Place Your Bets - Pharmaceutical Executive


Place Your Bets

Pharmaceutical Executive

Analysts say there is room for multiple drugs in the large prostate cancer market, and the most likely competition is Dendreon's immunotherapy Provenge. The promise of that vaccine, which is currently once again in Phase III trials, caused prostate cancer patients to take to the streets and protest against FDA when it requested additional data. Dendreon expects results this October. If the data are consistent with what has been seen in the past, studies will show that Provenge extends life by 3.3 months. However, abiraterone has extended life by more than two years among clinical trial subjects.

Cougar is also part of an emerging crop of companies that are developing cancer drugs based on analogs of Vitamin D—more specifically its active metabolite calcitriol—because of its ability to inhibit cell proliferation and angiogenesis, and induce differentiation and apoptosis. Specifically, it has begun to test a drug called seocalcitol for multiple myeloma and prostate cancer. It's much further down the pike, but offers up some promising science—and certainly, some competition.

TRENDWATCH: VITAMIN D As if we needed more excuses to call in sick and go to the beach. Now, new science shows the promise of Vitamin D therapeutics in treating a broad range of conditions. "Someone was telling me that their trainer at the gym was going to Miami, and not bringing any sunscreen," says Miller Tabak's Fundleyter. "The trainer said they wanted to soak up the Vitamin D—and you know when your trainer knows about Vitamin D, that's a hot area."


Small, safe investments offer solid upside to revenue

Let's face it: America has a massive addiction to pain meds. Whether it's Fentanyl or Vicodin or the "hillbilly heroin" OxyContin, people just can't seem to stop using—and abusing—prescription narcotics.

FDA has signaled that it is looking for safe, abuse-resistant pain drugs, not just drugs with more efficacy. In response, most firms have stocked their pipelines with reformulated opioids. It may not be enough. Witness how the recent FDA Advisory Committee on pain found OxyContin's reformulated doses not abuse-resistant enough, and gave a thumbs-down to Cephalon's Fentora for an expanded indication to manage pain outside of cancer—even with a RiskMAP.

But Javelin took a different tack. You see, while opiates provide users with a quick high, these drugs come with a host of undesirable side effects for patients, including constipation, nausea, and respiratory depression.

Instead, Javelin is developing an injectable version of diclofenac, a well-known NSAID that inhibits the body's ability to synthesize prostaglandins, and therefore limits inflammation and pain in the hospital setting. While it is currently in Phase III for the treatment of post-operative pain in the United States, the company already received UK market clearance to market Dyloject in October 2007. The UK's NICE found it safe, effective, and perhaps most important, worth it. NICE paid the company's asking price, and the drug is on 90 percent of UK hospital formularies, according to the company.

"The best thing we did was to complete a solid pharmaco-economic analysis," says Martin Driscoll, a board member who stepped up to serve as CEO in March. The company conducted a head-to-head study against the UK gold standard, Novartis' Voltarol, which has the same active compound but is given by slow infusion. Javelin showed that Dyloject, given through a bolus injection, saved time and $100 per patient when compared with the market heavyweight. And when compared with opiates, patients had fewer side effects, which meant shorter hospital stays and fewer hospital-borne infections like MRSA. "Now for each hospital, we're not having to discount at all," says Driscoll.

The company is also developing other compounds, including intranasal ketamine (which at least the Department of Defense thinks is interesting and kicked in $5 million for development) and intranasal morphine.


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