Cambridge, MA-based Targanta Therapeutics (NASDAQ: TARG) received a harsh blow last week as the FDA declined to approve it sole drug candidate, an antibiotic called oritavancin intended to treat antibiotic-resistant infections like MRSA. Today Targanta announced staff cutbacks intended to help the company conserve capital while it seeks approval for oritavancin in Europe and tries to get the drug back on track for approval in the United States. The company will reduce its workforce by 86 people, or about 75 percent, leaving it with only 27 employees. We have updated Xconomy’s Boston Tech Layoff Tracker with the latest numbers.

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Targanta Therapeutics is getting ready for a day next month that will go a long way toward determining whether it can sell its first marketed product. The Cambridge, MA-based biotech company, said it has been asked to appear before an FDA advisory committee on Nov. 19 to make its case for why regulators should approve oritavancin as a new antibiotic for tough-to-treat skin infections.

Targanta’s application for approval includes data from 2,100 patients in clinical trials, including those who enrolled in two final-stage studies that reached their goals, the company said. The FDA deadline for reviewing the application is December 8.

Oritavancin, as we wrote about last month, is given in a three-to-seven day course of therapy. That means patients with nasty pathogens like drug-resistant MRSA could end up spending less time in the hospital than if they take generic vancomycin in twice-daily infusions for 10 to 14 days, or Cubist Pharmaceuticals’ Cubicin in a 7- to 14-day course of treatment, Targanta CEO Mark Leuchtenberger says. The dream with oritivancin, though, is for it to be given in a single shot, which at least one clinical trial has shown may be as effective or more effective than the standard three-to-seven day course. We’ll find out more details at an upcoming medical meeting.

The FDA panel will also review another antibiotic for complex skin infections, Theravance’s Telavancin. The South San Francisco-based company has had its application held up because of previously announced “data integrity” issues with its application, which led three clinical trial sites to be scrubbed out of the database. That’s the sort of thing that can lead to tough questioning from FDA reviewers, so they might not be in the best of moods to hear about the latest, greatest advances with antibiotics.

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Plenty of investors have been skeptical about Targanta Therapeutics’ claim that it has an antibiotic that can kill drug-resistant pathogens like MRSA with a single shot. That’s what the Cambridge, MA-based company (NASDAQ: TARG) claimed in a press release on Sept. 2, when the stock closed at $7.46. Since then, it’s dropped to $6.83 at the close Friday.

Still, the idea is intriguing, so I called CEO Mark Leuchtenberger to learn more about this drug, oritavancin, and where’s it’s headed. He talked about results from a mid-stage clinical trial called “Simplifi” which showed that a single dose, or a single dose followed by one follow-up five days later, was comparable to a three-to-seven -day course of therapy with the drug.

The company is saving the detailed results for an upcoming medical meeting, Leuchtenberger says. He won’t say when or where the data will be presented, but “it will be one of the big ones,” he says. If the data are persuasive to physicians and scientists at the meeting, the implications are big. A single infusion of the Targanta antibiotic would save a lot of time and hassle at hospitals, which treat the toughest bacterial infections with generic vancomycin in twice-daily infusions for 10 to 14 days, Leuchtenberger says. Another option, Lexington, MA-based Cubist Pharmaceuticals’ Cubicin, needs to be given in a regime lasting seven to 14 days, he says.

Even though Wall Street isn’t buying into Targanta’s results yet, the news is positive and “has to be viewed as modestly worrisome for Cubist investors,” said Thomas Shrader, an analyst with Rodman & Renshaw, in a note to clients. He added that Cubist has said almost half of its sales come from outpatient use of its drug, and that “single or infrequent dosing of oritavancin might someday trump this advantage and threaten the Cubicin franchise.”

“We think there’s potential here for a paradigm shift in the market,” Leuchtenberger says.

Oritavancin was originally developed at Eli Lilly (NYSE: LLY) in the 1990s, before the Indianapolis-based drugmaker decided to get out of the antibiotics business, Leuchtenberger says. The drug was passed on to Brisbane, CA-based Intermune (NASDAQ: ITMN), which ran out of money to develop it in 2003, which allowed Targanta to get hold of it, Leuchtenberger says.

The drug is attractive because it is extremely potent, meaning it can do the job of killing bacteria in a relatively low dose, and it has the ability to last in the body for about two weeks, Leuchtenberger says. It doesn’t get metabolized, and it is excreted through the bile ducts, not the kidneys like other antibiotics, he says, which means it’s unlikely to cause kidney toxicity.

The drug has hit its goals of treating infections in two pivotal trials, with the three-to-seven-day course of therapy, and Targanta has applied for FDA clearance to sell the drug in that form. The FDA’s deadline to complete its review is Dec. 8. Still, even if it presents positive data on the Simplifi trial, Targanta will need to do another pivotal trial in the single-shot form before it can market the drug for that purpose, Leuchtenberger says.

As long as the high-dose single shot doesn’t cause unusual side effects, then it should have an advantage because “the more drug you have in the body, the more chance you have to eradicate the bacteria in it,” Leuchtenberger says. In animal studies, the single-shot formulation was even better than the smaller doses spread over several days, the Targanta CEO says, and he notes that the data so far from humans “is consistent” with the findings in animals.

That sounds like a teaser of things to come.

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Targanta Therapeutics, the Cambridge,MA-based developer of potent hospital-based antibiotics, is on the rise today. The company’s oritavancin treatment, in a single dose or an infrequent dose, showed comparable safety and effectiveness to a three-to-seven day course of therapy tested in previous trials against complicated skin infections. The new results came from a mid-stage clinical trial called Simplifi, which enrolled 300 patients.

Shares of Targanta (NASDAQ: TARG) climbed 5 percent to $7.40 at 11:38 a.m. Eastern time today.

Oritavancin is Targanta’s lead drug candidate against tough-to-treat skin infections, like the antibiotic-resistant pathogen that makes headlines, MRSA. Two previous trials met their goals in the more frequent dose, and the company is using that data to seek FDA approval. The agency’s deadline to review that application is Dec. 8, but Targanta already has its sights set on improving the product. “A single or infrequent dosing regimen could make oritavancin the go-to drug of choice among physicians who are seeking an effective and convenient weapon for their antibiotic armamentarium,” said Mark Leuchtenberger, Targanta’s CEO, in a statement.

Targanta’s statement today didn’t include details on exactly how the single-dose regimen stacked up with the earlier trial results. The full data on the Simplifi trial should be presented by the end of the year, the company said. For now, it is being used to design a Phase III clinical trial that could pave the way for usage in the single-dose format.

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Shares of Targanta Therapeutics (NASDAQ: TARG) got a small boost today on the news that the Cambridge, MA-based firm has submitted an application to the FDA for approval of its antibiotic oritavancin for the treatment of complicated skin infections caused by the “superbug” MRSA and other gram-positive bacteria. The stock opened at $9.08, up from yesterday’s close of $8.83, and climbed as high as 9.40 before closing the day at $9.00.

The FDA submission incorporates data from more than 2,100 people in 19 clinical trials, according to the announcement, and includes Phase 3 data showing that the antibiotic is effective in just three to seven days. The submission marks an important step toward the company’s goal of winning approval for oritavancin, which was originally developed by Eli Lilly back in the 1990s, by year’s end. Targanta is pursuing additional indications for the drug, and is also developing antibiotics for treating bone infections.

Targanta has gotten a rather chilly reception from the market. The company debuted in October at $10 per share, well below its target price range of $12 to $14, and has spent most of the subsequent months hovering between $9 and $9.50. Should Targanta pull off the approval of oritavancin—which would compete with vancomycin and Lexington, MA-based Cubist Pharmaceuticals’ Cubicin in the increasingly hot market for treating MSRA and other complicated skin infections—the climate around the company could get decidedly warmer.

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Cambridge biopharmaceutical company Targanta Therapeutics staggered out of the blocks as its stock made its public debut today. The company (NASDAQ: TARG), which is focused on developing antibiotics to combat serious infections, opened at $10 per share and at just before 2:30 p.m. was limping along at $9.51 (down about 5 percent), not too far from its low for the day of $9.20.

The lackluster trading was not the first disappointment surrounding Targanta’s IPO. Yesterday the company priced 5.75 million shares of common stock at $10 per share, well below its target price range of $12 to $14 per share. The pricing gave Targanta an initial market cap of roughly $210 million.

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Targanta Therapeutics, a Cambridge biopharmaceutical company focused on developing antibiotics to combat serious infections, today set the terms of its impending IPO, announcing plans to sell 5.75 million shares of common stock at between $12 and $14 a share. In the mid-range of the pricing, after commissions, discounts, and other expenses, the company said it expects to realize net proceeds of about $68 million.

Targanta acquired the rights to its lead product, oritavancin, in 2005. According to its SEC filing, the company believes it has enough data to support FDA approval of the drug for its first indication (complicated skin infections), and hopes that approval will come in late 2008.

A successful Targanta IPO would herald a great comeback for its CEO Mark Leuchtenberger, who just over a year ago (in June 2006) announced the demise of his previous company, Cambridge-based Therion Biologics, after its two lead products—both cancer vaccines—failed to meet expectations in clinical trials. Therion, where Leuchtenberger served as President and CEO, was a high-flyer that took in more than $120 million in three rounds of financing, much of it from German billionaire Hans-Werner Hector, a co-founder of the software firm SAP. After the disappointing trials, Hector cut off a $50 million line of credit he had extended to the company, according to Mass High Tech.

Leuchtenberger, who headed the Massachusetts Biotechnology Council search committee that recently tapped Robert Coughlin as the new MBC president, has said in the past that he learned a painful lesson with Therion—never to be so dependent on one source of financing. If successful, the IPO, coupled with a $70 million round of venture financing earlier in the year, should help with that.

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