12 January 2008
Small molecule pharmaceuticals dominate pharmaceutical product approvals
Almost 85% of all novel pharmaceutical products approved globally
between 2004 and 2006 were small molecule pharmaceutical drugs, says
new research.
A report from URCH Publishing Pharmaceutical Product Approval Trends, 2007, which analyses the trends emerging in new product approvals, reveals that small molecule pharmaceutical drugs continued to prevail in early 2007. Among the 23 new pharmaceutical products approved in the first half of 2007 were 22 small molecule pharmaceutical drugs and one monoclonal antibody.
Moreover seven out of the total of 40 new products approved in 2006, were novel biologics or monoclonal antibodies. Steven Seget, author of the report, says, "Even though only five new monoclonal antibodies have been approved during the three year period, each new drug is forecast to generate peak market sales in excess of US$500 million".
Among other trends that the report highlights is that more than 70% of all new pharmaceutical products approved between 2004 and 2006 received an initial approval in the U.S. In terms of number of approvals as well, the U.S. was slightly ahead of Europe with 38 in 2006 to Europe's 31 in the same year.
The study says the leading companies by number of new drug approvals in the first half of 2007 are GSK with three and Wyeth with two. Also, the leading generic product by number of applicant approvals in 2006 was meloxicam, which was approved for 21 different companies. The drug belongs to the group known as non-steroidal anti-inflammatory drugs (NSAIDs) and can be used to relieve pain and inflammation in rheumatic disease and spondylitis.
Merck's Gardasil will generate global sales in excess of US$3 billion in 2011.
Among the 11 new pharmaceutical products approved in 2006 likely to generate peak sales in excess of US$500 million, six drugs are forecast to reach blockbuster status by 2011. The leading 2006 approved product by forecast sales in 2011 is Merck's Gardasil/ Silgard (human papillomavirus vaccine), which is forecast to surpass sales of US$3 billion in 2011. Other potential blockbusters include Exforge, Prezista, Gardasil, Invega and Chantix.
Merck's Gardasil/ Silgard (human papillomavirus vaccine) was first approved in June 2006 in the US and in September 2006 in Europe. It achieved global sales of US$235 million in 2006 and is forecast to generate global sales of US$3,100 million in 2011.
Gardasil is the first cancer vaccine, preventing cervical
cancer caused by human papillomavirus (HPV). Boston.com
reported that advisers called Gardasil 'an important advance' in the fight
against cervical cancer as it protects against two high-risk strains of human
papillomavirus that cause most of the infections leading to cervical
cancer.
