Another Antibiotic Discovery And Development Company Is Downsizing

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!!!!!!!!

FDA Delays Approval of Ceftobiprole to treat MRSA

U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson and Basilea saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic targeted mainly against infections caused by methicillin-resistant Staphylococcus aureus (MRSA), is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted with the NDA until issues of data integrity had been resolved. The FDA has asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union. A new application in the United States is planned within a year.

Late last week, FDA rejected an NDA for another antibiotic, iclaprim, being developed by Arpida, another Swiss company. It has been a bad two weeks at FDA for approval of new antibiotics—drugs that we desperately need.

Until next time….

Happy Thanksgiving

 

FDA Advisory Panel Rejects another NDA for a New Antibiotic

A Food and Drug Administration (FDA) advisory panel Thursday rejected a proposed antibiotic by Arpida Ltd. (ARPN.EB) to treat serious skin infections, a Food and Drug Administration spokeswoman said. The rejection was expected because results from Phase III clinical trials showed that patients taking iclaprim (a trimethoprim-like antibiotic) had lower cure rates than Pfizer's Zyvox (linezolid) which was used as a comparator antibiotic in the studies.

The panel voted 17 to 2 against a question that asked whether the data presented demonstrated the safety and effectiveness of iclaprim for the treatment of skin infections. Although FDA isn’t required to follow the advice offered by its advisory panels, the agency typical follows the panels’ recommendations. This means that it is unlikely that FDA will approve iclaprim to treat complicated skin and soft structure infections (cSSIs).

This is bad news for Arpida Ltd, a small, Swiss biopharmaceutical company and Americans with cSSIs infections that are caused by  multiple drug resistant bacteria.

Until next time…

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