In 2004, I was an enthusiastic postdoctoral researcher in Eric Lander’s lab at the Broad Institute, with the job I had dreamed of since I was 10 years old. Growing up in Paducah, KY, I read Isaac Asimov’s The Genetic Code. And while I understood nothing of its meaning, I fell in love with the idea of being a human geneticist when I grew up.

I had a particular disease passion that had also been part of the plan since that time: autoimmune genetics. You see, I have a remarkable family. Nearly one-third of my relatives within 3 degrees have an autoimmune disorder. Even at my young age, I somehow knew those weren’t good odds. I knew that “things run in families” and that my family seemed to have autoimmunity in spades. You can imagine my surprise when 20 years afterwards, I realized I was, in fact, a human geneticist in the most renowned tank of genomic thinkers around studying autoimmune disease.

It was a thrilling time to be a geneticist. The human genome sequence was complete. The first thorough map of variation in the genome (single nucleotide polymorphisms or SNPs) was nearly complete. Unconstrained by data to the contrary, it felt like we were turning a corner to truly identify the variation that conferred risk to disease.

But in May of 2004, I began to get very nervous because of an unexpected result we found with one of the most talented teams of autoimmune geneticists in existence: the International Multiple Sclerosis Genetics Consortium. Parenthetically, these folks are absolutely who you want at the front lines of genomic inquiry. They are dogged, thoughtful, and careful about the research they do.

At that time, we were following up on one of the key variants that conferred risk to multiple sclerosis or MS: HLA-DRB1-0201 (or “DR2″). As background, about 40 percent of all patients with MS have the DR2 variation in their genome. By comparison, only 20 percent of the general population has this variant. When you run the statistics, it turns out that this is probably one of the strongest associations in all of autoimmune genetics. So it seemed very reasonable to all of us involved that if we gathered enough patients who had MS and looked separately at the patients with and without DR2, we would expect that we might uncover that there were two types of MS.

To imagine this hypothesis, I visualize genetic “skylines.” While MS may appear to be a “single” disease population based on clinical measures, we hypothesized that the disease resulted from two different genetic skylines. Our experiment was to determine whether … Next Page »

Comments (17) | Reprints | Share:          

Seattle-based Allozyne has made a small set of job cuts after it was unable to pull the trigger on its plan to go public late last year, Xconomy has learned.

Allozyne has let go some of its scientific staff, according to a source close to the situation. When asked how many jobs were eliminated, and how many employees remain at Allozyne, CEO Meenu Chhabra said there was no downsizing but that “we redistributed functional areas.” That decision came days after Allozyne scrapped a plan to go public through a merger with San Francisco-based Poniard Pharmaceuticals. If the deal had gone through, privately held Allozyne would have gotten a NASDAQ listing that would have enabled it to raise more money from mutual funds, institutions, and hedge funds that only invest in public companies.

“We are gearing up for Phase 3 work and are redistributing the talent to focus on clinical development and regulatory tasks,” Chhabra said via e-mail. “That said, discovery and early stage activities are alive and well.”

She didn’t say exactly how many employees remain at Allozyne, but before Christmas, Chhabra said the company had about 20 employees.

Allozyne has spent about $50 million since its founding in 2005 and was down to its last $1.3 million in cash at the end of June, according to recent regulatory filings. But when Allozyne walked away from the Poniard merger, it raised a still-undisclosed amount of cash from Arch Venture Partners, MPM Capital, and OVP Venture Partners, Chhabra said in a Dec. 22 interview. The money will be used to help the company push ahead with a plan for 2012 to move its lead multiple sclerosis drug into the third and final phase of clinical trials normally required for FDA approval, Chhabra has said.

Comments (4) | Reprints | Share:          

Seattle-based Allozyne wasn’t able to go public this year, so it has fallen back on Plan B, tapping its existing venture capital backers one more time in a bid to create more value around its lead multiple sclerosis drug candidate.

Allozyne, which has spent about $50 million since its founding in 2005 and was down to its last $1.3 million in cash at the end of June, has raised an undisclosed amount of new venture capital from its existing investors, according to CEO Meenu Chhabra. The money from Arch Venture Partners, MPM Capital, and OVP Venture Partners will be used to help the company push ahead with a plan for 2012 to move its lead multiple sclerosis drug into the third and final phase of clinical trials normally required for FDA approval, Chhabra says.

“The syndicate is extremely excited that we are on a Phase III trajectory in 2012,” Chhabra says.

Allozyne remains a private, independent company after it pulled the plug on a six-month effort to merge with San Francisco-based Poniard Pharmaceuticals (NASDAQ: PARD), which was supposed to turn Allozyne into a public company. Selling the proposal to shareholders took longer than expected, and the deal ultimately fizzled because Poniard had fallen out of compliance with NASDAQ listing requirements that say a company must have a minimum market capitalization of $15 million. That was the whole point of the transaction—getting a NASDAQ listing in order to tap large funds that invest in public companies—so it no longer made sense to go through with the deal, Chhabra says.

