Emergent BioSolutions and HPA Announce Botulinum Vaccine Collaboration

GAITHERSBERG, MD and LONDON -- Emergent BioSolutions and the United Kingdom-based Health Protection Agency (HPA) announced a two-year collaboration for the development of vaccines to prevent botulism.

These two leaders in biodefense vaccines have long-established capabilities in the prevention of botulism dating to the 1950s. In a series of agreements, Emergent and HPA committed to the sharing of technology and expertise to develop both toxoid and recombinant botulinum vaccines. There is currently no licensed vaccine in the world to prevent botulism.

This collaboration represents a significant move forward in the development of a vaccine to prevent the deadly disease botulism, said Emergent BioSolutions CEO, Fuad El-Hibri. Botulism is ranked just behind anthrax and smallpox in terms of the threat it poses as a potential weapon of bioterror.

The deal with Emergent BioSolutions fits well with our corporate goal to realize value from the HPAs intellectual assets through collaboration with industry for public health benefit and builds on our long history in the field of biodefense, said HPAs head of business development, David Rhodes.

The Emergent/HPA Collaboration
Emergent and HPA have entered into a series of agreements, including both license agreements and development agreements, which provide for the development and commercialization of vaccines for the prevention of botulism. Under these agreements, Emergent holds worldwide, exclusive (except in the United Kingdom where HPA retains rights for UK public health purposes), royalty-bearing rights to manufacture, market and sell botulinum vaccines that incorporate HPAs patented technologies and know-how. In addition, both parties will hold rights under any future patents or proprietary technologies developed under the development program. Emergent has committed to minimum expenditures of $2 million for the development of these products over a two-year period. In the United Kingdom, HPA retains a non-exclusive right to manufacture and sell botulinum vaccines for UK public including its National Health Service health needs

The initial objectives for these programs will be the development of both multivalent botulinum toxoid vaccines and multivalent recombinant botulinum vaccines. The botulinum toxoid vaccine under development, which targets a number of serotypes, is derived from a pentavalent botulinum toxoid vaccine previously produced by Emergent. That vaccine has been used in more than 11,000 people for more than 30 years under INDs held by the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Defense. The toxoid vaccine is manufactured from native botulinum toxin using methods similar to those used for the production of other licensed toxoid vaccines, including vaccines such as tetanus that have been in continuous use worldwide for more than 70 years. Emergent expects that this program offers the fastest and most reliable route to producing an IND stockpile and for ultimate regulatory approval of a multivalent botulinum vaccine.

The recombinant botulinum vaccine development program, which is at an earlier stage, targets specific serotypes. This development program will use recombinant technology to express the non-toxic LHN portion of the toxin molecule for use as the vaccine antigen. The LHN recombinant vaccine may possess significant advantages over vaccines based upon the Hc portion of the toxin. Initial data has demonstrated efficacy in a variety of animal models and has shown advantages in stability, immunogenicity, and the potential for multivalent formulations.

Threat
Botulinum toxin poses a major bioweapon threat due to its extreme potency and lethality, as well as the need for prolonged intensive care among affected persons. Botulinum toxin is the most poisonous substance known to man. Terrorists have already attempted to use botulinum toxin as a bioweapon. On at least three occasions between 1990 and 1995, the Japanese cult Aum Shinriko dispersed aerosols at multiple sites in downtown Tokyo, Japan and at US military installations in Japan. Following the 1991 Persian Gulf War, Iraq admitted to the United Nations inspection team to having produced 19,000 liters of concentrated botulinum toxin, of which approximately 10,000 liters were loaded into military weapons.

Disease
Botulism is a disease caused by the toxins of Cl. botulinum bacteria. These toxins are the most potent known to man and, as a comparison of lethality, botulinum toxin is 10 million times more potent than cyanide on a gram for gram basis. Seven distinct types of botulinum toxin have been identified and designated as serotypes A through G. The A, B, and E serotypes are those most commonly seen affecting man, although the F serotype has also been occasionally seen. The remaining serotypes (C, D, and G) are not known to naturally cause disease in man.

Botulism is generally characterized by a progressive descending motor paralysis, which affects the shoulders, upper arms, lower arms, respiratory muscles, and legs. If left untreated, death may be caused by paralysis of the respiratory muscle and subsequent suffocation. Other symptoms seen with botulism include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth, and generalized muscle weakness.

Natural outbreaks of botulism are generally due to ingestion of preformed toxin in spoiled foodstuffs (foodborne), contamination of wounds by the Cl. botulinum bacteria (wound botulism), or in the case of infants, by ingestion of the organism, (infant botulism).

Source: Health Protection Agency