In the 2+ days of JP Morgan presentations that I was able to attend (I was sharing a badge with a colleague), my favorite private company presentation was MetaPhore's and my favorite public company presentation was PCYC's. I'll comment on PCYC here. For it, I participated in the break-out session as well.
I was thoroughly impressed by the CEO (himself a medical oncologist) and by the scientist and the marketing guys he brought with him to the breakout. The marketing guy headed up BMS's oncology and HIV marketing group. He worked for BMS for 16 years.
PCYC owns 100% of its drug candidates and will market the oncology product itself. They have $81M cash and no debt, with a $30M/yr burn. With luck, they'll begin marketing in 2006, so they've got enough cash to get from here to there.
They have a very elegant strategy for the pivotal trial of their lead oncology drug, Xcytrin. The drug shows promise in a wide variety of cancers, but for the pivotal trial they have picked brain metastases in lung cancer patients. 50% of lung cancer patients already show brain metastases when first diagnosed with lung cancer. As the brain metastases spread, they rot the brain, so the symptoms are terrible -- progressive loss of multiple cognitive functions. For Pharmacyclics' clinical endpoints for their pivotal trial, the FDA has approved a 2-month improvement in time-to-neurological-progression: i.e., they only need to show that they can slow the progressive loss of cognitive function by 2 months. That's an endpoint that they should easily surpass, based upon what seem to have been well designed Phase 2 trials. They secured a Special Protocol Assessment from the FDA for the pivotal trial (they are one of the first companies to do so -- the FDA only adopted the SPA program in May 2002), so the FDA can't switch endpoints on them. They expect to complete the pivotal trial in mid-2005. They've secured fast track status from the FDA, so they could be marking this drug by 2006. They'll build their own small sales force of 60-80 and focus on 7,000 high prescribers.
Manufacturing won't be a problem. Their compound is synthesized from readily available materials at a low cost. Large scale batches of product have already been produced for the upcoming trials.
The drug has a unique mechanism of action. It is from a class of molecules called teraphyrins, which are related to naturally occurring biologics, like chlorophyl. Teraphyrins cause programmed cell death -- that is their natural biological role: cellular apoptosis. Xyctrin has a natural affinity for cancer cells. Cancer cells have a higher electrical charge than normal cells and that higher electrical charge is what causes the preferential uptake of Xyctrin into cancer cells, such that lethal concentrations are achieved.
They also have a Teraphyrin called Antrin in Phase 2 trials for atherosclerosis. Similar principle. There is preferential uptake into arterial plaques. For this product they use a light source to activate the drug once it has been locally injected into the plugged artery. They are looking to partner Antrin.
Marc |
