Penn Bioinvestor's  Instablog

DCTH is at the front of regional treatment of cancer with a promising therapy to shrink tumors in the liver. Delcath’s Percutaneous Hepatic Perfusion (PHP™) technology allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug. PHP™ is an investigational treatment currently undergoing testing in Phase III and Phase II clinical trials.

Minimally invasive – PHP™ utilizes a series of catheters and extracorporeal filters to infuse high doses of chemotherapeutic agents to tumors in the liver with minimal systemic exposure.

Higher Dosing – PHP™ allows infusion doses exceeding those of systemic or intra-arterial administration.

Treatment Flexibility - PHP™ can be performed in an operating room or in a radiology suite under local or general anesthesia.

Repeatable Procedure - Unlike surgical isolated hepatic perfusion (IHP), which can be performed only once, PHP™ can be repeated several times. Patients within the trial usually receive the treatment at four-week intervals and up to ten treatments have been administered to a patient.

Decreased Toxicity - Filtration of the hepatic venous effluent can reduce systemic exposure of chemotherapy by 80% to 90% compared to hepatic artery infusion alone.

Today, DCTH started to analyze Phase III data:

DCTH Sequence of events from here on:

Data complete in February 2010

FDA submission April 2010

Endpoints are much more than double that of control group

Coincident with FDA submission, or maybe before, expect a paper published in JAMA or NEJM after all Trial Center heads (including NCI) unanimously agree on findings which will be a big event

Partnering discussions are being held in over 3 countries for exclusive geographic marketing rights and once the first agreement is established DCTH’s stock price will be moving north

Reference to active negotiations should not have been mentioned in Hobb’s November press release as its set up an expected time certain and a concomitant stream of worries for unsophisticated or impatient investors who assume “the negative” when no press release has been made according their own mental and unjustified timetable

Stock pressure is to be expected with some parties understandably cashing-in to lock in realized gains. Actually, weak hands are relinquishing to strong investors who are picking DCTH up for steal. Yes, downward stock movement is worrisome, but unjustified.

Nothing is wrong but the company wants to insure tight lips and DCTH will not issue a press release just to calm the price of its stock.

Expect a partner, either Asian or US, next year to expand on platform technology and expedite trials and front all costs for Hepatitis and Colorectal indications

When there is a release it will be legitimate and with positive news

Do your own homework, your money, your decision.

Everybody with a financial stake in biotechnology will be watching Ironwood Pharmaceuticals this week, as it attempts to pull off the biggest initial public offering the industry has seen in years.

The Cambridge, MA-based company, which filed its original IPO prospectus on Nov. 20, is now primed to go ahead and start selling its first shares on the NASDAQ market this week under the ticker IRWD, according to Renaissance Capital. If the company and its investment bankers pull the trigger, this will be a monster deal for a biotech company still in the product development phase. Ironwood could raise as much as $306 million if it can command the high end of its forecasted price range of $14 to $16 a share, which would establish an initial market valuation of more than $1.5 billion.

Biotech has been itching for someone to come along and whet the appetite of Wall Street for new companies, so that venture capitalists and entrepreneurs can realize the big paydays they need to justify the risks of drug development. Only one biotech company in the drug development stage, Seattle-based Omeros (NASDAQ: OMER), has gone public in the past two years, and that was a dud. So if Ironwood can find demand for its shares at the high end of its range, and the stock price rises on the first couple days of trading, it could provide a lift to the entire industry, including both public and private companies, according to three veteran market watchers I spoke with on Friday.

“There is huge buzz about it, and it could be bigger than most biotech IPOs in recent memory. The whole industry is waiting with baited breath and watching how it trades,” says Bob Nelsen, managing director of Arch Venture Partners in Seattle. “There is no question they will get a good price and get out, so the big question is what happens post-IPO. If it goes out strong, the number of followers will be much larger. If it goes out weak, only a few super-high-quality deals will get through the window. My fingers are crossed.”

Then again, a couple others I spoke with said that Ironwood is clearly a different beast than the average biotech. So while it will have an impact on the sector as a whole, it won’t necessarily re-ignite the IPO market.

“It’s a great story, but it’s more of a singularity,” says Richard Pops, the CEO of Cambridge, MA-based Alkermes (NASDAQ: ALKS), a longtime market watcher with no ties to Ironwood. “There aren’t five other Ironwoods teed up behind them.”

What’s different about Ironwood? The company has an oral pill in development that has already passed two pivotal clinical trials, so much of the clinical trial risk has been removed. The product is for a potentially vast market of millions of people who suffer from chronic constipation and irritable bowel syndrome, and who don’t have good treatment options. And Ironwood already has big partners to market the drug in North America, Europe, and Asia.

“This is going to be a large, liquid stock from the beginning, and that right there makes it different from a lot of others,” Pops says.

The more typical kind of biotech IPO would be for a company with an exciting platform technology, and products that face far more risks ahead than Ironwood, Pops says. That kind of company is more likely to command a $300 million to $400 million market capitalization, not $1.5 billion, he says.

Many venture capitalists, even though they know their portfolio companies don’t have the same kind of profile as Ironwood, are drawing up their IPO prospectuses based on the assumption that Ironwood will pry open the window of opportunity, says Doug Fambrough, a general partner with Oxford Bioscience Partners in Cambridge. One reason is the sense that Ironwood might be one of those rare opportunities that has crossover appeal into the wider world of investors who control a lot of capital, but don’t normally get involved in the life sciences.

“It’s widely expected to draw general investors who otherwise won’t play in the biotech space,” Fambrough says, noting that if Ironwood does well, the generalists might look for more opportunities like it. And that would help guys like him. “If Ironwood performs well, that will affect the mood of investors in the more specialized biotech community,” Fambrough says.

BEMA Granisetron utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek) to deliver the FDA approved antiemetic drug granisetron (also known as Kytril^®, marketed by Genentech). Granisetron is known as a selective 5HT-3 receptor antagonist, which are the most widely used treatments for the prevention of nausea and vomiting related to chemotherapy and radiation. Sales of 5HT-3 antagonists exceeded $1.7 billion in 2008.

Based on the outcome of the discussion with FDA, Phase 3 development could occur as early as the beginning of 2011. BEMA Granisetron would be the third BEMA product to enter clinical development and follows the recent FDA approval of the first product to use the BEMA drug delivery technology, ONSOLIS (fentanyl buccal soluble film), for the treatment of breakthrough pain in opioid tolerant patients with cancer. The company also announced last month positive Phase 2 results for its latest pain product, BEMA Buprenorphine, a potential treatment for acute and chronic pain.

I think the stock, at less than $4, is relatively cheap. The jury is definitely still out on the commercial launch of the breakthrough cancer pain film Onsolis, but I think the approval of that drug, plus the positive results from BEMA Buprenorphine in pain following dental surgery, validate BioDelivery's drug delivery technology.

With the pipeline progress, I see a double of stock price from here.