By Brady Huggett

Cubist Pharmaceuticals Inc., knocking down pins en route to a new drug application filing for its product, Cidecin, achieved the primary endpoint in its second pivotal trial in complicated skin and soft-tissue infection resulting from Gram-positive bacteria.

¿It¿s an important milestone in the sense that the company is trying to establish a robust data package,¿ said Michael King, an analyst for Robertson Stephens in New York. ¿One thing the FDA wants is consistency, which is why it asked for two trials. I think it significantly reduces the risk that something unforeseen could happen.¿

The trial, named Study 9801, demonstrated Cidecin (daptomycin for injection) was equivalent to the comparator agents vancomycin and semi-synthetic penicillins per the protocol reviewed and approved by the FDA. Lexington, Mass.-based Cubist plans to present the data at the Infectious Disease Society of America¿s 39th annual meeting in San Francisco near the end of the month, so company officials did not reveal much about study details.

¿It¿s a noninferiority trial,¿ said Jennifer LaVin, senior director, corporate communications, at Cubist. ¿There were four patient populations and we achieved the equivalence across all four.¿

The four patient populations were intent-to-treat, modified intent-to-treat, clinically evaluable and microbiologically evaluable.

The sister trial, Study 9901, also reached equivalence across all four patient populations. That trial was completed in March and Cubist presented data from the study in both April and September. (See BioWorld Today, March 15, 2001.)

Cidecin is the first in a new class of investigational drugs called lipopeptides and has exhibited the ability in vitro to kill a range of Gram-positive bacteria.

With two Cidecin trials down, Cubist¿s community-acquired pneumonia (CAP) Phase III trial stands as the last piece needed for an NDA filing.

¿The gatekeeper to filing is the finishing of the CAP2 study,¿ LaVin said. ¿We will complete enrollment on track to file in [mid-year 2002]. That¿s been one of our goals and we are still on track for that. We¿ll file all at once. It¿s common for antibacterial products to file for multiple applications.¿ LaVin added that whether Cubist would seek accelerated approval for the drug or not will ¿depend on the actual dossier¿ and the data within.

Achieving its primary endpoint in the 9801 trial triggered a $1.25 million milestone payment to Cubist from Gilead Sciences Inc., of Foster City, Calif. Gilead signed on early this year to market Cidecin in the European Union and also Switzerland through a $44 million licensing agreement. (See BioWorld Today, Jan. 9, 2001.)

Which begs the question: Who will market Cidecin to the rest of the globe, especially big-money North America?

¿We intend to make an announcement by the end of this year for the North American partnership,¿ LaVin said. ¿We aren¿t looking to strictly license it out.¿

LaVin said Cubist was weighing three options: doing the marketing itself, using a contract sales organization, or some type of co-promotion with a big pharmaceutical company.

Some analysts, including King, have Cubist reaching profitability in 2005. Its third-quarter figures are due for release before the markets open Nov. 1, LaVin said, but second-quarter numbers show Cubist lost about $16.8 million over the period and had cash and cash-equivalent reserves of approximately $116 million as of June 30. Analysts have predicted the annual worldwide market for Cidecin at between $250 million and $750 million.

Cubist has Ceftriaxon, an oral generic formulation of Basel, Switzerland-based F. Hoffman-La Roche Ltd.¿s Rocephin, a cephalosporin, in preclinical studies, to fill in behind Cidecin. Intravenously, Rocephin generates about $1.2 billion in sales.

¿It¿s early, but we are optimistic about Ceftriaxon and the oral daptomycin,¿ King said. ¿But the main driver will be Cidecin for the next couple of years.¿

Cubist¿s stock (NASDAQ:CBST) fell $1.19 Thursday to close at $36.71.

No Comments