12:00 AM
 | 
Mar 28, 2005
 |  BioCentury  |  Finance

Ebb & Flow

When Guilford (GLFD) licensed its GPI 1485 neuroimmunophilin ligand to Symphony Neuro Developmentlast year, the move was designed to let GLFD focus on starting Phase III trials of its Aquavan sedative. But the four Phase III trials of Aquavan were put on hold last week because of adverse events seen in one of the studies

With the future of Aquavan now up in the air, the neuroimmunophilin program is a logical fallback. Both GLFD and Symphony Capital note that the future of GPI 1485 will be determined solely by its Phase II data.

In June 2004, Symphony Neuro raised $43 million and in-licensed GPI 1485 from GLFD for central and peripheral nervous system disorders. GLFD received a scaling three-year option to buy back the newco and the compound at prices starting at $75.1 million in April 2005, increasing to $119.8 million in March 2007 (see BioCentury, June 21, 2004). At the end of 2004, GLFD had $109.5 million in cash and equivalents.

"The decision to buy back GPI 1485 rests exclusively on Phase II data," said GLFD spokesperson Stacy Jurchison. "We hope to have those data by year end or early next year." The compound is in three Phase II trials - two in Parkinson’s disease (PD) and one in post-prostatectomy erectile dysfunction.

Similarly, Symphony Capital Managing Director Mark Kessel told Ebb & Flow that the Aquavan news "has nothing to do with our compound. If the trials are successful, it’s probably a good economic idea to buy the compound back, as we’ve taken the development risk. But if not, it should be easy to find a buyer."

GPI 1485’s clinical history isn’t spot-free. The compound (formerly NIL-A) did not show substantial reversal of motor symptoms associated with PD in a previous Phase II trial. The data prompted then-partner Amgen(AMGN) to return the compound (see BioCentury, July 30, 2001). The highest dose of GPI 1485 did showa trend toward improving the study’s secondary endpoint of dopamine transporter density compared to placebo.

On the week, GLFD crumbled $1.60 (41%) to $2.34. The good news is that Aquavan met the primary efficacy endpoint in the trial for which GLFD reported data. Going forward, the company said it will explore lower doses, but cautioned that the review may delay an NDA submission.

Hefty toll

Since it was formed in 1997 as CpG ImmunoPharmaceuticals, Coley has raised about $144 million in venture money. Now, with its first product deal in place, the company could receive more than triple that amount from partner Pfizer (PFE). The deal for Coley’s ProMune cancer compound includes a $50 million upfront payment to Coley and up to $455 million in milestones.

Coley Senior Vice President of Finance and CFO Charles Abdalian told Ebb & Flow that most of the milestone money would be triggered by regulatory events.

ProMune, a toll-like receptor 9 (TLR9) agonist, is in...

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