If you just read the headlines and watch the reality shows, the life of a tech entrepreneur probably sounds something like this: Work hard, play hard, raise tons of money, change the world, retire early. It’s a swashbuckling, mile-a-minute joyride filled with the best and the brightest.

Except when it’s not. The flip side of that wide-open adventure and hard-charging culture can be an extreme sense of loneliness when things don’t work out—a spiral of dread and depression that can be fatal, as Cheezburger Network CEO Ben Huh told us this week.

In a remarkably personal blog post, Huh tells how the failure of his dot-com bubble-era company Raydium left him stuck in a dark, depressed place, face-to-face with thoughts of suicide.

“Was I not meant to be an entrepreneur? Will I never get to pursue my dreams again?” Huh wrote. ”I spent a week in my room with the lights off and cut off from the world, thinking of the best way to exit this failure. Death was a good option—and it got better by the day.

“I don’t remember why I left my room. The most meaningful act I performed on my long climb out was to leave that room. It was the best decision I made in my life. … It wasn’t for several months that death no longer became an option, but leaving that room and dealing with reality was the best antidote to a make-belief world where life just wasn’t worth it.”

Huh was moved to write about his experience from years ago by the recent death of Ilya Zhitomirskiy, the 22-year-old co-founder of social networking startup Diaspora. While no official cause of death was given at the time, The New York Times reported that “friends and associates of Mr. Zhitomirskiy said there were indications of suicide.”

I talked with Huh Wednesday afternoon—he was in New York attending a conference—to learn more about why he wanted to make such a personal topic extremely public. Huh said that, months before Zhitomirskiy’s death, he had spoken with another Diaspora co-founder about the startup’s struggles.

“It was very clear to me that they were struggling. They were struggling at a fundamental, conceptual level of who they were,” Huh says.

He also notes that the loneliness may have been compounded by the fact that Diaspora raised seed money through Kickstarter, the online crowd-funding platform—which meant they were fully in charge, but also didn’t have a venture capitalist or angel investor who could provide close guidance. “Even thought they were loved by so many people, they were really, truly alone.”

“When I read about Ilya’s death, it was one of those things where even before the reports come out that they suspect it was suicide, you just kind of know,” Huh says.

As an entrepreneur who’d been through the dark times, Huh says he wanted other young people who might be in a similar position that there was a way out—to break the sadistic comfort that depression can provide, find something to do, and get on with your life.

That can be extremely difficult in the startup world, where your company or product is more than a 24-7 job: “It’s everything that you are,” Huh says. “When that falls apart—that’s the only purpose for living.”

And for all the talk of prizing failure, learning from mistakes, iterating, and moving on, Huh says, the entrepreneurial culture doesn’t do enough—at least publicly—to confront the obvious dark sides of crashing and burning along the way.

“For a culture that supposedly embraces fast failures and pivots, we don’t talk about the psychological and emotional effects of those failures,” Huh says. “We’ve actually come up with a safety word for failures, called ‘pivot.’ We’ve kind of swept it under the rug.”

His tale is one of renewal and redemption in the end. As Huh eloquently writes, surviving his depression left him with the perspective and strength to handle another failure, should it come his way. “Nine years after I left that room, I would call Brad Feld to invest $30 million in my odd-ball company. Before I picked up the phone, I thought long and hard about losing that money—every single penny of it. And I was OK with it.”

Huh does worry about some negative effects of laying some very deep, personal moments out in public. “Is an investor going to say no because of what I went through? Will this divert the attention of what I do to this topic?” he asks. “As the CEO and founder, the thing I’m most focused on is the welfare of my company and employees.”

A day after the post went up, however, the positive responses were flowing in. Huh says people who read the post were sending thanks for his story to the Cheezburger Twitter account, with some saying they also had struggled with depression.

Entrepreneur Dan Shapiro, now at Google after its acquisition of Sparkbuy, was among the people giving Huh public kudos for sharing his tale.

“Building a startup is about the highest of highs and the lowest of lows. The problem is that while people shout about the highs from atop the tallest mountains (or TechCrunch), the lows are suffered in private,” Shapiro told me in a follow-up email. “It’s a feat of profound courage to share your darkest moments. With more brave truth-tellers like Ben, perhaps we can avoid tragedies like what befell poor Ilya.”

“Part of me felt like so many people struggle with this,” Huh says. “I feel good that I wrote it.”

Comments (1) | Reprints | Share:          

Can brain disorders be treated more effectively by fine-tuning key receptors in the brain, rather than turning them completely on or off? That’s the question Boston-based Third Rock Ventures’ latest startup, Sage Therapeutics, hopes to answer with a new class of treatments it is developing to treat diseases such as schizophrenia and depression. Third Rock started Sage today with $35 million and a duo of co-founders who are well known in the neuroscience space: Eli Lilly veteran Steven Paul, who is now the director of the Helen and Robert Appel Alzheimer’s Disease Research Institute at Weill Cornell Medical College in New York, and Douglas Covey, professor of biochemistry at the Washington University School of Medicine in St. Louis.

Sage is developing “allosteric receptor modulators,” which are designed to balance the activity of neurons in the brain. The drugs address neurotransmitters such as GABA and glutamate, which control signals transmitted between neurons. When the receptors that produce these brain chemicals go awry—causing them to be either overly active or not active enough—disorders of the central nervous system can result.

The problem with many drugs on the market today, says Third Rock partner Kevin Starr, is they turn neurotransmitters all the way up or they turn them off all together. “That might not be the best way to restore the natural signaling in the brain,” he says. “You don’t want to hit these receptors over the head. You want to fine-tune them.”

Sage is founded on a proprietary chemistry-based technology that enables the development of novel allosteric receptor “modulators”—drugs designed to tweak their activity rather than just shutting them on or off.

Paul says one project the company is working on involves finding drugs that will boost the glutamate receptor called NMDA, which is believed to be underactive in the brains of patients with schizophrenia. “NMDA was a very active area of research when I was at Lilly,” says Paul (who is also one our New York Xconomists). But finding … Next Page »

Comments (1) | Reprints | Share:          

Today a company called Tal Medical is starting up in Boston with the goal of developing an entirely new approach to treating depression, inspired by a specific type of magnetic field found in some MRI imaging machines. The research is still very early, but the treatment—developed at McLean Hospital in Belmont, MA—was promising enough to win backing from Boston-based PureTech Ventures and to attract an impressive slate of talent, including former Eli Lilly executive Steven Paul, who will serve as the founding chief scientific officer.

PureTech and a few individual investors are seeding the company with an $800,000 investment, says PureTech managing partner Daphne Zohar. The company’s founding CEO is Nessan Bermingham, a biology Ph.D. and managing partner of Boston-based Bio Equity Capital, which is not an investor in the seed round.

Tal, which means “rhythm” in Hindi, was born from an accidental discovery. Ten years ago, McLean was participating in a study of patients with bipolar disorder that involved imaging their brains with MRI machines. “The person doing the study noticed the patients were looking at her in the eye—they weren’t looking at their shoes—and they were being more interactive when they came out of the machine,” Bermingham says. The bottom line, he says, was their moods were greatly improved after just a short time in the MRI machine. “This happened again and again.”

So a team of McLean researchers began to try to figure out what exactly it was about this particular MRI device that was affecting the brain. They determined that it was Low Field Magnetic Stimulation (LFMS)—an oscillating magnetic field that they believed was resetting the brain’s natural rhythm. They performed and published clinical trials first on animals, and then on patients with major depressive disorder and bipolar depression. The results, says Bermingham, were compelling. In the animal trials, “the level of effect was similar to Prozac,” Lilly’s groundbreaking anti-depression drug, he says. Early data from human trials shows a statistically significant improvement in symptoms.

PureTech consulted with Lilly veteran Paul prior to licensing the technology from McLean, Zohar says. “His background is in the drug side, but he was intrigued … Next Page »

Comments | Reprints | Share:          

Prexa Pharmaceuticals, a Boston-based biotech developing experimental drugs for treating central nervous disorders, announced it wrapped up a $7 million Series B funding round from Advent Healthcare Ventures and new investor Shire Pharmaceuticals. Prexa, which previously raised $3.1 million in Series A money, was co-founded by Advent in 2006 and is working on molecules to safely enhance dopamine activity and norepinephrine activity, to improve on existing treatments for for ADHD, depression and Parkinson’s disease.

Comments | Reprints | Share:          

Oddball product names are one of the occupational hazards of biotech writing. Drugs in particular can be hard to spell, and often hard to pronounce. While I can practically type telaprevir, telaprevir, telaprevir in my sleep at this point, I can almost feel the reader reaction when that scientific name flows from my keyboard.

ZZZ….

Alas, there’s no Steve Jobs-style marketing whiz in this business, handing down tablets from the heavens, and bestowing upon them a magical name like “iPad.” But lately, the business of giving brand names to prescription drugs seems to have gone from boring to weird.

Check a few of the newly-coined drug names—Incivek, Adcetris, Yervoy, Viibryd, Zytiga, Xgeva. Somewhere, the folks who sell Coca-Cola must be giggling at their friends who went into pharmaceuticals. How are you supposed to create an identity for a product, when people can’t even spell or pronounce it, much less have any sense of what it means?

There’s a reason so many drug names look so weird. A good drug name is supposed to check lots of boxes. It should be easy for doctors to spell accurately when they scribble it down on a prescription pad. It should be memorable. It should be used in every country around the world without triggering some cultural confusion or sensitivity. It ought to be consistent with the science or clinical application that distinguished the product through years of development, yet the brand name shouldn’t be so geeky that it’s obtuse for patients. Ideally, you’d want it to trigger some relevant connection to your product.

It’s all easier said than done, says Vince Budd, the senior vice president at Addison Whitney, a brand consulting firm in Charlotte, NC. Besides the creative challenge of doing all that, there are legal and regulatory barriers for pharma companies. Lawyers for the drug companies watch carefully to make sure no one is infringing on any of their thousands of brand trademarks, to make sure nobody can ride the coattails of a consumer hit like Pfizer’s sildenafil (Viagra). Once a name can be shown to be unique from a trademark perspective, it’s still got a long way to go. Companies can easily spend more than a year, sometimes two years, getting through the creative process, the trademark process, and then FDA approval process.

The FDA is getting particularly tough, rejecting about four out of every 10 name proposals, because it wants to avoid medication mix-ups that can lead to dangerous—sometimes deadly—adverse reactions, Budd says. The poster child for brand confusion is Celebrex (a pain medication) getting mixed up with Celexa (an anti-depressant).

“If you want to name a potato chip, all you have to know is whether you can own the trademark,” Budd says. The effort to become uber-differentiated from everything else in pharmaceuticals, Budd says, leads to some of those new names you see. “You’re getting names that are crazier and crazier,” he says.

There are really two different of drugs to think about for naming purposes. There are drugs that are trying to reach mainstream consumers, and drugs that really only need to connect with physicians. Budd, whose firm helped name a new drug for depression, Viibryd, was hoping to convey … Next Page »

Comments (11) | Reprints | Share:          

Randal “RJ” Kirk is building another biotech winner. The billionaire Virginian, who is chairman of Newton, MA-based pharmaceutical company Clinical Data (NASDAQ:CLDA), has been a catalyst for the firm’s new FDA approval of an antidepressant.

Kirk, a major shareholder in Clinical Data for years and chairman since 2004, has advocated for the 39-year old firm’s transformation from a diagnostics and research company to a pharmaceutical developer, according to company CEO Drew Fromkin. This strategy paid off hugely yesterday as the company’s stock surged by more than 50 percent on news that its antidepressant, vilazodone, had garnered FDA approval on January 21.

Vilazodone’s approval is among of string of successes that Kirk, an attorney by training, and his business partners have had in biotech. He was previously founder and chairman of Radford, VA-based New River Pharmaceuticals, which was sold to the Ireland-based drug company Shire for $2.6 billion in 2007. New River developed a drug for attention deficit hyperactivity disorder (ADHD) that Shire markets as Vyvanse. Forbes reported that Kirk cleared $1.2 billion from Shires’s buyout of New River. He had also made millions on the 1998 sale of a Virginia drug distribution company he co-founded called General Injectables & Vaccines.

“His ownership and involvement are clearly material,” says Robert Hazlett, a biotech analyst for BMO Capital Markets, who gives Clinical Data’s stock an “outperform” rating. “He has a longstanding presence in healthcare broadly and drug development specifically.”

Kirk controlled about … Next Page »

Comments (1) | Reprints | Share:          

Arena Pharmaceuticals is getting ready to make another run for U.S. regulatory approval of its obesity drug, and now it has some clinical trial data that the FDA has said it wants to see.

The San Diego-based biotech company (NASDAQ: ARNA) is announcing today that its experimental weight loss treatment, lorcaserin (Lorqess), reached all three of its main goals in a clinical trial called Bloom-DM, which enrolled 604 overweight or obese patients who also have Type 2 diabetes. The study essentially showed that these patients, who are generally tougher to treat than other overweight and obese patients, had a similar experience to more than 7,000 patients who participated in the last two pivotal trials, Bloom and Blossom. Some details are being released today to investors, while more details are expected to come out later at a medical meeting and peer-reviewed scientific journal.

Today’s data release represents Arena’s hope for redemption after what has been a brutal couple of months. The company’s application to market its treatment was ripped by FDA staff in September over some concern about tumors in rats, and then the agency formally turned down Arena’s application to start selling lorcaserin, saying it offered only “marginal” ability to help people lose weight. The FDA, in its complete response letter to the company, recommended that the company turn in detailed reports on this other study, Bloom-DM, to provide more evidence that the drug helps people who face the doubly whammy of obesity and diabetes. An estimated two-thirds of people in the U.S. are considered overweight or obese, which puts them at risk for a slew of other chronic, and costly, ailments like cardiovascular disease, arthritis, and depression.

So while the potential benefit—and market—for an effective weight loss would be huge, the FDA has also made clear through its actions this fall against both Arena and one of its competitors, Mountain View, CA-based Vivus (NASDAQ: VVUS), that any new drug developer must clear an extremely high bar for safety and effectiveness if it wants to start selling a new product to millions of people in need. San Diego-based Orexigen Therapeutics (NASDAQ: OREX), the next obesity drug developer in line at the FDA, will either learn from these lessons and advance onto the market, or step into yet another buzz saw when it appears before an FDA advisory panel on December 7.

Arena CEO Jack Lief wasn’t making any predictions about whether the Bloom-DM study will put his company over the top, but he expressed his usual confidence, and how this latest study will help buttress his argument that lorcaserin deserves a spot in the U.S. market.

Jack Lief

“Patients with type 2 diabetes have much more difficulty losing weight than other patients. And although we believed they would benefit, you have to demonstrate that. This study has demonstrated they benefit as well,” Lief says.

Arena plans to crunch the numbers on this latest study, and discuss the new evidence with the FDA before the end of the year, Lief says. Arena’s partner, Japan-based Eisai Pharmaceuticals, remains committed to pushing forward with the program, a spokesman said.

