Seattle-based Dendreon (NASDAQ: DNDN), the developer of what it hopes will be the first FDA-approved treatment to actively stimulate the immune system against cancer, said today the U.S. regulatory agency has received its amended application and set a deadline of May 1, 2010 to complete its review. The company is seeking clearance to start selling sipuleucel-T (Provenge) for men with prostate cancer that’s no longer controlled by standard chemical castration therapies. The application includes data from a 512-patient study which showed the drug could extend lives by a median of four months when compared with a placebo.

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Few doctors knew much about a rare brain infection called PML back in 2005, when two patients on a hot new multiple sclerosis drug from Biogen Idec and Elan died from the side effect. The infection, at the time, was generally considered a death sentence. But now with three years of data from more than 60,000 patients worldwide who have taken natalizumab (Tysabri) under strict monitoring by physicians, a new picture is emerging that shows PML is still very much a serious threat, but that it isn’t nearly as deadly as first feared.

While each and every confirmed case of PML, known formally as progressive multifocal leukoencephalopathy, scares investors in Cambridge, MA-based Biogen (NASDAQ: BIIB) and Ireland-based Elan (NYSE: ELN), I sought to assemble a big picture view of exactly how deadly PML really is when I interviewed Al Sandrock last week. He’s the senior vice president of neurology R&D at Biogen, and an assistant clinical professor of neurology at Harvard Medical School.

Before diving too far into the numbers about the risk of Tysabri, a little background is required. This drug, an antibody treatment designed to block certain white blood cells that cause MS when they attack nerves, has a history of also making patients vulnerable to infection. Biogen and Elan yanked it off the market in February 2005 after two cases of the brain disease were confirmed among patients taking the drug; a month later, a third case was confirmed. But legions of patients still demanded the drug, considered to be the most effective medicine on the market at reducing the disabling nerve damage from multiple sclerosis flare-ups. The FDA allowed the drug to return to the market in July 2006 after determining its benefits outweighed the risks, but it also forced doctors into a strict monitoring program to keep an eye out for the early signs of PML.

This matters not just for doctors and patients, but for Biogen’s and Elan’s financial futures. The drug, Biogen’s fastest-growing product, generated $560 million in sales in the first nine months of this year. (The importance of this drug is one reason why investors get so ticked at Biogen when it isn’t exactly forthcoming about every newly diagnosed case, but that’s a bone to pick another day.)

When the drug came back on the market, its FDA-approved prescribing information contained a prominent warning that about 1 out of every 1,000 patients on the drug were likely to get PML. But that was really just a forecast, and the actual risk-benefit balance for this drug is really a moving target that shifts over time when a new case is confirmed. So I sought to build a simple chart when I spoke to Sandrock that provides a snapshot of PML cases in February 2005, when the drug was pulled off the market because of the PML risk, versus those confirmed as of yesterday. Here’s what I gathered:

The February 2005 figures came from clinical trial data and formed the foundation for the FDA-required warning of the 1-in-1,000 chance of getting PML. The more recent figures include all the experience of patients who have gotten the drug since it was returned to the market in July 2006. The thing that jumped out at me was the fact that only five of the 27 confirmed patients with PML have died—meaning that the current survival rate stands at over 80 percent.

That curious fact has been buried under a rash of scary headlines …Next Page »

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Even more bad news from Genzyme (NASDAQ:GENZ). Following the news on Friday about new contamination found in treatments made at the Cambridge, MA-based biotech firm’s Allston, MA, plant, the company says today the FDA informed it that the agency won’t approve its application to market Pompe disease drug alglucosidase alfa (Lumizyme) made in large-scale batches until it addresses deficiencies at the facility.

Genzyme, which already has approval to make the drug in smaller bioreactors, said that it plans to request a meeting with the FDA to discuss what needs to be done to garner approval of the product made in larger containers. Meantime, the firm is making the drug in smaller batches under the name Myozyme. Genzyme plans to hold a conference call at 12 pm ET to discuss the FDA’s response.

The FDA is forcing Genzyme to get an additional approval of alglucosidase alfa—an enzyme replacement therapy for patients with rare lysosomal storage disorder—made in larger bioreactors because slight changes in manufacturing process such as the batch size can have an impact on the finished product. Back in April 2006, the treatment was the first of its kind approved for Pompe disease in the U.S., and it’s been one of Genzyme’s fastest-growing sellers. The company says that it needs approval of the treatment made in 4,000-liter batches at a factory in Belgium to meet global demand for the treatment. And this isn’t the only Genzyme drug in short supply. The company has experienced shortages of its top sellers, Cerezyme and Fabrazyme, after a viral contamination struck its Allston factory in June.