Moving on, Allozyne turned to additional private financing, and continues to talk with partners and mull other options, like another reverse merger or a conventional initial public offering of shares, Chhabra says. The company has about 20 employees, and hasn’t made any staff cutbacks, she says.

Allozyne’s next strategic move depends heavily on an aggressive clinical development plan for its lead asset, AZ01. Allozyne is looking to leapfrog from Phase I trials all the way to Phase III—skipping the usual intermediate step, Chhabra says. The company believes that is possible because it isn’t blazing a completely new trail with a new molecular entity, but rather is taking an existing drug the FDA knows well—interferon-beta—and packaging it in a new way so it can be injected less frequently than the existing products on the market. Weston, MA-based Biogen Idec (NASDAQ: BIIB) has established this quicker-than-usual regulatory pathway with its own version of a long-lasting version of interferon-beta.

The Allozyne proposal, which it plans to make to the FDA at a meeting in early 2012, will be to enroll 700 patients who will be … Next Page »

Comments | Reprints | Share:          

Clinical data, startup financings, and collaborations, oh my. It’s been a busy New England life sciences news week.

—Cambridge, MA-based Genzyme revealed that its experimental multiple sclerosis treatment, alemtuzumab (Lemtrada), significantly reduced relapses and disability in a Phase 3 trial where it was tested head-to-head against Rebif, a form of interferon sold by EMD Serono and Pfizer. The drug from Sanofi’s Genzyme reduced relapse rates by 49 percent and reduced the risk of worsening disability by 42 percent.

—Lexington, MA-based Avaxia Biologics recently announced a $2.2 million investment led by Cherrystone Angels in Providence, RI, with participation from Boston Harbor Angels and undisclosed individual investors. Avaxia is developing an anti-inflammatory drug by inoculating pregnant cows and collecting antibodies from their milk.

—Third Rock Ventures, Frazier Healthcare Ventures, and Bessemer Venture Partners led a $15 million Series A investment in Allena Pharmaceuticals of Newton, MA. The startup, whose team comes from the now Eli Lilly-owned biotech Alnara, is working on enzyme-based oral treatments for kidney and urologic diseases.

–Agios Pharmaceuticals of Cambridge took in $78 million in an oversubscribed Series C financing. The money comes from existing investors Arch Venture Partners, Flagship Ventures, and Third Rock Ventures, and Celgene (NASDAQ: CELG), who Agios has been collaborating with on developing cancer-starving drugs.

—Speaking of drug collaborations, Cambridge-based Aileron Therapeutics expanded a partnership it first inked with Roche in 2010. The two companies had been working on turning Aileron’s “stapled peptide” technology into cancer treatments in two programs, and announced this week that they would add a third, focused on inflammatory diseases.

Comments | Reprints | Share:          

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.”

Comments (1) | Reprints | Share:          

Today’s news: Weston, MA-based Biogen Idec, the largest maker of injectable treatments for multiple sclerosis, met its goals in a second clinical trial for an oral pill to treat the disease. The pill reduced flare-ups by 44 percent when taken twice per day, and by 51 percent if taken three times a day. Bedford, MA-based iRobot announced layoffs last week of 8 percent of its staff, or 55 employees across Massachusetts, North Carolina, and California, despite showing a strong third quarter profit. Boston startup accelerator MassChallenge awarded $1 million to be split across 17 startups, and Bay State companies collectively raised $250 million in venture capital last month. The total funding for the third quarter was $505 million, down by about half from the previous quarter when there was talk of a tech bubble.

In case you missed it this morning, have a listen. The Xconomy Report airs every Friday morning at 7:49am on 89.7 FM.

Comments (1) | Reprints | Share:          

It was a meaty New England life sciences week, with clinical advances, new funding, CEO hires, and acquisitions headlines.

—Sanofi hired David Meeker as the new CEO of its Cambridge, MA-based Genzyme unit. Meeker, who got started at the company in 1994, will move into his new role on November 1 and will lead the rare diseases and multiple sclerosis divisions. Other Genzyme units have already been integrated into Sanofi’s global operations.

—My colleague Arlene took a closer look at Cambridge-based Rhythm Pharmaceuticals, a startup developing diabetes and obesity drugs. Rhythm is navigating a crowded but struggling drug space with licensed compounds from the French biotech company Ipsen.

—Lexington, MA-based Cubist Pharmaceuticals (NASDAQ: CBST) will acquire Adolor for $4.25 per share in cash ($190 million total), plus milestones for Adolor’s experimental drug for treating chronic opioid-induced constipation, ADL5945. That pushes the total value of the deal to $415 million. The transaction was made possible, Cubist says, when pharma giant GlaxoSmithKline (NYSE: GSK) dropped out of a co-promotion deal with Adolor (NASDAQ: ADLR) after their drug for accelerating healing after bowel surgery ran into safety issues and was only cleared for in-hospital use.

—Weston, MA-based Biogen Idec (NASDAQ: BIIB) met its goals in a second clinical trial of its first pill for multiple sclerosis. In the study, Biogen’s pill reduced MS flareups by 44 percent when patients took it twice a day, and by 51 percent when they took it three times a day. The company’s stock shot up 7.6 percent to $115.07 per share at 10:06 Eastern time after the news. Biogen also announced it would pay $45 million upfront to South San Francisco-based Portola Pharmaceuticals to collaborate on autoimmune disease drugs.

—Atreaon, a new Newton, MA-based biotech company, raised $8 million of a potential $20 million equity round, according to an SEC filing. And Watertown, MA-based Arsenal Medical, a developer of biomaterial-based treatments, said it was spinning out a new company called 480 Biomedical. It also announced it had raised $3 million and 480 had raised $15 million, from return Arsenal investors return investors Polaris Venture Partners, North Bridge Venture Partners, and Intersouth Partners. The new spinout will focus on developing scaffold and delivery technology for treating a form of peripheral vascular disease known as SFA occlusive disease.

—Cambridge-based BIND Biosciences and Watertown-based Selecta Biosciences each received $25 million from Rusnano, a $10 billion Russian federation fund focused on nanotechnology startups. Each company, which will establish Moscow subsidiaries, also took in another $22.25 million from new and existing investors.

—Cambridge-based Vertex Pharmaceuticals (NASDAQ: VRTX) announced revenues of $659 million for the quarter ended September 30, its first ever profitable quarter from its own product sales. (Vertex turned a profit once before due to a one-time milestone payment.) The $221 million ($1.02 a share) profit last quarter was drive in part by Vertex’s new FDA-approved drug telaprevir (Incivek) for patients with hepatitis C that was cleared by the FDA in May.

Comments | Reprints | Share:          

Biogen Idec’s new oral pill for multiple sclerosis passed its first pivotal trial back in April, and today the company got the confirmation it was looking for from a second major study.

The Weston, MA-based biotech company (NASDAQ: BIIB) said today that dimethyl fumarate (BG-12) met its main goal of reducing multiple sclerosis flare-ups over a two-year period in a study of 1,430 patients with relapsing forms of MS. As a twice-daily pill, the Biogen Idec drug was able to reduce MS flare-ups by 44 percent when compared to a placebo, and by 51 percent when it was given three times a day, the company said. Both doses of the new treatment showed “favorable” safety and tolerability, Biogen Idec said, that was similar to what scientists saw this spring in another study of about 1,200 patients. The drug also met all its secondary goals in the study, in both doses, the company said.

Shares of Biogen Idec rose by $8.20 a share, or 7.6 percent, to $115.07 at 10:06 am Eastern time after the news.

“We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients,” said Doug Williams, Biogen Idec’s executive vice president of R&D, in a statement. “We are gratified by these strong efficacy and safety results, which, when combined with BG-12′s oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible.”

The new oral drug is critical for Biogen’s long-term competitive standing as the world’s largest maker of multiple sclerosis drugs. Biogen’s key franchises today are with the injectable therapies interferon beta (Avonex), and natalizumab (Tysabri). But each of these products has its weaknesses—patients tend to relapse on interferons over time and grow weary of the injections, while Tysabri is dogged by a dangerous side effect known as PML. Many of the 400,000 U.S. patients with multiple sclerosis have long desired oral pill alternatives, and haven’t had one until recently. Swiss pharmaceutical giant Novartis won FDA approval a year ago for fingolimod (Gilenya). Another oral MS drug from Hawthorne, NY-based Acorda Therapeutics (NASDAQ: ACOR) called dalfampridine (Ampyra) is cleared by the FDA to improve walking ability of MS patients.

Thomas Wei, an analyst with Jefferies & Co, wrote earlier this week that he heard positive feedback about the oral MS drug from Biogen, when he surveyed 17 neurologists at a recent medical meeting called ECTRIMS. He has a $124 a share price target on Biogen stock.

“Many physicians deferred judgment when asked about BG12, citing the lack of head-to-head data relative to other oral therapies,” Wei wrote in an Oct. 24 note. “However, there was universal acknowledgment that the data from the first Phase 3 trial of BG12 was highly robust. For those willing to give an opinion, we found that BG12 was always the oral drug of choice.”

Comments | Reprints | Share:          

One of the scientists at Biogen Idec pushing for a new kind of regenerative medicine got some of her most valuable experience, and inspiration, back in the day at Genetics Institute. So we’re thrilled to have Sha Mi join what is shaping up to be a truly special gathering of alumni from GI, one of the pioneering companies in the Boston biotech scene.

Sha Mi, the distinguished investigator in Biogen’s discovery neurobiology group, has agreed to join the lineup of confirmed speakers at the next big Xconomy Boston life sciences event—”The Genetics Institute Impact” on Dec. 14. Sha Mi, who worked at GI from 1995 to 2000, will join the ranks of speakers who will offer a short story about one of their favorite memories from their GI days.

Besides Sha Mi (who sometimes goes by “Misha”) you can expect to hear these short stories from Adelene Perkins of Infinity Pharmaceuticals, Tuan Ha-Ngoc of Aveo Pharmaceuticals, Abbie Celniker of Eleven Biotherapeutics, Tony Evnin of Venrock Associates, and John Knopf of Acceleron Pharma. Plus, we’ll have a keynote chat with the two scientific co-founders of GI—Tom Maniatis and Mark Ptashne—along with longtime CEO Gabe Schmergel.

Sha Mi, distinguished investigator, Biogen Idec

Sha Mi is best known these days for her discovery work on a drug that seeks to be the world’s first regenerative medicine for multiple sclerosis. This experimental drug, which Biogen Idec has advanced into clinical trials, is designed to block a protein called Lingo-1 that interferes with the body’s production of myelin, the fatty insulating coating around nerve fibers. People with multiple sclerosis have an overactive immune system that eats away at the myelin layer, and they have no ability to regenerate myelin to protect their nerves. That means nerve impulses that control speech, vision, and movement get short-circuited, sort of like when an electrical wire is stripped of its insulation.

According to Sha Mi’s hypothesis, the new drug should be able to help regenerate the protective myelin coating around nerves. And if you can regenerate myelin, it’s conceivable you can restore lost neurological function, like the ability to see, talk, and walk. It will take a long time to find out if this works in humans, but the experimental drug has already cleared some significant hurdles by making it into the clinic.

I’m personally excited to hear Sha Mi tell her story about a memorable time at GI that help propel her along her current path. And I’ve heard great feedback from many GI alumni, and friends of GI alumni, who are looking forward to this special event. Tickets are going fast, so if you haven’t gotten one yet, be sure to sign up here at the registration page. See you there Dec. 14.

Comments (1) | Reprints | Share:          

Any company that aspires to get a listing on the stock market had better be ready for marathon hours with investors, accountants, and lawyers. But there’s a special thicket of challenges to work through when you’re introducing yourself to the NASDAQ the way Seattle-based Allozyne is.

The privately-held biotech company is taking the backdoor route to an IPO by acquiring the shell of a public company—San Francisco-based Poniard Pharmaceuticals (NASDAQ: PARD). So besides running their regular business, a few new tasks have piled up in front of Allozyne CEO Meenu Chhabra and finance chief John Bencich. They need to rustle up another 2.2 million votes from Poniard’s existing shareholder base to authorize the deal and, assuming that happens, they need to introduce themselves and their newly merged company in a hurry to Wall Street.

Poniard’s shareholders, who have lost most of their money on a drug that failed in a trial for small-cell lung cancer, could be excused for feeling too jaded to turn in their votes. And Allozyne is an unknown quantity to most Wall Street investors—it has an unfamiliar protein engineering technology platform, and a lead drug candidate for multiple sclerosis that’s still in the first of three clinical trial stages normally required for FDA approval of a new drug. That basically means it needs to gather a lot more proof that it works before investors, in today’s market, will get excited.

For the always-enthusiastic Chhabra, it just means she’s got a lot of work to do.

“I’ve been doing a lot of cardio,” Chhabra joked, referring to how she’s been shuttling between meetings with investors on the East Coast.

For now, there are some key terms investors need to settle on to seal the deal. Allozyne is asking Poniard shareholders to trade in 15 to 25 of their existing shares to get just one back, in what’s known as a reverse stock split that companies often do to prop up their stock prices above $1. If those terms are accepted, Poniard shareholders will get about 35 percent ownership of Allozyne.

If Poniard shareholders go for the new structure, then Allozyne will have to go about the hard work of redefining the company. Allozyne has raised $43 million since it was founded in 2005, and has gone through long stretches in stealth mode, keeping competitors in the dark. To go public via this route, Allozyne will have to disclose much more about its strategy and risks through a new regulatory filing called an S-4. The document will be similar to an S-1 investor prospectus for a traditional IPO, Bencich says.

Meenu Chhabra

For now, Allozyne’s executives are out doing what they can to prime the pump of interest. “The response is encouraging. It’s a fresh story no one has heard of before,” Chhabra says.

Allozyne considered a conventional IPO, but decided against it. Some biotechs have done well in recent stock market debuts, such as Parsippany, NJ-based Pacira Pharmaceuticals (NASDAQ: PCRX), but several have tried, found little investor appetite, and withdrew IPO paperwork. San Diego-based Ambit Biosciences, and Durham, NC-based Aldagen are a couple recent examples. “If you look at what’s happening in traditional IPOs, there are painful processes,” Chhabra says.

Chhabra is trying to build a base of interest with Poniard shareholders, and then to bolster that interest by setting up a couple of catalytic events. If Allozyne can complete the deal as planned in the late part of the third quarter or early fourth quarter, Chhabra says she has a couple important steps in mind for the early days of the new public company. One, she plans to release more data from the second part of a Phase I clinical trial of Allozyne’s long-lasting multiple sclerosis drug, AZ01, which I reported on first in January at the JP Morgan Healthcare Conference. And two, Chhabra says she plans to … Next Page »

Comments (1) | Reprints | Share:          

New York City-based Coronado Biosciences has raised $25.8 million, according to a regulatory filing. The company is developing immunotherapy approaches to treating acute myeloid leukemia, inflammatory bowel disease, multiple sclerosis, and other autoimmune diseases. It previously raised $21.6 million in November 2010.

Comments | Reprints | Share:          

Sometimes biotech startups can find a backdoor route to going public without going to all the trouble of doing an IPO, and that’s what Seattle-based Allozyne just did today.

Allozyne, the developer of a long-lasting protein drug for multiple sclerosis, said today it has agreed to a merger with San Francisco-based Poniard Pharmaceuticals (NASDAQ: PARD) in which the little private company is essentially acquiring Poniard. Allozyne CEO Meenu Chhabra will lead the newly combined company, Allozyne shareholders will own 65 percent of the new entity, and Allozyne will control four of the seven board seats.

The combined company, to be headquartered in Seattle, plans to develop Allozyne’s experimental drugs and technology, and find a partner to carry on with Poniard’s lead asset, a cancer drug called picoplatin.

Poniard, the company known years ago as Seattle-based NeoRx, has retained its listing as a public company, but has essentially turned into a shell of its former self since picoplatin failed in the third and final phase of clinical trials in November 2009. The company lost about 80 percent of its stock value that day, and the stock was valued at just 19 cents a share today before the Allozyne deal was announced—meaning Poniard was only worth about $11 million heading into today.

So this is a deal that enables Poniard shareholders to get some new drugs that might be worth something, while it provides Allozyne with a way to connect with a new class of public investors, and potentially provide liquid returns for the venture capitalists who have put $43 million into the company since its founding in 2005.

“I’m extremely proud that an Accelerator company, if this merger closes, will be publicly traded. It will be a first for us,” says Carl Weissman, the founder and CEO of Accelerator, the Seattle-based biotech incubator that started Allozyne. “It’s a real testament to how great the company has done.”

Chhabra, a former dealmaker with Novartis, summed up what it means to Allozyne in a short conference call with investors. “We can now access the public markets to accelerate our strategic plan.”

Meenu Chhabra

There are a number of moving parts to the actual deal that were outlined in a statement. Under the deal, Poniard shareholders will issue shares to Allozyne shareholders based on an exchange ratio to be determined when the transaction closes. Allozyne shareholders are expected to own 65 percent of the company, while Poniard shareholders will get 35 percent. Bay City Capital, one of Poniard’s largest shareholders, has agreed to loan the company about $2.4 million at an 18 percent annual interest rate. The board will be composed of four Allozyne directors—Chhabra, Steve Gillis of Arch Venture Partners, Michael Steinmetz of Clarus Ventures, and Carl Weissman of Accelerator/OVP Venture Partners. The board will also include Poniard’s current CEO, Ron Martell, one other director selected by the Poniard board, and one more independent director selected by a majority of the board.

Leerink Swann advised Poniard on the financial aspects of the deal.

For those new to the Allozyne story, the company’s lead drug, AZ-01, is designed to be a long-lasting form of interferon beta, which has the potential to reduce the number of injections that multiple sclerosis patients need to control their disease. The company, based on technology licensed from Caltech, is also working on ways of engineering different properties into protein drugs, like attaching toxins to make them more potent, or devising ways to make them specifically hit two biological targets instead of just one. The company revealed some early-stage clinical trial results for its multiple sclerosis drug in an Xconomy exclusive earlier this year at the JP Morgan Healthcare Conference.

Comments (6) | Reprints | Share:          

Biogen Idec, after weeks of speculation in the local real estate market, has confirmed it is considering options to move its headquarters back from the suburbs to Cambridge, MA, as CEO George Scangos seeks to foster a more close-knit culture between the company’s R&D and commercial operations.

“We’re working on it. We’ll see if it’s practical,” Scangos says. “We don’t have anything signed. We are exploring a number of options.”

Scangos’ latest remarks came on Tuesday during an interview with Xconomy at a temporary office being set up for top Biogen executives in Cambridge’s Kendall Square. While Scangos says he is still spending most of his time at the company’s new headquarters in Weston, MA, he has personally carved out the new temporary office (with fresh pastel paint on the walls you can still smell) on the second floor of 10 Cambridge Center, closer to the center of R&D and biotech drug production.

No new letter of intent or lease has been signed in Cambridge, Scangos says, but he elaborated on some of the issues he’s been considering in regard to a potential move to Cambridge.

“There are some practicalities to consider,” Scangos says. “We have a long-term lease [in Weston]. If we were to move everybody back here, we’d need a lot more space. We’d have to be able to get that at a price that’s reasonable, and we’d have to deal with a sublease.”

Scangos’ latest comments build on remarks he made last month in an interview with Reuters, and at the Convergence conference, which prompted speculation about a potential move of the sales, marketing, and administrative offices back to Cambridge. In those comments, Scangos said he didn’t like having executive offices that are separate from the company’s R&D facilities in Cambridge. The suburban facility lacks energy, and is isolated from the company’s labs, he said.

The decision to move Biogen’s headquarters to Weston was made in the fall of 2008, under previous CEO James Mullen. Scangos took over last summer. “It wouldn’t have been my choice. In an ideal world, we’d all be back in Cambridge,” Scangos said at Convergence on May 20. “But we don’t live in an ideal world. We’re looking into it [a move], but I don’t know if it’s realistic or not.”

In the Tuesday interview with Xconomy, Scangos repeated some of the reasons he wants to bring the R&D and commercial group back together in one place.

George Scangos in his temp office at 10 Cambridge Center

“What I don’t like is the split where we have sales and marketing sitting in Weston and R&D sitting here,” Scangos says. “Today, I’m the only member of senior management who’s here. Everyone else is in Weston. That’s not optimal. If we could get everybody together, I would very much like that. It’s more sensible to have everyone in one location. You can talk, go down the hall, have lunch together, just meet people randomly, and get really good discussions going between departments of R&D and commercial.”

The practicalities which Biogen will have to iron out to do that aren’t trivial. Back in the fall of 2008, the company signed a 15-year lease on a 356,000-square foot office building in Weston; it started moving into the new space during mid-2010. Shortly after signing the new lease, Biogen explained in its annual report to shareholders that “we anticipate that the Weston facility will decrease our overall occupancy cost per employee.” About 500 people had their offices moved from Cambridge to the 74-acre Weston site just a year ago. Biogen has about 4,400 employees worldwide.

Biogen will still have facilities in multiple locations around Massachusetts, and the world, even if the company executes on the idea of moving its headquarters back to Cambridge. The company owns 508,000 square feet of space in Cambridge, and leases 885,000 more square feet of space in Massachusetts, at locations in Weston, Wellesley, Waltham, and Somerville, according to the company’s most recent annual report.

While cost savings were cited as a reason for the suburban move in 2009, Biogen’s fortunes have changed quite a bit in the year since Scangos took the helm. Scangos put his stamp on … Next Page »

Comments | Reprints | Share:          

Cambridge, MA-based Proteostasis Therapeutics has found a big new benefactor to support its R&D against neurological diseases.

Proteostasis said today it has formed a strategic alliance with Ireland-based Elan to develop traditional small molecule drugs and diagnostics with Proteostasis against neurodegenerative diseases like Parkinson’s, Huntington’s, and multiple sclerosis. Elan, the developer of the hit multiple sclerosis drug natalizumab (Tysabri), has agreed to invest $20 million into the small company, and may pump in another $30 million over the next five years. In return, Elan is getting a 24 percent ownership stake in Proteostasis now, a seat on its board of directors and scientific advisory board, and the first chance to exclusively license new drug compounds from the collaboration, the companies said in a statement.

Proteostasis has been pretty quiet lately, but it made a splash in the Boston biotech scene in September 2008 when it raised a whopping $45 million in its initial venture financing from HealthCare Ventures, Fidelity Biosciences, New Enterprise Associates, Novartis Option Fund, and Genzyme Ventures. The founding science came from the San Diego labs of Jeff Kelly at The Scripps Research Institute and Andrew Dillin at the Salk Institute for Biological Studies, and Richard Morimoto at Northwestern University.

As I described in a feature story a year ago, Proteostasis is about delving into biology that seeks to alter protein pathways that deteriorate as people age, which can lead to neurodegenerative diseases like Alzheimer’s and Parkinson’s. When people are young and healthy, they might produce amyloid plaques, for example, but a network of proteins works to dispose of them. One theory is about Alzheimer’s is that as people age, this garbage disposal network weakens, amyloid plaques build up, and it leads to the cognitive impairment in the brain that’s associated with Alzheimer’s.

Today’s statement had a few details on what each party is supposed to bring to the table. It said that Proteostasis will contribute its discovery technology, novel biological targets, and drug candidates. Elan plans to contribute with its proprietary animal models, biology, medicinal chemistry, and clinical development.

Proteostasis’ president and chief scientist, Peter Reinhardt, said Elan is “a proven leader” who will help speed up the R&D progress at Proteostasis. Kelly Martin, Elan’s CEO, added: “This initiative with Proteostasis reinforces our commitment and strategic business objective of being an exceptionally high-caliber, science-driven company and provides a multitude of opportunities for Elan to advance its position as a world leader in the broad field of neuroscience.”

This isn’t the only Boston-Ireland connection we’ve seen in these pages lately. Elan recently agreed to sell one of its divisions to Waltham, MA-based Alkermes (NASDAQ: ALKS) for $960 million in cash and stock.

Comments | Reprints | Share:          

Weston, MA-based Biogen Idec (NASDAQ: BIIB) said today that it has received a positive opinion from a committee of the European Medicines Agency, which should pave the way to begin sales in Europe of fampridine (Fampyra) as a new treatment for multiple sclerosis. Based on the committee recommendation, Biogen Idec said it expects to be cleared to begin sales within 67 days. Hawthorne, NY-based Acorda Therapeutics (NASDAQ: ACOR) developed the drug, sells it in the U.S., and granted Biogen a license to commercialize the product outside the U.S.

Comments | Reprints | Share:          

Alkermes has struck a big acquisition deal that vaults it into the club of “Big Biotech” companies it has long yearned to join.

The Waltham, MA-based biotech company (NASDAQ: ALKS) is announcing today it has agreed to acquire Elan Drug Technologies, the chemical formulation and manufacturing unit of Ireland-based Elan (NYSE: ELN) in a deal valued at $960 million in cash and stock. The new company, to be called Alkermes plc, will be incorporated in Dublin, although Alkermes CEO Richard Pops will remain as chairman and CEO of the new trans-Atlantic company.

By obtaining the drug technology unit of Elan, Alkermes is adding a group of 450 employees in Ireland, and building out a portfolio of 25 commercial products under one corporate banner. Five of those products are expected to be significant revenue drivers for the future. The combined company is expected to have diversified revenues exceeding $450 million from a combination of product sales, drug royalties, and manufacturing income.

The big strategic move clearly puts Alkermes into the class of “Big Biotech” companies that are profitable and diversified enough to remain big and stable for the long haul—unlike most biotechs, which often live or die on the success of one or two products. Pops talked about his desire to put Alkermes in that top-tier category of biotech companies in an interview with Xconomy more than two years ago.

“This merger will bring the scale and resources for strategic and balanced investment across the whole product continuum, from R&D innovation to clinical development, to world-class manufacturing and commercial expansion,” Pops said in a statement.

The financial terms of the deal are pretty straightforward. Elan will get $500 million in cash upfront, and 31.9 million shares of stock in the new Alkermes plc, which represents about a 25 percent equity ownership stake. Alkermes is paying for this deal partly by securing a $450 million loan commitment from Morgan Stanley and HSBC. Elan will remain an independent company, with less debt. The company relies heavily on its part ownership with Biogen Idec in the hit multiple sclerosis drug natalizumab (Tysabri).

Alkermes’ historic strength as a company comes from its ability to make drugs remain stable for longer periods of time in the bloodstream, enabling less frequent injections. It generates cash from royalties on Johnson & Johnson’s anti-psychotic risperidone (Risperdal Consta), as well as naltrexone (Vivitrol), its own drug for combatting addictions to opioid-based painkillers. The company is also in position to collect sizable royalties on a once-weekly injectable drug for diabetes, exenatide once-weekly (Bydureon) being developed by Amylin Pharmaceuticals and Eli Lilly.

By getting Elan Drug Technologies, Alkermes is obtaining a stake in two recently approved drugs, paliperidone palmitate (Invega Sustenna) for schizophrenia and dalfampridine (Ampyra) for multiple sclerosis.

All five of those drugs have long patent lives and “significant growth potential in large therapeutic areas,” Alkermes said in a statement.

Elan retains the right to name one independent director to the board of Alkermes plc, as long as it holds a 10 percent ownership stake. Alkermes’ board currently has 10 members.

The deal must be approved by Alkermes shareholders, and pass an antitrust review in the U.S. The companies said they expect the deal to close before the end of September.

Alkermes plans to host a webcast conference call to discuss the deal at 8:30 am ET today.

Comments | Reprints | Share:          

Immune Design aspires to become a bigger company, and now it has recruited a CEO from a bigger company.

The Seattle-based vaccine developer is announcing today that its new chief executive is Carlos Paya, the former president of Elan, the Ireland-based biotech company which has significant operations in South San Francisco. Paya is replacing Immune Design’s founding CEO, Steve Reed, who will continue to serve on the company’s executive management team and board. Bruce Carter, the executive chairman, is staying in his position.

“We are fortunate to have someone of Dr. Paya’s caliber joining Immune Design,” Reed said in a statement.

