Author: Ryan McBride

Ryan McBride wrote:

MDRNA, the Bothell, WA-based developer of gene-silencing drugs, could give itself a longer cash runway in a proposed merger with Cequent Pharmaceuticals, of Cambridge, MA. The companies announced plans this morning to combine in an all-stock deal worth about $46 million.

Last week, MDRNA (NASDAQ:MRNA) said its cash would keep the company afloat only into the second quarter of this year. Today the company is saying that its merger with Cequent—a venture-backed biotech that has raised at least $17.7 million in equity from backers such as Ampersand Ventures, Pappas Ventures, Yasuda, and Novartis Option Fund—would enable the combined firm to operate for the rest of 2010. Both firms hope to close the proposed merger by July.

In addition to cash, Cequent would bring MDRNA its novel technology in the burgeoning field of RNA interference (RNAi), which involves turning on and off certain genes to treat diseases. Cequent’s technology uses engineered E. coli bacteria to deliver RNAi drugs orally into the gut, and the company’s lead drug candidate for treating a rare genetic disease called familial adenomatous polyposis (FAP) with this approach is due to begin initial human clinical trials sometime between now and the end of June, according to the company.

The proposed merger would give investors in MDRNA a 56 percent ownership stake in the combined outfit, with Cequent’s backers owning the rest of the company. The plan is to keep the company headquartered in Bothell under the leadership of MDRNA’s current CEO, J. Michael French, while Cequent CEO Peter Parker would become the chairman of the company’s board of directors. Cequent’s office in Cambridge would become the combined company’s hub of clinical operations.

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

[Updated, 4/01/10, 4:40 pm] Amag Pharmaceuticals has struck a deal to expand global marketing of its best-selling drug. The Lexington, MA-based company (NASDAQ:AMAG) reports this morning that it has licensed its iron deficiency anemia drug to Japanese drug giant Takeda Pharmaceutical Company in a deal that includes $60 million in initial fees.

The deal gives Takeda an exclusive license to all therapeutic uses of Amag’s drug, ferumoxytol (Feraheme), in Europe, former Soviet states, Asia Pacific countries (excluding China, Japan, and Taiwan), Canada, and Turkey. Amag, which received FDA approval in June 2009 to market the drug as a treatment for iron deficiency anemia in adults with chronic kidney disease, will continue to control rights to the drug and handle sales of the product in the U.S. [Editor’s note: The word “therapeutic” was inadvertently omitted from the paragraph above when this story was published this morning.]

For Amag, this deal provides cash to seek additional approvals for ferumoxytol as well as an organization to sell its lead product in the next big potential market for the drug, Europe. The company plans to file an application with the European Medicines Agency in mid-2010 for permission to market the drug in European Union countries for patients with chronic kidney disease. Takeda has agreed to pay Amag $220 million in milestone fees for meeting certain development goals with the drug as well as double-digit royalties on Takeda’s potential sales of the product in the territories included in the deal.

“Takeda’s global presence, their pipeline that includes complementary products to [ferumoxytol] and their strength in the marketing and commercialization of therapeutics across many specialties where iron deficiency anemia is present makes them the ideal partner,” Brian Pereira, Amag’s president and CEO, said in a statement.

Last year, Amag took in $15.8 million in revenue from sales of ferumoxytol. The iron-replacement drug, which is intended to boost the amount of oxygen-carrying proteins in blood, is given to patients intravenously. About $500 million in injected iron-replacement drugs are sold annually for the some 400,000 Americans with kidney failure, according to analysts at Robert W. Baird.

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Here’s where the rubber hits the road for Leon Amariglio, Doron Harlev, and the startup they co-founded, Rhythmia Medical. After spending years to create an advanced system for mapping hearts during cardiac procedures, Rhythmia plans to test its technology in humans for the first time this year, Amariglio tells Xconomy.

The Burlington, MA-based company’s investors will soon get to see whether the $12 million they’ve pumped into Rhythmia since its launch in 2004 was worth the gamble. Norwich Ventures, of Waltham, MA, and Wyomissing, PA, has the most riding on Rhythmia among the startup’s investors, most of whom are either individual doctors, or business experts like MIT entrepreneurship professor Ed Roberts. The firm plans to begin a clinical trial of its catheter-based system in Europe in the coming months, testing the technology in fewer than 100 patients who are undergoing procedures to correct their irregular heartbeats, according to the firm’s co-CEO, Amariglio.

When asked how he felt about entering human studies, Amariglio said, “It’s exciting because it’s real, and it’s great to finally to be here.”

Rhythmia is attempting to improve the speed and resolution of the catheter-based systems that cardiology specialists called electrophysiologists use to get a three-dimensional view of the heart and the location of tissue responsible for irregular heartbeats, or arrhythmias. These systems are key to pinpointing the problematic heart tissues before they are destroyed to treat a patient’s arrhythmia. But existing technologies often require electrophysiologists to spend two to three hours to get a clear picture of the heart and where the culpable tissue resides.

Amariglio and Harlev, the other co-CEO of Rhythmia, decided to start their company without having any technology to solve this problem. (They met in the early half of the last decade while Amariglio was a student at …Next Page »

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

The Jackson Laboratory, a Bar Harbor, ME-based nonprofit provider of genetic research and lab mice, said yesterday that its president and CEO Richard Woychik is stepping down from his post. Woychik, who took over as chief executive in 2002, told the nonprofit’s board of trustees that he is open to staying on while the firm searches for his replacement. The organization, a major biotech employer in Maine, has a total of 1,318 employees in Maine and Sacramento, CA, and an annual budget of $170 million for the current fiscal year.

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Genzyme’s manufacturing operations are facing further scrutiny in the aftermath of viral contamination found at its Allston Landing plant last June. The FDA informed the Cambridge, MA-based company (NASDAQ:GENZ) yesterday that the agency is taking action to make sure that the firm is making its products in compliance with manufacturing regulations, according to the company.

Genzyme, the world’s largest maker of enzyme-replacement therapies for rare diseases, is now expecting that the FDA will be reviewing operations at the Allston plant for “an extended period” and may require to the company to make payments to the government. However, the firm says that it doesn’t expect the agency’s actions to interrupt production of its Gaucher disease therapy imiglucerase (Cerezyme) and its Fabry disease treatment agalsidase beta (Fabrazyme), both big moneymakers for Genzyme that are produced at the Allston facility.

The Fabry drug has been in short supply since the viral contamination was discovered at the Allston plant in June, and Genzyme has only recently brought production of the Gaucher treatment up to normal levels after it too was scarce for the second half of 2009. The company is also hoping that the agency’s action doesn’t interrupt finishing work at the plant on alglucosidase alfa (Myozyme), a Pompe disease therapy, and thyrotropin alfa (Thyrogen), which is used in patients with thyroid cancer.

Over the next few weeks, Genzyme plans to discuss the extent of the FDA’s enforcement action with agency officials, said company spokesman Bo Piela. The agency is likely to require its own inspectors or a third party to monitor production at the plant, he said, but the duration of the inspections and how much they will cost the company will need to be worked out with regulators.

In pre-market trading, Genzyme’s stock was down $2.01 or 3.4 percent to $57.09 per share at 9:28 am Eastern time.

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Epizyme, a high-flying startup focused on the hot field of epigenetics, has recruited a new CEO and a new chief dealmaker. Robert Gould started work this week as chief executive of the Cambridge, MA-based biotech, having resigned from a big job at the Broad Institute of MIT and Harvard.

Gould has served on the board of directors at Epizyme since its founding two years ago, as it has grown from one to 20 employees and closed a $40 million Series B financing. (The firm has now raised a total of $54 million from New Enterprise Associates, MPM Capital, Kleiner Perkins Caufield & Byers, Bay City Capital, Astellas Venture Partners, and Amgen Ventures.) He’s replacing founding CEO Kazumi Shiosaki, a managing director at MPM, as part of a transition plan in which she will remain a board member of the company.

Besides Gould, Epizyme has also brought on Jason Rhodes, a former VP of business development at Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ:ALNY), to lead deal-making activities as the startup’s chief business officer. Rhodes certainly got exposed to a lot of deals during his stint from 2007 to this year at Alnylam, the RNA interference company; Alnylam has active partnerships with Roche, Novartis, Takeda Pharmaceuticals and other big drug companies.

Both executives spoke of the huge opportunity for Epizyme in the field of epigenetics, which involves turning on and off certain genes without altering the underlying code of DNA. Based on the company’s epigenetics research, Epizyme is in the early stages of pursuing small molecule drugs that block enzymes believed to be involved in cancer, called histone methyltransferases. The startup says its research could also lead to the discovery of drugs for diseases outside of the cancer field, where it will focus its initial efforts. It’s got a local rival in Cambridge’s Constellation Pharmaceuticals, which is also doing epigenetics research to find cancer therapies.

Gould, 55, left the Broad Institute after spending three years in charge of a group that looked for potential medical applications for scientific discoveries made at the renowned genomic research center in Cambridge. He was previously a vice president at Whitehouse Station, NJ-based Merck (NYSE: MRK), where he worked on ushering 20 drugs into clinical trials. In his new post, Gould hopes to eventually begin testing Epizyme’s drugs in cancer patients, but he declined to provide a timetable for when trials will begin or the specific types of cancer the company plans to treat.

Robert Gould, CEO of Epizyme.

When asked why he took the job, Gould said he is “anticipating the exciting possibilities in treating cancer and in epigenetics.” He added, “[It] seemed to me to be a great opportunity to continue building a company.”

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

[Updated — 3/22/10, 11:30 am Eastern time] There will be no proxy battle between billionaire Carl Icahn and Biogen Idec this year. Cambridge, MA-based Biogen (NASDAQ:BIIB) says this morning it has struck a deal with Icahn in which two new members have been added to Biogen’s board of directors, including one of the candidates Icahn nominated back in January.

The deal gives Icahn greater control over Biogen’s board and Biogen a reprieve from what could have resulted in a third year of wrangling with Icahn over board seats at its annual meeting. Icahn has agreed to back Biogen’s slate of candidates for open board seats at the company’s annual meeting and drop any plans to wage a proxy battle with the company this year.

As part of the pact, Icahn’s nominee Eric Rowinsky and biotech industry veteran Stephen Sherwin, Biogen’s pick, have joined Biogen’s board of directors. Rowinsky and Sherwin are two of the four nominees that Biogen will endorse and now Icahn will support for election to the firm’s board later this year. Rowinsky and Sherwin will need to be elected at the annual meeting to stay on the board because their appointments expire this year. As planned, Biogen CEO James Mullen, who recently announced his plans to retire, and Biogen director Bruce Ross are finishing their terms on the board and will not seek reelection. (Editor’s note: More detail about the appointment of Rowinsky and Sherwin to Biogen’s board was added to this paragraph.)

Biogen’s deal with Icahn comes as it searches to replace Mullen, who has often been a target of Icahn’s criticism related to the poor performance of the company’s stock. Mullen plans to retire in June. The deal could be an effort from both sides to make the company more attractive to a prospective CEO to replace Mullen. (Who wants to take over a company pitted in a proxy battle, let alone one with an influential investor like Icahn?)

Icahn has also agreed to end his petition to amend Biogen’s bylaws to limit the number of members of the company’s board to 12. The company is expected to operate temporarily with 13 board members until this year’s annual meeting, after which the number will be 12. At that point, Icahn, who gained two seats on the company’s board last year, will control 25 percent of the board. He has been a proponent of trimming expenses and reprioritizing R&D efforts at the company to boost its stock price.

Comments (2) | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Ischemix is facing the biggest hurdle in its 11-year history. The Maynard, MA-based biotech firm is launching the first human study to test the effectiveness of its drug that’s supposed to protect heart tissue from injuries that often occur when blood flow is restored in cardiac surgeries.

The drug, called CMX-2043, is the only contender the company has that’s ready for clinical trials, says CEO Duffy DuFresne. Without backup clinical candidates, the success of the firm’s Phase IIa trial in treating ischemic-reperfusion injury is hugely important to the future of the company.

Success would be a major leap forward for both Ischemix and the treatment of ischemic-reperfusion injuries, for which there are no FDA-approved therapies despite many previous attempts. The closely held company—funded primarily by its chairman, and its medical director—has enough money to pay for the mid-stage clinical and not much else beyond that, according to DuFresne.

“The good news is that we’ve raised enough money to carry us to the end of this trial,” DuFresne says, “the bad news is that we’re not funded beyond that and additional funding is going to have to be determined by how encouraging our results are.”

The clinical trial is expected enroll 200 to 220 patients, many of whom are undergoing surgeries to unblock their arteries and implant stents to restore blood flow, according to DuFresne. The firm’s drug, which was previously tested for safety in healthy people, will need to prove that it’s both …Next Page »

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Cambridge, MA-based Forma Therapeutics has formed a partnership with the Leukemia & Lymphoma Society of White Plains, NY, to discover drugs for immune cell cancers, according to a press release. No financial details were revealed. The partnership will focus on blocking a protein known as “Bcl-6,” which plays a role many lymphomas. Forma has been on a roll on the fund-raising and partnership fronts, having revealed more than $50 million in funding last year as well as a drug-discovery deal with Lexington, MA-based Cubist Pharmaceuticals (NASDAQ:CBST).

Comments (2) | Reprints | Share:  

 
 
 

Ryan McBride wrote:

The potential riches for makers of obesity and diabetes treatments are irresistible to biotech entrepreneurs and investors. Rhythm Pharmaceuticals, a drug developer focused on these multibillion-dollar markets, has closed a $21 million Series A round of funding, according to the firm.

Rhythm has been quietly incubating at the Boston offices of MPM Capital. Then on Friday, the startup made some news when it revealed an exclusive licensing deal with the rising French biotech power Ipsen, which is supplying Rhythm with molecules based on two hormones that play roles in regulating metabolic functions. Paris-based Ipsen is a fast-growing biotech that pulled in about $1.4 billion in revenue last year.

Rhythm president and co-founder Bart Henderson, who was previously an entrepreneur-in-residence at MPM, tells Xconomy that the Ipsen molecules, or peptides, compose the entirety of his young startup’s pipeline. The first-round financing, led by MPM and the venture firm New Enterprise Associates, will fund the firm’s first two clinical trials slated to begin this year and in 2011. Ipsen owns a 17-percent stake in Rhythm, and has a seat on the startup’s board of directors.

Henderson says he was familiar with the technology from Paris-based Ipsen from his tenure as chief dealmaker for Cambridge, MA-based …Next Page »

Comments (1) | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Venture capitalists are giving the risky field of gene therapy a new dose of confidence—and cash. Genetix Pharmaceuticals, a 17-year-old developer of gene therapies, has replenished its coffers with a $35 million Series B round of venture capital.

The Cambridge, MA-based company attracted the fresh capital after a study in France showed that one of the firm’s gene therapies blocked the progression of a debilitating brain disorder called adrenoleukodystrophy (ALD) in two children. This is the disease that was featured in the acclaimed 1992 film “Lorenzo’s Oil,” the true story of a husband and wife who searched for a cure for their son with the crippling illness. While much testing will be required to bring the gene therapy to market, Boston’s Third Rock Ventures and Cambridge-based biotech giant Genzyme were convinced that there was enough promise in the data to make big bets on the company.

Third Rock and Genzyme Ventures, the venture unit of Genzyme (NASDAQ:GENZ), are the new investors in Genetix’s second-round financing, according to the company. The round includes investments from the firm’s previous VC backers Easton Capital, Forbion Capital Partners, and TVM Capital. The new funding came with major management changes at Genetix: Third Rock partner Nick Leschly is leading the firm as interim president; Phil Reilly, a venture partner at Third Rock, has become chief medical officer; and Mitchell Finer, a veteran biotech executive, is the new chief scientist. Genetix CEO Alfred Slanetz is leaving the firm.

Gene therapies, which typically use viruses to deliver healthy genes into cells to treat diseases, have never been approved for the market nor lived up to the hype they initially generated about two decades ago. Genetix is one example of renewed faith in the science in some scientific and investor circles. The company, one of hundreds like it that formed in the 1990s to develop gene therapies, was recapitalized in 2004 and licensed technology from the French …Next Page »

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

It’s a far cry from a hot market for initial public offerings these days, but there are reasons to believe that the long-awaited “IPO Window” is slowly opening for venture-backed companies in the Boston area.

Sensata Technologies, an Attleboro, MA-based maker of sensors and switches, jumped through the IPO window yesterday, pricing its initial public shares at $18 apiece. By offering 31.6 million new shares, Sensata (NYSE: ST) raked in a fresh $568.8 million. This price was, however, on the low end of the company’s hoped-for range of $18 to $20 a share. (Sensata, whose business dates back to 1916, is a former unit of Texas Instruments that Bain Capital took over in a leveraged buyout in 2006. So this isn’t a traditional venture-backed company IPO by any means.)

Next in line appears to be Cambridge, MA-based cancer drug developer Aveo Pharmaceuticals. Aveo plans to raise about $100 million, in an IPO that’s scheduled to price today, according Renaissance Capital. And though the company fell short of its estimated price range of $14 to $16 per share for its public debut, Cambridge-based Ironwood Pharmaceuticals (NASDAQ:IRWD) managed to pull off an IPO last month for $11.25 per share that netted the firm $203 million. Fortunately for investors, Ironwood stock has traded up ever since, closing yesterday at $12.65.

The IPO drought for venture-backed startups in recent years has been a major bummer for both maturing startups and their investors. When public markets aren’t receptive to IPOs, it blocks one avenue that venture firms use to get liquid cash returns after years of locking it away in a startup. For private companies, the lack of a healthy IPO market forces some to look elsewhere for funding to keep their operations afloat. It can also make it harder to entice employees when there isn’t a realistic chance that all their sweat equity will someday turn into financial equity.

One recipe for venture-backed companies to break into the public markets appears to be having a product on or close to the market, which significantly reduces the risk for public investors. For example, A123 Systems (NASDAQ:AONE) made a successful public debut in September, which raised more than $400 million, in part because the Watertown, MA-based company was already generating revenue from sales of its advanced lithium-ion batteries. Ironwood’s IPO followed the firm’s successful completion of two pivotal trials for its lead treatment for constipation.

We’ve compiled a list of New England-based life sciences and technology companies that are in registration to go public. (While we’ve cross-referenced our list with the Renaissance Capital website, please let us know if we’ve missed any.)

Here’s the list of active Boston-area IPOs:

—Aveo Pharmaceuticals, a Cambridge, MA-based developer of cancer treatments, could launch its IPO sometime this week. A big question is whether the firm’s IPO price range of …Next Page »

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

Attleboro, MA-based Sensata Technologies says it begins trading on the New York Stock Exchange today after completing its initial public offering yesterday at $18 per share. The IPO was priced at the low end of the proposed $18 to $20 range. Yet the 31.6 million shares sold in the maiden offering raised a total of $568.8 million. Sensata Technologies (NYSE:ST), a maker of sensors for the auto industry as well as switches and controls for lighting and heating systems, is incorporated in The Netherlands but has its headquarters in Massachusetts. The Sensata business, which has roots that date back to 1916, is a former unit of Texas Instruments that was purchased in a leveraged buyout led by Boston-based Bain Capital in 2006.

Comments | Reprints | Share:  

 
 
 

Ryan McBride wrote:

PatientsLikeMe, a Cambridge, MA-based provider of a social networking website for patients, reports today that the Swiss drug giant Novartis is supporting the startup’s development of a new online community for people who have received organ transplants. No financial details about the startup’s deal with Novartis were revealed. Novartis, which has a large R&D organization in Cambridge, has worked with PatientsLikeMe in the past to learn about patients with multiple sclerosis, for which PatientsLikeMe has an online community. (Xconomy covered PatientsLikeMe’s strategy for working with pharma customers like Novartis last month.)

Comments | Reprints | Share: