It was high society meets tech entrepreneurship last night. The setting: Bob Metcalfe’s townhouse in the Back Bay. The occasion: an annual reception and dinner before the finale of the MIT $100K Business Plan Contest, which takes place tonight at Kresge Auditorium. The players: all the finalists and event organizers, plus a few venture capitalists from Polaris Venture Partners, and other guests.

This year’s gathering marked the end of an era. That’s because, as you probably know, Metcalfe the VC and inventor—that’s Professor Metcalfe now—has moved to Texas as a faculty member at UT Austin and will probably sell his Beacon Street home. Which raises the question of where this stellar event will take place in future years. But let’s not worry about that just yet.

Metcalfe, dressed fashionably in a jacket, tie, and sneakers, greeted each guest at the door, and posed for pictures with $100K finalists and organizers (including Kourosh Kaghazian) throughout the evening. As an aside, one finalist said to me, “How do you ‘invent’ the Ethernet? Do you just decide one day you’re going to do it?” (I had to admit it was a good question.)

Each of the six teams gave a quick pitch from the staircase above the first-floor landing. As usual, it was an impressive array of businesses spanning high-tech, social tech, life sciences, cleantech, and energy.

William Sanchez from CoolChip Technologies (which won the $200K MIT Clean Energy Prize earlier this week) talked about developing more efficient heat sinks to save energy in data centers. David Jia from Upkast described his company’s virtual file system for managing your data from Facebook, Flickr, Google Docs, work drives, laptop, and personal devices, all on a unified Web interface. Lindsay Stradley and David Auerbach told the story of Sanergy, which is building low-cost toilets and sanitation systems, starting in Kenya, to collect waste and convert it to fertilizer and electricity.

Auerbach had the sound bite of the night: “Join us as we turn shit into gold.”

Next up, Anand Dass talked about Green Logistics (winner of the MIT Elevator Pitch Contest last fall), which plans to make special air-shipping containers that are lighter than conventional containers and collapsible, so as to save a bundle on jet fuel. Matt Hirsch and Vikram Anreddy introduced Sensactive, which is designing a 3-D gesture interface for mobile devices. (Best application: pulling the slingshot out of the screen in Angry Birds.) And Heather Kline from Zinaura Pharmaceuticals talked about her company’s drug candidate for epilepsy and pain treatment, which she says targets new seizure pathways without causing toxicity, addiction, sedation, or cognitive impairment.

Whew, that’s a very wide-ranging set of ideas. But over drinks and dinner, I got to know … Next Page »

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The FDA slapped down Santa Clara, CA-based Xenoport (NASDAQ: XNPT) and GlaxoSmithKline hard a year ago, but the companies have made a heck of a comeback. Glaxo and Xenoport proved it today by winning clearance from the FDA to start selling a new drug for restless leg syndrome. Shares of Xenoport rocketed up 57 percent in after-hours trading on the news.

The FDA is allowing the sale of Xenoport’s long-lasting form of gabapentin enacarbil (Horizant) to patients with moderate to severe forms of restless legs syndrome, a neurological disorder in which people have involuntary leg movements, frequently at night while trying to sleep. The drug is the first of its kind specifically approved by the FDA to treat this disorder.

Xenoport looked like it was in big trouble in 14 months ago, when the FDA shot down its application for approval of the new drug, citing data that suggested it may cause cancer in rats. The company lost two-thirds of its stock value right away, and responded by cutting half of its workforce to save cash after the FDA action. But now the FDA has apparently re-considered the risks and benefits offered by the new medication. Estimates vary on how many people actually have this disorder, and medical professionals will surely debate how often it warrants medical treatment, but Xenoport and Glaxo say something like 1.5 to 2.7 percent of adults in developed countries have “medically significant” symptoms.

Glaxo and Xenoport didn’t say in their statement how much the drug will cost.

“Clinical experience has substantiated that Restless Legs Syndrome, also referred to as Ekbom Disease, is a long-term neurological condition characterized by an urge to move caused by unpleasant sensations in the legs,” said Richard Bogan, chairman and chief medical officer of SleepMed of South Carolina in Columbia, SC, and a clinical trial investigator, in a Glaxo/Xenoport joint statement. “Our experience has shown that patients with moderate-to-severe primary Restless Legs Syndrome can suffer from a range of disruptive symptoms and may benefit from a new treatment option.”

Those who follow generic drug names will recognize gabapentin, as a generic drug that was once heavily marketed by Pfizer under the brand name Neurontin. That drug, while FDA-approved for epilepsy, achieved more than $1 billion status largely on the strength of sales for unapproved uses, known as “off-label” prescriptions. While it’s legal for doctors to prescribe a drug for that use, it’s illegal for companies to market a drug for a use which hasn’t been cleared as safe and effective by the FDA.

While doctors were prescribing gabapentin to patients with restless leg syndrome in the past, Xenoport developed its own new chemical entity that facilitated absorption, and which led to a process in which the new drug is converted into gabapentin.

The FDA-recommended dose of the new drug is 600 milligrams, taken once daily with food at about 5 pm, according to the Glaxo and Xenoport statement. The drug can affect patient’s ability to drive, sleepiness, and dizziness, the companies said.

Xenoport plans to discuss the FDA approval in more detail with investors at 9 am Eastern/6 am Pacific tomorrow on a conference call. I expect lots of chatter about how the questions on animal data were resolved, followed by a lot of pencil-sharpening about sales projections. Lots of people will be listening in, since Xenoport shares shot up $3.62, or about 57 percent, to $10 after the news broke.

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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 »

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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 »

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[Updated and corrected: 1 pm Pacific 9/9/10] NeuroVista has said next to nothing in public about how its technology works, until today. After sitting down for an exclusive interview with CEO John Harris at his office in Seattle’s Fisher Plaza, all I can say is that if its technology is half as good as he envisions, NeuroVista will transform the way people live with severe forms of epilepsy, and possibly other neurological diseases that affect millions of people.

[Correction: An earlier version of the story said NeuroVista was founded in 2005.] The company, founded in 2002, generated curiosity a year ago when it raised $33.8 million in a second round financing led by big-name venture firms like Advanced Technology Ventures, Delphi Ventures, Three Arch Partners, Sprout Group, and Foundation Medical Partners. Harris gave just one interview at the time, and issued a bland statement about improving quality of life for patients with epilepsy, without saying how the product works. “We haven’t even shown this technology to many venture groups,” he says.

So now the big secret can be let out: NeuroVista is developing an implantable device that is designed to predict a seizure before it happens, and can warn a patient to get ready. The concept has tantalized neurologists since the 1970s, because some, but not all, patients can feel a seizure coming on and prepare accordingly. But a systematic warning system has never come close to becoming a reality. If it can be done by detecting a coming storm in the brain’s electrical wave readout (known as an EEG), then patients could stop living in fear, and find a safe place to lie down right before a seizure, or maybe take a fast-acting drug to prevent it.

Or, if such a device could signal when the brain is behaving normally, then patients could feel confident going to work, or going out to a restaurant. An estimated 750,000 people in the U.S. could potentially benefit from such a system, because their seizures aren’t controlled by existing neuro-suppressant drugs, Harris says.

“People have been talking about this since the 1970s, and I wouldn’t say this is proven, but this the best approach I’ve seen,” says Brian Litt, a neurology and bioengineering professor at the University of Pennsylvania, and a member of the company’s scientific advisory board. “I decided these guys are coming up with a significant solution, and I can either help them with the concept or watch this bus pass my station.”

So there’s a big dream here, for sure. But how is this thing really supposed to work?

Harris showed me. It starts with a thin wire electrode that a neurologist would insert through the skull onto the surface of the brain to record EEG brain waves (hey, nobody said anything about this being minimally-invasive). The wire would run down the back of the neck … Next Page »

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Marlborough, MA-based Sepracor, maker of the insomnia drug Lunesta, announced today that it has signed an exclusive licensing deal with Bial covering development and commercialization of the Portuguese company’s anti-epileptic compound BIA 2-093 in Canada and the United States.

Under the terms of the agreement, Bial will receive $75 million up front and is eligible for up to $100 million in additional payments if it meets development and regulatory milestones. Sepracor is to handle the New Drug Application filing with the U.S. Food and Drug Administration, which it said in a press release should occur late this year or in early 2009. Presuming BIA 2-093 is approved by the FDA, Sepracor expects U.S. product launch by early 2010.

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