Paya’s prior job was at Elan, the company known for developing the hit multiple sclerosis drug natalizumab (Tysabri). He oversaw commercial, marketing, R&D, and clinical operations there since November 2008. Before that, he was with Indianapolis-based pharma giant Eli Lilly (NYSE: LLY), as vice president of Lilly Research Laboratories. Paya, an immunologist by training, was a member of the faculty at the Mayo Clinic before going into the pharmaceutical industry.

Immune Design was founded in 2008 with technology from the Caltech lab of Nobel Laureate David Baltimore, and from Reed’s team at the Seattle-based Infectious Disease Research Institute. The technology is based on a vector from Baltimore’s lab that makes it possible to specifically stimulate dendritic cells of the immune system, which are known for sending sentinel warning signals about pathogens to other cells of the immune system. That targeting ability is being combined with synthetic chemical compounds called adjuvants, which are used to boost the effectiveness of vaccines.

The adjuvants from Reed’s lab, when combined with Baltimore’s precise delivery system, offer an opportunity to trigger highly potent, more specific immune responses in the body than vaccines from the past, according to Rick Klausner, a partner with The Column Group, one of the company’s founding investors.

The company has raised $50 million in two rounds of venture financing, and last year struck its first major partnership with AstraZeneca’s MedImmune unit to develop new vaccine candidates.

Comments | Reprints | Share:          

Biogen Idec’s (NASDAQ:BIIB) stock price is soaring this morning after the Weston, MA-based biotech company reported a bump in first quarter revenue and new details about a successful late-stage clinical trials for its oral multiple sclerosis drug.

Shares of Biogen were up more than 22 percent to $105.83 as of 10:23 am Eastern time. The company reported that its revenues for the first quarter increased 9 percent to $1.2 billion, aided by increased sales of its big-selling multiple sclerosis drugs natalizumab (Tysabri) and interferon beta-1a (Avonex). Also, executives during a call with investors reportedly gave more vivid details about the benefits of its oral MS drug, dimethyl fumarate (BG-12), than were provided earlier this month when the firm announced that a late-stage study of the drug was a success.

Biogen, the world’s largest provider of multiple sclerosis drugs, is aiming to extend its franchise with an oral MS pill. Its existing therapies for the disease are injected, and an oral pill could offer greater convenience to patients. In September, Swiss drugmaker Novartis was the first to gain FDA approval for an MS pill, fingolimod (Gilenya), for relapsing forms of the disease. Israel-based Teva Pharmaceutical (NASDAQ:TEVA) is also in the running with an MS pill called laquinimod, which is in late-stage development.

Biogen said this morning that the firm’s oral MS drug reduced the proportion of patients who suffered relapses of the disease by 49 percent after two years compared with those on a placebo, and patients on the drug also showed a 38 percent reduction in disability progression, Reuters reported. These details build on what the company said on April 11 about the drug’s performance in a pivotal Phase III trial of 1,200 patients called DEFINE, which met its primary and secondary goals. The company is also conducting a separate Phase III trial of the drug called CONFIRM, the results of which are expected in the second half of this year.

Comments (1) | Reprints | Share:          

BG Medicine (NASDAQ:BGMD) took the long road to becoming a public company, scrapping its first attempt in 2008 and then spending just more than a year to wrap up its second IPO campaign this past February.

In a recent interview, Pieter Muntendam, the CEO of the Waltham, MA-based medical diagnostic company, told me how BG Medicine weathered the rough IPO climate and shared the company’s outlook for its main product: a test that assesses the prognosis of heart failure patients.

The public markets seem loath to buy into a life sciences company IPO. The select few firms that have actually completed an IPO have typically had to drop the asking price for their shares before buyers would commit. BG Medicine was no exception. The firm settled for $7 per share in its public debut in February, roughly half of what the company had previously sought for its stock, according to regulatory filings.

There was also some confusion about BG Medicine’s IPO plans in December when the company failed to price its shares on schedule. That sparked at least one media report that BG Medicine had again withdrawn its IPO.

In fact, the company never withdrew its IPO. Muntendam explained that the company decided not to price its IPO in December because of timing, with many people closing their books toward the end of the year.

“The biggest surprise for us was when … Next Page »

Comments | Reprints | Share:          

Hawthorne, NY-based Acorda Therapeutics (NASDAQ: ACOR) announced that the United States Patent and Trademark Office issued a patent on the company’s 10 milligram, sustained-release version of dalfampridine (Ampyra) to treat multiple sclerosis. The patent is set to expire in 2026. Acorda saw its stock skyrocket April 14 on a report from RBC, which speculated that if the patent on the drug extended through 2024, it would be worth at least $10 per share in cash flow to Acorda. All told, the company’s stock had risen more than 30% since April 13, to $28.30, prior to the release of the news before the market opened today.

Comments | Reprints | Share: