Biotech Values

[DewDiligence]

EU’s CHMP Approves NVS’ Menveo Vaccine

[The FDA issued a CRL for Menveo in Jul 2009 citing CMC issues (#msg-39188485); NVS replied to the CRL one month later, and an FDA decision is expected in early 2010. Please see actual PR for footnote references.]

http://www.novartis.com/newsroom/media-releases/en/2009/1365021.shtml

›Novartis meningococcal vaccine Menveo® recommended for approval in the European Union for prevention of disease in adolescents and adults

• Investigational vaccine Menveo demonstrates a protective immune response in four of the five major bacteria groups responsible for meningococcal disease

• Meningococcal disease is a major cause of bacterial meningitis and sepsis with high consequent disability and mortality rates worldwide

Basel, December 18, 2009 – Novartis Vaccines announced today that Menveo® (Meningococcal Group A, C, W-135 and Y-CRM Conjugate Vaccine) has received a Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The investigational conjugate vaccine is recommended for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. Menveo is designed to help protect against four of the five major groups of meningococcal bacteria, which are leading causes of bacterial meningitis – an infection of the membrane around the brain and spinal cord – and sepsis – a bloodstream infection, [2].

The CHMP recommendation serves as the basis for a European Commission licensing Decision. The CHMP is recommending that the European Commission grant Marketing Authorization for Menveo in all 27 European Union (EU) countries, which is expected during the first quarter of 2010. Regulatory review for Menveo by the US Food and Drug Administration is ongoing.

Upon licensure, Menveo is expected to be the first conjugate vaccine to be commercially available in Europe to help protect against four major groups of meningococcal bacteria. Meningococcal disease is a sudden, life-threatening illness that can lead to death within 24 to 48 hours of the first symptoms, , . Of those who survive, as many as one in five will suffer life-long after effects, such as brain damage, learning disabilities, hearing loss and limb loss.

“The Committee’s positive recommendation of Menveo is a significant advance in the fight against meningococcal disease,” said Professor Ray Borrow who heads the Health Protection Agency’s Vaccine Evaluation Unit in the UK. “Five groups of meningococcal bacteria cause the majority of meningococcal disease cases around the world. Since it is impossible to predict which meningococcal bacterial group one might come into contact with, a vaccine that offers effective protection against four of the groups should be extremely effective in preventing and controlling the disease. It is a welcome development.”

“This is an important milestone toward our vision to eradicate this devastating, deadly and unpredictable disease,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. “We are confident that broad coverage with Menveo will eventually be available to all age groups.”

Menveo was developed using conjugate technology, which was also used to develop Novartis Vaccines’ meningococcal group C conjugate vaccine, Menjugate®. A conjugate vaccine is developed by attaching a polysaccharide antigen – the key component of a vaccine that prompts the body to respond to infection – to a carrier protein. When utilized in a national immunization program, conjugate vaccines (such as those designed to help protect against Hib, pneumococcal and meningococcal group C disease) have reduced the number of people (both vaccinated and unvaccinated) who carry the bacteria that cause the disease.

Adolescents are particularly susceptible to meningococcal disease and are more likely to carry the bacteria than other age groups. In addition, adolescents and young adults have relatively high death rates from meningococcal infection. A study in the United States found that nearly a quarter of meningococcal infections in 15- through 24-year-olds were fatal[8].

Menveo has been administered to more than 18,500 people and is currently in multiple Phase III clinical studies in infants and toddlers worldwide.

About meningococcal disease

Meningococcal disease is a sudden, life-threatening illness that progresses rapidly and can lead to death within 24 to 48 hours of the first symptoms. Meningococcal infection is a leading cause of bacterial meningitis — an infection of the membrane around the brain and spinal cord — and sepsis – a bloodstream infection[2]. The bacteria that cause meningococcal disease — Neisseria meningitides — can be divided into groups. Five groups of meningococcus cause the majority of all meningococcal disease cases around the world.

Because the initial symptoms of meningococcal disease can be similar to flu-like symptoms, it can be difficult for health care professionals to diagnose early. Classic symptoms, such as neck stiffness and petechial rash, do not appear until relatively late in the illness — 13-22 hours after the first symptoms appear.

According to the World Health Organization (WHO), approximately 5-10 percent of those who contract meningococcal disease will die, even if they are diagnosed and receive treatment. Of those who survive meningococcal disease, as many as one in five will suffer life-long side effects, such as brain damage, learning disabilities, hearing loss and limb loss.

Infants are the most vulnerable population and represent the greatest unmet need. About 6-10 percent of children under 12 months of age who contract meningococcal disease will die[9].

About Novartis Vaccines’ global meningococcal franchise

Menveo vaccine is based on the same proprietary technology Novartis Vaccines pioneered to produce Menjugate®, a meningococcal serogroup C conjugate vaccine approved outside the U.S. since 2000 for use in individuals from 2 months of age through adulthood. The company has already distributed more than 26 million doses of Menjugate around the world. Novartis also produced MenZB®, a vaccine against a strain of meningococcus B specific to a recent outbreak in New Zealand.

Novartis Vaccines is a global leader in providing vaccines to protect against deadly meningococcal disease. Through industry-leading scientific expertise, the company is focused on extending critical meningococcal vaccines research. In addition to developing Menveo vaccine, Novartis Vaccines is developing a recombinant protein vaccine for its potential to provide broad coverage against multiple strains of serogroup B, for which no vaccine is currently available.‹