California Biomedical Industry - California Healthcare Institute

Infectious diseasesPharmaceutical advancementsThere were various anti-infectivetherpaies for HIV, hepatitis B andbacterial infection:••Gilead’s combination ofelvitegravir + emtricitabine +tenofovir disoproxil + cobicistatis a once-daily single tablet of fourdrugs investigated for the treatmentof HIV infection and is colloquiallyknown as the ‘quad pill’. Theproduct combines the company’sTruvada (emtricitabine + tenofovirdisoproxil) with its experimentalintegrase inhibitor elvitegravirand the cytochrome P450 3Ainhibitor and pharmacoenhancercobicistat/GS 9350. Phase III trialsare comparing the quad regimenwith Atripla and ritonavir-boostedReyataz plus Truvada, respectively.••Dynavax is developingHeplisav (V 270), a vaccine forthe prevention and treatment ofhepatitis B virus infection. Theproduct consists of Dynavax’sproprietary immunostimulatorysequence that targets Toll-likereceptor 9 (TLR9) combined withHBV surface antigen, HBsAg,to stimulate an innate immuneresponse. The ISS technologyfacilitates switching from a Th2immune response to a Th1 responseto the antigen, thereby evokingstrong cytotoxic T-cell activityagainst the pathogen.••Optimer’s fidaxomicin is anarrow-spectrum macrocyclicantibiotic which inhibits thebacterial enzyme RNA polymerase.Paradigm shift: Managingpublic health through ourschoolsFor years, the Centers for DiseaseControl and Prevention (CDC) urgedonly those whose health could bemost compromised by a bout of flu— toddlers, pregnant women and theelderly — to be vaccinated. Then, in2008, the federal agency altered itsstrategy to not only prevent the worsteffects of the seasonal viral infection butalso to curtail its spread. Consequently,CDC now encourages all Americansolder than six months to get vaccinatedannually.California is heeding the call andrecognizes that no subset of thepopulation is more exposed or exposesothers more frequently than children.The California Department of PublicHealth, in conjunction with the state’sschool districts and county healthdepartments, has dispensed tensof thousands of flu vaccines in the2010-2011 flu season. An estimated125,000 of those doses were FluMist,an intranasal spray manufacturedby MedImmune. The biotechnologycompany maintains facilities inMountain View, Santa Clara, andHayward.FluMist has been clinically proven to bemore effective than injected vaccines inschool-aged children and, anecdotally,to be less stressful for children toreceive. While contraindicated forpeople with asthma or other respiratoryconditions, FluMist is appropriate for85 percent of all children.Chris Ambrose, senior director ofmedical affairs at MedImmune, notedthat over the past several years morethan half of California’s countieshave instituted school immunizationprograms, making the state a “definiteleader” in flu prevention. The effortwas aided when Assembly Bill 1937(Ch. 203 of 2010) was signed into lawin August 2010. The bill, introduced byAssemblyman Nathan Fletcher of SanDiego, authorizes public health officialsto supplement the work of school nursesand allows other nursing professionalssuch as registered nurses, nursepractitioners and licensed vocationalnurses, to staff the school-basedinfluenza immunization programs.The change is that school programs nolonger have to be implemented solely byschool nurses.“AB 1937 gave schools a bigger pool ofhealthcare professionals from whichto draw,” Ambrose said, “which is asignificant benefit to schools and schoolnurses.” He added that the ability to usea wide variety of nursing professionalsenables districts to complete theirvaccination programs more quickly.While set up specifically for seasonal flu,the bill would enable health officials torespond quickly to pandemics and otherhealth emergencies, if needed.34 | California Biomedical Industry 2011 Report