Author: Luke Timmerman

Luke Timmerman wrote:

Catabasis Pharmaceuticals has just raised a load of cash. The Cambridge, MA-based biotech company has raked in an initial $7.7 million in equity financing out of a venture round that could be worth as much as $39.7 million, according to a regulatory filing.

The company, which lists an address at 161 First Street in Cambridge, is led by president Jill Milne, according to the filing. Catabasis’s company website doesn’t say much at the moment, although Milne, a former senior director at Sirtris Pharmaceuticals and a director at Pfizer, says on her LinkedIn profile that she founded Catabasis in July 2008.

The startup, which disclosed that it had obtained $2 million in debt financing in January, now has some big hitters on its board of directors. The group includes Maggie LeFlore of MedImmune Ventures; Jeff Leiden of Clarus Ventures; and Michael Ross of SV Life Sciences. Michael Jirousek, another Sirtris veteran, is the chief scientific officer at Catabasis, according to his LinkedIn profile.

The company hasn’t issued a press release, and I left a message for Milne this morning at the office. I’ll update this space if I hear back from her. But the Catabasis company website offers a very basic description of what the company is about. It is developing drugs for inflammatory and metabolic diseases, with the idea of returning the body toward its natural state of balance, known as homeostasis. The compounds are being designed to focus on lipid mediators, specifically by taking advantage of the ability of protective effects of omega-3 fatty acids against heart disease.

“Additionally, there is a growing body of clinical and preclinical evidence that [omega-3 fatty acids] have therapeutic potential for the treatment of neurodegenerative disorders, age-related macular degeneration, and cancer,” the company says on its website.

Catabasis is seeking to use what it calls “SMART-linker” technology that improves the delivery, potency, and effectiveness of two specific omega-3 fatty acids.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

One of Seattle’s oldest biotech companies was rejected by U.S. drug regulators in the past week, while another is on pins and needles awaiting what most analysts expect will be an imminent FDA approval.

—How much will people pay for a new prostate cancer drug that will help men live a median of four months longer than a placebo? That’s one of the big questions at Seattle-based Dendreon (NASDAQ: DNDN) as it enters the final days before the FDA says whether the drug, sipuleucel-T (Provenge), is ready for the market or not. I polled seven analysts on their price projections, and dug into some of the factors that Dendreon has to consider when it sets the price.

—The FDA rejected Seattle-based Cell Therapeutics‘ application to sell a new drug for non-Hodgkin’s lymphoma, pixantrone. This was the obvious outcome, since the FDA’s cancer boss, Richard Pazdur, gave the company a public dressing down at an advisory committee hearing last month, and the panel of cancer experts voted 9-0 against it. Cell Therapeutics (NASDAQ: CTIC) hoped to get out of this jam by holding a shareholder meeting where it would win authorization to sell millions of more shares, but it postponed that meeting, probably because it was unable to get a quorum of shareholders—a problem that has dogged the company in the past. A subsequent conference call about the company’s future plans struck me as so absurd I chose to Tweet about it in real-time, but not spend more time writing. If you really want to follow this in more depth, read a blistering opinion piece from TheStreet.com’s Adam Feuerstein.

—We had some encouraging news from Eastern Washington this week. Waltham, MA-based PerkinElmer said it agreed to acquire Spokane, WA-based Signature Genomic Laboratories for $90 million in cash, to strengthen its genetic testing and molecular diagnostics business.

—The University of Washington has confirmed what a top commercialization official predicted a year ago—that the university has been awarded $300 million in federal stimulus money. I gathered that fact from a Technology Alliance talk by one of UW’s leading genome scientists, Debbie Nickerson. But she talked in more depth about her “new Corvette”—a $25 million gene-sequencing center that her team hopes will prove it was worth Uncle Sam’s investment.

—I promised myself that I’d avoid cheesy puns like “fledgling” when describing the latest angel investment network in the Northwest, but it can now be said that it is starting to take flight (that’s a little better isn’t it?). This was a story about Wings, the new angel network for medical device investors, which got started at its inaugural meeting yesterday, in which it reviewed business plans of three startups.

—Dendreon had one other nugget of news this week. It hired Varun Nanda as the senior vice president in charge of commercialization of sipuleucel-T (Provenge). Nanda has a ton of experience with cancer drugs, having previously worked at the Genentech unit of Roche. He better be a quick study, because Dendreon is awaiting word from the FDA by May 1 on whether it has the green light to start selling the product.

—Fate Therapeutics, the San Diego-based company that counts University of Washington stem cell researcher Randall Moon as a scientific co-founder, is expanding its mini-empire into Canada with the acquisition of Verio Therapeutics.

—Liberty Dialysis, a Mercer Island, WA-based company that operates more than 100 dialysis clinics around the U.S., received an undisclosed amount of financing from a group of investors that includes Ignition Partners.

—As the dust settles on healthcare reform, Stewart Lyman helped show readers one of the overlooked elements of the new law that will provide a windfall of tax benefits for biotech companies.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Genzyme (NASDAQ: GENZ), the Cambridge, MA-based biotech giant, has agreed to add activist investor Ralph Whitworth to its board of directors immediately, according to a report this evening on the Wall Street Journal’s website, which cited a person familiar with the matter. Adding Whitworth could make things more difficult for another activist shareholder, billionaire Carl Icahn, who is calling for significant change at Genzyme in the wake of its manufacturing troubles of the past year. Relational Investors, Whitworth’s firm, has a 4 percent stake in Genzyme.

Whitworth reached a “mutual cooperation” agreement with the company in January. That deal said he would support the biotech’s nominees for the board at the 2010 annual meeting scheduled for June 16, but if Whitworth wasn’t satisfied with the nominees, Genzyme would name him to the board in the fall. Whitworth, who is based in San Diego, talked about his goals for fixing things at Genzyme in this interview in January with my colleague in San Diego, Bruce Bigelow.

A Genzyme spokesman didn’t immediately respond to an e-mailed request for comment late Wednesday night.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

PerkinElmer (NYSE: PKI), the maker of scientific instruments based in Waltham, MA, said today it has agreed to acquire Spokane, WA-based Signature Genomic Laboratories for about $90 million in cash, according to a regulatory filing. The move will enable PerkinElmer to strengthen its genetic testing services and expand into molecular diagnostics, particularly cancer diagnostics, according to a statement. Signature has about 120 employees.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

How much will people in the U.S. pay for a new prostate cancer drug that helps dying men live a few months longer? This is one of the tricky questions Seattle-based Dendreon (NASDAQ: DNDN) is wrestling with these days. The decision will have a significant impact on how successful Dendreon is for years to come.

The issue is all about how much to charge for an immune-boosting treatment for elderly men with terminal prostate cancer, called sipuleucel-T (Provenge). Dendreon showed last year in a clinical trial of 512 men that this drug helped men live a median time of four months longer than those on a placebo, with minimal side effects. Dendreon is seeking clearance from the FDA to start selling the treatment, and the agency’s deadline to complete its review is May 1. If approved in the U.S., the Dendreon drug would be the first in a new class of therapies that actively stimulate the immune system to fight tumors.

Most of Wall Street projects this drug will emerge as a billion-dollar blockbuster in a few years. JP Morgan analyst Cory Kasimov, for one, forecasts $1.49 billion in U.S. sales in 2014. But his model, and all the rest, are based on a lot of unknown factors at this time, like how much the drug will cost, and how many men will get prescriptions. Dendreon hasn’t said anything specific about its pricing plan, other than an often-repeated line about how the product will be priced similarly to “other novel biologic drugs that extend lifespan“—which is sort of a coded way of saying, “This drug will save your life, and it will be expensive like all the rest.” A spokeswoman for the company declined to comment for this article.

Analysts have reported on a wide variety of estimates on what Provenge will cost, between $40,000 and $100,000. While different analysts use different models, I found that the expected price is about $61,714, according to the average estimate of seven analysts surveyed by Xconomy. But this is truly a guessing game at the moment. While Kasimov uses $65,000 as his estimated price per patient, he says it could run as high as $75,000 to $100,000. You can see the estimates listed from all seven analysts in the chart below.

There are a lot of factors to consider as Dendreon makes the decision on the actual price of what would be its first marketable product. Set the price too low, and it would fail to recoup enough of the $783 million deficit the company has racked up since its founding in 1992. The company’s stock (NASDAQ: DNDN) would probably tumble. Dendreon also would probably struggle to keep up with demand from patients, leaving many of them frustrated at their inability to get a potential life-saving drug.

But setting the price too high is obviously a perilous thing to do as well. Insurers would probably set up all kinds of red tape to ensure the drug is being prescribed in precise accordance with the FDA-approved label, creating hassles for doctors that they might prefer to avoid. Competitors …Next Page »

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

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

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

The Northwest’s new medical device angel investing network, called Wings, is showing more signs that it is starting to get off the ground.

Three local medical device startups have been picked by the Wings selection committee to give 10-minute talks at the angel network’s inaugural invitation-only meeting this Wednesday. The entrepreneurs made it through a vetting process that saw 28 initial applications, says Stephanie Barnes, the program manager for Wings. At the meeting, Russell Investments CEO Russell Doman will give an overview on the investment climate to a group of at least 35 prospective medical device angel investors, Barnes says.

There’s no guarantee that any of them will secure investments. But the hope is that the event will make introductions between entrepreneurs and experienced investors, who could go on to obtain follow-on investments from other angels around town, says Wings president Stefan Kraemer. If all goes well—and Wings now has six sponsors providing some initial support—then it will plan to do its events on a quarterly basis, Barnes says.

The idea for the medical device angel network, which I first profiled back in February, comes at a tough time for the medical device industry. The industry has been squeezed by rising unemployment and the ensuing loss of health insurance that creates, which has put pressure on hospitals to apply more scrutiny of purchases of new equipment. Many entrepreneurs have complained bitterly about new legislation that raises taxes on medical device makers too.

But Wings hopes that by harnessing some of the creative juice of some of the region’s successful medical device entrepreneurs, they will be able to provide the money and mentorship that new startups can use to navigate the tough terrain. One common theme in the applications so far is that entrepreneurs are finding clever ways to demonstrate some proof of their concepts on shoestring budgets, Kraemer says.

“These companies won’t need $50 million or $100 million,” Kraemer says.

Here’s who will present to the Wings group on Wednesday, with a snippet on what they aim to do:

—Steven Dimmer, the CEO of Bellevue, WA-based Innovative Pulmonary Solutions, will talk about his vision of a new method for treating chronic obstructive pulmonary disease without leaving any implant behind in the patients’ lung tissue. Dimmer is a former vice president of R&D at Seattle-based Calypso Medical Technologies.

—Brian Glaister, CEO of Seattle-based Empowering Engineering Technologies, will describe his idea for an orthopedic device that could help disabled people get around without a wheelchair or a walker.

—Kevin Connolly, a serial device entrepreneur who’s now CEO of Redmond, WA-based SRS Medical, will talk about his plan for a new device to diagnose urinary incontinence.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Mersana Therapeutics has snagged its first big partnership. The Cambridge, MA-based company that makes drugs last longer in the bloodstream has formed an alliance with Israel-based Teva Pharmaceutical Industries that could be worth as much as $334 million over time for developing a new polymer-based drug for cancer and other diseases.

Mersana isn’t saying how much money it is getting up front from Teva, although the smaller company could receive as much as $334 million over time if its compound, XMT-1107, reaches every development, regulatory, and sales goal in the deal. Teva has also agreed to pay all the development expenses, except in Japan, where Mersana retains full commercial rights to the drug. If the compound wins regulatory approval elsewhere in the world, Mersana stands to get royalties that are worth a percentage of total sales.

“It’s a validation of our work to have this partnership,” says Julie Olson, Mersana’s CEO. “Despite what people may say, Teva is a smart company.”

Teva is best known as the world’s largest maker of generic drugs, not for work in discovering or developing groundbreaking new therapies. The big company doesn’t even have an internal discovery operation, so for it to become a developer of novel therapies, it truly has to look outside its own walls. Teva’s vision is to morph into something more diversified than it is today, a company with $30 billion in annual revenue by 2015, and about one-third of that cash coming from brand-name pharmaceuticals, Olson says.

As Olson mentioned, not everyone in the pharma and biotech world is a big fan or believer in this vision of a new Teva. Bothell, WA-based OncoGenex Pharmaceuticals (NASDAQ: OGXI) found that out in December, when it trumpeted a new deal with Teva, which left investors so unimpressed, they drove down OncoGenex shares by more than 20 percent the next day. Olson, a former dealmaker at Pfizer, said she noticed that, and that she was satisfied that Teva had done solid homework on Mersana, and vice versa, before the deal was done. “We looked at them very carefully and came away impressed,” Olson says.

Julie Olson

What is Teva getting its hands on? The drug, XMT-1107, is designed to modify a fumagillin molecule that’s supposed to fight tumors by cutting off their blood supply. This is similar in concept to drugs like Roche’s bevacizumab (Avastin) or Pfizer sunitinib (Sutent), although the fumagillin drug isn’t made to hit the same target as the others, known as VEGF.

Other companies, notably Takeda Pharmaceutical and Abbott Laboratories, have tried to develop fumagillin molecules for cancer. Those programs showed some anti-tumor activity, but they sputtered because they didn’t last long enough in the bloodstream, and crossed over the blood-brain barrier and caused nervous system side effects like insomnia, agitation, and severe loss of balance, Olson says. So Mersana sought to apply its platform technology to the problem. The idea was to take a fumagillin molecule similar to the others that have been tested, and then attach it to a proprietary biodegradable polymer which Mersana calls a “Fleximer.” This polymer, attached to the fumagillin with a strong covalent chemical bond, is supposed to keep the drug stable in the bloodstream much longer than the drug by itself, and keep it from crossing the blood-brain barrier where it can cause nervous-system side effects, Olson says.

Data to prove this concept is still quite preliminary. The Teva folks bought in after they reviewed tests from mice and rats, which showed the Mersana drug was better at suppressing tumor growth than the other anti-VEGF compounds. The Mersana drug is thought to last long enough in the bloodstream that it can be given via IV every three weeks, Olson says. The compound is ready for its first clinical trial to begin before the end of June, which will assess safety at a variety of escalating doses. Results should be ready in 18 to 24 months, Olson says.

The deal provides enough financial support that Mersana will be in position to grow a bit, from 20 employees now to about 25 or 26, Olson says. The company will look to add some development expertise as it enters clinical trials, but also some research talent to help accelerate its plan to apply the Fleximer technology to the tricky problem of RNA interference drug delivery. Plus, the company still has 100 percent ownership rights to its lead compound, a polymer-enhanced version of camptothecin chemotherapy, which it calls XMT-1001.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Nobody will ever confuse San Diego’s Sorrento Valley for Sand Hill Road. And that’s not a bad thing if you’re one of the guys at Avalon Ventures.

“The story is really that Avalon is now one of just two really active life sciences venture funds in San Diego, which is the third largest biotech hub in the world,” says Jay Lichter, a managing director with Avalon.

I sat down with Lichter, one of four managing members at Avalon, to talk about this phenomenon during my visit to San Diego in December, and followed up with him again a couple weeks ago. A lot was being written then, and still is, about the decline of the entire venture capital industry, and its impact in particular on San Diego’s longtime stalwarts of the life sciences community.

San Diego’s Forward Ventures, which has shed several partners, has shifted its strategy to an ultra-lean model, as Bruce recently reported. Enterprise Partners Venture Capital hasn’t said for sure what it plans to do when it is time to raise a new fund. While other national firms have individuals who are well-connected on the ground in the local life sciences scene—Venrock Associates’ Bill Rastetter and Sofinnova Ventures’ David Kabakoff come to mind—the only two firms left with sizable operations in San Diego and do a lot of local investing are Avalon and Domain Associates, Lichter says.

(Drew Senyei, a managing director for Enterprise Partners, challenged the assertion that his firm has gone quiet. “We have made small investments in seed companies this year. We have two companies in registration for an IPO and four companies in active M&A process at venture multiples. Yes, we are busy.”)

Still, new venture funds have been hard to come by. Domain, spearheaded by partners Eckard Weber and Jim Blair, is one of the rare VC success stories of the past year, having raised a new $500 million life sciences fund back in August. It has flexed its muscle through a string of sizable investments, including VentiRx Pharmaceuticals, Meritage Pharma, and Sequel Pharmaceuticals.

While Domain often seeks out specialty pharma companies moving through the middle stages of clinical trials, Avalon has carved out its niche in the really early-stage, startup phase. It has placed smaller bets on companies like Zacharon, Otonomy, and aFraxis. Back in December, Lichter told the story about how Avalon flew in some top biologists for a retreat at The Lodge at Torrey Pines, just to talk about some of the big problems in biology, and some elegant experiments to test new concepts.

Jay Lichter

Lichter is fully aware this runs against the current in venture capital, where funds are scrambling to gin up some quick returns in late-stage companies to spruce up their balance sheets just in time to hit up pension funds and endowments for another round of fundraising. This isn’t a trend that Avalon is seeking to follow, Lichter says.

“We get involved at the cocktail napkin stage,” Lichter says. “It’s pure venture investing. Early stage. High-risk. High-reward. Most people don’t want to do it anymore.”

A poster child for the popular style of venture funding is Cambridge, MA-based Gloucester Pharmaceuticals, which was a story I covered last fall. I recounted for Lichter how Gloucester raised $29 million in August, just a week before it was scheduled to go before an FDA advisory committee hearing with pivotal clinical trial data for a new cancer drug. The panel vote was a slam dunk in favor, the FDA approved the drug as expected a couple months later, and Gloucester was acquired for $340 million in December by Summit, NJ-based Celgene (NASDAQ: CELG).

Presto, it was a return on investment inside of six months for biotech VCs, who ordinarily would have to wait a decade or more for an early investment to bear fruit.

It’s almost like venture capitalists woke up one day and decided they wanted to become fast-money hedge funds, I said. Lichter didn’t disagree. “Good for them. But …Next Page »

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

The woman in charge of spinning University of Washington technology out into the business world, Linden Rhoads, boldly predicted a year ago that UW would pull in $300 million from the federal stimulus. Now one of UW’s top genome scientists, Debbie Nickerson, has confirmed the number, and says a big chunk of the loot is going into her cutting-edge lab.

The UW has been awarded about $300 million from the American Recovery and Reinvestment Act, AKA the “stimulus,” Nickerson said Friday at the Technology Alliance’s Science and Technology Discovery Series. That investment has created about 2,000 local jobs, Nickerson says. About $25 million of taxpayer money, funneled via the National Institutes of Health, has been used to create a new Northwest Genome Center.

(After double-checking with help from UW computer scientist Ed Lazowska, I found that $193 million of stimulus money has arrived at the university already; the total climbs to $270 million when counting the second year of guaranteed stimulus grants, and to $300 million if you count stimulus grants for things other than research.)

Those are big-time dollars, and a lot of responsibility to deliver a payoff. But Nickerson, doesn’t come across as someone full of self-important hot air. A native of Queens, NY, where her family calls her “Dr. Genomey” pronounced like “Juh-know-me?” in a Queens accent. She was unusually good at breaking down the sometimes impenetrable jargon of genomics into plain English, and explaining why the Northwest Genome Center matters.

Debbie Nickerson

“This is my new Corvette,” Nickerson said.

The center—which also has received support from the Washington Research Foundation and the state’s Life Sciences Discovery Fund—is more about the potential for the science and human health than it really is about jobs. While Nickerson has been able to hire a few biotech industry veterans during the downturn, and some promising college grads, which she notes in this NIH-produced video, she didn’t say exactly how many people the Northwest Genome Center has hired.

Most of the work involves highly automated operation of “next-generation” gene sequencing instruments. These tools, and the software that helps store the data, have enough horsepower to plow through a sequence of about a billion A, C, G, and T chemical base pairs every day. That’s up from a few million per day a decade ago, and about a thousand a day back in 1992 when people doubted whether something like the Human Genome Project was even possible.

Today’s machines don’t make perfectly accurate reads on the first run-through, but they are fast enough that it’s practical for scientists to run through a genome 50 times over to correct for errors, Nickerson says.

That speed and efficiency allows genome scientists to ask new questions, Nickerson says, like how tiny variations can make a big difference in physical traits. (She illustrated that with a slide that highlighted the difference in height between NBA star Shaquille O’Neal …Next Page »

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Cell Therapeutics (NASDAQ: CTIC) apparently has had enough humiliation for one day. The Seattle-based biotech company postponed a special shareholder meeting this morning at its headquarters along Elliott Bay, after announcing that the FDA rejected the application for its only cancer drug with a shot at reaching the U.S. market anytime soon.

About a dozen shareholders showed up at 10 am Seattle time on the third floor of Cell Therapeutics’ stylish headquarters, which features track lighting, pastel wall colors, and sweeping views of Elliott Bay. The meeting, in which shareholders will be asked to authorize the company to sell as many as 1.2 billion shares, has been rescheduled for the same time on May 14. Cell Therapeutics usually has trouble getting a quorum of shareholders to vote on matters like these, because it has a lot of shareholders in Italy who don’t turn in their ballots. So it wouldn’t surprise me if the company failed to get a quorum to vote on that question.

Cell Therapeutics founder and CEO James Bianco didn’t show up to face the shareholders this morning, although company spokesman Dan Eramian told me in the hallway that the company is planning a conference call for 4:30 pm Eastern/1:30 pm Pacific today. We had to chat in the hallway because the company barred me from attending this meeting as a member of the press, saying it was open only to shareholders of record. As many of you who follow me on Twitter know, I offered some pocket change to buy a share so I could attend, but they could not accommodate me on the spot. (TheStreet.com’s columnist Adam Feuerstein cheekily offered to start a pledge drive to help me get in the door, but alas, the meeting adjourned in a just a few minutes.)

Seriously, though, I have a few questions that I couldn’t get answered. Like why shareholders would allow the company to issue as many as 1.2 billion shares, further diluting their existing stakes in a stock that’s already worth less than a buck? Who are the people who invested $20 million in Cell Therapeutics after it was shot down 9-0 by a panel of FDA cancer drug experts last month? Did those people listen to the same brutal critique that I heard? In what way do they think Cell Therapeutics can generate positive returns? Do they think the company can afford the time and expense of another clinical trial to support approval of pixantrone for non-Hodgkin’s lymphoma? Or do they think that paclitaxel poliglumex (Opaxio), a drug that already failed three pivotal clinical trials in 2005, will rise from the dead?

I will listen in to today’s conference call (dial-in number is here), but I’m not holding my breath for any substantive answers.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Cell Therapeutics suffered what I called a “humiliating public beatdown” last month in front of an FDA advisory committee, and now the FDA has made it official in writing. The Seattle-based biotech company said its application to market a new lymphoma drug in the U.S. has been formally turned down by the FDA.

The FDA apparently didn’t need to wait until its statutory deadline of April 23 to deliver the bad news in its “complete response” letter to the company. The agency said that if Cell Therapeutics wants clearance to start marketing pixantrone (Pixuvri) in the U.S. for patients with non-Hodgkin’s lymphoma, it will need to run another clinical trial to prove it is safe and effective. Cell Therapeutics said it has had some preliminary talks with the FDA about what such a trial would look like, and that it plans to pursue an “expanded access” program to make pixantrone more widely available to patients even without being able to sell it.

The FDA’s rejection is no surprise, given the harsh public comments made last month at a panel of the Oncologic Drugs Advisory Committee. The panel voted 9-0 against recommending approval of pixantrone. The FDA’s chief cancer drug reviewer, Richard Pazdur, slammed the application in his remarks, noting that Cell Therapeutics was seeking approval on the basis of a “single, incomplete trial.” The chair of the FDA panel, Gail Eckhardt of the University of Colorado at Denver, said the Cell Therapeutics application was “disturbing,” partly because it only enrolled 140 of the 320 patients needed to generate a statistically valid result the way the trial was originally designed.

Cell Therapeutics took the unusual step of quoting a cancer researcher in its press release who took a critical shot at the FDA.

“This is a sad outcome for our patients with relapsed/refractory aggressive NHL,” said Dr. Stanley Marks, chief medical officer for the University of Pittsburgh Cancer Centers, in a Cell Therapeutics statement. “I was disappointed that an agency charged with providing treatment hope for patients with life threatening diseases like relapsed/refractory non-Hodgkin’s lymphoma would ignore clinically meaningful improvements in overall response rate and progression-free survival, let alone complete responses, something we all wish for our patients, but with existing treatments rarely achieve.”

Cell Therapeutics, as I noted in an analysis after the FDA panel, still says it hopes …Next Page »

Comments | Reprints | Share:  

 
 
 

Luke Timmerman wrote:

Amplyx Pharmaceuticals, a San Diego-based drug developer, has raised an initial round of $1.5 million in financing. The investors included Golden Seeds, Life Science Angels, and Tech Coast Angels. The company, led by CEO Elaine Heron, is developing technology to improve existing drugs by controlling their concentration and time they hit their targets, according to a statement. The company noted that Golden Seeds is a national angel investment network that invests in women-led companies.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Dendreon (NASDAQ: DNDN), the Seattle-based developer of an immune-stimulating drug for prostate cancer, said today it has hired Varun Nanda to be its senior vice president of commercial operations. Nanda was formerly the senior vice president and head of global oncology for Roche, the world’s largest maker of cancer drugs, with hits like rituximab (Rituxan), bevacizumab (Avastin), and trastuzumab (Herceptin). Nanda’s responsibility will be to lead the commercial push for Dendreon’s sipuleucel-T (Provenge), including its sales and marketing. The FDA has a deadline of May 1 to complete its review of Dendreon’s application to market the drug in the U.S.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

It’s hard to believe, but eight days have zipped by since we held the big Xconomy event on the 20-year outlook for life sciences in San Diego. Sure, I already wrote up a little summary of what our great panel of speakers had to say at this event, but I admit I have been a little on the tardy side when it comes to posting the photo gallery.

For those who missed the earlier coverage, this event packed the house at Biogen Idec in San Diego, with about 175 people who came to hear from a stellar panel of speakers, to meet some of San Diego’s coolest life sciences startups, and to indulge in some high-level networking. The panel was moderated by John Mendlein of Fate Therapeutics,was was joined by Paul Schimmel of The Scripps Research Institute, Dan Bradbury of Amylin Pharmaceuticals, and Rusty Gage of the Salk Institute for Biological Studies. We also heard brief 4-minute “burst” presentations from Ambrx, Helixis, Receptos, and VentiRx Pharmaceuticals.

While I was busy keeping everything on track and running with a microphone to get questions from the audience, Xconomy’s founder and CEO Bob Buderi snapped the images below on his digital camera. We heard a lot of feedback that people really enjoyed themselves, and I think they weren’t just saying that to be nice. If you missed the festivities, don’t worry, we plan to hold more events like this in San Diego.

But for today, click here to enjoy the photos. And next time, yes, I’ll try to get them posted a little sooner.

Comments | Reprints | Share:  

 
 
 

Luke Timmerman wrote:

The Seattle biotech scene had a smattering of blurbs this week from a few of the lesser-known names. But at least one local organization is clearly starting to emerge.

—Sage Bionetworks, the Seattle-based nonprofit seeking to spark an open source movement for biology, secured a $5 million grant from the state’s Life Sciences Discovery Fund. This is just the latest show of support from an impressive, and growing, list of organizations rallying their money and talent behind the vision of former Merck executive Stephen Friend. Research teams at the University of Washington and the Fred Hutchinson Cancer Research Center also nailed down $5 million grants.

—Seldom do I ever get a chance to write about anything innovative in the pipeline for Alzheimer’s disease, the condition that robs an estimated 5 million elderly Americans from their memory and cognitive thinking skills. Nothing on the market today really works. But this week, we had an in-depth feature on the team at Vancouver, BC-based Allon Therapeutics who are testing peptide drugs that are designed to work unlike anything on the market today.

—Frazier Healthcare Ventures and Arch Venture Partners, the two deepest sets of pockets in Seattle biotech venture capital, placed a big bet this week on San Francisco-based Achaogen. The company, a developer of antibiotics that are supposed to fight multi-drug resistant bacterial infections, raised $56 million in a Series C venture round that included Frazier, Arch, and some of their best-known friends on the national VC scene.

—The biotech lab and office are usually not the place to find astute political commentary, but the newly passed healthcare reform law matters for biotech in a number of ways. Richard Pops, the CEO of Waltham, MA-based Alkermes, argues in this national guest editorial that the time for political engagement is far from over, as industry leaders need to start paying attention to the next round of negotiations to renew the Prescription Drug User Fee Act, which governs how companies do business with the FDA.

—Ken Stuart of Seattle Biomedical Research Institute, one of the Northwest’s pioneers in global health, pointed out in a guest editorial that while World Health Day was celebrated this week, it was really a reminder that global health awareness has become deeply interwoven into everyday life in Seattle’s South Lake Union neighborhood.

—Bothell, WA-based MDRNA (NASDAQ: MRNA) made a couple of moves to help boost its dwindling cash reserves. The company formed a research deal with Pfizer, and acquired Cambridge, MA-based Cequent Pharmaceuticals, another RNA interference drug developer.

—Stratos Genomics, a Seattle-based developer of low-cost gene sequencing technology, has been pretty stealthy about what it’s up to, but this week it attracted the former CEO of Roche Molecular Diagnostics to its board of directors.

—Last but not least, we have launched a new channel at Xconomy to showcase all the Health IT news we dig up around here. For the Seattle biotechies out there who are watching the big trends in genomics, you may want to check out the first and second installments of a two-part interview I did with Illumina CEO Jay Flatley that ran on our San Diego and Health IT channels this week.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

The Fate Therapeutics mini-empire already extends from coast to coast, and now it’s expanding northward. The San Diego-based developer of stem cell technologies has agreed to acquire Ottawa, Canada-based Verio Therapeutics to grab a few more bright minds, and some clever techniques for developing drugs that spark the body to regenerate damaged tissue.

Financial terms of the deal aren’t being disclosed, but it’s safe to say this won’t break the bank at Fate, which raised $30 million in a Series B venture round last November. The acquisition means that Fate will now have its headquarters in San Diego, a new operation in Ottawa, and research labs that it sponsors in Seattle and Boston, says spokeswoman Jessica Yingling. The combined company will have 40 employees, and enough cash to operate for two years, she says.

So if this deal doesn’t really amount to much money, why does it matter? Fate, as avid readers know quite well, took a big step forward last fall, when one of its founders showed that he could coax ordinary adult cells to morph into an embryonic-like state with a combination of cheap and readily available small-molecule drugs. This is important because it could be useful for generating human tissues in the lab for use in drug discovery—and it could make it practical for the first time for Big Pharma companies to do so at an “industrialized” scale.

Even a few months before Fate co-founder Sheng Ding published his big discovery, Fate noticed an important, and potentially complementary, discovery from its Canadian peers at Verio Therapeutics. A team led by Michael Rudnicki, a Verio co-founder and regenerative medicine researcher at the University of Ottawa, published a paper last year that showed it could identify certain stem cells that act as progenitors for skeletal muscles, as well as the molecular pathways involved in the cells’ transformation into muscle. What’s more, the researches showed that certain biologic molecules could activate those pathways to regenerate muscle tissue. The work was published last June in the journal Cell Stem Cell.

Michael Rudnicki

That’s important for Fate, because the company is looking for specific molecular pathways that can be activated in the body—particularly with conventional small molecule drugs—to trigger a regenerative effect. That’s thought to be a more efficient, and less risky, way to stimulate regeneration of tissues than the “cell therapies” most people think when they think of stem-cell based treatments. Fate, at least in its early days, isn’t concentrating on creating such therapies, which would involve injecting patients with stem cells that are thought to be able to regenerate damaged cells. Instead, it wants to use the knowledge it gleans from stem-cell science to come up with drugs that can coax the body’s existing cells into repairing or regenerating damaged tissues.

For its part, Verio already has several biologic drug candidates that might …Next Page »

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Seattle-based Frazier Healthcare Ventures is leading a $65 million Series C venture investment in San Francisco-based Achaogen, a developer of new antibiotics that fight multi-drug resistant infections. Alta Partners also participated in the financing, along with existing investors Arch Venture Partners, 5AM Ventures, Domain Associates, Venrock Associates, Versant Ventures, and the Wellcome Trust. Bob More, a general partner with Frazier, will join Achaogen’s board in connection with the deal.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Yesterday, we ran the first installment of a wide-ranging interview with Illumina CEO Jay Flatley. He talked a bit about some of the major competitors he sees emerging in the fast-paced world of gene sequencing, and how he hopes San Diego-based Illumina (NASDAQ: ILMN) can maintain an innovative edge, even as it grows into a big company with about 1,800 employees.

Today, we offer up the second half of the conversation.

Xconomy: In terms of being in San Diego, you’ve got Illumina, and you’ve got some critical mass with your competitor here in Life Technologies in sequencing. You’ve also got wireless talent here with Qualcomm. How do you see the genomic instrument capabilities converging over time with wireless technology in a way that’s useful for a healthcare system moving more toward wellness?

Jay Flatley: It’s absolutely going to happen. It’s already starting to happen. Our instruments increasingly will be spitting out their data over wireless networks. We already have the ability to monitor and control our HiSeq product from an iPhone application. Our customers can sit in their living room and monitor the quality scores coming off their HiSeqs. From a management of the instrumentation perspective, that’s already happening.

We’ve built a prototype iPhone application that is sort of a delivery vehicle of how someone could carry genomic information and communicate and interact wirelessly. That could be with your physician. It could be over social networks. It could be in a bar. I think wireless is the way it’s going to go. The data will be in the cloud, and it will be moved around wirelessly.

Jay Flatley

X: But your bread and butter business is still going to be selling those instruments, which are an expensive piece of equipment. How much bigger do you see this market getting in unit volume, or maybe becoming more democratized as the price of sequencing comes down and more researchers can do it?

JF: Our goal is to make this as ubiquitous as PCR [polymerase chain reaction], and I think that’s where it’s headed. Sequencing will become such a fundamental tool of molecular biology research that every lab that’s serious in the field will have to have access to next-gen sequencing one way or another. Either in their lab or the lab next door. The footprint of the instruments is going to shrink. Usability will get better. Sample prep is going to get simpler. We’re probably less than 10 years from the day when a drop of blood gets put in and the sequence comes out 10 minutes later. That’s the way it’s going to be. We think all babies are going to get sequenced in 10 years, that will be a routine way you do post-birth characterization. The data set will go into an electronic medical record. There will be some filtered masks over that data set that allow different constituents to access it under certain privacy controls for different reasons. You may need to authorize your physician to look at parts of it, you may want them to look at all of it. But I think that’s where the technology will head.

X: It’s interesting that you brought up privacy. I was meaning to ask whether there are any policy changes that you think need to happen before people can become comfortable enough with this idea to really participate in a big, broad way?

JF: The GINA [Genetic Information Nondiscrimination Act of 2008] bill went a long way. It set a framework for preventing discrimination based on genetic information. What’s going to have to happen is there will have to be some test cases. How does that look when it’s applied and executed? No doubt we’ll see some test cases there in the next five years. But the thinking is moving …Next Page »

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS

Luke Timmerman wrote:

Sage Bionetworks, it can now be said unequivocally, is on fire. The Seattle-based nonprofit that aims to spark an open-source movement for biology, has secured one of three $5 million grants that were announced this afternoon by the state’s Life Sciences Discovery Fund.

The state’s biotech fund, which suffered a deep round of budget cuts a year ago, picked just three proposals as winners in the most recent round of grants. Besides the Sage Bionetworks effort spearheaded by former Merck executive Stephen Friend, another $5 million grant went to a team of ultrasound researchers at the University of Washington led by Tom Matula. And a third program, led by Peggy Porter at the Fred Hutchinson Cancer Research Center, was awarded a $5 million grant to set up a multi-institutional system for collecting and sharing biological specimens for cancer research, diagnosis, and treatment.

“These world‐class teams will create critical information, material, and technological resources that are expected to provide competitive advantages to Washington’s researchers and companies and, ultimately, accelerate the development of new diagnostics and therapeutics for serious health conditions,” said Lee Huntsman, the executive director of the Life Sciences Discovery Fund, in a statement.

The latest $5 million grant provides just the latest in a string of booster shots that have gone to Sage Bionetworks. This nonprofit, which really only got going inside the Hutch in August, has secured financing from Pfizer, Merck, Quintiles, the Canary Foundation, the National Cancer Institute, and Cure Huntington’s Disease Initiative, among others.

Friend’s vision is to convince biologists from around the world to dump their experimental data into a public commons, instead of holding it close to the vest until they publish their Eureka moments in a high-impact scientific journal. By sharing data openly, Sage hopes to stitch together “network biology” models that seek to connect the dots between variations in DNA, RNA, and proteins, and understand how that is correlated with clinical symptoms of disease that physicians see. If Sage can help create these network models, the thinking goes, it ought to help drugmakers do a better job of predicting which drugs will succeed in clinical trials, and help physicians prescribe the right drug to the right patient.

Here’s a brief look at the other two programs receiving support from the state:

—Matula’s team will seek to establish a Washington Molecular Imaging and Therapy Center, which will seize on UW’s existing expertise in ultrasound, recruit new faculty, and support novel research projects, the Discovery Fund said. “Partnerships with clinicians, industry, and venture capitalists are anticipated to accelerate clinical translation and commercialization,” the Discovery Fund said in a statement.

—Porter’s team will set up a consortium among research centers to collect and share biological specimens that are necessary to develop new diagnostics and drugs. The consortium will have an informatics system to analyze data coming from the specimens, and the researchers will set up a standard method for material transfer and intellectual property management, the Discovery Fund said. The consortium includes the Hutch, UW, and Seattle Children’s Hospital and Research Institute. The idea “represents a collaboration between patients and researchers that provides an opportunity for cancer patients, their families, and friends to contribute to basic science and exciting discoveries that may one day lead to cures,” the Discovery Fund said.

The grants were picked from a group of 19 proposals that were vetted earlier by a panel of experts from the American Association for the Advancement of Science, the Discovery Fund said. They were rated on scientific merit, and potential to improve health care and economic benefit in Washington state.

Comments | Reprints | Share:  

 
 
 

UNDERWRITERS AND PARTNERS