Nabi describes Altastaph as a polyclonal antibody for the prevention and treatment of S. aureus infections in patients at immediate risk for infection or patients with immune systems unable to respond adequately to vaccine. Altastaph is produced by vaccinating healthy volunteers with the company’s StaphVAX vaccine, and then harvesting the anti-staphylococcus antibodies to capsular polysaccharides (protective outer sugar coatings on S. aureus bacteria) from S. aureus types 5 and 8. Nabi reports that these two types account for upwards of 85 % of all S. aureus infections.

The use of specific antibodies for the prevention and treatment of infectious diseases is by no means a novel concept. Specific antibodies are used in the prevention of Hepatitis B, Rabies, RSV and in the treatment of Tetanus and Diptheria. A search of the BioHorizon.com Emerging Health Technology Surveillance System database yields two other antibody-based therapies targeted against S. aureus: Aurexis (Phase 2) and Veronate (Phase 3). We have assigned 45 innovation points to Altastaph.

S. aureus infections are responsible for significant morbidity and mortality in low birth-weight neonates. Estimates of the incidence of VLBW in the United States are in the 14-15/100, 000 population range corresponding to a burden of illness score of 11. Demand/diffusion scoring is difficult at this stage of development; we have assigned the default score of 10.

Altastaph receives a final BioHorizon Emerging Health Technology Impact Score of 28 placing it in our Low Impact Technology category. No assessment activities are recommended for health services clients at this time.

Technology Details
Target Disease / Indication: Staph. Aureus infections
Technology Classification: Drug
Body System: Multiple Systems
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase 2
BioHorizon Impact Score: 28/100 – Low

rPA is a recombinant, synthetic protein that is postulated to prevent the complications of anthrax infection by inducing antibodies that bind to and neutralize potent anthrax toxins. The only currently available vaccine for anthrax in the United States is AVA, which requires a primary series of three subcutaneous injections given 2 weeks apart, followed by three additional subcutaneous injections given at 6, 12, and 18 months. Annual booster injections of the vaccine are recommended thereafter.

In December 1997, the U.S. Department of Defense announced a plan to vaccinate all U.S. military personnel with AVA. As of April 2000, 425,976 service members had received 1,620,793 doses of anthrax vaccine under the DoD’s Anthrax Vaccine Immunization Program. In October/November 2001, approximately 10,000 persons were advised to take 60 days of post exposure prophylaxis because of potential exposure to anthrax in several U.S. states as a result of a bioterror attack. 22 cases of anthrax resulted from this intentional release of Bacillus anthracis.

While data released by VaxGen for rPA102 looks promising, it is very preliminary in nature. Ideally, the next anthrax vaccine would have an improved safety and efficacy profile when compared to AVA as well as the benefit of a simplified dosing schedule. As for the degree of impact of an anthrax vaccine, the ongoing assessments by the U.S. government and its Advisory Committee on Immunization Practice concerning the potential risk of an anthrax outbreak are critical. Currently, Biohorizon maintains its Moderate Impact Technology designation for rPA102 and recommends no specific assessment activities for this vaccine.

Technology Details
Target Disease / Indication: Anthrax
Technology Classification: Drug/Vaccine
Body System: Multiple Systems
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase II
BioHorizon Impact Score: 48/100 – Moderate

The FDA-approved OraSure® Oral Specimen Collection Device is a generic device developed for the purpose of collecting, preserving, and transporting oral fluid specimens. It uses a simple, two-minute collection procedure that can be performed by any trained personnel. OraQuick Rapid Antibody Test has been approved for the detection of antibodies to HIV-1 in oral fluid gathered by this device as well as the detection of antibodies to both HIV-1 and HIV-2 in plasma samples. The FDA has required OraSure Technologies to perform certain post marketing studies.

There are an estimated 65 million HIV tests performed in the United States annually. The cost of testing with OraQuick is estimated at somewhere between 8 and 20 dollars per test. Positive tests must be confirmed by follow-up tests as per existing screening tests.

Point of care diagnostic testing for HIV, and the option for the use of oral fluid versus blood as the specimen of choice, make for a potent combination when it comes to the predicted rate of diffusion of OraQuick Rapid Antibody Test. The potential for this test to transform HIV screening in the United States certainly exists. At the present time, Biohorizon has designated OraQuick as a Moderate Impact Technology as it does not significantly increase the cost of treatment/diagnosis per patient, a requirement for the High Impact Technology designation. However, Biohorizon does recommend that clients with significant HIV screening exposure commence assessment activities.

Technology Details
Target Disease / Indication
HIV

Technology Classification
Diagnostic Test

Body System
Multiple Systems

Program Area
Medicine/Infectious Disease

Regulatory Status
Approved

BioHorizon Impact Score
56/100 – Moderate

In 1999–2000, an estimated 30% of U.S adults aged 20 years and older, nearly 59 million people, were obese, defined as having a body mass index (BMI) of 30 or more. An estimated 71.5 million Americans reported current use (past month use) of a tobacco product in 2002, a prevalence rate of 30.4 percent for the population aged 12 or older.

Rimonabant is a selective cannabinoid type 1 (CB-1) receptor blocker. Endocannabinoids are naturally occurring substances in the brain and other areas of the body that play a role in controlling a number of physiologic activities, including food intake and energy balance. They also regulate the reinforcing effect of nicotine.

We continue to monitor Sanofi’s plans for Acomplia’s FDA submission. Pending further information, we do not recommend preliminary assessment activities at this time.

Technology Details
Target Disease / Indication
Smoking Cessation/Obesity

Technology Classification
Drug

Body System
Multiple Systems

Program Area
Medicine

Regulatory Status
Phase III

BioHorizon Impact Score
75/100 – High