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Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it will lay off 85 of its 115 employees or almost 75% of its workforce. The news follows the FDA’s rejection of its application for oritavancin, an antibiotic it is developing to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant bacteria. The agency wants Targanta to conduct another Phase III clinical trial to further assess of oritavancin’s safety and efficacy.

The company estimates that the new clinical trial will cost about $20 million. Targanta CEO Mark Leuchtenberger said “We are no longer a pre-commercial company. We are back to being a Phase three company, and that requires us to right-size and to streamline our operations.”

Things are not going well for companies in the antibacterial drug discovery and development space. Late last month, FDA rejected Swiss-based Arpida’s NDA for iclaprim an antibiotic it was developing to treat complicated skin and soft infections caused by MRSA. Shortly after receiving the news, Arpida layed off roughly 72% of its employees and is down to about 30 employees like Targanta.

It is unfortunate that big pharma decided to abandon antibacterial discovery and development research about eight years ago. Consequently, development of  new, much-needed antibiotics has been relegated to financially-strapped, small biopharmaceutical companies whose likelihood of success is questionable.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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Cambridge, Mass-based Targanta Therapeutics announced Monday that it had finally submitted a new drug application to the U.S. Food and Drug Administration for its lead product, the antibiotic oritavancin. As mentioned in a previous post Targanta executives had decided to delay the submission of the oritavancin NDA.

Oritavancin is being touted as a viable option for treating antibiotic-resistant bacterial infections. It would compete in the marketplace against drugs including telavancin being developed by Theravance and cubicin, an antibiotic offered by Cubist Pharmaceuticals Inc to treat skin and blood infections.

Targanta has backed up its application with data from 19 clinical trials including two late-stage human clinical trials. More than 2,100 patients took part in the clinical testing of the drug.

I wish Targanta luck–we need new antibiotics!

Until next time…

Good Luck and Good Job Hunting

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Two companies, Theravance and Targanta, have developed two new glycopeptide antibiotics, similar to vancomycin that the US Food and Drug Administration (FDA) will consider for approval. This is very welcome news because antibiotic treatment options continue to diminish as bacterial antibiotic resistance continues to skyrocket. Unfortunately, like vancomycin, both antibiotics must be administered intravenously to treat infections.

Theravance filed a new drug application(NDA) with FDA for telavancin, a bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The company received an approvable letter from FDA for telavancin but was asked for additional information to determine whether the agency will approve the drug. Theravance received notice in December from FDA that the agency's Anti-Infective Drugs Advisory Committee will meet on February 27 to review the new information and make a recommendation on telavancin’s approvability.

Targanta expects to file a NDA for its antibiotic, oritivancin, in the first quarter of 2008. Oritavancin is a semi-synthetic glycopeptide antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Two Phase 3 studies for the treatment of complicated skin and skin structure infection (cSSSI) have been completed. The antibiotic was originally discovered in the mid 90s by Eli Lilly research laboratories. In 2001, Lilly licensed oritivancin to Intermune who subsequently finished the phase III studies, but delayed filing the NDA in 2004 because of adverse side effects including injection site phlebitis. In 2005, Intermune divested itself of oritavancin and sold the worldwide ownership rights to Targanta.

The company apparently delayed submitting its NDA for oritivancin to FDA (even though the data were available for a couple of years) because the agency has been described as fickle when it comes to antibiotic approvals. Apparently, Targanta executives wanted to see how telavancin fared with FDA before it filed its application. Nevertheless, approval of the ortivancin NDA is strongly contingent upon information describing the benefits of oritavancin over vancomycin.

While neither antibiotic is groundbreaking for the treatment of infections caused by Gram positive pathogens, they both offer certain benefits over vancomycin.  Further, the addition of these new antibiotics to our current antibacterial armamentarium is timely given the growing incidence of vancomycin-resistant bacterial isolates.

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