OK, for the stat nerds out there who want to want to dig into what we’ve learned here, now you can get your hands dirty.

Patients who entered this study had an average body mass index of 36, Lief says. People with a body mass index of 30 or greater—which translates to 5-foot-10 and 209 pounds—are considered obese, according to the National Heart, Lung, and Blood Institute. They also entered the study with an average score of 8.0 on their hemoglobin A1c counts—an important measurement of blood sugar control. People are generally considered normal at … Next Page »

Comments (1) | Reprints | Share:          

BrainCells Inc., the San Diego-based developer of drugs for depression and other neurological disorders, said today it has acquired a drug from London-based Proximagen that could have potential against various psychiatric diseases. BrainCells has agreed to pay as much as $51 million in upfront and milestone payments, plus royalties on future product sales, for the right to develop sabcomeline. The drug has been studied in 3,000 patients, and has been tested against Alzheimer’s disease and schizophrenia. BrainCells said it plans to study the compound as a treatment for depression.

Comments | Reprints | Share:          

Acquisitions were a big theme in the New England-area deal news this past week. We also saw several funding rounds and an intellectual property deal.

—Providence, RI-based Alektrona, a maker of smart-grid software and hardware, grabbed $250,000 in funding from the Slater Technology Fund, also of Providence. The money comes as part of a $510,000 seed funding round, which also included backing from NStar’s former chief information officer, Gene Zimon.

—Cara Therapeutics, a developer of treatments for pain and inflammation, raised $15 million in a Series D funding led by Rho Ventures. Alta Biopharma, Ascent Biomedical Ventures, CT Innovations, Devon Park BioVentures, Healthcare Private Equity, Mitsubishi International, and MVM Life Science Partners also participated in the financing for Shelton, CT-based Cara, which has now raised a total of around $43 million.

—Boston-based Gazelle, a website that facilitates the selling and recycling of used electronics, raised $12 million in a Series C funding round led by Physic Ventures. The financing also included Gazelle’s existing investors, Venrock Associates and RockPort Capital Partners. Gazelle says it will put the money toward scaling its businesses to meet new customer demand.

—Acton, MA-based Mintera, an optical-switch maker, was acquired by Oclaro, a San Jose, CA-based optical communications and laser technology firm, for $12 million in cash upfront. The deal could total $32 million if Mintera brings in revenues of $70 million over the next year and a half. Its revenue for the most recent fiscal year was in the neighborhood of $20 million.

—Euthymics Bioscience, a Cambridge, MA-based startup working on depression treatments that lack the side effects of many existing drugs, said it pulled in the first tranche of its Series A funding round, led by Novartis Venture Funds and Venture Investors. The financing could total … Next Page »

Comments | Reprints | Share:          

We saw a number of lesser-known New England-area biotechs surface with funding announcements, as well as feature stories looking at company strategies and drug development trends.

—Inverness Medical Innovations, a Waltham, MA-based maker of consumer diagnostic tests and disease management tools, announced it had changed its name to Alere, and shifted its stock symbol on the NYSE from “IMA” to “ALR.”

—Brighton, MA-based drugmaker Surface Logix raised $4 million of a round of equity, options, and warrants that could total $4.6 million. The startup is working on treatments for obesity and diabetes, and was founded with technology from Harvard chemist George Whitesides in 2001.

—-Lexington, MA-based Taris Biomedical, a spinoff company from MIT making a drug-device combination treatment for bladder conditions, announced it had hired Sarma Duddu as its president and CEO. Duddu comes from Cima Labs, a subsidiary of the Frazer, PA-based drugmaker Cephalon (NASDAQ: CEPH).

—Ryan took a look at Cambridge, MA-based Stromedix, a biotech company that is developing drugs to target the process, called fibrosis, that causes patient’s bodies to reject transplanted kidneys. The drug, STX-100, is licensed from Biogen Idec (NASDAQ: BIIB), and was originally projected to hit a mid-stage clinical trial by this point, but has been delayed a bit. Stromedix CEO Michael Gilman told Ryan he expects the FDA will let the kidney fibrosis study advance next year, and the firm has already gotten the regulatory green-light to begin mid-stage clinical trials of its treatment for a lung disease called ideopathic pulmonary fibrosis.

—DiagnosisONE, a Nashua NH-based provider of software for clinical-decision support, raised $5 million from Edison Venture Fund, to put … Next Page »

Comments (1) | Reprints | Share:          

Boston has a new startup working on what could help people battle depression, even if they didn’t respond to prior treatment, and without the weight gain and sexual dysfunction side effects that have plagued the field for years.

Cambridge, MA-based Euthymics Bioscience is off and running toward that goal, having secured the initial installment of a Series A venture financing that could total $24 million if the company hits a series of milestones. The deal was led by Novartis Venture Funds and Venture Investors, and the syndicate includes Hambrecht & Quist Capital Management, GBS Venture Partners, and the State of Wisconsin Investment Board. The company is led by chairman Campbell Murray of Novartis Venture Funds, and CEO Anthony McKinney, a former executive at San Diego-based Orexigen Therapeutics (NASDAQ: OREX), and Genzyme (NASDAQ: GENZ).

The company (pronounced you-THIGH-mix) takes its name from the Greek word for a good mood. The company got started by spending $2 million to acquire what was left of Somerset, NJ-based DOV Pharmaceutical. What DOV learned, as it was running out of money in late 2008, was that it might have developed the first drug that strikes a delicate balance by affecting three neurotransmitters in the brain—serotonin, norepinephrine, and dopamine. Early data from a study of 56 patients suggested the DOV product might be able to adjust those neurotransmitters in just the right way to get the attractive combination of a drug that improves mood, without causing sexual dysfunction, weight gain, or cognitive impairment that sometimes happens with an earlier generation of depression meds.

Anthony McKinney

If this can be proven in clinical trials, then Euthymics could have an important new treatment for a worldwide market estimated to be worth $20 billion a year.

“People have tried to do this for 20 years, and no one has been able to get in one molecule that modulates all three transmitters,” McKinney says.

Euthymics has an interesting backstory. While DOV was struggling during the fall of 2008, and investors were focused on its drug candidates at a later stage, the company quietly generated some promising early results from a compound then called DOV 21,947, and now dubbed EB-1010. Orexigen CEO Gary Tollefson, who had a long record at Eli Lilly working on huge neurology drugs like fluoxetine (Prozac) and duloxetine (Cymbalta), heard the buzz about this triple-acting anti-depressant. Tollefson, who was gravely ill with cancer at the time, looped in his chief operating officer McKinney, as they sought independent statistical validation for whether the DOV finding was legit.

They liked what they saw from the clinical trial, and also the business opportunity. Many of the older antidepressants have gone generic, and they don’t work for as many as two-thirds of patients. Some psychiatrists have experimented with combinations of generic drugs that work against serotonin, norepinephrine, and dopamine, but the regimen is hard to follow, and nobody had put a drug together that really worked as a single pill. Others had tried to do it … Next Page »

Comments (1) | Reprints | Share:          

A spate of financings dominated the headlines in the past week. We’ve got it summarized for you here.

—Brain Cells’ experimental antidepressant was no better than placebo in a mid-stage clinical trial, but the results hinted the drug might help people with a combination of depression and anxiety. Thecompany hasn’t decided what to do next, although it might pursue development of the drug for people with both depression and anxiety or post-traumatic stress.

—Cognionics, a startup formed by graduate students in engineering, science and business at UC San Diego, the Salk Institute, and The Scripps Research Institute, won the top prize of $25,000 in funding and $15,000 in legal services at the UCSD Entrepreneur Challenge. The company aims to develop a wireless sensor that can be used for remote monitoring of cardiac data and other health information.

—Otonomy, a company working on drugs for disorders of the ear, converted $10.5 million in bridge loans from Avalon Ventures into equity. The startup is working on drugs for Meniere’s disease, which causes dizziness and leads to hearing loss, and otitis media, an inflammation of the middle ear.

—Illumina was among five companies to receive letters from the FDA notifying them that the agency believes that genome-sequencing tests offered directly to consumers are medical devices requiring FDA approval. Illumina (NASDAQ: ILMN) got a letter because it knowingly provides two of the companies that sell genetic tests—23andMe and deCode Genetics—with gene-chip technology that has not been approved for clinical use. Besides Illumina, 23andMe and deCode, Navigenics and Knome received the FDA letters, which do not order the companies to stop selling the tests, but suggest it may not be legal to market certain genetic testing services. 23andMe and Navigenics are based in the San Francisco Bay area and Knome is based in Cambridge, MA.

—Bruce identified a trio of life sciences companies that raised fresh financing. Cylene Pharmaceuticals, a developer of cancer drugs, raised $6.1 million; Access Scientific, a medical device company, nabbed $2.6 million; and Ridge Diagnostics raised $577,000.

—Trius Therapeutics and the FDA agreed on a special protocol assessment establishing the design of a pivotal clinical trial for Trius’ lead drug candidate, torezolid phosphate. The company postponed IPO plans in March after new FDA guidelines delayed the pivotal antibiotic study.

Comments | Reprints | Share:          

New England-area deal-making news came back with a roar in the last week. We saw headlines of stock sales, myriad stages of venture funding, acquisitions, and a top venture capital firm’s moves to raise money for a new fund.

—Etouches, a Ridgefield, CT-based meeting planning company turned software-as-a-service business, said it raised $2.5 million in its first round of venture capital funding, led by Greycroft Partners. Cava Capital and Connecticut Innovations also participated in the financing for etouches, which makes software for managing events.

—Healthrageous, a maker of software designed to give personalized medical advice on issues like weight loss and diabetes, raised $6 million in Series A funding. North Bridge Venture Partners led the investment, and is also housing the startup in its Waltham, MA, offices until it finds Boston-area office space. Egan-Managed Capital and Long River Ventures also kicked in cash, which will go to hiring more engineers and other staff, and development of a platform for smartphones.

—New Haven, CT-based antibiotics developer Rib-X Pharmaceuticals pulled in $5.5 million of a round of debt and options that could reach $15 million, an SEC filing showed. The company took in a new CEO in March and has raised more than $158 million before the newest funding, since its founding in 2000.

—Exogenesis, a Billerica, MA-based developer of technology for improving implantable medical devices’ interaction with the body, raised $3.7 million of a planned $4.1 million round of equity funding. The company lists members of Inflection Point Ventures and Venture Capital Fund of New England as members of the board, according to a regulatory filing.

—Sonicbids, whose website enables bands to discover and book gigs, said it acquired San Francisco-based ArtistData. No financial terms were disclosed for the deal, but Boston-based Sonicbids says that ArtistData, which serves as a platform for publishing gig information, will be … Next Page »

Comments | Reprints | Share:          

Clinical Data (NASDAQ:CLDA), the Newton, MA-based drug developer, reports today that it has closed on the sale of 2.24 million shares of common stock. The stock offering brought in $32 million, of which the company plans to clear $30 million after expenses. The company is pursuing approval of its first drug, vilazodone, for treating depression. Last month, the FDA agreed to consider the company’s application for approval of the drug. Here’s a recent feature on Clinical Data’s big plans in the lucrative market for anti-depression pills.

Comments | Reprints | Share:          

BrainCells Inc. has made its name with a novel approach for treating depression, by stimulating the growth of new neurons. Now the San Diego-based company will have some hard choices to make, since a clinical trial showed its drug doesn’t work any better than a placebo for most people with depression. The results also suggest, though, that the drug might help those with a combination of depression and anxiety.

The findings were from a mid-stage study of 90 patients who were randomly assigned to get a once-daily dose of the BrainCells drug, a three-times daily dose, or a placebo. The patients were severely depressed, and weren’t helped by anti-depressant drugs. The study found after six weeks that the BrainCells drug was no different than a placebo in the overall treatment group, although it did appear to offer a benefit when given three times a day to a subpopulation of patients who had a combination of depression and anxiety. The drug was well-tolerated, BrainCells said. Results are being submitted for presentation at an upcoming medical meeting.

Any savvy biotech watcher knows that the word “subpopulation” sounds like a company digging around for something positive after the fact, which the study wasn’t designed or statistically powered to prove. BrainCells CEO Jim Schoeneck and chief scientist Carrolee Barlow acknowledge that the result isn’t statistically significant, and really is more of a hypothesis-generator for future trials than anything else. The company hasn’t made any firm decision yet on what its next move will be, although it will consider pursuing post-traumatic stress disorder and the combination of major depressive disorder and generalized anxiety.

An estimated 40 percent of depressed patients have these sorts of overlapping diagnoses, Schoeneck says. Only about 30 to 40 percent of depressed patients today are thought to benefit from existing anti-depressants. That’s still a very big number, and big potential market, when an estimated 20 million people in the U.S. are thought to suffer from depression.

Jim Schoeneck

“What we are excited about is that we enrolled patients with increased anxiety, and were able to treat a more difficult population,” Barlow says.

This experimental drug, BCI-540, is one of the two primary assets at BrainCells Inc. The drug was previously tested by Japan-based Mitsubishi Pharma as an Alzheimer’s treatment. BrainCells Inc. negotiated for a license to the compound after its in-house platform, which uses neural stem cells to create neurons in a lab dish, showed the drug could spark the kind of effect it likes to see, with an impact on the differentiation and survival of new neurons.

The other potentially valuable treatment at BrainCells is called BCI-952, a combination of a generic drug and a dietary supplement. Back in July, that drug showed “comparable” effectiveness to existing anti-depressants in a mid-stage study of 142 patients, according to that study’s lead investigator, Massachusetts General Hospital’s vice chair of psychiatry, Mauricio Fava. That unorthodox drug candidate is currently being formulated into a single pill that would be more convenient and commercially viable, Schoeneck says. The combination intrigued researchers because it offers fewer side effects than the existing meds.

It will be interesting to see if BrainCells presents the full results from the most recent BCI-540 study at a medical meeting, and what might be learned from it. Some of the investigators on the trial are excited about the result, Barlow says, because they saw a clinically meaningful benefit for some very hard to treat patients. But the company emphasized it is still combing through the data itself, and can’t really say which patients responded better than others or what it is about their genetics or environment that makes them respond better than the rest.

I asked Schoeneck if BrainCells has the capital it needs to take the next step in development on its own, and he says the company does. BrainCells Inc. raised $50 million back in April 2008, right before the worst of the recession became apparent. But back when I met with Schoeneck and Barlow at the JP Morgan Healthcare Conference in January, Schoeneck said the company will either need to raise more capital, or secure a Big Pharma partnership at some point. If and when that point comes, the company will have to have some pretty compelling data that BrainCells has discovered a truly different and powerful way for treating depression.

Comments (1) | Reprints | Share:          

Think of it as iCounseling. eCBT Trauma enables users with PTSD to categorize their thoughts and feelings, graph them over time, and e-mail the information to a caregiver. This app is built around cognitive behavioral therapy (CBT), an approach that involves systematically documenting thought patterns and emotions as a way of targeting ailments such as depression, eating disorders, and posttraumatic stress disorder. The $1.99 app for iPhone and iPod, released by Pittsburgh, PA-based MindApps in February, also features a linked directory of therapists, PTSD support groups, and information on the condition.

Comments | Reprints | Share:          

There’s a quilt hanging on the wall at PatientsLikeMe, made with different patches of fabric from members of the firm’s online community of multiple sclerosis patients. “We have it hanging in our office because it represents so much of what our site is about—individual experiences that, when pulled together, give you a very powerful collective view of patients living with MS,” says PatientsLikeMe co-founder and president Ben Heywood.

The Cambridge, MA-based firm has stitched together a growing business by facilitating peer-to-peer interactions among patients on its social networking site, and selling anonymous data from its members to customers in the research and pharmaceutical markets. The number of patients on the site grew impressively from about 25,000 in December 2008 to more than 55,000 as of early this month (not like the eye-popping number of people on Facebook or Myspace, but significant for the healthcare field, according to Heywood). The jump in users and the overall size of its business has caused the company to expand its workforce to from 20 employees a year ago to 30 employees today, says Heywood.

Yet patient social networking sites remain in search of a solid footing in healthcare. Heywood says that PatientsLikeMe generates the kind of real-world data on the health of patients that can’t be found anywhere else. He might be right. Traditional clinical databases used to track the health of patients might not offer the type of personalized information that a patient would share among her peers on a site like PatientsLikeMe. The company’s big challenge, though, is to convince more paying customers of the value of the data its members generate. This challenge is compounded by the fact that the healthcare industry is generally loath to break from convention and adopt new technologies.

Nevertheless, PatientsLikeMe has provided services such as customized research on patient health and Web-based surveys for some of the top-20 pharma outfits in the world, Heywood says. The company doesn’t disclose the identities of all its customers, but does name the Swiss drug giant Novartis and the Google-backed personal genomics firm … Next Page »

Comments (2) | Reprints | Share:          

Alkermes is known for making drugs stable and long-lasting in the bloodstream. Today, the Waltham, MA-based company is announcing it has invented a new way to do the same thing, but at lower cost and with fewer manufacturing hassles. There’s also the potential that the new technique could be used on more drugs, and lead to greater convenience for patients.

The company (NASDAQ: ALKS) is announcing today that it has invented a new platform, and filed a raft of patent applications, around what it calls LinkeRx technology. Alkermes intends to prove the value of this idea first with a modified version of aripiprazole, a $2 billion-a-year antipsychotic medication marketed by Bristol-Myers Squibb as Abilify. I got the rundown on what’s different about the new technology, and the business strategy behind it, during a conversation yesterday with CEO Richard Pops.

For those new to the story, Alkermes has built its company around the idea of taking existing drugs and packaging them in biodegradable polymer microspheres that last longer in the blood. This allows patients to take fewer injections, and avoid peaks and valleys of drug concentration in the blood that can come from once-daily therapies. The Alkermes technology is currently used in Johnson & Johnson’s risperidone (Risperdal Consta), a $1.4 billion annual seller, which helps schizophrenia patients stay on the meds they need, Pops says. Alkermes is also providing critical enabling technology for exenatide once-weekly, a diabetes treatment that San Diego-based Amylin Pharmaceuticals and Eli Lilly are trying to get approved by the FDA.

Richard Pops

While the microsphere technology represents Alkermes’ past and present, the new technology will be a big part of the future, Pops says.

“This is actually a big advance,” Pops says. “It’s been a glimmer in our eye for the last several years.”

This requires a little bit of background before diving in. Today, Alkermes uses an expensive, proprietary, sterile manufacturing process to encapsulate drugs with a biodegradable polymer in a microsphere. The polymer, when exposed to body temperatures, is designed to slowly dissolve and release the active drug. The finished product comes in a dry powder, which needs to be kept refrigerated so it doesn’t release the drug prematurely. It has to be mixed with a water-based solution, and shaken, before it can be injected into the patient.

“We said, ‘Let’s get rid of the polymers and see if we can re-engineer the molecule itself,” Pops says.

So Alkermes’ chemists went to work on LinkeRx. The method uses a proprietary linker and chemical tail that’s attached to an oral drug, which creates a new molecule that’s long-lasting and injectable. The newly engineered drugs don’t need to be kept in a refrigerator, and can be distributed … Next Page »

Comments | Reprints | Share:          

San Diego-based BrainCells Inc. surprised the field of psychiatry last August, when a clinical trial showed that it could relieve symptoms of depression with an odd combination of an anxiety drug and a common dietary supplement. Six months later, the company is in the thick of plotting the next steps to turn this into a potential commercial hit.

In its provocative study of 142 patients, BrainCells showed that a low-dose generic buspirone, an anti-anxiety med, and the dietary supplement melatonin were able to achieve “comparable” effectiveness to standard treatments, known as selective serotonin reuptake inhibitors, according to Mauricio Fava, the vice chair of psychiatry at Massachusetts General Hospital. The company has been pretty quiet since then, but I caught up with BrainCells CEO Jim Schoeneck and chief scientist Carrolee Barlow a couple weeks ago at the JP Morgan Healthcare Conference to find out more about where BrainCells is going to take this drug in the future.

The data to support the BrainCells drug is potentially a big deal both scientifically and medically. The new drug is thought to have a completely different way of working than standard meds, by stimulating the growth of new neurons in the brain, what’s known as neurogenesis. The new mode of treatment could have a big impact on mental health, because an estimated 20 million people in the U.S. suffer from depression, the standard drugs don’t work for everybody, and they can cause side effects like weight gain and sexual dysfunction. The BrainCells combination drug didn’t show any side effects like that, so it might be an important new option for millions.

“The depression data we showed has really been the big story over the past few months,” Schoeneck says.

Before anybody gets too excited, this drug isn’t going to arrive at the corner pharmacy anytime soon. BrainCells still has a lot of work to do before it can leap ahead into a pivotal trial that could win FDA clearance to start selling the drug, code-named BCI-952. The earlier trial involved separate pills containing buspirone and melatonin. That’s not really commercially practical because both drugs are cheap and commonly available as individual components, and it’s hard to make sure patients regularly comply with a two-drug regimen.

Jim Schoeneck

So BrainCells has been working on turning BCI-952 into a proprietary oral pill that would be taken once a day, before bedtime, Schoeneck says. The company is also working to make sure it has strong intellectual property around this new molecule, he says.

Once the company is confident that it has the formulation right, it will run a similar mid-stage clinical trial. Schoeneck wouldn’t say much about what this trial will look like, but it will be a rigorous study in which patients are randomly assigned to get the drug or a placebo, and doctors and patients won’t know which is which.

The data is obviously important, but the company has been explaining to a lot of its peers in the neurology world how it came up with such a surprising finding without just chalking it up to luck. That requires a bit of explanation of BrainCells’ drug discovery platform. Back in December, Barlow said she was “swarmed” when she gave a poster presentation at the American College of Neuropsychopharmacology (try saying that one five times fast).

BrainCells, as I described in this feature back in December 2008, was built on a combination of technologies from the labs of Fred “Rusty” Gage at the Salk Institute, and Rene Hen and Eric Kandel at Columbia University. The platform uses neural stem cells to create adult … Next Page »

Comments (3) | Reprints | Share:          

The new CEO of Quanterix isn’t afraid to dream big, and say it out loud.

“We participate in an $8 billion market,” says CEO Dave Okrongly, referring to the business of antibody-based diagnostics. “Quanterix can be a platform for that whole $8 billion market.”

Okrongly was named CEO of the Cambridge, MA-based company in September, and now that he’s been settling in for a while, I got a fresh update just yesterday. The company is the latest brainchild of Tufts University chemistry professor David Walt, who previously hit gold with Illumina (NASDAQ: ILMN), the San Diego-based genetic analysis powerhouse. Quanterix hasn’t said much publicly since it raised $15 million in venture capital back in August 2008, so I’ve been curious for some time about the company’s game plan for approaching the first segments of that $8 billion antibody-based diagnostics market.

Before diving into that, I first wanted to know a little about Okrongly. It turns out he’s got a doctorate in chemistry, and a resume with a lot of commercial experience, most recently as the senior vice president of the molecular diagnostics unit at Siemens Healthcare Diagnostics. Earlier in his career, he caught the startup bug at Applied Immune Sciences, an early gene therapy company that was acquired in 1995 by what’s now Sanofi-Aventis.

So while Okrongly, 51, rose in the ranks at big companies, and introduced a number of clinical diagnostic tests around the world, he felt the urge to come back to a startup to create something new. When he first heard about Quanterix, he didn’t think it was for him. “It seemed early and raw,” he says.

Then he met personally with Walt, who changed his mind. “I thought, holy cow, this could change the whole way we do immunodiagnostics. I gotta give this a run. This is a transformative technology with top-notch people around it.”

Dave Okrongly

Walt is equally enthused about the new leader at Quanterix. “Dave has exactly the right blend of diagnostics experience and strong technical background. He has helped push the company’s market strategy forward while helping it achieve its technical milestones,” Walt says.

The initial idea at Quanterix is to find a way to detect trace quantities of proteins in the blood, which could be an early warning sign for cancer or a neurodegenerative disease like Alzheimer’s or Parkinson’s. Quanterix says its test is about 1,000 times more sensitive than the gold standard ELISA assays. The older tests employ specific antibodies that are made to bind with certain biomarkers, known as antigens.

Some of these older tests can be quite cheap and reliable, but they also have their limits. One of the emerging ideas in biology is that tumors and other diseased tissues spill off specific proteins in the bloodstream, but these proteins generally come in trace amounts too small to be detected by the standard ELISA tests. The Quanterix system is designed to detect thousands of single molecules simultaneously, with proprietary chemistry and what the company calls “a relatively simple” instrument with a light source, optics, a digital camera, and an automated handling system. Software is then used to analyze the images.

Quanterix is betting that its ultra-sensitive tests can fill some of the gaps that ELISA tests struggle with. One well-known example is the prostate-specific antigen (PSA) screening test … Next Page »

Comments | Reprints | Share: