If you’ve turned on your TV anytime in the last, oh, decade or so, you’ve no doubt been bombarded by ads imploring you to “ask your doctor” about Drug X. And you’re well familiar with the routine: You get treated to happy images of folks dancing, perhaps, or walking their dogs in pretty green meadows, while a soothing voice in the background tells you that Drug X may cause you to lose your ability to drive safely, lose your vision, or lose your mind.

Forgive the exaggeration but you get the picture.

Well, the FDA isn’t pleased with the pharmaceutical industry’s advertising practices. So it’s proposing a new set of rules that would not only limit the ability of drug advertisers to use so many cheerful images, but may indeed force them to place more emphasis on their products’ potential side effects.

The FDA actually proposed the new rules back in 2010. But it re-opened the matter to public comment on January 27, after it published the results from an experiment it sponsored to measure the impact of distraction on consumers’ ability to understand the risks and benefits of drugs being advertised. The rules would pertain to direct-to-consumer (DTC) ads for prescription drugs on television or radio.

The original proposal is rather bulky. But here are the basics of what the FDA is suggesting: The agency wants to amend the rules for DTC advertising to more clearly define the standards for determining whether side effects are presented in a “clear, conspicuous, and neutral manner.” For example, the new guidelines would dictate that the adds cannot include “distracting representations,” such as statements, images, or sounds that might draw the audience’s attention away from those laundry lists of potentially adverse events.

So what exactly makes an ad distracting? The FDA’s proposal doesn’t really spell it out clearly, but you can get a hint of what the agency was thinking in the newly released report on its study, which it titled, “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements.” The FDA planned the study to answer a number of questions. Among them: Do visual images that are positive in tone affect viewers’ ability to comprehend the risks inherent in a product? Do positive images influence how people feel about the product? And if the advertiser super-imposes text onto the images—spelling out the side effects—does that change how viewers perceive the product?

All good questions, to be sure. To answer them, the FDA asked 2,000 consumers to go online and watch an ad for a fake blood-pressure drug called Zintria. But the participants didn’t all see the same ad. Some heard the side effects cited while watching “mildly” positive images (rocks, chairs, metal arches), while others saw “strongly” positive images (babies, puppies, girls jumping with beach balls). Some viewers saw the side effects spelled out in superimposed text, while others didn’t.

Not surprisingly, those who watched cute babies and puppies while hearing about the side effects felt better overall about the product than those who watched the more boring images. Both groups, however, understood Zintria’s risks just fine—and they really got it when the side effects were displayed on the screen in clear text, too.

The FDA has published the study on the Web and re-opened the proposed rules to comments, which the public can submit up until February 27 (instructions below).

We here at Xconomy are plenty distracted by the plethora of peppiness in drug advertising. Here are our votes for … Next Page »

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Here at Xconomy, it’s unusual for us to shift far from our focus on the business of innovation—especially to cover something off the local police blotter.

But the 2010 murder of retired biotech CEO and angel investor John G. Watson hit close to home for San Diego’s innovation community, especially among local life sciences investors and members of the San Diego chapter of the Tech Coast Angels (TCA). Shortly after Watson’s body was discovered on June 8, 2010, San Diego police arrested Kent Thomas Keigwin, who knew Watson and had been working as a financial advisor in a local office of Wedbush Securities.

The case came to an end Friday, when a San Diego jury convicted Keigwin of first-degree murder, identity theft, attempted grand theft of personal property, burglary, and forgery. Deputy District Attorney Sharla Evert argued that Keigwin killed Watson to steal his money, firing a stun gun at Watson and strangling him inside Watson’s La Jolla apartment. The prosecutor said Keigwin used personal information he found in Watson’s wallet to impersonate him, transferring some $8.9 million from Watson’s accounts.

Keigwin’s lawyer, Deputy Public Defender Stacy Gulley, argued that the evidence showed only that Keigwin had committed a theft.

The trial began on Nov. 7, and ended exactly two weeks later. Dana Littlefield of the San Diego Union-Tribune reports that jurors also found Keigwin guilty of committing the murder under special circumstances—murder for financial gain and murder during a robbery. That makes him eligible for a sentence of life in prison without parole.

During his years in San Diego, Watson’s social network consisted mostly of the local innovation community. As I reported at the time, he was a 65-year-old bachelor and former pharmaceutical executive who had settled into his retirement in La Jolla after moving to San Diego several years earlier to run Ionian Technologies. Watson was active in the Tech Coast Angels, a group of individual investors who fund and mentor early stage startups, and Connect, San Diego’s nonprofit group for technology and entrepreneurship.

Judge Frederic Link, who presided at the trial, set Keigwin’s sentencing hearing for Jan. 20, at 9 a.m. in the downtown San Diego County Courthouse.

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When Ashleigh Palmer joined Boonton, NJ-based biotech company Unigene Laboratories as CEO in mid-2010, he faced a turnaround challenge that others might have considered way too daunting. The 30-year-old company was struggling to make money from a disjointed set of assets, which included a promising but, in Palmer’s view, under-marketed technology that could be used to turn injectable peptides—or protein-based drugs—into easy-to-swallow pills. Unigene was in debt and in need of a rescue. Furthermore, says Palmer, it had been managed by the two scientist-founders, who were brothers. “There’s the first warning sign,” Palmer says. “Family and business often don’t go well together.”

Wall Street has yet to be convinced that Palmer has what it takes to turn around Unigene’s fortunes. Unigene (NASDAQ: UGNE), which went public in 1985, was delisted in 1999 and pretty much left for dead by investors. On November 9, Unigene announced a net loss of $7.2 million for the third quarter ended September 30, on $3.4 million in sales. The company’s revenues included royalties from a nasal spray it developed to treat the degenerative bone disease osteoporosis—a product that that Unigene licensed to Maple Grove, MN-based Upsher-Smith Laboratories but that hasn’t been selling well due to competition.

The stock, as usual, barely budged—edging down 2 percent to $1 after the earnings announcement.

Palmer has been doing his best to get investors to focus on the good news. In conjunction with its earnings announcement, Unigene announced positive Phase 2 trial results on an osteoporosis drug it is developing with European drug giant GlaxoSmithKline (NYSE: GSK). The drug is an oral form of parathyroid hormone (PTH), the protein that’s the basis of Eli Lilly’s blockbuster osteoporosis injection teriparatide (Forteo). In the trial, Unigene’s drug produced a statistically significant increase in bone mineral density in the lumbar spine—a measure used to predict fracture risk. It was the result the companies were hoping to see.

Wall Street’s reaction? Crickets.

Then, yesterday, the company announced that an osteoporosis drug it was manufacturing as part of a partnership with Novartis (NYSE: NVS), Danish drug developer Nordic Biosciences, and Cedar Knolls, NJ-based Emisphere performed poorly in a late-stage clinical trial. Unigene has already received $13.7 million out of $18.7 million in potential payments from Novartis under a 2004 licensing agreement, and Palmer said in a statement that the setback would make little difference to the company’s turnaround effort. Still, it was enough to knock Unigene’s stock down by a dime.

As far as Palmer is concerned, the company’s relationship with GSK is the key element of his turnaround plan. GSK first partnered with Unigene in 2002 with the intention of developing a synthetic, oral form of PTH. But the first generation product didn’t work, and GSK lost confidence in Unigene, Palmer says. So shortly after he joined the company, Palmer and his team went to GSK and presented new data on … Next Page »

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Cambridge, MA-based Genzyme, owned by French drug giant Sanofi (NYSE: SNY) said today its experimental drug to treat multiple sclerosis, alemtuzumab (Lemtrada), reduced relapse rates by 49 percent and dropped the risk of of sustained worsening of disabilities by 42 percent in patients treated in a pivotal, Phase 3 trial. The drug was tested in a head-to-head trial against a form of interferon sold under the brand name Rebif by EMD Serono and Pfizer (NYSE: PFE). Genzyme plans to file for FDA approval of the drug in the first quarter of 2012, and it will be reviewed in an expedited manner by the FDA, which has granted it “fast track” status.

Genzyme scientists are particularly encouraged by how long-lasting the drug’s effects are proving to be. In the trial, one group of patients received alemtuzumab as a daily IV injection for five days, but then didn’t receive any medication for a year, at which point they were given the drug again for three days. The patients in the comparator group, by contrast, had to take interferon “subcutaneously” (injected under the skin) three times a week throughout the two-year trial period. “The contrast is obvious,” says Michael Panzara, therapeutic area head for multiple sclerosis, immune diseases, and neurology for Genzyme. “Even though our drug is active for a short period of time, the change it creates in the immune environment persists.” Panzara points out that in a previously reported five-year trial, patients only got two courses of alemtuzumab, but its efficacy lasted for the entire duration of the trial.

Alemtuzumab is an antibody that works by targeting a protein on cell surfaces called CD52. Genzyme’s research suggests that the drug depletes the T and B cells believed to be responsible for cell damage in MS. “When the cells come back, they are different,” Panzara says, “and we believe that leads to the prolonged effect.”

Patients in the trial suffered from a form of the disease called relapsing-remitting multiple sclerosis, and they had previously failed to respond to other therapies. Patients with this type of MS suffer episodes of weakness, sensory changes, severe fatigue, and other symptoms that “cause neurological deficits that do not go away,” Panzara says. “It knocks them out of work, it limits their ability to interact with their children.”

David Meeker, who became CEO of the Genzyme unit on November 1, believes the efficacy and dosing regimen offered by alemtuzumab in the trial are unprecedented. “This trial focuses on a population of patients who are underserved,” he says. “They continued to progress on other therapies. We’re confident we will be able to offer a highly differentiated offering for these patients.”

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Merck (NYSE: MRK) outlined progress on several of the drugs in its pipeline today during its annual R&D and business briefing for Wall Street analysts and investors, which was held at the drug giant’s Whitehouse Station, NJ headquarters.

CEO Kenneth Frazier began the day by acknowledging that Wall Street has been impatient with the company’s progress in advancing novel drugs to market. Despite the fact that the company has won FDA approval for five new products this year—including boceprevir (Victrelis) to treat hepatits C—the company’s stock has been declining over the last six months, dropping from $36 in May to $33.80 yesterday. “We recognize we can’t ask you—our investors—to wait for us to achieve our long-term aspirations,” Frazier told the audience at R&D Day.  ”I want you to know we intend to perform in the short term.”

Merck’s R&D chief Peter Kim started by highlighting several drug candidates in Merck’s late-stage pipeline. Kim reviewed recent data on a range of drugs to treat such conditions as osteoporosis, atherosclerosis, and chronic insomnia. Kim vowed to submit eight new drugs to the FDA for approval in 2012 and 2013.

During R&D day, Merck outlined recent progress on six novel drug candidates, including two the company detailed for the first time. First is MK-3102, an oral drug to treat … Next Page »

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NPS Pharmaceuticals’ (NASDAQ: NPSP) wild week continues today with the release of Phase 3 trial results on NPSP558, its experimental drug to treat hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone. The study shows that in 53 percent of patients, the drug achieved its treatment endpoint, namely that patients were able to halve their intake of Vitamin D and calcium supplements—which must be taken in dangerously high doses to control the symptoms of the disease.

Shares were up 11 percent in pre-market trading to $6.25.

Just one week ago, NPS’s stock took a 33 percent hit on news that three patients in a trial of its other lead drug candidate, teduglutide (Gattex), had developed cancer and two of them died. NPS CEO Francois Nader and other top executives spent much of last week on the phone with Wall Street analysts explaining why they were certain there was no evidence of a link between the drug—which is being developed to treat a rare disorder called short bowel syndrome—and the cancer cases. The company’s earnings report on Thursday contained no big surprises. Nevertheless, NPS’s stock closed Friday at $5.61, well below its October 31 opening price of $6.91.

Based on the results of the NPSP558 trial, the company says it will file for FDA approval in 2012. NPS is still on track to file for FDA approval of teduglutide by the end of this year.

If all goes well, estimates Leerink Swann analyst Joshua Schimmer, NPS could be bringing in annual sales of $58 million on NPSP558 and $109 million on teduglutide by the end of 2014.

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Today, during its third-quarter earnings announcement, Lexington, MA-based AMAG Pharmaceuticals (NASDAQ: AMAG) announced the departure of its CEO, Brian Pereira, and a restructuring plan designed to decrease its operating expenses. Wall Street applauded, pushing the embattled company’s shares up 18 percent to $16.21.The news came just a couple of weeks after shareholders voted down Amag’s plan to merge with Allos Therapeutics (NASDAQ: ALTH).

Amag spent the last several years trying to morph from a maker of diagnostic-imaging products to an inventor of cutting-edge drugs. But the company’s first therapeutic product, ferumoxytol (Feraheme) to treat iron deficiency, ran into safety issues, and the stock fell from $50 a share in 2009 when the product was introduced to below $14 earlier this year. The company sold about $15 million worth of the product in the third quarter and said its market share grew from 11 percent to 13 percent.

Under Pereira, who became CEO in 2006, Amag has started investigating ferumoxytol’s potential in broad markets, such as women with heavy menstrual bleeding or post-pregnancy anemia, and cancer patients. The company’s plan to buy Allos in an all-stock deal worth $686 million would have given it a product called pralatrexate injection (Folotyn), used to treat T-cell lymphoma. But investors were not wowed by the prospect of a single-product company merging with another single-product company.

Some analysts are cautious about Amag’s future. Jefferies & Company analyst Eun Yang called sales of ferumoxytol “sluggish” in a report today and put a price target on the stock of $12. Yang concluded: “shareholders could be better served if AMAG divests Feraheme, returns its value & current cash (~$11.8/sh) to shareholders.”

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On Monday morning, the phones were ringing off the hook at NPS Pharmaceuticals’ (NASDAQ: NPSP) Bedminster, N.J. headquarters, but no one could hear them. The freak autumn snowstorm over the weekend knocked out the company’s phone lines. And CEO Francois Nader and other top executives had lost power at their nearby homes, so they couldn’t charge their cell phones. The timing of this mini natural disaster couldn’t have been worse: At 9 a.m. Monday, the company released results from a pivotal trial of its lead drug to treat a rare intestinal disorder—data that revealed that three patients in the trial developed cancer, and two of them died.

The stock market opened and NPS’ stock took a harrowing free fall, plummeting 33 percent to $5.17 a share. That fact that this was all happening on Halloween only added to the spookiness of the situation. That afternoon, Nader and Bo Joelsson, who is leading the development of the drug for NPS, spent about an hour on a conference call trying to soothe the frayed nerves of Wall Street analysts. “It was a perfect storm,” Nader told them—a phrase he repeated in a phone interview the next day with Xconomy.

This morning, NPS will be releasing its third-quarter financial report and holding another conference call with analysts, during which Nader expects to field some additional questions about the cancer cases in the trial. “We’re working internally to determine whether there’s more we can say to dispel any misunderstanding,” Nader (who recently joined our ranks of Xconomists) said on Tuesday.

NPS is developing the drug, called teduglutide (Gattex), to treat short bowel syndrome, a disease that affects about 15,000 patients in the U.S. The three patients who developed cancer—two had lung cancer and one a gastrointestinal tumor—were participating in the trial at sites in Poland. Both lung cancer patients had been long-time smokers.

Unbeknownst initially to NPS, the clinic where the two lung cancer patients were treated had a staggeringly bad track record: a rate of lung cancer among short-bowel-syndrome patients that’s 66 times higher than that which occurs in the general population. Nader suspects … Next Page »

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Parsippany, N.J-based Pacira Pharmaceuticals (NASDAQ: PCRX) announced today that the FDA approved its long-acting form of a pain drug called bupivacaine, which Pacira brands as Exparel. The approval marked a positive end to a bruising drug-development saga that began a dozen years ago. It also brightened up Pacira’s otherwise so-so third-quarter earnings, which the company also announced today. It said sales in the quarter dropped to $4 million from $4.5 million in the same quarter a year ago, and the quarterly loss widened to $9.5 million from $7.9 million.

Pacira—which maintains corporate offices in New Jersey and manufacturing and R&D operations in San Diego—expects to launch its new product in January to treat post-surgical pain. The company said in a statement today that the FDA approval was sufficiently broad to support an aggressive rollout to hospitals. The company also said that as part of a deal it formed in September, Durham, N.C.-based Quintiles will provide 63 salespeople to market the pain product.

Pacira started life as DepoTech, a San Diego company that developed a controlled-release drug-delivery technology called DepoFoam, which is part of the drug the FDA approved today. UK-based SkyePharma acquired DepoTech in 1998, but failed to manage it successfully, so a group of venture capitalists bought it in 2007 and reformed it as Pacira. Those VCs—MPM, HBM BioVentures, OrbiMed Advisors, and Sanderling Ventures—brought on board Dave Stack to run Pacira, primarily because of his success at The Medicines Company, where he helped turn the blood thinner bivalirudin (Angiomax) into a $400-million-a-year product.

