Big Pharma giants are gathering in Chicago this week to wine and dine doctors at the American Heart Association’s Scientific Sessions, hoping docs will keep prescribing their multi-billion dollar heart drugs. Not many little biotechs can compete in this league, but Hayward, CA-based Anthera Pharmaceuticals is hoping to lay some groundwork for a new drug that could give Big Pharma another way to generate billions from treating heart attacks.

Anthera (NASDAQ: ANTH) is a small fish in this pond, having raised about $37 million in its initial public offering and burned through just about $93 million of investor cash in its five-year history. Anthera certainly fell off a number of radar screens when its stock dipped from its initial price of $7 to a low of $2.82 earlier this year. But the company has since bounced back to $6.12 at yesterday’s close, and is clearly eager to show some early-stage clinical trial of its lead drug at the American Heart Association meeting on Wednesday.

The idea at Anthera is to help prevent relapses in seriously ill heart patients by tamping down excess inflammation. The idea that inflammation causes plaque buildups in blood vessels to rupture, leading to heart attacks and strokes, hasn’t been solidly established in the scientific community, but evidence has been mounting for years to support the idea. Anthera, founded in 2004, is now in the midst of working to prove that a once-daily anti-inflammatory pill can significantly reduce the risk of heart attack, stroke, and death when taken in combination with the whole kitchen sink of other drugs like cholesterol-lowering agents, blood pressure meds, and anti-clotting agents. If Anthera can gather that kind of proof, it may have a drug that could be taken by as many as 1.5 million patients in the U.S. who get rushed to the hospital each year with a heart condition and are hoping to avoid a relapse that could be debilitating or fatal. The drug could be worth “multi-billions,” Anthera says.

“This is a true paradigm shift in the treatment of cardiovascular disease,” CEO Paul Truex says.

Anthera has at least a couple years of work ahead before it will know if it can live up to that billing. But the company has clearly staked out an interesting strategy in pursuit of the next big market for cardiovascular disease, in a way that a little cash-burning biotech company might actually be able to handle. The company, founded in 2004, got its early backing from Vantage Point Venture Partners, Sofinnova Ventures, Caxton Advantage Life Sciences Fund, HBM BioCapital, and others.

The lead drug Anthera’s investors are betting on here is varespladib methyl (A002), which was originally designed by Eli Lilly and Japan-based Shionogi to … Next Page »

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It’s keep-your-fingers-crossed time for the people at Arch Venture Partners and the Fred Hutchinson Cancer Research Center in Seattle. Both organizations have millions of dollars at stake in the upcoming initial public offering of Ikaria.

Ikaria, a Clinton, NJ-based company developing futuristic “hibernation-on-demand” technology with roots at the Hutch, is hoping to cash in on its promise next week. The company is seeking to sell 10 million shares to IPO investors at a proposed range of $15 to $17 next week, according to Renaissance Capital. The deal could bring in as much as $195 million if Ikaria can command the high end of its price range, and underwriters like Goldman Sachs and Morgan Stanley exercise their right to buy another 1.5 million shares, according to a filing with the Securities and Exchange Commission.

If Ikaria can pull the trigger on this deal, it will be a windfall for Arch, the largest life sciences venture investor in Washington state. Arch, one of the founding investors in Ikaria back in 2005, has 3.5 million shares the company, which will be equal to a 7.8 percent ownership stake once the IPO is complete, according to the most recent SEC filing on October 26. If Ikaria prices its IPO at $16, or the mid-point of its proposed range, then the company will have a beginning market capitalization of $711 million, and Arch’s stake will be worth about $56 million, according to my calculations based on regulatory disclosures.

Neither Arch nor any other venture investor in Ikaria will be able to cash out immediately because it is prohibited from selling any shares for at least 180 days, as part of a typical “lock-up” agreement.

This transaction is in the midst of an SEC-mandated quiet period, so Arch’s managing director in Seattle, Bob Nelsen, said he has no comment. Same goes for Ulrich Mueller, the vice president of technology transfer at the Hutch.

