With the passage of the Gain Act on June 2012 it makes it much easier for new antibiotics to gain approval. Specifically these antibiotics are called Qualified Infectious Disease Products (QIDP's) and the Gain Act provides the following incentives to companies developing these new antibiotics:
1. Exclusivity. Sponsors filing a NDA that qualifies as a QIDPs would be issued 5 years of market exclusivity in addition to the standard 5 years of exclusivity for a new chemical entity under Hatch Waxman. Therefore, QIDPs would qualify for 10 years of market exclusivity concurrent with or without patent protection
2. Priority Review. NDAs for QIDPs would qualify for Priority Review by the FDA, reducing the standard 12 month review period to 8 months.
3. Fast Track Status. Sponsors of QIDPs would be provided with early and frequent communications with the FDA, in addition to the typical review and communication opportunities, potentially speeding the path from Phase I to NDA filing.
Two companies developing new antibiotics are Trius (TSRX) and Durata (DRTX). Both DRTX and TSRX have completed phase III trials and are expected to submit NDAs later this year. Cempra is a little more behind but is interesting because it is developing antibiotics to treat prosthetic joint infections, gonorrhea, and community-acquired bacterial pneumonia. TRSX has had a nice run up trading at $8.62 the 52 week low/high is$4.41/$9.25. DRTX and CEMP are both trading at around $7.00, have around $100 million in cash., and market caps under $200 million. DRTX's 52 week low/high is $6.65/$10.63. CEMP's 52 week low/high is $5.26/$9.56. Another positive is that Cubist (CBST) is looking to acquire a company and all three of these companies have been mentioned as possible buy out candidates for Cubist. DRTX did a $46M secondary offering on April 2013 and CEMP did a $49M secondary offering on June 2013 so risk of further dilution this year is small.