Boston-based OvaScience is emerging from stealth mode with a technology designed to improve in vitro fertilization by rejuvenating tired eggs. Yesterday the company unveiled its technique, which is based on technology it licensed from Harvard Medical School and Massachusetts General Hospital. OvaScience co-founder Jonathan Tilly—director of the Vincent Center for Reproductive Biology at MGH—will talk in detail about the company’s science on October 19 at the American Society for Reproductive Medicine annual meeting in Orlando, FL.

OvaScience’s startup team has plenty of experience in the field of rejuvenation. The company’s CEO and co-founder is Michelle Dipp, previously vice president of corporate development at Sirtris—which was famously developing compounds based on the anti-aging supplement resveratrol before it was acquired for $720 million by GlaxoSmithKline (NYSE: GSK) in 2008. OvaScience co-founder Christoph Westphal was Sirtris’s founder and CEO. Dipp and Westphal are now partners at Longwood Founders Fund, which took part in OvaScience’s $6 million Series A round in July. Bessemer Venture Partners also participated in that round.

What’s more, one of the two key technologies behind OvaScience’s product was developed by none other than David Sinclair, the Harvard scientist who discovered resveratrol’s role in promoting longevity. The compounds that OvaScience licensed from Sinclair’s lab activate mitochondria—tiny power plants in cells that provide the energy for them to divide and grow.

The crux of OvaScience’s technique comes from MGH’s Tilly, who in 2004 discovered a type of stem cell in the ovary that matures into eggs. OvaScience’s approach involves isolating these egg stem cells from the patient, taking mitochondria from those cells, and then injecting … Next Page »

Comments | Reprints | Share:          

Can drugs that supposedly “activate” a controversial target—sirtuin proteins—stop or even reverse the aging process? A new report this week said “No.” According to this report, published Wednesday night in Nature, sirtuin activators do not extend lifespan in roundworms and flies and earlier studies that said they did were flawed. Nonetheless, GlaxoSmithKline (GSK) continues to invest hundreds of millions of dollars into developing drugs to hit these targets—more about their findings below—and if the drugs work, for whatever reason, the scientific squabbles will not matter.

I recently had the chance to hear Harvard professor David Sinclair talk publicly about his and GSK’s research into sirtuin activators. Sinclair was the scientific founder of Sirtris and he reported at a forum on longevity in Cambridge, MA, that GSK has high hopes of near-term confirmation in mice that some sirtuin activators do extend lifespan. Based on its continued investment, GSK still believes that the $720 million acquisition of Sirtris in 2008 was a smart one.

The Nature report, just the latest in a series of publications that question the sirtuin-longevity link, will be even tougher for Sinclair and other sirtuin researchers to overcome. The new research reported that sirtuin proteins, when overexpressed in nematode worms and fruit flies, do not actually have an effect on longevity. This directly contradicts the original publications linking Sir2 and other sirtuins with increased lifespan. The new report further goes on to contradict the landmark 2006 paper, also published in Nature, in which Harvard researchers led by Sinclair reported that mice fed resveratrol which, they demonstrated using expression analysis, activated sirtuins, live on average 20 percent longer and in some cases much longer than that.

The same researchers, both at University College London, went on the record as sirtuin skeptics in 2007. David Gems and Linda Partridge then set out to prove their claim that the original sirtuin and resveratrol findings, which led to the founding and eventual acquisition of Sirtris, were irreparably flawed. Building on earlier reports that the round worms used in the original studies carried a gene that control organisms did not carry, and that it was this gene that predisposed the worms to live longer, Gems and Partridge showed in this paper that organisms identical to one another except for the expression level of sirtuins could not be made to live longer.

Sirtuin research is nothing if not contentious. Apparently eager to fan the flames, Nature in the same issue this week published a rebuttal from Leonard Guarente, the author … Next Page »

Comments (2) | Reprints | Share:          

The big guys are getting bigger: Three prominent venture and private equity firms with Boston representation are in the news this week about raising big new funds.

How does this affect startups and innovation? Probably not all that much, other than being part of the natural cycle of money flow. But it’s interesting, and possibly encouraging, to see big investors having some initial success in what remains a very difficult fundraising environment. Perhaps the IPO and exit markets are heating up.

I’m reminded of what micro-VC David Beisel (whose quarterly Web Innovators Group meeting is this Monday) said, when he predicted that over the next 10 years, big venture firms will raise even larger funds. (As a corollary to that, Bob Nelsen from Arch Venture Partners remarked last fall, in response to the notion of VC contraction, that “it’s hard to kill a venture fund, but it’s easy to kill a venture partner.”)

OK, here’s the news around town:

—Bessemer Venture Partners is planning to raise a new fund in the neighborhood of $1.5 billion, according to a report in Bloomberg this morning (based on unnamed sources). The firm’s last fund, completed in 2009, was about $1.35 billion, the report says. Bessemer is known for its investments in companies like Skype, LinkedIn, Yelp, American Superconductor, Endeca, Sirtris, VeriSign, and Vertica.

—Greylock Partners announced this week that it has expanded its present fund to $1 billion (up from $575 million in late 2009) and has formed a growth-stage fund to focus on more established companies. Greylock’s later-stage investments—about 40 percent of its dollars since early 2006—include Constant Contact, Zipcar, Pandora, Redfin, Facebook, and Groupon.

—Summit Partners is raising a $500 million venture fund and a $3 billion growth equity fund, according to a report in Mass High Tech this morning, which cites SEC documents filed for a growth-stage fund and a venture fund. Summit closed a $300 million venture fund and a $3 billion growth fund back in 2005, the report says. The firm’s investments have included Casa Systems, Innov-X, Winshuttle, and Cloudmark.