It’s much harder to pin down the exact stake the Hutchinson Center has in the Ikaria IPO, but it’s clearly smaller than Arch’s. The Hutch, and Ikaria’s scientific founder Mark Roth, aren’t listed in regulatory filings among Ikaria shareholders who have a 5 percent ownership stake or greater.

Mark Roth

Still, the Hutch has got to have high hopes for this deal. The Seattle-based cancer research center received 807,500 shares of common stock in Ikaria, plus 142,500 shares of preferred stock, when it was originally spun out of the center in 2005, according to an exhibit attached to the Ikaria investor prospectus. It’s unclear based on my reading of the SEC documents how many shares the Hutch still has, or what percentage that represents today. The company did complete a one-for-2.72 reverse stock split on October 25 as it made final preparations for the IPO, which means that pre-IPO holders will have about one-third as many shares as they did before the split.

Plenty of well-known individuals around Seattle have stakes in this deal. Roth, the scientific founder, was granted 2,187,790 shares in the original Hutch license agreement in 2005, according to a regulatory filing. Ben Shapiro, a former executive vice president at Merck, and a former member of the Ikaria board, had 5,000 shares of preferred stock after the Series A venture financing. Steve Gillis, a managing director at Arch and the co-founder of Immunex and Corixa, held … Next Page »

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DecImmune Therapeutics has made some news this morning after what appears to be a long silence. The Cambridge, MA-based developer of drugs for tissue damage has raised $1 million in equity funding from Astellas Venture Management, the VC arm of Japanese drug maker Astellas Pharma, according to the company.

DecImmune (formerly Natural Antibodies) said that it has also been awarded $2.2 million in a Phase II Small Business Innovation Research grant from the National Institutes of Health. The firm’s other financial backers include Cambridge-based HealthCare Ventures and Amgen Ventures, the investment unit of Thousand Oaks, CA-based biotech giant Amgen (NASDAQ:AMGN). Both Amgen and HealthCare Ventures invested in the firm in 2006 and they have put in a small amount of funding as part of the recent financing with Astellas, said David Hoey, a company spokesman. DecImmune, founded in 2003, has now raised just over $3 million from investors, according to Hoey.

“The funding we’re announcing today is clear recognition of the technical progress we’ve made to date and for the broad potential of DecImmune’s technology,” said Chris Mirabelli, a managing director of HealthCare Ventures and CEO of DecImmune, in a statement.

The company’s research is based on the discovery—by founders Michael Carroll and Francis Moore of Harvard Medical School—of a molecular target on cells that touches off an immune response that leads to inflammation and tissue damage. The firm is developing peptide- and antibody-based drugs to block the molecular target and thus the tissue-attacking immune response. Its NIH grant will fund the firm’s research of treatments to reduce tissue damage from burns, and the venture funding from Astellas and its previous backers will go toward its program to find drugs that rescue cardiac tissues from injury after heart attacks, Hoey said.

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Now I say this for sure, I’m not going to drop dead from a heart attack anytime soon.

Sure, I’ve seen the doctor before and had all the usual heart disease tests done—cholesterol counts, measurements of fat in the blood (triglycerides), blood pressure, the old-fashioned family history. But now I got some unequivocal signs on a high-resolution screen, which I could see in real-time, about how my arteries looked during an ultrasound scan at Bothell, WA-based SonoSite (NASDAQ: SONO).

SonoSite is pitching doctors on using ultrasound as one more tool in the endless battle to help predict, and possibly prevent, life-threatening cardiovascular events. The company is urging primary care doctors to use its portable ultrasound imaging machines to look inside a couple of arteries, to see precisely just how much plaque is building up there.

The company is so pumped about what this test can do, it invited me over to its offices last week to experience it firsthand. Even though I’m not personally worried about having a heart attack or stroke, and I certainly wouldn’t spend my own time and hard-earned money on such a test, I figured I’d give it a try because so many people are curious. Pfizer’s cholesterol-lowering drug atorvastatin (Lipitor) became the world’s best-selling drug with more than $12 billion in annual sales based on the notion that it could help people lower their risk of cardiovascular disease beyond improving their diet and exercise. In a country where junk food and the sedentary lifestyle rule, there are plenty of doctors looking for ways to strike genuine fear into patients with a new, more visual way of illustrating serious health risks. An estimated one in three people die from cardiovascular disease.

“There’s a whole community in medicine now that is serious about wanting to help people avoid a heart attack,” says SonoSite CEO Kevin Goodwin.

Kevin Goodwin

The test, which has actually been around a few years, is what’s called the Carotid Intima-Media Thickness (CIMT) exam. This is a measurement of the two inner layers of the carotid artery—an artery on each side of the neck that supplies the brain with blood. Studies over the past 20 years have shown that a thickening of this arterial wall can be an early sign of heart disease risk, at least when people are compared with peers of the same age, race, and gender.

SonoSite’s idea is to make this test fast and easy enough so that a primary care physician can incorporate it into his or her ordinary workday. SonoSite sells the doctor a $4,000 software upgrade, loaded with algorithms to analyze data on arterial thickness, and installs it on one of the company’s portable ultrasound machines. The exam itself usually takes 10 minutes or less.

Sharon Hall, one of the company’s sonographers, showed me how this works inside an exam room at the company. She ran the ultrasound probe along the right side of my neck, and then … Next Page »

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The sector was firing on all burners in the past week with fresh developments in devices, drug development, wireless health, and weight loss (just ask Larry Smarr). You can catch all the latest here.

—Sequenom (NASDAQ: SQNM), which scrubbed the launch of its diagnostics test for Down syndrome a year ago over “mishandled data,” is resuming development on a new testing schedule. The company also raised $51.6 million for R&D, commercial product development and general corporate purposes.

—Cytori Therapeutics reported (NASDAQ: CYTX) announced encouraging results from two small, placebo-controlled studies of its fat-derived regenerative cell therapy in cardiac patients. The double-blind studies, which were conducted in Europe, should pave the way for a larger test in 150-250 heart attack patients, the company said.

—Pathway Genomics fired the next salvo in the personal genome-testing wars with its announcement that it will begin selling genetic tests this week at 80 percent of Walgreens stores nationwide. Consumers can choose the $249 test that looks for a total of 46 genetic and health conditions, or a $179 test  that will look for either 23 genetic conditions or 23 health conditions.

—Sotera Wireless CEO Tom Watlington told me the company is preparing to test the ViSi, a wireless device that continuously monitors blood pressure, respiration, temperature, blood oxygen levels and heart rate, at five Southern California hospitals. If ViSi works, Sotera could begin marketing the device to hospitals during the first quarter of 2011, he said.

—Two San Diego companies were recognized for their innovations at the Wireless Life Sciences Investor Meeting in La Jolla, which was attended by 200 people, nearly double last year’s number. CortiCare, of San Diego, which provides remote and continuous electroencephalography monitoring of patients admitted to a hospital intensive care unit for signs of micro-seizures, was a finalist in the Best Clinical Applications category. Great Connections, which just moved to San Diego from Sweden, has technology that transmits ultrasound and X-ray medical images to any mobile device.

—Luke chatted with Internet pioneer Larry Smarr about his personal … Next Page »

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Cambridge, MA-based Molecular Insight Pharmaceuticals is gearing up for a pivotal clinical trial of a new type of diagnostic tool for spotting early signs of blockages in the heart that can lead to a heart attack or stroke.

Molecular Insight (NASDAQ: MIPI) is making this strategic move after reviewing detailed results from a 510-patient mid-stage study of its experimental imaging agent, which the company hopes to market under the name Zemiva. (I wrote about preliminary results from the study back in December.) Used in conjunction with standard cardiac tests, the imaging agent was able to help doctors accurately detect heart blockages 85 percent of the time, compared with 52 percent for standard testing alone—a difference that was highly statistically significant. The experimental diagnostic was also able to correctly identify patients who were not at risk of a cardiac event about 90 percent of the time, compared with 72 percent on the standard diagnostics.

The findings didn’t make the cut for a coveted late-breaking presentation at this weekend’s American College of Cardiology annual meeting in Orlando, FL, so the company is issuing a press release instead to get the news out to investors who will be gathering there in a few days. The company hopes to publish the findings soon in the Journal of Nuclear Cardiology, says CEO John Babich.

“This is showing unequivocal clinical benefit,” Babich says.

If Molecular Insight can prove that in the final stage of clinical trials, it could represent a big change in early diagnosis of heart attack. Something like 3.5 million Americans turn up in the emergency room every year with chest pain, forcing doctors to figure out quickly whether the patient is in danger of a heart attack. Conventional diagnosis, which relies on stress tests, can take several hours, but diagnostic imaging using Molecular Insight’s agent can be done just 10 minutes after injection.

This imaging agent, which is used in combination with a nuclear medicine camera like those used for bone scans, is also able to spot heart damage that occurred in the past 30 hours. “You can manage the patient appropriately even if they show up many hours after symptoms have resolved. And that is the big difference: there is no other imaging agent that can do that,” said James Udelson, chief of the division of cardiology at Tufts Medical Center, and the study’s principal investigator, in a company statement.

Still, like a lot of big clinical trials, this one didn’t go completely according to the plan. About one-third of all the patients in the study, 165 people, were excluded from the final analysis because hospitals either didn’t properly follow the study protocol, or didn’t capture all the necessary data. This can partly be explained by a strict protocol that didn’t allow doctors to ask for a second image to be taken to clarify an issue raised in an initial snapshot, as is often done in hospitals, Babich says. It’s also partly because emergency rooms are big, busy places where it’s sometimes difficult to stick to the rigorous criteria of a clinical trial. This trial required a lot of work—images taken with the company’s agent were read by an independent panel of three experts, and a definitive diagnosis was made by a panel of cardiologists who looked at four different measurements. Patients were followed for 30 days after they were admitted to the hospital.

So there were a lot of moving parts, and protocol violations do happen, but there were still a lot in this study. When I asked Babich if he was upset by that, he was blunt. “Of course I am,” he says.

Nonetheless, Molecular Insight has discussed this data with the FDA, and the regulators apparently told the company that it could amass enough evidence to win approval to sell the diagnostic with a single final-stage clinical trial, provided it shows “robust results.” The company is working on designing that new protocol, with an eye toward getting started in early 2010. The trial will probably enroll 700 patients at about 50 sites in the U.S. and Canada, Babich says. Molecular Insight is now looking for partners to help make that happen, he says.

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Cambridge, MA-based Molecular Insight Pharmaceuticals said today that its experimental imaging agent, when combined with standard diagnostic tests, reached its goal in a clinical trial of detecting early signs of cardiac ischemia—or reduced blood flow to the heart–which can lead to a heart attack or stroke.

Molecular Insight (NASDAQ: MIPI) said the Phase II study enrolled 510 patients who were brought to the hospital with chest pain and were suspected to be at risk of a heart attack or stroke. The patients got either a combination of a scan using the company’s imaging agent (called Zemiva) and standard diagnostic tests, or the typical workup alone. Researchers found the study reached its main goal of accurately improving the detection of ischemia over the standard of care. The results from this study, called BP-23, confirmed the findings from an earlier mid-stage study called BP-21.

Molecular Insight’s imaging product is a fatty acid attached to a radioactive molecule. Healthy heart muscle cells absorb the fatty acids and begin to metabolize them, while the unhealthy cells can’t do so—because of this, when a patient’s heart is viewed with a nuclear medicine camera, Molecular’s imaging agent shows up in the healthy tissue but not in diseased regions of the heart, helping clinicians detect damage, Molecular’s acting CEO John Babich explained to Ryan earlier this week in an interview.

The company believes this test will offer a convenience advantage over conventional testing. The standard tools enable pictures of blood flow to help doctors diagnose heart conditions, but they rely on stress tests (such as walking on a treadmill) to get the heart moving and take several hours to provide a diagnosis, Babich says. One key difference with Molecular’s product, he said, is that it can enable imaging without stress tests, and diagnostic imaging can be done 10 minutes after injection, Babich says. The imaging agent could be used to quickly diagnose some 3.5 million Americans per year who enter emergency rooms with symptoms of heart disease, he says.

Based on the positive finding in a Phase II study, Molecular Insight plans to discuss the design of a late-stage clinical trial in the first three months of 2009, Babich says. The company’s imaging agent has already been cleared for three years in Japan, and marketed under the name Cardiodine.

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