This week’s New England deals list includes a mix of life sciences and IT companies.

—Lexington, MA-based T2 Biosystems, a developer of a system for identifying biological substances such as proteins, small molecules, viruses, and DNA more cheaply and quickly than existing methods, took in $23 million in Series D financing. New T2 investor Aisling Capital led the round, which also included return backers Flagship Ventures, Polaris Venture Partners, Flybridge Capital Partners, Physic Ventures, Partners Healthcare, Arcus Ventures, RA Capital, Camros Capital, and WS Investments.

—Boston-based online data storage firm Carbonite raised $62.5 million in an initial public offering, selling 6.25 million shares at $10 per share. That was the bottom end of a range ($10 to $11) that Carbonite (NASDAQ: CARB) had already lowered earlier on the day it priced. Late last month it had said it expected to price the shares at $15 to $17 each.

—My colleague Greg wrote about how Harvard University’s Office of Technology Development is looking to raise another fund of $20 to $30 million, up from its $10 million “Accelerator Fund,” created to help the school’s scientists commercialize their inventions.

—Amesbury, MA-based Fluidnet, a maker of electronic infusion pumps for administering IV fluids, raised $19.8 million of an offering that could hit $25 million, according to an SEC filing.

—Proteon Therapeutics, a Waltham, MA-based kidney and vascular drug developer, nabbed $15.2 million from 19 investors, an SEC filing showed.

—Lexington-based Pulmatrix raised $14 million in Series B financing, to bring its total funding raised to $60 million. The investment came … Next Page »

Comments | Reprints | Share:          

If you were to poll Wall Street a few months ago for impressions of Alkermes’ naltrexone injection (Vivitrol), you’d hear a number of things. Most aren’t good.

It’s a bust. They still own that? Who cares?

Seeing the name Vivitrol in my inbox, I must admit, makes me think first about a drug that never lived up to its promise in treating alcohol addiction, which triggers the “delete e-mail immediately” reflex. Waltham, MA-based Alkermes (NASDAQ: ALKS) knows that no one wants to hear rosy forecasts for this drug as a treatment for alcohol addiction. After more than four years on the market, it generated just $7.7 million in the final quarter of 2010. But Alkermes is hard at work now to see if this drug can mount a comeback by fighting another serious public health problem—addictions to opioid-based narcotics like heroin and prescription painkillers like oxycodone.

“Vivitrol in opioid addiction is a whole different ballgame than Vivitrol in alcohol,” Alkermes CEO Richard Pops said when we chatted a few weeks ago in San Francisco. As Cory Kasimov, an analyst with JP Morgan who surveyed doctors in December put it, “there is indeed an established pharmaceutical marketplace for the treatment of opioid dependency (unlike alcoholism) and physicians are interested in using Vivitrol.”

The FDA first cleared the once-monthly injectable version of Vivitrol as a treatment for alcohol addiction in 2006. The data to support its safety and efficacy was strong, Pops says. Alkermes’ partner, Frazer, PA-based Cephalon (NASDAQ: CEPH) was optimistic, pumping in a lot of money and getting little in return, Pops says, before it basically gave up and handed the drug back to Alkermes in December 2008.

Richard Pops

Not much new really happened for this product until last October, when the FDA approved Vivitrol for its second use, as a treatment for opioid-based addictions. Janet Woodcock, the director of FDA’s Center for Drug Evaluation and Research said that day in a statement that Vivitrol’s new approval, “represents a significant advancement in addiction treatment.”

While skeptics breezed past that announcement, Alkermes has been working behind the scenes to better understand this market. As Pops puts it, the customers and their motivations are completely different. While there are an estimated 18 million people in the U.S. with alcohol dependence problems, only about 1 million seek treatment, and most of them just get counseling. In contrast, about 1.6 million people in the U.S. are addicted to opioid-based drugs, and about three-fourths of them seek treatment, which comes in a combination of medication and counseling, Pops says. Many opioid-based drug addicts also cycle through the criminal justice system over and over, costing states and counties a fortune. Massachusetts alone spends more than $100 million a year on one therapy buprenorphrine and naloxone (Suboxone) to help treat opioid addiction, and $300 million for methadone (the drug doctors often use to wean people off heroin). Massachusetts alone spends more money on dealing with substance abuse than it does on higher education, Pops says. It’s little surprise that in an era of budget cutting, Gov. Deval Patrick has taken a personal interest in what his constituents at Alkermes have come up with—not just because it might bring business revenue into the state, but it might save the state some money and trouble.

While alcoholics get counseling as the standard of care, opioid-drug addicts tend to get Suboxone, which has become a $1 billion-a-year seller for U.K.-based Reckitt Benckiser Pharmaceuticals, Pops says.

