September 28 2009 03:00
GlaxoSmithKline has sealed an innovative €1.5bn (£1.38bn) contract with Brazil guaranteeing sales of its pneumococcal vaccine, designed to prevent pneumonia and meningitis, over the entire life of the product.
The deal marks a watershed in negotiation of a long-term contract in a way that provides GSK with an agreed price and volume, starting at €11.50 a dose and falling to €5 in future years.
Most drugs and vaccines are sold over far shorter periods and subject to uncertainties over arbitrary price reductions, as well as the threat of competition from rival low-cost generic alternatives.
The deal comes as GSK continues to expand in emerging markets and is diversifying away from drugs into vaccines and other products.
The company agreed to supply enough doses of Synflorix to vaccinate the 13m children requiring coverage each year for at least eight years, underpinned by a technology transfer agreement that will eventually allow Brazil to manufacture the vaccine itself.
Brazil's health minister and Andrew Witty, GSK's chief executive, unveiled the deal in London on Friday to strengthen Brazil's pharmaceutical research and development capacity, including a €17m joint project to develop a Dengue vaccine. Depending on the extent of technology transfer and Brazil's ability to manufacture the vaccine, which Mr Witty described as "probably the most technically complex vaccine in the world", GSK may still earn some income even after the contract ends.Some countries, including Brazil, have threatened or introduced compulsory licenses to overturn drug company patents and permit competition or force price reductions.
The price represents a significant discount tothat of about €35-€40 a dose at which the vaccine is sold in Europe, but the high volumes and long timescale provide unusual certainty to the company. The action also sets a baseline for sales in other middle-income countries, and for the Advance Market Commitment, a bulk purchase agreement with donor governments to help buy the vaccine for low- income countries.Mr Witty said: "This wasn't the first and I don't believe it will be the last such contract. It shows GSK and Brazil are really coming together with the same mindset."
Paulo Gadelha, president of the Fiocruz institute, which will produce the vaccine, stressed that the technology received could also be used to help it make other vaccines in future. He said his institute was already pledging to provide technology transfer to make low-cost drugs and vaccines for African countries, in what could provide a challenge for large pharmaceutical companies. Mr Witty said "there has to be enough economic flow to encourage GSK to continue" developing vaccines for predominantly low- income countries. Prevnar from Wyeth will be a big competitor, Pfizer getting Prevnar approval in EMEA from European Authorities last Friday from FT.com Braxil
Since Chartnuts, no surprise, since the loon ignores competing products & other "subtractive factors", had never heard of Synflorix before I told the loser about it, here is a summary of some differences, relying to some extent on Wiki:
Pneumococcal conjugate vaccine (PCV) is a vaccine used to protect infants & young children against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). There are currently two PCV vaccines available on the global market: Prevnar (sometimes called Prevenar) & Synflorix.
Prevnar, trade name of manufacturer WYE, is a heptavalent vaccine, meaning that it contains the cell membrane sugars of seven serotypes of pneumococcus, conjugated with Diphtheria proteins. In the US, vaccination with Prevnar is recommended for all children younger than two years, & for unvaccinated children between 24 & 59 months old who are at high risk for pneumococcal infections.
The vaccine was primarily developed for US & European epidemiological situation, & therefore it has only a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.
Prevnar is produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the US. The bacterial capsule sugars, a characteristic of these pathogens, are linked to CRM197, a nontoxic recombinant variant of diphtheria toxin (Corynebacterium diphtheriae).
The vaccine's polysaccharide sugars are grown separately in soy peptone broths. Through reductive amination, the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. CRM197 is grown in Corynebacterium diphtheriae strain C7 in a medium of casamino acids and yeast extracts.
The current 7-valent formulation contains serotypes 4, 6B, 9V, 14, 18C, 19F & 23F, & results in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants in the US.
In 2009, WYE will introduce Prevnar 13, which contains six additional strains (1, 3, 5, 6A, 19A & 7F), protecting against the majority of remaining pneumococcal infections.
Synflorix, manufactured by GSK, received a positive opinion from the European Medicines Agency for use in the European Union in January 2009. Synflorix is a ten valent vaccine meaning that it contains ten serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F) which are conjugated to a carrier protein. GSK received European Commission authorization for Synflorix in March 2009.
Synflorix contains the same seven pneumococcal serotypes in Prevnar. In addition, Synflorix protects against serotypes 1, 5 & 7F. Eight of the ten serotypes are linked to a protein carrier derived from non typeable Haemophilus influenzae.
Here then is a summary:
Prevnar 13: 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F & 23F.
Synflorix: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F.
I don't know whether Synflorix' carrier offers advantages over Prevnar's, or was selected to avoid patent issues. Nor do I know if the added serotypes are more prevalent in the developing world.
Many have questioned whether Prevnar, optimized against ear infections, is worth the price. WYE may agree, since they widened its serotype spectrum.
In the developing world, whence future growth must come, price will certainly be an issue.