Comments (1) | Reprints | Share:          

With 2010 almost in the books—and a lot of people grounded by the Northeast blizzard—it seems like a good time to take a break and look back at some of Xconomy Boston’s top stories of the year.

These are not necessarily the ones that generated the most traffic (although in some cases they did). Instead, they are stories that best exemplify what we try to deliver to our readers day in and day out—the stories behind the companies, ideas, and people that are helping to create the future of innovation in our network of cities.

Our Boston editor’s picks span a wide range of subjects, from young startups (Baydin, Krush, Energesis) to established public companies (Genzyme, Vertex, Unica, Progress Software), from software and information technology to life sciences, biotech, and energy. They range from unique breaking news stories (Resveratrol) to in-depth features (TripAdvisor), Q&As (John Glaser, Arif Padaria), and commentary/analysis (entrepreneurial Walk of Fame).

Without further ado, here are our top 20 stories of 2010, sorted by sector:

Top 10 Tech Stories

Krush Founder Gina Ashe, Survivor of Horrific Car Crash, Has New Lease on Startup Life

Q&A on Startups and Investing Strategy with Massachusetts Clean Energy Center’s “State Angel” Arif Padaria

Why Rich Levandov Invested Early in Zynga, and Why It Took Off—Lessons Every Entrepreneur Should Consider

Twitter Plea Helps Baydin Get Seed Money from Angel Investor Dave McClure; Startup Moving to the Valley Next Month

Kendall Square Wants an Entrepreneurial Walk of Fame—and So Should Every Innovation Hub

The Unica Story: Yuchun Lee’s Journey from MIT Blackjack Team to IBM Acquisition

Is Boston Becoming a Hub for Female Tech Entrepreneurs? Maybe, and Here’s Why

Tim Berners-Lee and Group of Boston Web Gurus Leading New MIT Class to Get Linked Data to Market

Reinventing Progress Software—Boston’s Next Billion-Dollar Company?

TripAdvisor: The Travel Company That’s Really All About Data

.

Top 10 Life Sciences Stories

Avila Therapeutics Pursuing Rival to Lung Cancer Drug in Dana-Farber Lawsuit

Energesis Pharmaceuticals, Co-Founded by Sirtris Vet, Seeks to Tap Power of “Good Fat” in Fighting Obesity and Diabetes

Genzyme Boss Henri Termeer Not Ready to Sell to Sanofi, Ride Into the Sunset, Sources Say

Former Sirtris Execs’ Nonprofit Starts Selling Resveratrol with Potential Anti-Aging Effects Online

John Glaser, Boston’s Top Hospital Geek, Talks About Obama’s Health IT Plan and Getting Booted from Catholic School

Vertex, Worth $7.5B, Eagerly Awaits Final Proof that Hepatitis C Drug Works

Cooking with the Genzyme Recipe: New Players Funding Rare Disease Drugs in Boston

The Genetics Institute Alumni: Where Are They Now?

Prominent Flatley Family Launches Boston Nonprofit for Cystic Fibrosis Drug Research

Chairman Bill Young: Next Biogen Idec CEO May Be a Scientist

Comments (2) | Reprints | Share:          

London-based GlaxoSmithKline has terminated a mid-stage clinical trial of SRT501 in patients with advanced multiple myeloma, the company said in a statement e-mailed to Xconomy today. The firm acquired the drug, a formulation of resveratrol, in its $720 million buyout of Cambridge, MA-based Sirtris Pharmaceuticals in 2008.

Sirtris has captured wide media attention because of the potential anti-aging benefits of the naturally occurring chemical resveratrol, which can be found in the skin of red grapes and in red wine.

Glaxo decided to end the trial after a review of data from the study found that the formulation of resveratrol “may only offer minimal efficacy while having a potential to indirectly” cause kidney complications that often occur in myeloma patients, according to the company’s statement. The Myeloma Beacon first reported the news about the recent decision to terminate the trial yesterday. Multiple myeloma is a type of cancer found in plasma cells.

The Phase IIa clinical trial tested the use of SRT501 with and without the approved cancer treatment bortezomib (Velcade), according to the government’s clinical trials website.

Glaxo had suspended enrollment of the study in April of this year after cases of acute kidney failure were found in five study patients, according to the company. In the company’s analysis of these cases, it “concluded that these renal failure cases were most likely due to the underlying disease, as kidney complications related to myeloma occur in up to 50 [percent] of cases. However, the formulation of SRT501 was not well tolerated, and side effects of nausea/vomiting/diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure,” the company said.

Glaxo, which continues to operate Sirtris as its subsidiary in Cambridge, said that it is now focusing on “selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties.” Those selective activators include compounds known as SRT2104 and SRT2379.

Comments (2) | Reprints | Share:          

[Updated 8/13/2010 9:30 EST. See below.] New England’s biotech and healthcare sector yielded a number of interesting stories this week.

—Joanna Horobin, CEO of Syndax Pharmaceuticals, confirmed that the Waltham, MA-based cancer-drug developer has raised $6 million in a convertible debt financing round planned to total $7 million. The new funds will support a clinical trial of Syndax’s drug, entinostat, as a treatment for breast cancer.

—Ryan spoke with Johannes Fruehauf, co-founder and president of ViThera Laboratories, about his startup’s efforts to “weaponize” bacteria and turn them into treatments for bowel disorders and other ailments. The Cambridge, MA-based company also provides contract research services, using the income from that business to help support the development of its own technology.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ:VRTX) reported that its experimental hepatitis C drug, telaprevir, works as well when taken for 24 weeks as when take for twice as long. The findings will like form part of Vertex’s case for approval of the drug in the U.S. and European markets next year.

—RNAi drug developer Dicerna Pharmaceuticals closed a $25 million Series B round of financing led by new investor Domain Associates and joined by return backers Abingworth, Oxford Bioscience Partners, and Skyline Ventures. The Watertown, MA-based startup has an approach to RNA interference that’s somewhat different from than that of rivals such as Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ:ALNY)—and which may help Dicerna overcome a major challenge in the field, delivering the gene-silencing molecules deep into the body.

—Wellesley, MA-based Mercator Therapeutics raised $2 million in seed funding from angel backers. CEO Chris Guiffre said the new funds will help Mercator gain a license to its technology, which targets cancer-killing agents to tumor cells, and to do early research in cancer.

—Boston Heart Lab raised $10 million in an equity and rights financing, according to an SEC filing. The Framingham, MA-based firm provides technology for measuring cholesterol levels and programs tracking the health of people with cardiovascular disease.

—The Healthy Lifespan Institute, a Boston nonprofit founded by former executives of Sirtris Pharmaceuticals and others, has begun online sales of the red wine chemical resveratrol, which is purported to have anti-aging effects, as a dietary supplement. [Editor's note: An earlier version of this story erroneously indicated that the formulation off the supplement was the same as one Sirtris originally developed as a drug called SRT501. Though the supplement is made in the same synthetic process as SRT501, the group says that the drug was tested in liquid form in capsules of 5 grams and the supplement is provided in powder form in 250-milligram capsules.] One of the nonprofit’s ultimate goals is to study the effects of resveratrol and other non-pharmaceutical interventions on the aging process, according to Christoph Westphal, one of the founders of the organization and the former chief executive of Sirtris.

Comments | Reprints | Share:          

Christoph Westphal is leaving his CEO job at Sirtris Pharmaceuticals, the Cambridge, MA-based developer of drugs that target genes linked to the aging process, to get back into the venture capital game, according to an e-mail Westphal sent to friends and colleagues as well as Xconomy.

Westphal says in his note that he is taking over as head of SR One, Glaxo’s venture capital arm. He’s also working with fellow Sirtris alumni Michelle Dipp and Rich Aldrich on a new Boston venture firm, Longwood Founders Fund, according to the note. (Last week the Boston Globe reported that Glaxo is backing Longwood Founders Fund, which appeared on our radar back in February.)

Still, Westphal isn’t relinquishing all of his ties to Sirtris, which Glaxo bought in May 2008 for more than $700 million. He is going to be keeping a close eye on the advancement of Sirtris’s drugs for diseases of aging as co-chair of the Sirtris scientific advisory board. George Vlasuk, who was named president of Sirtris last year and has been in charge of its day-to-day operations, will replace Westphal as the firm’s CEO, according to Westphal’s e-mail.

Westphal’s career move could be viewed as a return to his roots in the life sciences industry. He first joined Sirtris as a co-founder and interim CEO in 2004, while he was a general partner at Polaris Venture Partners in Waltham, MA. (He eventually left Polaris to lead Sirtris full-time.) During his days as a venture capitalist at Polaris, he was a founder of other high-profile biotech firms in the Boston area such as Alnylam Pharmaceuticals (NASDAQ:ALNY), Momenta Pharmaceuticals (NASDAQ:MNTA), and Acceleron Pharma.

Glaxo is now giving Westphal the keys to its own corporate venture fund, at a moment of big change at SR One. Westphal is becoming president of the fund, taking over the responsibilities previously held by Russell Greig, a 30-year Glaxo veteran. Greig left SR One last month, according to this report by the In Vivo Blog. That departure created an opening at the exact moment when corporate VC arms are gaining prominence as traditional venture firms falter, In Vivo noted.

The SR One position can be one of the plum jobs in biotech venture investing. According to the SR One website, the firm operates as an independent unit of GSK and has invested $600 million since 1985. The fund invests in companies all over the world, and some of its portfolio companies in the Boston area include Aileron Therapeutics, Genocea Biosciences, and Concert Pharmaceuticals.

[Disclosure: Xconomy's brand new life sciences columnist, Sylvia Pagán Westphal, is married to Christoph Westphal. Sylvia had no involvement in this story, we swear!]

Comments | Reprints | Share:          

[Corrected 1/28/10, 3:15 pm. See below] Alnara Pharmaceuticals has received a big financial boost at a critical time. The Cambridge, MA-based biotech firm says it has nabbed $35 million in a Series B funding round as it puts the finishing touches on the paperwork it needs to complete before asking the FDA for permission to sell its first product, an enzyme-replacement drug for patients with cystic fibrosis.

The firm’s new investor, MPM Capital, led the second-round financing, which included contributions from Bessemer Venture Partners, Frazier Healthcare Ventures, and Third Rock Ventures. Ashley Dombkowski, a managing director at MPM, is joining the board at Alnara as part of the funding round. With the new capital, the company has now raised $55 million since it was founded in 2008.

Alnara has ambitious plans for how to use its latest infusion of cash. By the end of the first quarter, the firm plans to file a new drug application to get U.S. approval of liprotamase, a pancreatic enzyme-replacement therapy that helps patients with cystic fibrosis to digest fats, proteins, and carbohydrates, according to Alexey Margolin, the company’s co-founder and CEO. The money will be needed to complete the application and prepare for the potential commercial introduction of liprotamase, which could hit the U.S. market as early as the fourth quarter of this year.

Robert Gallotto, the chief operating officer of Alnara, said that the firm expects to rapidly capture a significant portion of the estimated $400 million annual market for pancreatic enzyme replacement therapies in the U.S.

Liprotamase could provide big benefits to both cystic fibrosis patients as well as Alnara’s investors. Pancreatic enzyme treatments have been used for decades by patients whose pancreases are unable to produce enough of certain enzymes that people need to break down and digest certain fats and proteins. Traditionally, the enzymes are harvested from pig pancreases, and patients swallow a few capsules with their meals. Alnara, on the other hand, makes liprotamase with microbial enzymes in a process that is similar to how synthetic insulin is made. [Editor's note: The original version of this paragraph erroneously described liprotamase as a "genetically engineered copy of a natural human enzyme," though it is a recombinant microbial enzyme that is not a copy of human enzyme, according to a spokeswoman for Alnara.]

Alnara believes its treatment has several advantages over those made with pig enzymes. For one, the engineered, or recombinant, enzymes don’t carry the same risk of harboring viruses that the pig enzymes do. (However, Alnara acknowledges this safety risk is largely theoretical, because there have been no reported viral contamination in the previous treatments with pig enzymes.) Also, liprotamase can be taken in much lower doses than existing treatments, because the treatment is designed to prevent the digestive system from degrading its enzymes before they are needed. The company says that its research shows that patients need about five capsules of liprotamase per day, compared with 20 capsules per day for people who take competing treatments. The dominant competitor in this market is … Next Page »

Comments | Reprints | Share:          

There’s new a dynamic at work in Big Pharma’s acquisitions of biotech companies in Boston and elsewhere. Drug companies don’t only want to buy biotech firms to enhance their R&D pipelines, they want to bring the innovators behind the biotechs into the fold—and often give them prominent roles in the parent company. (This is a change from the past practice of pharma buyers gutting biotechs post-acquisition.) So last week, we conducted exclusive video interviews with two biotech executives whose firms have been recently acquired by large pharmaceutical companies and who reflect the new era—Deborah Dunsire, CEO of Millennium: The Takeda Oncology Company, and Christoph Westphal, CEO of Sirtris, a GSK company.

Both were brought into the Big Pharma fold last year (Dunsire became an employee of Takeda Pharmaceutical Company after the Japanese drug giant acquired Millennium for a whopping $8.8 billion last May, and Westaphal joined the ranks of GlaxoSmithKline in June 2008, when the British pharma powerhouse bought Sirtris for $720 million.) And both were given roles on the front lines of product innovation at their respective companies. So we asked both Dunsire and Westphal about what they think are the most exciting new therapeutic platforms in their industries, and what big drug-makers need to do to maintain their edge.

Not to give too much away, but both pointed to different technologies or platforms poised to transform their industries. Dunsire answered the second question with why she things Big Pharma is going to get smaller—and how that could be good for innovation. Westphal good-naturedly riffed on a comparison between the challenges faced by pharma and by journalism.

Both these interviews took place at last week’s Xconomy Forum: Pharma’s Bet on Boston Innovation in Cambridge, MA, where Dunsire and Westphal gave keynote addresses. But before you watch the videos, here’s my disclaimer: I’m a writer, so please remember that when you’re listening to the stammering interviewer (me) who is (thankfully) off camera. Also, give ample credit to the man behind the video camera, our own Richard Freierman, whose job title at Xconomy is business manager (but who obviously does much more than make sure the lights stay on.) Finally, please forgive all the background noise with Dunsire’s video. While we spoke with Westphal before the event got going, the party was in full swing (as you can hear) when we caught up with the Millennium CEO.

Deborah Dunsire

Christoph Westphal

Please let us know what you think about these videos, and how we could make such interviews better in the future.

Comments | Reprints | Share:          

I’m dashing this message off right before I get on a plane for Xconomy’s big event tomorrow afternoon: “Pharma’s Bet on Boston Innovation.” Only a few tickets are left for this gathering at the Hyatt Regency in Cambridge, MA.

I’m personally excited to fly in from Seattle for this event because it will bring together some of the world leaders in biotech and pharmaceutical R&D, all of whom happen to live in the greater Boston area (and who I usually talk to by phone and e-mail). The headliners are Christoph Westphal, the CEO of Sirtris and the senior vice president of GlaxoSmithKline’s Centre of Excellence for External Drug Discovery, and Deborah Dunsire, the CEO of Millennium: The Takeda Oncology Company. They will be able to share their experience of leading a growing biotech company, getting acquired by a big company, and then being given more resources to drive innovation in Boston instead of getting lost in a corporate shuffle.

We also have brought together several biotech leaders who have put together partnerships or attracted investment from Big Pharma companies, including speakers from Aileron Therapeutics, Hydra Biosciences, and Enlight Biosciences. Top venture capitalists from the Novartis Venture Funds, MedImmune Ventures, Advanced Technology Ventures, Flagship Ventures, and PureTech Ventures will be there to add perspective on how their companies are looking to create technologies that Big Pharma will want to buy. We will also hear from one of the region’s biotech success stories, Lebanon, NH-based GlycoFi, on what it’s like to be absorbed within a larger pharma company, in this case, Merck.

Here’s a podcast I did about the event.

I’m really looking forward to hearing what these folks have to say about the future of the pharmaceutical business, and the opportunities they see emerging in the Boston area. You can find more information about the agenda and how to register at the list minute here.

See you there tomorrow.

Comments | Reprints | Share:          

Europe’s drug regulators were not kind to a couple of Massachusetts biotech firms this week, but other New England life sciences companies had happier news to report.

—European drug regulators turned down Lexington, MA-based Antigenics’ bid for approval to market vitespen (Oncophage), a “cancer vaccine” for patients with kidney cancer. Shares of Antigenics (NASDAQ: AGEN) tumbled on the news.

—Ryan made a visit to the yeasty-smelling labs of Lebanon, NH-based Mascoma, where researchers are aiming to engineer microbes that can more efficiently produce ethanol from cellulose-rich materials such as wood chips, switch grass, and corn stalks. Mascoma is currently ramping up pilot production at a facility in Rome, NY, and hopes to complete one of the first commercial-scale cellulosic ethanol plants—in Kinross, MI—by 2012.

—Nuclea Biotechnologies raised $3.4 million in new equity financing. The Pittsfield, MA-based startup is developing genomic tools for cancer research and diagnosis.

—Ryan made the rounds of the big healthcare IT symposium put on by Partners HealthCare’s Center for Connected Health. The field is currently riding a wave of interest tipped off in part its inclusion in the economic stimulus bill, he explained, and the event attracted a mix of physicians, entrepreneurs, hospital administrators, academics, and technology executives. Ryan gave a great run-down of highlights from the event.

—Natalizumab (Tysabri), the multiple sclerosis drug from Cambridge, MA-based Biogen Idec (NASDAQ: BIIB), has reportedly come under fresh scrutiny from European regulators now that a total of 23 patients on the treatment have been diagnosed with a rare, potentially fatal brain infection called PML. According to Reuters, the European Medicines Agency has initiated a review to discuss any additional measures necessary to ensure the safety of the drug, which is also approved for Crohn’s disease. Shares of Biogen, and its partner Elan (NYSE:ELN) fell on the news.

—Wellesley, MA-based BioAssets Development Corporation inked a $30 million deal granting Frazer, PA-based Cephalon (NASDAQ: CEPH) to acquire the company. BioAssets will be eligible for various additional payments if Cephalon exercises the option and certain regulatory and sales milestones are reached.

—Boston-based American Well, provider of a Web-based system for remote medical consultations, raised $10 million in new equity funding, according to a regulatory filing. Investors in the round were not named.

—Luke gave a sneak peak of next week’s Xconomy Forum, which will explore how Big Pharma is seeking to boost its pace of innovation—and chances of success—in a notoriously risky industry. We’re all really excited about the event, which will include keynoters Deborah Dunsire, the CEO of Millennium: The Takeda Oncology Company, and Christoph Westphal, the CEO of Sirtris, and the senior vice president of GlaxoSmithKline’s Centre of Excellence for External Drug Discovery.

Comments | Reprints | Share:          

Cambridge, MA, biotech standout Sirtris has been a quieter operation since it became a subsidiary of drug giant GlaxoSmithKline last summer. But the firm’s drugs, heralded for their potential anti-aging effects, appear to be advancing through the clinic without a hitch.

Brian Gallagher, senior director of corporate development at Sirtris, disclosed during a recent meeting at Harvard Medical School that Sirtris has begun to recruit patients for a mid-stage clinical trial of its lead drug candidate, SRT-2104, for Type 2 diabetes. I don’t typically deem the initiation of a Phase II clinical trial all that newsworthy, but this one is interesting, in part because London-based Glaxo paid $720 million for Sirtris before the startup had accumulated very much human clinical data. Data from this sort of trial could provide an indication of whether Glaxo’s bet is likely to pay off.

Sirtris is developing drugs that have the potential to have a huge impact on the treatment of diseases of aging such as diabetes, cancer, and Alzheimer’s. And in the space of about five years, the firm has grown from a startup founded around Harvard professor David Sinclair’s discovery about the anti-aging effects of so-called sirtuin enzymes (which are activated by the red-wine chemical resveratrol) to a subsidiary of a major pharma company with the therapeutic assets and resources to significantly impact human health.

In the new trial, Sirtris will test its SRT-2104 drug candidate in about 200 patients with Type 2 diabetes in the UK and Eastern Europe. Like in most mid-stage clinical trials, the primary aim of the study is to show whether the drug is safe and tolerable in those patients. Yet the secondary goals of the study are to show whether the drug reduces blood sugar levels and to measure the drug’s effect on patients’ insulin levels. The large trial isn’t expected to yield any data before late … Next Page »

Comments | Reprints | Share:          

There were a wide variety of developments in the Boston-area life sciences sector over the past week. Companies in the headlines included big ones like Genzyme and Covidien as well as smaller startups such as Humedica and Tetraphase Pharmaceuticals. Here are some highlights:

—We got an early look at Cambridge, MA-based Humedica’s strategy for developing next-generation clinical analytics systems, as well as some insights into why Bain Capital Ventures, General Catalyst Ventures, North Bridge Venture Partners, and Leerink Swann have pumped $30 million into the young company. Company CEO Michael Weintraub talked about how the firm could become a U.S. Census of sorts for healthcare.

—Genzyme faced more setbacks due to previously tainted bioreactors at its Allston, MA, plant. The Cambridge -based biotech powerhouse (NASDAQ:GENZ) revealed that it’s going to take longer than expected to resume full production of its enzyme-replacement drug agalsidase beta (Fabrazyme) for Fabry disease. Also, the company is anticipating lower sales than previously estimated for both agalsidase beta and imiglucerase (Cerezyme).

—Sirtris CEO Christoph Westphal gave Xconomy the first media interview about a new nonprofit group that he and his colleagues are launching in the Boston area to promote longer healthy lives. Can the red wine chemical resveratrol really help people live longer? Westphal talked about how his new group, the Healthy Lifespan Institute, plans to answer that big question and more.

—After a period of poor stock performance for Cambridge-based biotech Alkermes (NASDAQ:ALKS), company Chairman Richard Pops has jumped back into everyday operations as CEO—a post he left in … Next Page »

Comments | Reprints | Share:          

Christoph Westphal, the CEO of biotech firm Sirtris, says that he and several of his colleagues are forming a new nonprofit group in the Boston area called the Healthy Lifespan Institute. The institute is being formed to research non-pharmaceutical measures that people can take to live longer and healthier lives and to educate people about the aging process, Westphal tells Xconomy.

While Sirtris, a Cambridge, MA, subsidiary of drug giant GlaxoSmithKline, is developing drugs to treat diseases of aging such as Type 2 diabetes and cancer, the new nonprofit group will be focused on educating people about the aging process and conducting human clinical studies into whether such interventions as reducing caloric intake or taking supplements like resveratrol will prolong healthy living. While the plant-derived resveratrol could be considered a pharmaceutical, depending on how it’s defined, a key to the potential life-extending measures of interest to the institute is that they are not traditional FDA-regulated therapeutics. The institute, which is due to officially launch within six months, is expected to be a separate entity  from Sirtris. Though the nonprofit group will certainly be tapping the expertise of people affiliated with Sirtris to advance knowledge of the human aging process.

The past decade or so has been rife with discoveries about the biological underpinnings of how cells and organisms age. For example, studies show that animals such as mice and monkeys on low-calorie diets live longer than animals that eat more. Other animal studies indicate that the red wine chemical resveratrol can mimic the effects of calorie restriction to prolong life. Sirtris’ leadership in this field prompted London-based Glaxo to acquire the startup for $720 million in June 2008. Yet the pharmaceutical industry is primarily focused on developing new drugs for diseases. Aging isn’t considered a disease. So there’s a large need for “rigorous controlled studies” that show the effects of non-FDA regulated measures such as calorie restriction and resveratrol in humans, according to Westphal.

“It’s a pretty straightforward mission statement: to increase healthy lifespan,” Westphal said. “I think there are few people who would disagree with that, and I think it’s a very worthy mission.”

Westphal believes it will cost tens of millions of dollars to fund the human clinical studies that the institute plans to conduct, yet he says that the focus of the nonprofit effort right now is to bring together leaders in the science of aging. The other people involved in the Healthy Lifespan Institute include David Sinclair—the Harvard Medical School professor who co-founded Sirtris with Westphal and others—MIT biology professor and Sirtris scientific adviser … Next Page »

Comments (3) | Reprints | Share:          

It didn’t bother me that my attendee badge was missing from the registration booth when I arrived at Convergence: The Life Sciences Leaders Forum in Newport, RI, last week. I suspect it was stolen by the same conference gremlins who bilked my badge at the NVCA annual meeting this spring, the 2007 BIO meeting in Boston, and several other events that I’ve attended in recent years. And though I started my stint at Convergence down one badge, I left it up a fist full of business cards, courtesy of the life sciences and healthcare innovators, executives and investors who had assembled for the three-day confab.

The gathering, organized by Boston-based Future Forward Events, produced plenty of unexpected moments, like when Genzyme’s iconic chairman and CEO Henri Termeer told attendees, during his fireside chat with Sirtris CEO Christoph Westphal, that Westphal had called him for advice during Sirtris’ negotiations last year with drug giant GlaxoSmithKline. (Read on for other tidbits from the Termeer-Westphal chat.) Unsurprisingly, much of the discussion, at least for the first two days of the meeting that I attended, centered on the dramatic changes occurring in the industry due to the dour economic climate and the ongoing policy and leadership changes in Washington, D.C. And in a change from years past (this is the sixth year for the event), everything was on the record unless the speaker clearly stated otherwise. Which means I can share many of the insights I gleaned from the panels and speakers and from my conversations during the event’s ample mingling opportunities. I even did a couple posts on Twitter during the event. Here are some highlights:

—Healthcare policy wonks were well represented at Convergence, and for good reason. The life sciences industry faces major hurdles due to policy changes under discussion at the federal level. Alan Eisenberg, executive vice president of emerging companies at the Biotechnology Industry Organization, listed the top policy issues that the industry group is following, including: proposed patent reforms and their potentially detrimental effects on life sciences firms; the regulation of generic, or “follow-on,” biotech drugs; improving the opportunities for firms in the industry to raise capital; and, perhaps most important, healthcare reform. On some of the big spending plans currently circulating in Washington, Eisenberg said: “Any one of these has the potential to suck the oxygen out of capital.”

—As I mentioned, we were clued in on some of the behind-the-scenes conversations that took place between Sirtris’ Westphal and Genzyme’s Termeer before London-based Glaxo purchased Cambridge, MA, Sirtris for $720 million last spring. Termeer told the audience that Westphal … Next Page »

Comments (1) | Reprints | Share:          

There are three weeks and one day to go before XSITE—the Xconomy Summit on Innovation, Technology, and Entrepreneurship, which we are holding at Boston University on June 24—and we are pumped. We are finalizing the agenda, and have added a host of fantastic new speakers, including inventor extraordinaire Dean Kamen. We’re also putting the finishing touches on some great panels that uncover some of the incredible strengths (many of them underappreciated) of New England’s innovation community.

We are pleased to be part of Innovation Month in New England, and hope XSITE 2009 will serve as a great anchor for the month by devoting a full day to innovation and bringing together key players from across the innovation spectrum. Speakers at XSITE will include leading executives from EMC, IBM, Microsoft, Alnylam, and Sirtris/GlaxoSmithKline, as well as top entrepreneurs such as Yet-Ming Chiang of MIT and A123Systems; Tillman Gerngross of Dartmouth, GlycoFi, and Adimab; Mick Mountz of Kiva Systems; and Christina Lampe-Onnerud of Boston Power (who just announced ambitions to build a 600-employee battery plant in Massachusetts). And we’re very excited about keynote speakers Juan Enriquez of Excel Medical Ventures, and, of course, Dean Kamen.