When Xconomy met with Stack last May, he talked with us in a conference room bearing a sign that said “Exparel War Room,” which seemed fitting considering that he called the drug “the hardest thing I ever did in my life.” Indeed, getting to FDA approval wasn’t easy. In 2009, Pacira laid off a third of its workforce when the drug failed an early trial. Pacira pulled off an IPO in February of this year, raising $42 million, but the share price of $7 was about half of what Stack was expecting.

The company had expected to hear from the FDA on its bupivacaine product in July, but because the agency had requested additional information from Pacira, it extended the decision date by three months. Pacira’s shares dropped from $15 in late May to $9.56 as the FDA deadline approached. The stock went on a wild ride Friday as shareholders waited for the FDA news, zooming from a high of $11.10 to a low of $9.30 before settling to close at $10.18.

Pacira said today it expects revenues of $14 to $16 million for the year—about flat with last year’s results. Analysts on average expect the company to pull in revenues of $45 million next year.

Pacira’s shares were up 17 percent to $11.96 in pre-market trading today.

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When it’s time for a scrappy tech startup with a bootstrapped culture to expand its footprint, the conventional thinking might go something like this: Hire young, hungry people who won’t blow through too much of your coin, and hold onto that staff until you absolutely have to take the plunge into grown-up salaries and benefits.

Seattle-based Appature didn’t go the conventional route. When it became clear that maintaining big accounts with drug and medical device clients required more hands-on staff attention, the medical-marketing startup decided to go for very experienced people.

“We believe that the right people for our business, for the long term, are going to be the ones that are coming to our company to build a business. Because we’re going to be in ‘building a business’ mode for a really long time,” CEO Kabir Shahani says. “And we’re the sort of people that are really never done—the same way software’s never done, building a great business is never done.”

That’s just one of the lessons for a growing business I was able to glean from a recent chat with Shahani at Appature’s downtown Seattle headquarters. The company is at one of those pivotal moments in its lifespan: After bootstrapping its way to profitability and taking its first outside financing in late 2009, Appature now has its first remote offices, is looking for more headquarters space in Seattle, and has seen its pipeline of deals swell to 10 times the size it was a year ago.

That’s a nice place to be if you’re an entrepreneur. But it’s also potentially perilous for a startup—how do you maintain the culture and values that the founders have put so much time into developing now that you’re a farther-flung, growing operation?

Shahani jumps up to the whiteboard to illustrate this task. Most companies, when you smooth out all the wrinkles, want to grow in a pretty straight upward line. But in reality, you often run into something that looks more like a series of stairs—and Shahani says Appature is in the middle of taking another one of those steps up right now.

“These [moments] are like getting your foot up off one stair and onto the other, and because you have more people and you have a lot more weight when you’re trying to do that, it’s a pain in the ass,” he says with a laugh. “It’s really exciting, and it’s super schizophrenic.”

To rewind a bit on the basics: Appature was founded in early 2007 by Shahani and technical chief Chris Hahn, who met while at the former social networking startup Blue Dot. The company sells cloud-based software services that help pharmaceutical and medical device companies market their products, both to doctors and to consumers, through targeted advertising.

On the physician side, that represents a major change in the way that drug and device marketing had been done for years. Think former cheerleaders making office visits, pens and prescription pads and samples and swag, speaking gigs, rounds of golf, and so on.

But with insurance reimbursement rates sliding, doctors are having to cram in more patients to make the same money—leaving very little time for sales calls.

“To the point where now, you’ve got a majority of physicians’ offices have limited their hours in terms of, ‘We’ll only see reps one day a week, or the … Next Page »

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It is hard to overestimate the importance of Steve Jobs on the American psyche. The co-founder and guiding force of Apple has died, succumbing to a long illness after only recently stepping down as chief executive. 
But his impact continues beyond his life, his business, his industry, his leadership, and his vision. One only needs to go to the Apple flagship retail store in Manhattan to feel his effect on the individual and industrial landscape. On any day of the year, the store is packed with tourists, many of whom are from other countries. In these moments, Jobs and his company personify an American cultural and business ideal of itself: “We invent these kinds of miracle things.”

Since this is the exact feeling (message, if you will) that the U.S. and global pharmaceutical industry would like to leave with the general public—as well as its traditional stakeholders of providers, payors, patients and regulators—what could pharma leadership take away from Jobs’ legacy?

Let’s start with the leader himself. Jobs’ name is listed on 313 patents. This is one of the most eye-opening points circulating around Jobs’ resignation. Can any actions (never mind words) speak louder than that in telling employees and the world how the company’s CEO views innovation? I challenge you to find it.

I realize that it can be difficult to make an apples-to-oranges comparison between the businesses of consumer technology, and that of … Next Page »

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It’s not every day that you see one Big Pharma company handing an award to another, but that’s just what happened yesterday at the New York Academy of Sciences. New Brunswick, NJ-based Johnson & Johnson (NYSE: JNJ) gave its Dr. Paul Janssen Award for Biomedical Research to Napoleone Ferrara, the Genentech scientist whose discoveries contributed to the development of the blockbuster cancer drug bevacizumab (Avastin), and a related treatment, ranibizumab (Lucentis), for the blinding disease macular degeneration. Genentech, based in South San Francisco, is a unit of the Swiss drug giant Roche.

In conjunction with the award presentation, J&J convened a top-flight group of scientists for a day-long scientific symposium on the future of treatments such as those that Ferrara spearheaded. Ferrara is most famous for his work with vascular endothelial growth factor (VEGF), a protein that promotes blood-vessel growth. His findings contributed to the birth to a new class of drugs—anti-VEGF compounds that starve tumors by cutting off their blood supply, and preserve sight by drying up the leaky blood vessels that cause macular degeneration.

The success of anti-VEGF drugs has brought a mix of celebration and criticism to Genentech. Sales of the cancer product hit $7.5 billion last year, while the macular degeneration drug brought in about $1.6 billion in sales. But late last year, an advisory panel to the FDA recommended the agency revoke its approval for the cancer product to be used in treating breast cancer, based on clinical trial results that suggested it didn’t work more effectively than other treatments. Genentech appealed the decision. Meanwhile, ranibizumab has been under pressure from eye doctors because of its $2,000-per-dose price tag. Many are choosing to use tiny doses of bevacizumab instead, which they can get for $20 to $50 per dose.

Although the commercial controversies did play into the discussion at the award presentation, the scientists chose to focus more closely on work being done to better define VEGF—and hence to improve treatments designed to block it. Ferrara described work in his lab to understand … Next Page »

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[Updated 8/25/11 12 p.m. See below.] Today the FDA approved icatibant (Firazyr), a drug made by Shire (NASDAQ: SHPGY) to treat a rare disease called hereditary angioedema. The drug, which Shire picked up in its 2008 acquisition of Germany-based Jerini, was developed for the U.S. market by Shire’s Human Genetic Therapies unit in Lexington, MA.

Hereditary angioedema is an inflammatory disease that affects about 8,000 people in the U.S.. Icatibant is approved to treat the disease’s major symptom: acute attacks of painful swelling, which can occur in various areas of the body, such as the face, hands, and feet.

Shire developed the drug as an injection just under the skin that patients can do themselves—a clear differentiation from other products on the market, which have to be dosed in hospitals or doctors offices. In June, an advisory committee to the FDA recommended that the agency approve the drug, and 11 out of the 13 members of the group voted in favor of self-administration. Today’s approval includes labeling that allows patients to inject themselves with the drug and includes counseling on how to do so.

That ability for patients to dose themselves should be a major marketing advantage, says Hugh Cole, global franchise leader at Shire Human Genetic Therapies. The drug inhibits a hormone called bradykinin, which is responsible for inflammatory symptoms such as pain and redness. There are competitors on the market that target other … Next Page »

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Shares of Tarrytown, NY-based Regeneron (NASDAQ: REGN) were down 4 percent in morning trading to $54.95 on news that the FDA has delayed its decision on the company’s macular degeneration drug by three months. The company had initially expected to hear by August 20 if the drug, called aflibercept (Eyelea), would be approved. But the FDA classified Regeneron’s recent responses to questions regarding the chemistry, manufacturing, and controls as a “major amendment” to the original approval application, according to a press release, and extended the date for a decision to November 18. The drug addresses a multibillion-dollar market and thus is expected to be Regeneron’s first major foray into the commercial pharmaceutical market.

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A U.S. District Court judge ruled in favor of New York-based Pfizer (NYSE: PFE) in a patent-infringement case brought by Israel’s generic drug giant Teva (NASDAQ: TEVA) over impotence blockbuster sildenafil (Viagra), according to a press release. Teva had been trying to invalidate Pfizer’s patent so it could market a generic version of the drug, but the ruling upholds Pfizer’s patent protection until 2019. Sildenafil is one of Pfizer’s biggest hits, bringing in $1.9 billion in sales in 2010.

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Pulmatrix, the Lexington, MA-based company with an unusual strategy for fighting diseases of the lungs, is announcing today that it has secured $14 million in a Series B1 venture round, bringing the total amount raised by the company to $60 million. All of Pulmatrix’s existing investors participated, including Polaris Venture Partners, 5AM Ventures, Arch Venture Partners, and Novartis Venture Fund.

The company also announced that it will advance its lead compound, called PUR118, as a new treatment for cystic fibrosis, and chronic obstructive pulmonary disease (COPD)—an umbrella term for diseases like emphysema and chronic bronchitis that commonly affect smokers. Recently completed Phase 1 studies in healthy volunteers showed the new drug was safe and well-tolerated, the company reports, so Pulmatrix will move the treatment into additional trials designed to measure PUR118′s effects on airway inflammation and mucus. The new cash, says CEO Robert Connelly, “will get us through these critical studies over the next 18 months, which will put us in position to plan larger, pivotal studies.”

Pulmatrix is using its technology platform, which it calls iCalm, to create aerosol treatments that attack lung ailments from three directions. First, they have positively-charged ion-based compounds, like calcium and magnesium, which stimulate the immune system to fight off many different pathogens that people breathe in all the time, like viruses and bacteria. “We have the ability to take on all comers—we can deal with any airborne infection, ” Connelly says. Secondly, the drugs produce an anti-inflammatory effect without the use of steroids-a common ingredient in many lung remedies. And finally, they help clear mucus from the lungs.

PUR118 is a dry powder that patients can inhale. Pulmatrix initially developed it as a liquid formulation, called PUR003, which patients had to inhale via a somewhat bulky machine called a nebulizer. Pulmatrix reformulated the drug so it could be used like an asthma inhaler—a far more … Next Page »

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Dennis Purcell is the senior managing partner of New York-based Aisling Capital, one of the top venture capital firms in the life sciences industry, with $1.65 billion under management. In 2009, Aisling closed its third fund, worth $650 million.

Aisling Capital’s first fund started up in 2002 with the goal of supporting startups across the entire healthcare products industry, including biotechnology, medical devices, aesthetics, and consumer health products. One of the big names it backed was Adams Respiratory, which developed Mucinex, the cough-and-cold product that’s become famous for its somewhat disgusting mascot, Mr. Mucus. Reckitt Benckiser bought Adams in 2007 for $2.3 billion cash. Aisling also invested in obesity-drugmaker Vivus (NASDAQ: VVUS)—but was lucky enough to take it public and sell its stake before Vivus ran into regulatory hurdles getting its weight loss product approved.

Life sciences startups are clamoring for Aisling’s support: The firm’s partners meet with more than 600 companies each year, but only invest in five to 10. Aisling’s typical investment is $20 million to $40 million.

Purcell has been managing two of Aisling’s funds since 2000. Prior to joining Aisling, Purcell managed the life sciences investment banking group at Chase H&Q. He currently serves on the boards of Aisling portfolio companies Dynova Laboratories and Xanodyne Pharmaceuticals.

Purcell recently sat down with Xconomy New York to chat about life sciences, consumer healthcare, and investing in a space where the payoff is sometimes long to come—and anything but guaranteed.

Xconomy: What is Aisling’s investment philosophy?
Dennis Purcell: We call it “where life science meets lifestyle.” Individuals are taking much more interest in their own health. People are willing to pay out of pocket for … Next Page »

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Ventrus Biosciences CEO Russell Ellison jokes that he doesn’t know how his mother would have reacted if he told her 20 years ago what he’d be doing today. Jokes help when you work at a place like Ventrus (NASDAQ: VTUS), where the lead drug candidate may just become the first ever FDA-approved prescription product to treat hemorrhoids. Ventrus’ two other clinical candidates are difficult to describe in detail, this being a family-friendly website. But let’s just say they also address what could be delicately called “below-the-belt” disorders.

Ventrus’ Wall Street debut has been nothing to joke about, however. The New York City-based company went public at $6 a share last December, raising $17.4 million. The stock traded all the way up to $21 in the spring—making Ventrus one of the few successful biotech IPOs of the last several years—before settling into the $12-a-share range.

On July 14, Ventrus priced a secondary offering at $10 a share and managed to raise an additional $45 million. “A lot of people bet against us,” Ellison says, noting that many short traders piled in, expecting Ventrus’ stock to drop on the secondary offering. “But it was a successful deal.”

Hemorrhoids don’t appear on the top of many drug companies’ priority lists—and that’s exactly why Ellison sees an opportunity in Ventrus’ lead drug, VEN 309. The only marketed remedies for hemorrhoids are over-the-counter products like Preparation H, which merely mask the painful symptoms, Ellison says. Steroids are sometimes prescribed, but they can also be ineffective. That spells opportunity, he says. “Apart from surgery, there aren’t many options for patients,” Ellison says.

VEN 309 is a compound that limits the activity of 5-HT2A receptors, which have been implicated in the blood-vessel clotting and contraction that leads to hemorrhoids. The drug improves blood flow through those restricted vessels, which also lessens pain, itchiness, and other symptoms. Unlike most compounds … Next Page »

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The economic deep freeze is thawing for IPOs on U.S. exchanges, according to a quarterly report issued today by the Ernst & Young accounting firm.

The number of companies in registration for an initial public offering increased to 140 during the three months that ended June 30, according to the latest the “Ernst & Young U.S. IPO Pipeline” study. That’s almost 24 percent more than the 113 companies that were registered during the same quarter last year, according to Ernst & Young’s data. Beneath story, I’ve put together a list of companies in the IPO pipeline for each Xconomy city as of June 30.

Ernst & Young says the 140 companies now in the lineup represent a potential total of $23.7 billion in estimated market valuation. That’s down from the $25.3 billion in total value during the same quarter last year, but the highest number of companies registered to go public since late 2007, when the financial crisis was beginning to engulf the U.S. economy. Just 28 companies were in registration at the end of the second quarter in 2009, one of the darkest periods of the recession.

A total of 42 companies went public on U.S. markets during the second quarter, a 13.5 percent increase over the 37 IPOs during the second quarter of 2010.

The warming trend is good news for the venture firms and other investors that view IPOs as a key way to keep the capital flowing to new companies, and to exit from startup companies with a return on their investments. Of the 140 companies in the IPO pipeline, venture capital firms back 40 percent, 31 percent are backed by private equity firms, and 23 percent are backed by both.

Technology-related IPOs accounted for 25 of the total companies in the pipeline at the end of the quarter, and they are trying to raise a total of $4.4 billion. The oil and gas industry was the next bigger sector, with 17 companies trying to raise a total of $4.6 billion. Other active sectors include financial companies, retail and wholesale, and diversified industrial products. Here’s a breakout of companies in the pipeline for each Xconomy city: … Next Page »

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Amag Pharmaceuticals CEO Brian Pereira recently told Xconomy he was shopping for acquisitions to round out the Lexington, MA-based company’s pipeline. Today Amag (NASDAQ: AMAG) delivered on that vow by announcing it would merge with Allos Therapeutics (NASDAQ: ALTH) in an all-stock deal worth $686 million. Allos, based in Westminster, CO, makes pralatrexate injection (Folotyn), a product to treat T-cell lymphoma. Amag makes ferumoxytol injection (Feraheme) to treat iron-deficiency anemia. Pereira believes the companies will achieve cost synergies of $55 to $60 million a year.

Wall Street isn’t buying it. Amag’s stock—which had been on the rebound after a host of safety questions depressed sales of its drug—fell 13 percent in morning trading to $16.55. Allos shares dipped a half-percent to $2.05.

What’s the problem? Both are single-product companies, and frankly neither one of them could be called a huge success. Amag is expected to sell about $55 million worth of ferumoxytol this year—about as much as it sold last year. In May, Allos said it expected sales of about $48 million to $55 million this year. Analysts had been hoping for $62 million.

Whether two struggling companies can be stronger as a united front is an open question. Said TheStreet.com’s Adam Feuerstein in a brief post today, “It’s just two disparate and under-performing biotech companies getting hitched to, at best, save some money.” He called it the “worst bio-merger in history.” Amag did not immediately respond to a request for comment.

Indeed, if Amag’s goal is to build a pipeline, it may need to keep shopping for acquisitions. Amag doesn’t have its own research program. As for Allos, its entire R&D plan appears to be centered around the already approved pralatrexate. The company is currently conducting about eight additional trials of the drug in a range of cancers, including non-Hodgkin’s lymphoma, bladder cancer, and breast cancer.

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