Merck Announces Significant Developments in Gardasil and Revenue Growth

Merck, a multinational pharmaceutical company, has made significant announcements in recent days, including the approval of its cervical cancer vaccine, Gardasil, by the European Commission and a partnership with India's Council of Medical Research to study the vaccine. Additionally, the company has reported revenue growth and a decrease in marketing and administrative expenses.

Gardasil, the cervical cancer vaccine from Merck & Co., Inc., has been approved by the European Commission for use in children and adolescents aged 9 to 15 years and in adult females aged 16 to 26 years for the prevention of cervical cancer, high-grade cervical dysplasias/precancers, high-grade/precancerous vulvar dysplastic lesions, and external genital warts caused by human papillomavirus (HPV) types 6, 11, 16, and 18. The vaccine has also been approved in the United States, Mexico, Australia, Canada, New Zealand, Brazil, and several African countries.

Merck has also entered into agreements with ImClone Systems Incorporated to amend and supplement their 1998 development and license agreement covering Erbitux and other work in the field of EGFR-targeted antibodies. Additionally, the company has signed an alliance with Takeda Pharmaceutical Company for the development and commercialization of matuzumab, a humanized EGFR-targeting monoclonal antibody.

Merck & Co., Inc. announced its second-quarter earnings per share (EPS) for 2006, which were 73 cents, excluding a net charge for site closures and position eliminations. Including the impact of the net restructuring charge, reported EPS for the second quarter were 69 cents, compared to 33 cents for the second quarter of 2005. Net income was $1,499.3 million, compared to $720.6 million in the second quarter of 2005.

Key Takeaways:

  • Gardasil, a cervical cancer vaccine from Merck & Co., Inc., has been approved by the European Commission and is being marketed by Sanofi Pasteur MSD in 19 European countries.
  • The vaccine has been approved for use in children and adolescents aged 9 to 15 years and in adult females aged 16 to 26 years for the prevention of cervical cancer, high-grade cervical dysplasias/precancers, high-grade/precancerous vulvar dysplastic lesions, and external genital warts caused by HPV types 6, 11, 16, and 18.
  • Merck has partnered with India's Council of Medical Research to study Gardasil and has also partnered with PATH and the Gates Foundation to develop HPV vaccination programs for developing countries.
  • Merck has entered into agreements with ImClone Systems Incorporated to amend and supplement their 1998 development and license agreement covering Erbitux and other work in the field of EGFR-targeted antibodies.
  • Merck has signed an alliance with Takeda Pharmaceutical Company for the development and commercialization of matuzumab, a humanized EGFR-targeting monoclonal antibody.
  • Merck & Co., Inc. reported second-quarter earnings per share (EPS) of 73 cents, excluding a net charge for site closures and position eliminations, and net income of $1,499.3 million.
  • The company anticipates full-year 2006 EPS of $2.40 to $2.48, excluding restructuring charges related to site closures and position eliminations, and reported full-year 2006 EPS of $2.10 to $2.24.

Statistics:

  • Gardasil has been approved for use in children and adolescents aged 9 to 15 years and in adult females aged 16 to 26 years for the prevention of cervical cancer, high-grade cervical dysplasias/precancers, high-grade/precancerous vulvar dysplastic lesions, and external genital warts caused by HPV types 6, 11, 16, and 18.
  • Approximately 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year (40 each day) in Europe.
  • Gardasil has been approved in the United States, Mexico, Australia, Canada, New Zealand, Brazil, and several African countries.
  • Merck has partnered with India's Council of Medical Research to study Gardasil and has also partnered with PATH and the Gates Foundation to develop HPV vaccination programs for developing countries.
  • Merck & Co., Inc. reported second-quarter earnings per share (EPS) of 73 cents, excluding a net charge for site closures and position eliminations, and net income of $1,499.3 million.
  • The company anticipates full-year 2006 EPS of $2.40 to $2.48, excluding restructuring charges related to site closures and position eliminations, and reported full-year 2006 EPS of $2.10 to $2.24.

Sources:

  • European Commission
  • Merck & Co., Inc.
  • NewsRx.com
  • Biotech Business Week
  • India's Council of Medical Research
  • PATH and the Gates Foundation
  • ImClone Systems Incorporated
  • Takeda Pharmaceutical Company
  • Sanofi Pasteur MSD
  • Merck KGaA