tolerance, Sandoz's product has a slight advantage with an average 0.45 to 0.46 secondary effects per patient per year compared to 1.09 with Genotonorm.
The third argument concerns the ongoing development of Omnitrope. On April 20, Sandoz obtained a variation to its European marketing authorisation for a liquid version which is more likely to provide competition for the latest arrivals in the market, Novo Nordisk's Norditropin SimpleXx and Ipsen's Nutropin AQ.
Sandoz intends to launch liquid Omnitrope in the first half of 2008.
Tahiri considers this version to be a "new product" for which the company will be able to negotiate a different price with the French economic committee on health products (CEPS). Other liquid growth hormones have however obtained the same prices as lyophilised versions.
Sandoz also hopes to eventually be present in the other three potential biosimilar markets - insulin, haematopoietic growth factors and erythropoietin, which have overall sales of over 1.1 billion euros in France.
Sandoz was unable to give dates for launches of new biosimilars.
eh/cb/clg/rw
[6855] 29/05/2007 13:37 GMT - DIABETE