And for those of you who want to drill down into one of New England’s most vibrant innovation sectors, XSITE’s afternoon breakout sessions will offer you three to choose from. Our chief correspondent, Wade Roush, will host a session on Boston’s little-known—yet highly influential—assembly of digital entertainment and media firms: The Digital Entertainment Cluster: Boston’s Best-Kept Secret. It’s a topic near and dear to Wade’s heart, and sure to spark some lively discussion. Atlas Venture’s Jeff Fagnan, meanwhile, will provide a tour of what we’re calling The Health 2.0 Hub, the local people, institutions, and companies that are using innovations from IT to transform healthcare, from bench side to bedside and beyond. And energy innovators, executives, and investors will come together in a third session—Getting Energy Innovations to Market—to talk about what it takes to translate and scale new ideas in solar, wind, batteries, grid management, and energy efficiency into market realities.

The up-to-date agenda is here—sign up soon because early bird registration ends tomorrow. Also, when you sign up, please take our quick survey about the economy—we want your views on when it will improve, and which sectors will lead us out of recession. We will be revealing your predictions at XSITE.

Comments | Reprints | Share:          

Two major pieces of news from Elixir Pharmaceuticals today: first, the Cambridge, MA-based drug maker has just completed a $12 million round of equity financing led by MPM Capital, which joins current investors ARCH Venture Partners, Oxford Bioscience Partners, the Omega Fund and Physic Ventures. Kenneth Greenberg from MPM Capital will join Elixir’s Board of Directors.

Second, and potentially far more important, Elixir has granted Swiss drug giant Novartis the option to acquire the entire company following the completion of Phase IIa clinical studies of an oral diabetes drug Elixir has been developing. The drug, a “ghrelin antagonist,” interacts with hormones that regulate appetite and glucose and lipid levels in the body. If the drug turns out to be an effective way to control Type 2 diabetes, the Elixir compound could become an important asset for Novartis, which withdrew its application for FDA approval of its last big diabetes drug, vildagliptin (Galvus), last summer.

A sale of the company to Novartis could also provide a nice ending for Elixir, which has weathered unexpected difficulties since its creation in 1999. Founded by MIT biologist Leonard Guarente, the company focused for many years on researching drugs that might extend lifespan and treat metabolic diseases by manipulating a gene called Sir2. But a strong competitor emerged on the Sir2 front in the form of Cambridge, MA-based Sirtris, and Elixir’s main commercial focus gradually shifted to a pair of diabetes drugs, mitiglinide (Glinsuna) and metiglinide with metformin (Metgluna), that it licensed from a Japanese manufacturer and that may be submitted for FDA approval this year. Guarente left Elixir in 2006 and eventually joined Sirtris (which went on to be acquired by GlaxoSmithKline).

To fuel its ongoing diabetes research, Elixir hoped to raise $86 million in a planned initial public offering announced in late 2007. But the IPO was postponed in January 2008 and canceled in May 2008 in response to unpromising market conditions.

Now Elixir and its investors have another shot at an exit. The Novartis purchase option will kick in if the company can show the worth of its new ghrelin blocker in the Phase IIa clinical trial.  At that point, a planned initial payment and additional milestone payments based on regulatory and sales milestones could bring Elixir more than $500 million, the company said in its announcement.

Comments (2) | Reprints | Share:          

London-based drug giant GlaxoSmithKline has quietly spun off a biotech startup, Tempero Pharmaceuticals, in the life sciences haven of Cambridge, MA, to develop drugs to treat diseases in which the immune system goes awry and attacks healthy tissues, Xconomy has learned.

Tempero was incorporated in March, according to state of Delaware corporate records. The word has been out at least several months that Glaxo (NYSE:GSK) planned to spin off a project from its Immuno-Inflammation Centre of Excellence in Drug Discovery into a biotech startup. Glaxo revealed back in February at a Massachusetts Biotechnology Council event that the startup—which it didn’t name at the time—would focus on “advances in T-cell biology… to develop novel medicines for inflammatory and autoimmune diseases.”

Spiros Jamas, who managed the T cell project at Glaxo, is leading Tempero Pharmaceuticals as the startup’s CEO, according to a source familiar with the matter. Jamas was previously a global healthcare analyst for Boston-based financial firm State Street (NYSE:STT). Earlier in his career he served as chief executive of Enanta Pharmaceuticals, a Watertown, MA-based firm developing a drug for hepatitis C virus, as well as former biotech Alpha-Beta Technology, which was developing an anti-infective treatment before ending operations in the Worcester, MA, area several years ago. Jamas told me in an e-mail that he wasn’t in a position to talk about Tempero, and Glaxo’s U.S. corporate media office in North Carolina also declined to comment.

It’s unclear why Glaxo isn’t developing Tempero’s science internally. However, Glaxo has made efforts in the past to divide its vast research and development organization into smaller units that are highly focused on particular diseases. (For more on this strategy, check out this colorful piece from the InVivo Blog.) Also, Sirtris, the Cambridge, MA, biotech firm acquired by Glaxo last June for $720 million, continues to operate much like an independent biotech firm with its own offices, drug-development programs, and executive team.

There’s good reason for large drug makers such as Glaxo to adapt R&D operations to have the nimbleness and laser focus associated with biotech firms—the giant research divisions of the past have largely failed to produce enough new drugs to fuel their organizations. It’s no secret that drugs that generate tens of billions of dollars in annual revenue for major drug companies are expected to lose patent protection between now and 2012. From now through 2012, Glaxo is expected to lose patent protections on drugs—such as diabetes drug Avandia, osteoporosis treatment Bonviva, and cancer drug Hycamtin—that generated 2008 sales of $2 billion.

Perhaps a good dose of biotech business strategy, like the one Glaxo is employing with Tempero, will be good medicine for pharma companies.

Comments | Reprints | Share:          

There’s little arguing (at least from me) that the hottest ticket in town yesterday was the Boston Red Sox’ opening day game at Fenway Park—but for ardent biotech fans in the Hub there was arguably no better place to be than across the Charles River in Cambridge for the Boston Biotech Business Development Conference. The conclave featured senior-level professionals—representing a cross section of industry stakeholders from Big Pharma, large biotechs, and venture firms—who discussed and debated the opportunities and obstacles facing the embattled life sciences sector.

The event at the Charles River Hotel was no PowerPoint snoozer. There were some lively talks given by the top dealmakers from Cambridge-based biotech heavyweights Genzyme (NASDAQ:GENZ) and Biogen Idec (NASDAQ:BIIB) as well as drug giants GlaxoSmithKline (NYSE:GSK) and Merck (NYSE:MRK), among others. Several discussions focused on the importance of innovation in healthcare to surviving the economic slump and on challenges such as healthcare reform and generics competition. There was also some debate about whether innovation means breakthroughs in science, drugs that deliver substantial benefits for patients, products that garner premiums from healthcare payers, or some combination of the three.

Yet collective wisdom appeared to be that innovation—in various manifestations—is critical to survival of the life sciences industry. Many biotech firms are operating with less than enough cash to last a year, which means they must be innovative in how they use it, and companies raising money during the economic slump must clear a high bar with investors to show they have products that are truly novel and valuable. On the flip side, venture firms must prove that they can profit from innovation to garner limited capital from their limited partner investors. And with biotech investment dollars scarce, drug companies are wielding even more clout than before the economic meltdown—putting them in a position to gain rights to or ownership of innovative assets on the cheap.

Here are some of the highlights and colorful moments from the gathering:

—The line of the day (in my book) went to Ad Rawcliffe, senior vice president of worldwide business development for GSK: “Big Pharma is often the 800-pound gorilla … Next Page »

Comments (1) | Reprints | Share:          

These probably aren’t the rosy endings that VC backers had in mind when the promising Boston-area life sciences startups Magen BioSciences and Codon Devices were launched in recent years. But the news today is that Waltham-based Magen has been sold for less than it raised in its first round of financing, and the Boston Globe reports that Codon Devices is quietly shuttering its operations in Cambridge.

Magen, formed in 2006 to develop superior treatments for skin disorders, had all the makings of a future success story, with support from top Boston-area venture firms and scientific luminaries. Yet Wilmington, N.C.-based contract research firm PPD (NASDAQ:PPDI) says today that it has bought Magen for $14.5 million. That falls short of the $15.4 million that Magen tied down in its Series A round of financing. Lexington, MA-based Highland Capital led that maiden round, which included contributions from Flybridge Venture Partners in Boston and Lux Capital in New York, among other firms. Magen’s board of directors boasts some heavy hitters in the local biotech scene: Christoph Westphal, CEO of Cambridge biotech Sirtris; Rich Aldrich, founder of biotech hedge fund RA Capital in Boston; Phillip Sharp, a Nobel Laureate in physiology and medicine and a co-founder of Cambridge-based biotech Biogen Idec (NASDAQ:BIIB).

Codon, a maker of synthetic DNA fragments and other genetic materials, was similarly well-pedigreed. The firm’s scientific founders include Harvard Medical School sequencing guru George Church, MIT’s Drew Endy and Joseph Jacobson, and the University of California, Berkeley’s Jay Keasling. Codon’s venture backers included top names in life sciences investing such as Flagship Ventures, Highland Capital Partners, Khosla Ventures, and Kleiner Perkins Caufield & Byers. But lots of financial support, including a $31 million Series B financing wrapped up last year, apparently wasn’t enough to advance Codon into profitability—nor, evidently, were Codon’s efforts last June to reorganize and cut staff levels to focus resources on product development partnerships. In the end, it’s unclear how much of the money invested in Codon Devices was recouped.

Of course, the closing of Codon and the lackluster sale of Magen aren’t isolated incidents. In recent months, Waltham-based Dynogen Pharmaceuticals filed for bankruptcy protection after running short on the cash needed to develop drugs for gastrointestinal disorders like irritable bowel syndrome. And Foxborough, MA-based Cyberkinetics Neurotechnology Systems called it quits after its coffers ran dry while the company was developing a device to regenerate nerve cells in patients with severe spinal cord injuries.

At least for Magen, there’s still a pulse. Magen board members and investors did not reply to my requests for comment about the company sale this morning, but a spokeswoman from PPD says the research firm intends to keep the Magen operation and most of its workers in Waltham. Magen scientist Sandra Luikenhuis has joined PPD as executive director of dermatology, and is expected to lead development of the drug compounds that PPD is acquiring in its buyout of Magen. Magen licensed the compounds from drug giant Eli Lilly in 2007.

In a related development, PPD is selling its Piedmont Research Center business in North Carolina to Wilmington, MA-based contract research firm Charles River Laboratories International (NYSE:CRL) for $46 million in cash. PPD says that the sale is expected to offset the impact of its purchase of Magen.

Comments (2) | Reprints | Share: