Cambridge, MA-based Forma Therapeutics has struck a collaboration deal with the U.S. unit of Tokyo-based drug powerhouse Eisai that is focused on discovering drugs against normally intractable disease targets, according to the companies. Eisai is paying Forma $20 million in upfront and committed fees over a three-year period, according to the companies. The deal gives Eisai non-exclusive access to Forma’s proprietary compound library and cell-based screening platforms to aid in Eisai’s discovery of new drugs for its own pipeline. Forma is eligible for potential milestone payments and royalties on products that Eisai might decide to develop as a result of the collaboration.

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There’s a new round of interesting court filings in Boston-based Dana-Farber Cancer Institute’s lawsuit against a Bay Area biotech startup co-founded by Dana-Farber scientists. It’s the latest chapter in a case primarily concerning who has rights to a potential game-changing drug for lung cancer discovered at Dana-Farber.

Dana-Farber filed a lawsuit against Millbrae, CA-based Gatekeeper Pharmaceuticals in U.S. District Court in Boston on September 21. The lawsuit, as I explained last month, essentially asks the court to let Dana-Farber out of a previous agreement to license patent rights to the potential lung cancer drug, WZ4002, to Gatekeeper, a startup formed in March 2009 to commercialize the technology. Dana-Farber indicated in its complaint that the Swiss drug giant Novartis, a longtime supporter of the cancer institute, had come forward after the agreement was inked to claim it had rights to the molecule—and that Dana-Farber now believes that claim to be valid. Now the new round of court filings deal with the issue of whether Gatekeeper’s president, John Chant, should be allowed to intervene in the case.

At stake in the case is a potential drug for lung cancer—the most common cause of cancer deaths in the U.S—that could treat certain cases of non-small cell lung cancer that have built up resistance to existing drugs. Many patients today develop resistance to lung cancer drugs such as the blockbuster erlotinib (Tarceva) and the more infrequently prescribed Iressa (gefitinib), causing their cancer to relapse. The molecule in question in this case addresses the so-called T970M gene mutation, which is believed to be responsible for about half of cases of resistance. (The molecule’s discovery was described in a December 2009 article in Nature.)

In its response to Dana-Farber’s complaint, Gatekeeper asked the court, among other things, to order the cancer institute to license WZ4002 to the startup, and to order Novartis to pay damages for causing that license to be delayed. But the startup’s president, Chant, argued in a motion to intervene in the in lawsuit, filed last month, that the four members of his firm’s board of directors have not sought the types of damages from Dana-Farber and Novartis that Chant believes are in the startup’s best interest. In part, his argument is that the board members have conflicts of interest because three of them—Nathanael Gray, Pasi Janne, and Kwok-Kin Wong—are employees of Dana-Farber and one of them, Jeffrey Engelman, has served as a paid consultant to Novartis. If the court grants Chant’s motion, then he would have the legal standing to represent the company in this case.

On Monday, both Gatekeeper and Dana-Farber filed memoranda to oppose … Next Page »

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Genzyme has given its first-quarter 2010 earnings a $175 million haircut. The Cambridge, MA-based biotech firm (NASDAQ:GENZ) said today that it expects to pay that amount to the FDA due to deficiencies at its manufacturing plant in Allston, MA.

The company and the FDA are negotiating terms of a consent decree, under which the firm would agree to certain deadlines for addressing problems at the Allston plant, says Bo Piela, a spokesman for Genzyme. In addition to the $175 million charge, the company says that it expects to pay 18.5 percent of its revenues on sales of products shipped from Allston if it fails to meet deadlines for moving its deficient operation for filling medicine vials away from the plant. (In November, the FDA warned doctors that it found foreign particles in medicines made at the Allston plant, including fragments from a rubber vial stopper used in the deficient operation in question.) Those deadlines are still under negotiation. Also, the company is in talks with the agency about setting deadlines for when broader improvements will need to be made at the plant, and the company would have to pay $15,000 per day after those deadlines until the operations are compliant.

Genzyme says that it expects to wrap up negotiations with the FDA about the terms of the consent decree sometime in the second fiscal quarter of 2010. In the meantime, Piela says, the company has already begun to move the medicine vial filling operations from its Allston facility to its plant in Waterford, Ireland, as well as to a contract manufacturing facility owned by Hospira (NYSE:HSP), a specialty drugmaker based in Lake Forest, IL.

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We’re not much in favor of rigidly categorizing news by industry here at Xconomy, in part because we follow exciting companies that often transcend conventional definitions of what is a software, energy, or biotechnology business. But we do try our best to deliver breaking news and in-depth coverage to communities of readers, and one such community is clearly coalescing around the use of information technology in healthcare. To help bring that community more front and center, today we’re announcing the launch of a sector-specific channel for health IT news.

Our new Health IT channel features healthcare technology news coverage and other features from across the Xconomy network in Boston, San Diego, and Seattle, as well as other important “national” stories not specific to one of our cities. The channel has a new feature not found on our previous Life Sciences and Startups channels: the Health IT AppWatch, a section where we’re delivering news on applications that help consumers and medical professionals exploit the capabilities of the Web and mobile devices to improve their own well being or the health of those close to them or in their care.

As part of launching the new channel, we’re also boosting our efforts to provide insights and opinions from top innovators in the field of healthcare technology through our Xconomist Forum (the equivalent of our Op-Ed page), already one of the most popular and most-read portions of our site. And, as many of you may know, we are bringing our new focus on Health IT live through events on both coasts. We’re holding our first dedicated health IT event, Healthcare in Transition, at the MIT Media Lab on April 26. A few weeks later, on May 12 in Seattle, we are holding How Information is Transforming Medicine and Healthcare. Both those events feature leading executives, entrepreneurs, innovators, and investors from some of the most interesting and dynamic health IT startups and large companies around.

Our new channel, therefore, is a vehicle through which we’re setting out to capture the growing excitement and opportunities around using tech as a tool to revolutionize healthcare. The U.S. government is pouring billions of dollars into technology for sharing and storing electronic health records, recognizing the value of using information technology to improve the quality and economics of the healthcare system. But startups and their investors are already looking beyond the forthcoming surge in electronic health records adoption, rushing to fill a bevy of gaps in how information is gathered, analyzed, and shared throughout the healthcare system. Meantime, large established companies such as the data storage and management giant … Next Page »

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Just came back from the Washington Biotechnology & Biomedical Association’s annual meeting in downtown Seattle, where 500-plus biotechies and distinguished guests (including more than a few local politicians) gathered for a quiche-and-berries breakfast and some keen networking.

The keynote speaker was Elias Zerhouni, the former director of the National Institutes of Health and now a senior fellow at the Bill & Melinda Gates Foundation. Just a few highlights from his talk here:

Zerhouni laid out the top five challenges in public health, as he sees it. Nothing too surprising, but a good way to frame the whole healthcare discussion:

1. The shift from acute to chronic conditions. (“This is a worldwide issue,” he emphasized. “This is the new global health horizon.”)

2. Aging population.

3. Health disparities.

4. Emerging and re-emerging infectious diseases. (Pandemics, for example.)

5. Emerging non-communicable diseases. (Things like obesity and depression, the latter of which the World Health Organization predicts will be the No. 1 cause of disability and dysfunction for people aged 25-44.)

As a world-class radiology researcher, Zerhouni also spoke to the scientific challenges the industry faces. He said the fundamental scientific barrier to doing “translational” research—that which leads to new products like drugs or devices—is the complexity of biological systems involved in diseases. “The explosion of data does not equate to explosion of knowledge,” he said. (This is a common theme across all fields of science and technology.)

On this front, Zerhouni stressed the importance of both external and internal sources of innovation. Meaning, the state of Washington should “find ways of bringing in collaboration on the translation or creation of knowledge.” He pointed out that “building relationships with the Asian Rim is probably your strategic advantage.”

For the politicians in the audience, Zerhouni noted, “Today when you get elected or not elected, the main driver is jobs, jobs, jobs.” He said his dream is that in a few years, biomarkers and healthcare stats will impact political campaigns, to the tune of, “In my district, Body Mass Index has dropped from X to Y.” (Luke previously reported on the issue of jobs being the driver of public support for biotech.)

The last issue Zerhouni addressed was a particularly interesting one: culture wars around science and technology. “Don’t be oblivious to the political, cultural, and moral aspects” of biotech and biomedical work, he said. “Be careful to not assume that everyone in the world believes what you do is holy and good.” Having dealt with the profound issues of evolution vs. creation in Washington DC—most notably in the context of stem cell policy—Zerhouni was sharing some hard-earned wisdom that everyone in the room could take home with them.

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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 »

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Micronics has been around since 1996, so it hardly qualifies as a startup anymore. But the Redmond, WA-based biotech company has been moving in new directions over the last few years, and is now getting ready to bring its first diagnostic tests to the market.

The 28-person company has been in the microfluidics business—the design of tools to manipulate very small amounts of liquid (sometimes called “lab on a chip”)—since its inception 13 years ago, when it spun out of research from the University of Washington. More recently, says president and CEO Karen Hedine, the company has shifted into using its knowledge and inventions in microfluidics to create novel diagnostic tools.

Micronics has raised a total of about $25 million in funding, Hedine said, including $9 million in 2008 through private Series B investors and a Series C financing round led by the Southwest Michigan First Life Science Fund.

The company has decided to focus on infectious diseases, Hedine said. Micronics’ first diagnostic product, which it hopes to debut by the end of 2009, will be a small, disposable test for malaria. “We look at targets that are unmet needs,” Hedine said. “A malaria diagnostic is one of the most unmet needs out there.”

Right now, Hedine said, even in a best case scenario like a Western world clinic, diagnosing the disease usually requires several clinic appointments and at least a few weeks to get an answer back from the lab. Micronics hopes to turn those weeks into minutes, and reduce the amount of blood or urine required from a large vial to a few drops.

The malaria tests are aimed for use in developing countries, where the disease is most prevalent. Hedine said she expects Micronics’ customers might include clinics in these areas, as well as charity organizations, governments donating aid, non-governmental organizations, or militaries stationed in countries where malaria is common.

So far, Micronics’ money has come from three avenues, Hedine said: investment financing, revenue from lab equipment and consulting services, and grants or contracts for the development of some of its diagnostic tools. The tools are built on small, disposable plastic cards, and use minute amounts of fluids—for both the sample required from the patient and the chemical reagents needed to process it, Hedine said. They’re designed to run on a “finger-stick” worth of blood, similar to home blood-sugar monitors for diabetics.

After the malaria tests, Micronics plans to release a similar test system for E. coli, which has been a recent culprit in widespread food poisoning scares in the United States, as well as a portable, rapid blood-typing test whose development was funded by the U.S. Army. The company is also working with the Centers for Disease Control and Prevention to develop similar tests for HIV. Hedine said diagnostic tests for a panel of other STDs are further down the pipeline.

The malaria and E. coli tests will be ready for regulatory testing by the middle of the year, Hedine said, and she hopes they will be approved in time to be released before 2010. “We’re really revolutionizing the way testing is done,” Hedine said.

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