A pharmaceutical company developing a promising new mesothelioma drug has decided to end its relationship with its research and development partner. This move threatens to halt a clinical trial of the drug, FP-1039.
FP-1039 is a protein-based, fibroblast growth factor (FGF) ligand trap developed by Five Prime Therapeutics of San Diego, California. The company pulling out of the R & D partnership is GlaxoSmithKline.
GlaxoSmithKline is a very big name in pharmaceuticals. Its withdrawal from the partnership leaves much smaller Five Prime Therapeutics to continue the investigation of FP-1039 on its own.
The reason this puts the clinical trial at risk is that GlaxoSmithKline had primary responsibility for conducting it and collecting all the findings.
Mesothelioma Study of FP-1039 May Continue
However, there is a good chance Five Prime Therapeutics will be able to grab the baton and successfully run with it.
It turns out that Five Prime Therapeutics is flush with cash because of a deal it made last October with another pharmaceutical giant, Bristol-Myers Squibb.
In that deal, Bristol-Myers Squibb paid Five Prime Therapeutics $350 million with the promise of an additional $1.4 billion to come for the rights to a non-mesothelioma drug developed by Five Prime Therapeutics.
Business analysts said GlaxoSmithKline wanted to end its role in the development of FP-1039 in order to focus on other projects where the company thought it might have a better shot at dominating the market.
According to the analysts, the competition in the arena where FP-1039 would eventually be introduced promised to be stiff. For example, Bristol-Myers Squibb already enjoys a pretty solid foothold there.
And that’s why Bristol-Myers Squibb entered into the deal with Five Prime Therapeutics — to increase that foothold.
Some analysts think it’s actually OK that GlaxoSmithKline has bailed. They speculate that the company’s heart really wasn’t into FP-1039.
According to these market watchers, the licensing rights to FP-1039 were acquired by GlaxoSmithKline in 2012 as part of a $3 billion acquisition of a company called Human Genome Sciences.
Those licensing rights had been sold to Human Genome Services by Five Prime Therapeutics. But they were just part of the goodies grab-bag acquired by GlaxoSmithKline and not a specifically sought-after prize.
After GlaxoSmithKline announced it was breaking with Five Prime Therapeutics, word went out from Five Prime Therapeutics that it plans to complete the clinical trial.
The company said it is going forward with the clinical trial because it is encouraged by how well FP-1039 seems to work.
Clinical Trial Needs More Mesothelioma Patients
Before the split, Five Prime Therapeutics and GlaxoSmithKline announced they were seeking additional mesothelioma patients to join the FP-1039 clinical trial. The number of extra patients they wanted was 30.
FP-1039 is designed to prevent mesothelioma from spreading. It accomplishes this by disrupting protein signals mesothelioma cells send out as part of their grow-and-conquer process.
The clinical trial is only in Phase 1. Its purpose is to determine the safety of FP-1039 with regard to dosing, as well as use in general.
However, not enough solid data were forthcoming from the study, so the two companies decided to open it up to more mesothelioma patients.
GlaxoSmithKline had structured the trial so that there would be three groups of patients. Two of the groups consist only of patients with squamous non-small cell lung cancer.
The third group consists only of patients with mesothelioma. They are receiving FP-1039 along with mesothelioma chemotherapy made up of pemetrexed and cisplatin.
GlaxoSmithKline and Five Prime Therapeutics were going to announce the results of this clinical trial in June when the American Society of Clinical Oncology holds its next annual meeting.
This will still be the case if Five Prime Therapeutics is able to successfully complete the clinical trial without GlaxoSmithKline.