“We have made significant progress in bringing the Allston plant back in operation, and we will continue to work closely with the FDA to resolve these issues,” said Henri Termeer, Genzyme’s chairman and CEO, in a statement.

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Cambridge,MA-based biotech Alkermes said this morning that its long-acting naltrexone injection (Vivitrol) was more effective in treating opioid drug dependence than placebo in a Phase III clinical trial. The 250-patient clinical trial compared urine samples of patients who took the firm’s once-per-month injection of naltrexone versus those who took placebo over the last 20 weeks of a 24-week treatment period. Alkermes (NASDAQ:ALKS) said that it plans to file an application with the FDA for approval of its drug for treating opioid dependence in the first half of 2010. The FDA approved the drug for treating alcohol dependence in 2006.

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San Diego-based Cadence Pharmaceuticals (NASDAQ: CADX) said today that the FDA has pushed back its deadline for reviewing the company’s intravenous pain reliever by three months. The FDA’s new deadline for completing its review of IV acetaminophen is now Feb. 12. The company said it remains confident it will win FDA approval, although shares fell 5 percent today on the news.

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[Update: 6:22 pm Eastern, 11/13/09] Just when you thought it couldn’t get worse for Genzyme, it did. The FDA reported today that it has found tiny bits of garbage—steel, rubber, and fiber—in vials of five of the major drugs produced by the Cambridge, MA-based biotech company.

Genzyme (NASDAQ: GENZ) shares fell $3.89, or about 7 percent, to $49.28 at the close of trading today after the FDA made its disclosure on its website.

The agency said it found the new contamination in five of Genzyme’s top-selling products—imiglucerase (marketed as Cerezyme), agalsidase beta (Fabrazyme), alglucosidase alfa (Myozyme), laronidase (Aldurazyme), and thyrotropin alfa (Thyrogen), according to a report from the Associated Press. The FDA estimates the contamination only affects about 1 percent of Genzyme’s products, and the agency says that no serious side effects have been reported related to the latest contamination, according to the AP.

This is the latest major setback for Genzyme’s manufacturing operation, which was hit by a viral contamination in June that forced it to shut down production at its Allston Landing plant over the summer. That earlier contamination caused Genzyme to slash its sales estimates for the year, and created a new opportunity for competitors like Shire and Protalix Biotherapeutics.

Christopher Raymond, an analyst with private equity firm Robert W. Baird who covers Genzyme, said in a note to clients today that the latest contamination shouldn’t affect the company’s ability to start shipping new batches of imiglucerase and agalsidase beta to patients, but noted that “continued issues at Allston, and the fact that FDA inspection of Allston remains ongoing is not encouraging.” Fellow Baird analyst Tom Russo noted that “underscores the upside potential” of Shire to gain new market for its products.

[Updated comment from Genzyme, 6:22 pm Eastern, 11/13/09]

Genzyme issued a statement later Friday about the situation. The company says a global review of its safety database “has not identified any safety concerns to suggest that patients treated with Genzyme products have been exposed to foreign particles. However, a theoretical safety risk remains should a particle enter the bloodstream.”

The company added that doctors are being reminded to visually inspect vials for foreign particles before patients are injected. It says the rate of foreign particles in vials has not increased over time, although the company “remains committed to reducing the frequency of foreign particles in all of our products.”

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Several of New England’s life sciences firms had good news to report this week.

—Ryan gave a run-down of the key insights to emerge from our Xconomy Forum on pharma innovation. Sirtris CEO Christoph Westphal, for example, offered insight into one of the biggest biological mysteries around the Xconomy office: how Luke manages to eat so much and stay so thin.

—Cambridge, MA-based Gloucester Pharmaceuticals won FDA approval for romidepsin (Istodax), a treatment for a rare cancer called cutaneous T-cell lymphoma. Gloucester expects to begin marketing the drug in January.

—Noah Beerman took the reins of RXi Pharmaceuticals (NASDAQ: RXII), a developer of RNA interference drugs. Previous president and CEO Tod Woolf will remain on the Worcester, MA-based company’s scientific advisory board.

—Lexington, MA-based Concert Pharmaceuticals started human testing of an anti-HIV drug called CTP-518. Reaching the milestone will trigger a $12 million payment from Concert’s partner, GlaxoSmithKline.

—After announcing earlier this year that it was considering strategic options, including a sale, Cambridge-based Helicos Biosciences (NASDAQ: HLCS) took itself off the block, citing “improving standalone prospects and its current market valuation.”

—Cambridge-based Ironwood Pharmaceuticals inked a $75 million-plus deal with Japan-based Astellas Pharma. The agreement gives Astellas rights to market Ironwood’s lead drug candidate, the constipation treatment linaclotide, in Japan, Indonesia, the Philippines, Korea, Taiwan, and Thailand.

—Aileron Therapeutics, also of Cambridge, published research in the journal Nature indicating that its “stapled peptide” technology can be used to block the production of a protein called Notch that’s implicated in uncontrolled growth of cancer cells. Luke put the news in the context of Aileron’s efforts to develop drugs that hit previously unreachable targets.

—Ryan checked in with Cambridge-based electronic health records provider Dossia. After launching to much fanfare in December 2006, the non-profit is making slow progress in getting its system adopted, but it has recently solidified its leadership team and made other changes it hopes will help.

—Cambridge-based Alnylam Pharmaceuticals (NASDAQ:ALNY) announced the formation of an internal group called Alnylam Biotherapeutics focused on applying the company’s RNAi technology to increase the output of biomanufacturing processes.

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Some San Diego life sciences companies reported a burst of new financing, while embattled Sequenom told investors it’s trying to conserve its available cash. Here’s our rundown of the latest highlights:

—San Diego’s Trius Therapeutics, a venture-backed biotech developing a new antibiotic for treating acute and life-threatening bacterial infections, disclosed plans to raise as much as $86 million in an initial public stock offering. With additional funding, the company will proceed to Phase 3 clinical trials of torezolid, which Trius describes as a second-generation successor to linezolid, the Pfizer antibiotic known as Zyvox.

—Life Technologies (NASDAQ: [[ticker: LIFE]]), the Carlsbad, CA-based provider of biotech instruments and lab supplies, agreed to acquire Woburn, MA-based BioTrove, which has developed a high throughput gene expression and genotyping analysis system.

— SpectraScience, the San Diego medical device maker, has raised more than $4.3 million through a private placement that combines preferred shares and warrants. SpectraScience (OTCBB: [[ticker: SCIE]]) CEO Jim Hitchin told Bruce the offering closes a $5 million round the company began earlier this year.

—PaxVax, a San Diego startup backed by Seattle’s Ignition Capital, has raised $2 million of a planned $6 million investment round. The biotech founded in early 2007 is developing a new type of vaccine that is administered as oral tablets and avoids much of the requirements that conventional vaccines require.

—Sequenom, San Diego’s embattled diagnostics company, said it expects to end the year with $39 million in cash—but that’s not enough to get through 2010 without raising funds or slowing spending. In April, Sequenom (NASDAQ: [[ticker: SQNM]]) disclosed that it had “mishandled data” from a prenatal Down syndrome diagnostic test, indefinitely postponing that product launch.

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Alder Biopharmaceuticals keeps such a low profile that even after five years in business, few people in Seattle biotech know who they are. That changed yesterday as the private Bothell, WA-based company burst onto the local, and national, biotech scene by striking a deal with Bristol-Myers Squibb that could be worth more than $1 billion over time to create a new drug for rheumatoid arthritis.

Alder obviously was playing with a strong hand of cards in negotiations with multiple pharmaceutical companies, even though it hasn’t yet disclosed the results of a 120-patient clinical trial of its ALD518 drug candidate that ended this summer. But Alder has been working behind the scenes for months on this deal, and there were several serious bidders, says CEO Randy Schatzman.

Alder ultimately chose Bristol-Myers (NYSE: BMY) because it has experience in the rheumatoid arthritis field through its FDA-approved abatacept (Orencia) therapy, deep pockets, and a “very aggressive” plan to develop and market Alder’s drug not just for rheumatoid arthritis, but for a variety of disorders in which the immune system attacks healthy tissue, Schatzman says. This means that Alder’s drug, which is made to block an inflammatory protein known as IL-6, is thought to have the same kind of far-reaching potential that other biotech drugs that interfere with a different inflammatory protein called TNF. This approach could offer doctors an alternative to the $10 billion-a-year class of biotech drugs, like Amgen’s etanercept (Enbrel) and Abbott Laboratories’ adalimumab (Humira).

When asked directly whether Alder’s clinical trial shows it is competitive with the Amgen (NASDAQ: AMGN) and Abbott (NYSE: ABT) drugs, Schatzman said this:

“We think we’re going to give them a run for their money.”

Seattle Genetics co-founder and CEO Clay Siegall, an Alder board member, added, “This is a superb deal. It gets Alder on a trajectory for becoming one of the important biotech companies in Seattle. They are turning from a startup into a real emerging company.”

To really emerge, Alder sought a partner that had more than just money, but also a bold view of the opportunities with ALD518 and how to capitalize on them. “Their vision is for the same development plan we’d have if we had deep pockets,” Schatzman says. “This is not just for rheumatoid arthritis, but for other autoimmune diseases in which IL-6 is an important player. It’s a very aggressive approach.”

Everyone outside the company will have to wait to see just how good the Alder drug really is. That’s because the company applied for a late-breaking presentation slot at last month’s …Next Page »

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BioVex, the Woburn, MA-based company aspiring to create the first FDA-approved cancer-killing virus, has raised an additional $30 million in private financing to finish off a pivotal clinical trial needed to prove the virus is good enough to reach the U.S. market.

This latest round brings BioVex’s grand total of financing this year to $70 million; the firm nailed down $40 million in March. Participants in the new round include Morningside Venture, Ventech, MVM Life Science Partners, Sectoral Asset Management, and Ysios Capital Partners.

This batch of investors is betting on an idea that has fascinated cancer researchers for decades—oncolytic viruses. These are everyday viruses that are genetically modified to replicate inside tumors, provoking the immune system to mount an attack in the cancerous growth itself, while sparing healthy tissue. The BioVex treatment, OncoVex GM-CSF, takes one such virus and attaches it to GM-CSF, an immune-boosting drug. The combination is supposed to work by penetrating tumor cells and causing them to burst from the inside, while also sparking the immune system to hunt down any cancer cells that have spread throughout the body.

“If this is approved, it will be paradigm-changing,” says Philip Astley-Sparke, BioVex’s CEO.

BioVex has attracted the interest of researchers, and the investment capital, based largely on one study of 50 patients with forms of melanoma, a deadly skin cancer, that have spread through the body. That study found that 13 of the 50 patients (26 percent) had their tumors shrink after they got the BioVex treatment. More interesting, eight of the 13 responders had their tumors completely disappear, and their responses were long-lasting. Although patients who entered the trial had terminal diagnoses, usually giving them six to nine months to live, according to Astley-Sparke, more than half of patients were alive after one year (58 percent) and two years (52 percent), according to data presented at the American Society of Clinical Oncology in June. Side effects were mostly mild-to-moderate flu-like symptoms, researchers said.

“What’s really most impressive is the durability of the response,” Astley-Sparke says.

Those who follow cancer drug development know that melanoma is very tough to treat and has long been a graveyard for once-promising biotech drugs. So BioVex has to prove …Next Page »

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ZymoGenetics started really playing hardball with King Pharmaceuticals in August, and now a high-and-tight fastball has come right back at the Seattle biotech company.

The projectile in question is a lawsuit filed on November 2 by Bristol, TN-based King in the U.S. District Court in Eastern Tennessee; the suit accuses ZymoGenetics of false advertising, unfair competition, and other violations of federal and Tennessee law. King went so far to ask a federal judge to impose three temporary restraining orders to stop ZymoGenetics (NASDAQ: ZGEN) from making certain claims comparing the two drugs—and it was successful for a couple of days until Zymo got the restrictions overturned on Friday.

The suit, it seems, is at least partly a response to a move made in the summer by ZymoGenetics, maker of a drug for surgical bleeding, to try to get King’s rival product pulled from the market. For those not following all of the two companies’ maneuvering, here’s a quick summary.

The incumbent product, Thrombin-JMI, is made by Bristol, TN-based King Pharmaceuticals (NYSE: KG) for surgeons to dab or spray onto an organ that’s bleeding too much during surgery. The King product has been around in hospitals since 1995, and generated $255 million in sales a year ago. Surgical bleeding drugs (called topical hemostats in the operating room) are used in an estimated 1 million surgeries a year in the U.S.

But ZymoGenetics, whose own drug was approved in January 2008, has been arguing for years that it can do a lot better. The King drug is derived from clotting proteins called thrombins in cow blood. Since that’s from a foreign source, the human immune system recognizes it as such, and can spark a reaction that can lead to severe bleeding and death, ZymoGenetics has argued.

The challenger in this niche market, ZymoGenetics developed what it considers a safer alternative, recombinant thrombin, a genetically engineered copy of the human thrombin protein. Because the new drug is a human, rather than cow, protein, it shouldn’t provoke as many immune reactions or dangerous bleeding episodes, ZymoGenetics has contended. But ZymoGenetics has struggled to convince doctors that they need to switch, and it has backed away from earlier attempts to charge premium prices. The company forecasts that it will generate $28 million to $30 million in sales of the drug this year.

Back in August, ZymoGenetics found another venue besides the marketplace in which to wage this fight—the FDA. The company gathered evidence of two cases in which physicians attributed patient deaths to bad reactions on its competitor’s drug, and 23 more cases of severe complications. That was some of the ammunition contained in a 31-page citizen’s petition the company filed with the FDA, in which ZymoGenetics asked the agency to pull the drug off the market for the sake of public health. “There are physicians using Thrombin-JMI without a clear understanding of its risks,” said ZymoGenetics CEO Doug Williams in an interview with Xconomy in August. “There are at least three better alternatives in the marketplace now.”

King, a company with a $2.7 billion market capitalization, didn’t comment at the time. But it obviously decided that when ZymoGenetics started playing hardball, it was time to follow suit.

King challenged the ZymoGenetics citizen petition …Next Page »

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Gloucester Pharmaceuticals has won clearance to start selling its first cancer drug in the U.S.

The Cambridge, MA-based biotech company said today it has gotten the green light from the FDA to start marketing its romidepsin treatment, under the brand name Istodax, for patients with a rare malignancy of the skin known as cutaneous T-cell lymphoma. The drug is expected to be commercially available starting in January, the company said in a statement.

The news comes as little surprise since Gloucester won a unanimous recommendation in early September from an advisory panel to the FDA. Gloucester built its application to the FDA around a pair of mid-stage clinical trials of 167 patients in which about 40 percent experience a reduction in tumor size after getting intravenous infusions of romidepsin. Nausea, fatigue, infections, and vomiting were the most common side effects, and were mostly mild to moderate in severity.

The company looked like such a sure bet that less than one month before it made its pitch to the FDA panel, it raised $29 million from Novo A/S, Apple Tree Partners, ProQuest Investments, Prospect Venture Partners, and Rho Ventures.

Romidepsin is a member of a class of drugs known as histone deacetylase inhibitors. These treatments have been around a long time and have traditionally been used in neurological conditions: only relatively recently have they been considered potential cancer treatments, as I described in a preview story of the FDA panel review back in September. Merck introduced the first drug in this class for cancer, after it won FDA approval in October 2006 for vorinostat (Zolinza), also for cutaneous T-cell lymphoma. Zolinza generated just $9 million in sales in the first six months of this year, so Gloucester has to be hopeful that it can enlarge the market. The patient population with this condition is a small one—the disease affects about 1,500 people each year in the U.S.

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The local life sciences scene was pretty quiet this week, although we heard more than usual from medical device companies.

—Paul Yager, the University of Washington’s chair of bioengineering, offered a detailed status update on a tool called the DxBox his lab has been developing the past four years in collaboration with Redmond, WA-based Micronics, Seattle-based PATH, and Bothell, WA-based ELITech Group, all with the support of the Bill & Melinda Gates Foundation. They are seeking to develop a portable, fast, accurate, and rugged diagnostic tool to help doctors in the developing world, and while there’s been a lot of progress, it’s entered the “put up or shut up” phase, Yager says.

—Seattle-based Dendreon turned in its complete application to the FDA for clearance to start marketing its first drug, sipuleucel-T, (Provenge) in the U.S. This filing came a bit earlier than Dendreon had forecasted, but it’s also a lot later than the company originally hoped when it first asked the FDA for approval, which you can read more about in this Dendreon history piece I did back in April.

—The Institute for Systems Biology said it has commissioned Mountain View, CA-based Complete Genomics to sequence the full genomes of 100 individuals as part of a Huntington’s disease experiment. This experiment is said to be the largest ever to use full human genome sequences.

—We’ve seen a few medical technology companies that are seeking to repair damaged tissues without leaving behind any implantable devices, and Bothell, WA-based QuantumCor is the latest. CEO Vern Dahl described his company’s plan to do this for a form of heart failure known as mitral valve regurgitation.

—Seattle-based Calypso Medical Technologies, the maker of a device to pinpoint radiation therapy for prostate cancer to minimize side effects, formed a collaboration with Siemens Healthcare. The companies will seek to develop the technology for pancreas and lung tumors.

—We also had an insightful guest editorial from Anthony Rodriguez, a Ph.D. bioengineering student at the University of Washington and an aspiring entrepreneur. He contends that it takes a village to raise an entrepreneur, and that while a few organizations have made some effort to cultivate young entrepreneurs at the UW, the business community could be doing much more.

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TEDMED had Martha, Goldie, and other celebrity speakers, but San Diego-based Amylin Pharmaceuticals broke this week’s big news when it signed up a big Japanese partner to develop its line of obesity drugs. It’s all part of your regular dose of San Diego biotech news, and it’s ready now:

—Amylin Pharmaceuticals, the San Diego-based diabetes drug specialist, announced that it has formed a partnership with Japan’s Takeda Pharmaceuticals, which agreed to carry most of the development costs for Amylin’s weight-loss drugs. In return, Takeda gets a worldwide exclusive license to eventually commercialize Amylin’s experimental obesity drugs, including the combination of pramlintide and metreleptin, and davalintide.

—After a five-year hiatus, TEDMED founder Richard Saul Wurman, and president, Marc Hodosh (who also is an Xconomist), brought the conference on medical technology, entertainment and design to San Diego’s Hotel del Coronado. TEDMED announced during the conference, which included presentations by Boston Scientific co-founder (and Xconomist) John Abele, Martha Stewart, and Goldie Hawn, that the conference will return to the same location next October.

—I only had time to attend a fraction of the presentations at TEDMED last week. One of my favorites talks, though, was delivered by Bill Davenhall, who leads the health and human services marketing team at ESRI, the Redlands, CA, giant in geographic information systems. Davenhall talked about the importance of including patients’ “place histories” as part of their medical records and raised an interesting question: Will the electronic health record systems being created today have the capability to add data in new categories—such as “geo-medicine”–that aren’t typically included in today’s patient records?

—New York-based Xenomics filed a lawsuit against San Diego-based Sequenom that alleges Sequenom misrepresented the progress in its development of a prenatal test for Downs syndrome. Xenomix says it would not have licensed its patents to Sequenom had it known the truth.

—Denise profiled San Diego-based Sirigen, an early stage medical diagnostic company that is developing technology that uses light-emitting polymers to detect bits of DNA. Sirigen founder Brent Gaylord developed the technology at UC Santa Barbara, extending the significance of UCSB physicist and Nobel laureate Alan Heeger’s discovery of conductive polymers.

—The FDA told San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN) and its partner Eli Lilly the companies can now market exenatide (Byetta) as a frontline, standalone therapy for diabetes. The drug was previously approved for use with other drugs, or as a fallback option when other tretments failed.

—Vertex (NASDAQ: VRTX), the Cambridge, MA, biotech with operations in San Diego, said the latest trial of its telaprevir treatment for hepatitis C was able to attain the clinical definition of a cure in more than 80 percent of patients who got the drug. The finding is part of the mounting evidence Vertex is gathering on its quest to develop the first-of-its-kind protease inhibitor for the chronic liver disease.

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A number of New England’s life sciences companies had good news to report this week.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) reported results from clinical trials that indicate its experimental hepatitis C drug, telaprevir, could work well for patients who haven’t responded fully to standard treatments, and could be as effective taken twice a day as it is taken three times a day. Luke explains what the news means for Vertex’s efforts to capture a share of the potentially huge market for hepatitis treatments.

—Medical device maker Interlace Medical of Framingham, MA, won FDA clearance to market its minimally invasive device for removing uterine fibroids and polyps.

—Burlington, MA-based CorNova raised $2.5 million of a proposed $6 million in equity financing, according to regulatory filings. CorNova is developing coronary stents with platinum surfaces.

—Anti-inflammatory drug developer Virdante Pharmaceuticals completed a second closing of its Series A financing round, bringing the total collected so far to $30 million. Thomas, McNerney & Partners led the deal, which was joined by Osage Partners, Biogen Idec New Ventures, Clarus Ventures, MedImmune Ventures, and Venrock Associates.

—Bedford, MA-based iRobot (NASDAQ:IRBT) launched a new healthcare unit. Under the direction of technology veteran Tod Loofbourrow, the unit will focus on developing robots to help seniors live independently.

—Pharma giant Novartis declined an option to continue development of a hepatitis C drug from Cambridge-based Idenix Pharmaceuticals (NASDAQ: IDIX). Idenix, whose stock dropped on the news, will seek another partner to back development of the drug, IDX184.

—RNA-interference drug developer Cequent raised $3.35 million in the first tranche of a venture round that could be worth as much as $15 million. The Cambridge-based startup is engineering E. coli bacteria to deliver RNAi molecules designed to combat a certain type of polyp in the colon.

—Pulmatrix raised $30.2 million in a Series B venture round led by Arch Venture Partners and Novartis Bioventures Fund and joined by Polaris Venture Partners and 5AM Ventures. The Lexington, MA-based startup is using technology from MIT and Harvard to prevent flu viruses and other pathogens from invading lung tissue.

—Cancer diagnostics developer On-Q-ity of Waltham, MA, reportedly raised $21 million in a Series A round of venture capital from Mohr Davidow, Bessemer Venture Partners, Physic Ventures and Northgate Capital. The firm was formed through the merger of CELLective Diagnostics and The DNA Repair Company, both Mohr Davidow Ventures portfolio companies.

—Ironwood Pharmaceuticals of Cambridge and its partner, New York-based Forest Laboratories (NYSE: FRX), said that Ironwood’s lead drug candidate, linaclotide, fared well in two pivotal clinical trials. The drug is designed to relieve chronic constipation; Luke has all (and I mean all) the details.

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Seattle-based Dendreon said today it has completed all the necessary paperwork for its lead drug candidate, and handed over the amended application for approval to the FDA. The company had told investors to expect this milestone by “mid-November,” so this application came in a few days or even a few weeks ahead of schedule.

Investors have been antsy for months about Dendreon (NASDAQ: DNDN) turning in its amended application to start marketing sipuleucel-T (Provenge) as the first treatment of its kind to actively stimulate the immune system to fight prostate cancer like a virus. That’s because Dendreon reached its goal in a 512-patient study, known as Impact, back in April, generating the sort of evidence of safety and effectiveness that it will need to pass muster.

The FDA will now have a deadline of 180 days to finish its review of the application, although the FDA has to formally accept the application for review before it assigns itself a deadline, says Dendreon spokeswoman Katherine Stueland. Dendreon has said it expects to win approval by mid-2010.

This deadline matters a lot to Dendreon and prostate cancer patients. Dendreon’s stock has boomed this year from as low as $2.55 to as much as $30 on the assumption that its drug is a slam dunk with the FDA because of the results from the Impact study, and it has raised $221 million from investors to build up the manufacturing and marketing muscle it needs to make it a success. The company has also gone on a hiring binge this year as it seeks to make sure it has the talent to make the most of this drug, recently saying it plans to double in size to about 600 employees. If approved, the drug would be the first option of its kind for a disease that kills about 30,000 men in the U.S. each year, and an alternative to Sanofi-Aventis’ docetaxel (Taxotere) a chemotherapy that has been shown to extend lives, but also to cause nasty side effects.

Shares of Dendreon climbed 5 percent at the opening bell to $26.60 on the news.

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San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN) and its partner Eli Lilly got some positive news late Friday from the FDA. The agency now says the companies have clearance to market exenatide (Byetta) as a standalone therapy for diabetes, which means doctors won’t need to combine it  with other common drugs, or hold it in reserve as a second option in case other drugs fail.

Exenatide is Amylin’s biggest selling product, generating $678.5 million in revenue last year, accounting for about 90 percent of its sales. An estimated 23.6 million people in the U.S, or almost one out of every 12 people, is estimated to have diabetes, so the expanded approval of Amylin and Lilly’s drug may allow the companies to capture a larger percentage of patients. The one downside is that exenatide currently requires twice-daily injections, so it’s hard to say how many new patients who are eligible for the drug will opt to take it instead of cheaper and more convenient oral pills.

“The expanded indication gives physicians the option to prescribe Byetta as a first-line treatment, increasing the number of patients who may benefit from the medication and providing an opportunity to treat patients with Byetta earlier in the disease,” said Orville Kolterman, Amylin’s senior vice president of research and development, in a company statement. “Type 2 diabetes is a complex disease, so it is essential that healthcare professionals and their patients have a wide array of treatments that can effectively control blood glucose levels.”

A more important milestone for Amylin and Lilly will come in March, when the FDA has a deadline to complete its review of a once-weekly injectable version of exenatide. That’s the next version of the diabetes franchise at Amylin that analysts say has blockbuster sales potential.

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San Diego’s life sciences news picked up a bit last week amid fresh signs of the area’s growing prominence in the laboratory tools and diagnostics sectors.

—Carlsbad, CA-based Helixis, a startup maker of genetic analysis technology from the Caltech labs of Nobel Laureate David Baltimore and Axel Scherer, raised $1.8 million from unidentified investors, according to a regulatory filing. The amount is in addition to the $5.5 million the company reported raising in July. Helixis is developing products that attempt to make real-time polymerase chain reaction (RT-PCR) technology more accessible to the average researcher.

—Enigma Diagnostics CEO John McKinley told Bruce the UK-based medical diagnostics startup plans to close its current U.S. office in San Francisco and make a new office in San Diego its U.S. headquarters. McKinley estimated Enigma would have 30 employees in San Diego—“the diagnostics center for the U.S.,” as he put it—by mid-2010. The company has developed a desktop-size instrument based on advances in PCR (polymerase chain reaction) technology, which McKinley says can identify certain pathogens in less than 45 minutes.

—Sequenom, the San Diego-based maker of laboratory tools and diagnostics, disclosed that it agreed to accept a $1 million payment from Ibis Biosciences, a unit of Abbott Laboratories, to settle a patent infringement lawsuit. As part of the deal, Sequenom (NASDAQ: [[ticker: SQNM]]) granted Ibis a non-exclusive license to three mass spectrometry-based patents. Sequenom, meanwhile, remains under investigation by the Justice Department and Securities and Exchange Commission for “mishandling” experimental data in a clinical trial of its prenatal test for Down syndrome.

—Senomyx (NASDAQ: [[ticker: SNMX]]), the San Diego company using biotechnology to develop proprietary flavor enhancers and blockers, said S6973, a compound it has been developing to enhance the intensity of sucrose, was designated as Generally Recognized As Safe (GRAS) under federal regulations that govern food additives. The GRAS designation allows the company to begin commercialization of the sweetness enhancer, which enables foodmakers to reduce sugar in foods and drinks by as much as 50 percent and still provide an equivalent sweet taste, according to Senomyx.

—San Diego-based Ligand Pharmaceuticals (NASDAQ: [[ticker: LGND]]) agreed to pay $3.2 million to acquire ailing Metabasis (NASDAQ: [[ticker: MBRX]]), a developer of treatments for diabetes and high cholesterol. Ligand committed $8 million to finance Metabasis’ drug development programs within the next 42 months.

—The Burnham Institute for Medical Research made two key hires to support its translational research efforts. Paul Laikind, the co-founder of Gensia Pharmaceuticals, Viagene, and Metabasis, became the institute’s senior vice president of business development and chief business officer to help cut deals with biotech and pharma companies. Michael R. Jackson, formerly senior vice president of drug discovery at Johnson & Johnson, is now Burnham’s first-ever vice president for drug discovery and development, charged with translating Burnham discoveries into drug candidates primed for clinical testing.

—San Diego’s Arena Pharmaceuticals (NASDAQ: [[ticker: ARNA]]) is talking up the safety profile of its experimental obesity drug as it prepares to compete against experimental treatments from San Diego-based Orexigen Therapeutics (NASDAQ: OREX) and Mountain View, CA-based Vivus (NASDAQ: VVUS), both of which produced greater weight loss in clinical trials. None of the drugs have yet been approved by the FDA. Arena CEO Jack Leif told Luke that the company’s drug, lorcaserin, improved diabetic and cardiovascular health markers in clinical trial subjects. He also challenged the notion that lorcaserin is a subpar obesity treatment. “This is not a wimpy weight-loss drug,” Leif said.

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Stryker, the Kalamazoo, MI-based maker of orthopedic hip implants and other medical devices, said today that its biotech division in Hopkinton, MA, along with certain current and former employees, have been indicted by a federal grand jury for conspiracy to defraud the FDA.

The company (NYSE: SYK) disclosed on March 10 that its Stryker Biotech unit was the target of a federal grand jury investigation being conducted by the U.S. Attorney’s Office for the District of Massachusetts, according to a company statement released today. The charges include wire fraud, conspiracy to defraud the FDA, distributing a misbranded device, and making false statements to the FDA.

If the company is found guilty, it could face “significant monetary fines” and be barred from participating in state and federal healthcare programs, which could cause significant damage to Stryker Biotech’s business. “The company is disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter,” Stryker said in a statement, adding it will have no further comment.

The company is charged with illegal promotion of OP-1 human bone growth product and Calstrux, according to a regulatory filing in March. Stryker said that certain former employees have pled guilty to charges related to the investigation, according to its statement in March. The investigation specifically focused on the number of patients treated with OP-1 under one of the Humanitarian Device Exemptions granted to the company. Those exemptions are sometimes granted to companies to market devices for less than 4,000 patients, even if the product hasn’t completed the usual full sequence of clinical trials. Stryker says it was accused of submitting false reports to the FDA regarding the number of patients who were treated with OP-1.

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Interlace Medical, a Framingham, MA-based developer of medical devices for gynecologists, said today that the FDA has granted the firm clearance to market its MyoSure device for removing fibroids and polyps from the uterus without requiring incisions. About 80 percent of women develop uterine fibroids in their lifetime, and the annual cost of treating them in the U.S. is more than $2 billion, according to Interlace. The firm said it was gearing up to commercialize the device in June when it announced the closing a $20.5 million Series C round of financing.

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