Lilly expects to file an NDA for the antibacterial glycopeptide oritavancin by 2003, Senior VP-Pharmaceutical Products John Lechleiter, PhD, told the J.P. Morgan H&Q Healthcare Conference in San Francisco Jan. 8.

Oritavancin "has shown promise in treating serious Gram-positive bacterial infections, including those resistant to traditional antibiotics," the exec said. The drug is in Phase III trials.

"Our in vitro studies have shown that oritavancin is rapidly bactericidal against Gram-positive organisms," Lechleiter declared. "Unlike [Pharmacia's] Zyvox and some other, newer antibiotics, it kills - not merely suppresses - the bacteria."

Lilly will seek an indication for oritavancin (formerly LY-333328) for the treatment of Gram-positive bacterial infections, vancomycin- and teicoplanin-resistant enterococci, methicillin-resistant Staphylococcus aureus, methicillin-resistant coagulase-negative staphylocci, and penicillin-resistant Streptococcus pneumoniae.

Lilly estimates there are 730,000 cases of bacteremia each year in the U.S., nearly two-thirds of which are caused by Gram-positive infections. Bacteremia is blamed for nearly one-third of the deaths among ICU patients and is indicated in severe sepsis.

In addition, there are 2 mil. cases of complicated skin and soft tissue infections in the U.S. each year, and nearly 750,000 annual reports in the five largest European markets, Lechleiter estimated.

Oritavancin represents an opportunity for Lilly to re-enter the anti-infectives market, where the company once had a leading position with Ceclor. Lilly also sees the product as fitting into a re-energized critical care product line over the next several years.

The potential role of oritavancin in sepsis would make it a good fit with Lilly's potential anti-sepsis agent Zovant. Lechleiter noted that 40% of patients in Lilly's pivotal Zovant trial had a Gram-positive culture.

Regulatory filings for Zovant (recombinant activated protein C) in the U.S. and Europe are expected to be complete by the end of the first quarter.

Partial data from the Phase III Zovant PROWESS trial released by the Society of Critical Care Medicine show that the drug reduced sepsis death by 19.4% and increased the chance of survival by 38.1% after 28 days of use compared to placebo.

Lechleiter declined to comment on the results at the H&Q meeting, but noted the company will fully discuss the data on Feb. 11 at the Society of Critical Care Medicine's conference in San Francisco.

If Lilly meets the first quarter filing deadline, Zovant would have a chance to be approved in 2001 (¹ Also see "Amgen Aranesp, Anakinra Could Lead 2001 Biologics Approvals" - Pink Sheet, 8 January, 2001.).

The osteoporosis agent Forteo will also have a review deadline in 2001. Lechleiter told the H&Q audience that an application for parathyroid hormone was submitted "on schedule" late in 2000.

Lilly is seeking an indication for moderate to severe osteoporosis. The exact wording of the claim is likely to be debated during the review. Lilly's comments on a recent FDA guidance relating to PTH studies suggest the company's position (² Also see "FDA's Proposed Osteoporosis Definition For PTH Trials Questioned By Lilly" - Pink Sheet, 4 September, 2000.).

While Merck's Fosamax and Lilly's Evista reduce bone loss and slow bone reabsorption, Forteo "has been shown to stimulate new bone formation and prevent fractures both at the spine and overall at non-spinal sites," Lechleiter said.

Clinical results "suggest that because of its unique mechanism of action, Forteo will provide unprecedented improvement in both bone marrow density and, even more importantly, bone strength," the exec maintained.

Forteo "puts bone back into growth phase and stimulates the creation of healthy new bone," Lechleiter continued.

"As a result, Forteo improves not only the patient's bone-mineral density levels, it also strengthens the overall bone architecture. And it does so very rapidly."

Lilly will study the efficacy of Forteo and Evista (raloxifene) as a combination in upcoming Phase IV studies, Lechleiter noted.

Lilly Oritavancin Antibacterial Agent NDA Submission Targeted For 2003

More from Archive

More from Pink Sheet