There are important differences between that drug and the new one from Alkermes. The established product is essentially another form of opioid, like methadone, which keeps people … Next Page »

Comments (2) | Reprints | Share:          

When biotech firms get bad news from the FDA, the fallout can have a dramatic impact on everyone from the CEO to the bench scientists. But Waltham, MA-based biotech firm Alkermes (NASDAQ:ALKS) was able to escape a disappointing regulatory ruling last month without any impact on its day-to-day operations, Richard Pops, the company’s chairman and CEO, says.

Perhaps it’s a testament to the 23-year old biotech company’s strength. Last month, the FDA turned down a request for approval of a once-weekly version of the diabetes drug exenatide (Bydureon), which has been co-developed by San Diego-based Amylin Pharmaceuticals (NASDAQ:AMLN), drug giant Eli Lilly (NYSE:LLY), and Alkermes. Though Alkermes’s stock price has dropped by more than 20 percent since the news, the company’s operations have remained the same and it hasn’t made any dreaded layoffs.

“The energy level around the company is so high,” Pops says. “It’s so interesting because when you’ve seen the Bydureon actions at the FDA, if you came to Alkermes, you’d realize that operationally nothing has changed.”

It often takes genuine optimism and stamina to overcome lumps in the biotech game. Pops certainly has both traits. He took over as CEO last September after taking a two-year break from the job, which he previously held from 1991 to 2007. Even more, however, the company has steady revenue from two marketed products, primarily from the long-acting schizophrenia drug risperidone (Risperdal Consta), which is marketed by its partner Johnson & Johnson (NYSE:JNJ). Its second product is its naltrexone formulation (Vivitrol) to treat patients trying to kick alcohol and opioid dependence.

Indeed, the Bydureon news was a setback for Alkermes’s bottom line. The drug was expected to be a new and important source of product revenue for the company in the years ahead. That potential income stream will be delayed by more than a year as Amylin expects to reply to the agency’s request for more data on the treatment by the end of 2011. Though the drug relies on Alkermes’s drug-delivery technology, the company has no day-to-day responsibility for producing the drug or working with regulators to get it approved, Pops says.

This is important because it allows Alkermes to focus its internal research and development, while letting Amylin and Lilly do the heavy … Next Page »

Comments | Reprints | Share:          

Seattle-based Omeros (NASDAQ: OMER) said today that the National Institutes of Health has provided a four-year, $3.6 million grant to support mid-stage clinical trials of the company’s experimental anti-addiction drugs. The trials will examine whether the new drugs can help people suffering from addiction to opioid-based painkillers, nicotine, and alcohol, as well as compulsive behaviors like eating disorders. The trials will be conducted at the New York State Psychiatric Institute.  This is the second NIH grant the company’s anti-addiction program has received this year, Omeros said.

Comments | Reprints | Share:          

Alkermes (NASDAQ: ALKS), the Waltham, MA-based biotech company, is announcing today it has filed an application with the FDA to start marketing a long-lasting version of naltrexone (Vivitrol) for people who are addicted to opioid-based narcotics. The Alkermes treatment, a once-monthly injection, is already approved by the FDA for treating alcohol dependence. Alkermes has asked the FDA for a faster-than-usual six-month review of its new application.

Comments | Reprints | Share:          

Cambridge,MA-based biotech Alkermes said this morning that its long-acting naltrexone injection (Vivitrol) was more effective in treating opioid drug dependence than placebo in a Phase III clinical trial. The 250-patient clinical trial compared urine samples of patients who took the firm’s once-per-month injection of naltrexone versus those who took placebo over the last 20 weeks of a 24-week treatment period. Alkermes (NASDAQ:ALKS) said that it plans to file an application with the FDA for approval of its drug for treating opioid dependence in the first half of 2010. The FDA approved the drug for treating alcohol dependence in 2006.

Comments | Reprints | Share:          

Richard Pops is not the sort of guy to sit still and patiently wait for good things to happen. He took the CEO job at Cambridge, MA-based Alkermes when he was just 28 years old, built it from 20 employees to more than 400, and made it profitable by the end of his 16-year run at the helm in 2007. But when we had breakfast earlier this year at the JP Morgan Healthcare conference in San Francisco, he made it clear he wouldn’t be satisfied until Alkermes cracked the top tier of biotech companies with multi-billion dollar valuations, like Amgen, Genzyme, and Biogen Idec.

So when Alkermes’ stock (NASDAQ: ALKS) turned in an anemic performance this year, sliding down 11 percent in the first nine months, it shouldn’t have come as a surprise that a shakeup was coming. Pops—a still youthful and energetic age 47—swooped back in from the chairman’s role on Sept. 10 and replaced his onetime operations deputy, David Broecker, as CEO. When I spoke with Pops by phone a few days later to ask him why he did that, he essentially said the company needed an operations guy two years ago to manage global supplies and manufacturing for partners, but now it needs to get back to its roots and build itself up some more.

“David was well-suited to the strategy of the company at the time,” Pops says. “Now we’re going back into building mode again.” At the Morgan Stanley healthcare conference a few days after he took over, Pops elaborated a bit, telling investors, “you’ll see more energy around building our proprietary platform and doing business deals, and action around building the company.”

Alkermes (ALK-er-meez) was founded in 1987, and like the usual biotech company, it lost money for its first 20 years. The company’s forte has always been its expertise in making existing drugs more stable and longer-lasting in the bloodstream, allowing for less frequent dosing. Instead of betting the company on one in-house compound, a common boom-or-bust strategy in biotech, Pops struck deals with various partners who could help pay the R&D bills along the way, and mitigate the company’s risk.

Richard Pops

That strategy had its benefits in making Alkermes profitable by 2006, but all those partnerships mean that Alkermes today isn’t as independent as some of its biotech peers. Alkermes’ biggest cash cow, risperidone (Risperdal Consta), is marketed by a partner, Johnson & Johnson. The next big thing in the pipeline, which Pops calls “maybe the most important diabetes drug ever developed,” is an injectable treatment for diabetes called exenatide once-weekly. Alkermes provided key enabling technology, and stands to collect a 7 percent sales royalty on the drug. But how much cash that generates for Alkermes will depend on marketing decisions made by Eli Lilly and Amylin Pharmaceuticals—if those companies can win FDA approval.

Alkermes has the full commercial rights to a treatment to help people kick alcoholism, naltrexone (Vivitrol), but it has never become a big seller. The company is hoping to re-ignite Wall Street enthusiasm for that drug by proving it works to help people kick addictions to opioid-based narcotics.

Alkermes was put on the defensive by Wall Street on Aug. 26, and it was partly due to a decision by one of its partners. That was when Alkermes disclosed in a regulatory filing that Johnson & Johnson decided to quit developing a once-monthly version of risperidone, which could potentially offer even greater convenience than the existing Risperdal Consta, which patients take twice a month. J&J made the decision to drop the less frequently dosed Alkermes drug after it won FDA approval in July for a different treatment, paliperidone palmitate (Invega Sustenna), that is also dosed once a month. JP Morgan analyst Cory Kasimov, who has an “overweight” rating on Alkermes stock, called J&J’s termination decision”disappointing” … Next Page »

Comments | Reprints | Share:          

Alkermes is in the midst of a makeover. The Cambridge, MA-based company (NASDAQ: ALKS) is morphing from a steady-as-she-goes developer of technology that improves drugs for partners into a more classic biotech that swings for the fence. This means Alkermes is now getting in the high-risk and high-reward game that goes with developing new drugs on its own.

Today, the company is inviting analysts and investors to its headquarters for its first annual R&D day to give them a detailed rundown of what to watch for in the company’s pipeline. Late last week, I got a preview from CEO David Broecker, who wanted to talk about a couple of new drugs for alcohol addiction and pain.

Alkermes (ALK-er-meez) has been around since 1987, and has became known in the biotech industry for its expertise in making existing drugs more stable and longer-lasting in the bloodstream, which allows less frequent dosing. It licensed that technology to partners to help improve their products, and it scored a hit with a long-acting version of the schizophrenia drug risperidone, marketed by Johnson & Johnson as Risperdal Consta. That drug has become a $1.3 billion-a-year hit, has helped mentally ill patients stay on their meds better than older oral pills, and it has turned Alkermes into a consistently profitable company.

The company is trying to take advantage of that financial stability, by building up an internal R&D staff of 80 to 90 people with the capability to develop drugs from start to finish. Those people have been working on two specific drug candidates in very early stages of development that Broecker says he likes for alcohol addiction and pain.

“This is a coming out party for us,” Broecker says. “We’re not your father’s drug delivery company anymore.”

The story of Alkermes’ bid to develop its own drug actually traces its roots back to October 2006, when the company bought a library of experimental compounds from Rensselaer Polytechnic Institute in Troy, NY. These drug candidates were designed to block or stimulate opioid receptors on cells. That means they might have the potential to block pain in the same way that morphine does, and also treat addictive disorders.

The first drug that’s beginning to emerge from this library is called ALKS 33. This drug is designed to be a once-daily pill for people trying to kick an addiction to alcohol. What’s intriguing is that this drug isn’t broken down by the liver, like most other drugs. That can be a problem for people with alcohol addiction, who tend to already have damaged livers, Broecker says. Instead, this drug is filtered out via the kidneys, and excreted via the urine. The drug has the potential to be more potent, or effective in lower doses, than naltrexone (Vivitrol), the product Alkermes currently markets for treating alcohol addiction.

ALKS 33 has already passed through a preliminary clinical trial of 16 healthy volunteers, which shows … Next Page »

Comments | Reprints | Share: