FDA Calendar Updates: GSK, RIGL, SPPI

The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. CRL resubmissions are classified as either Class 1 (60-day) or Class 2 (6-month) reviews by the FDA once they are officially accepted by the Agency. My expectation is for the FDA to formally accept Spectrum's resubmission within 1-2 weeks and classify it as a Class 1 review. The new 60-day review deadline would be 9/8/09 if the Agency agrees with my assessment.

On 7/9/09, Rigel Pharma (NASDAQ:RIGL) announced that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in the recently completed TASKi2 Phase 2b clinical trial of 457 patients treated for up to 6 months. Consistent with the previous Phase 2a clinical trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The significant, early and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct corporate partnership discussions with respect to R788 and initiate a Phase 3 clinical program with R788 in RA in the first half of 2010 with a corporate partner.

On 7/9/09, GlaxoSmithKline (NYSE:GSK) announced that the World Health Organization (WHO) has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to Merck's (NYSE:MRK) Gardasil.

On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.

Disclosure: No positions.