MRSA

Basilea shares plunge on antibiotic delay

Tue, 18 Mar 2008 07:59:58 -0400

Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA regulators. The agency said that it would need more information on the antibiotic--which is partnered with Johnson & Johnson. In an approvable letter, the FDA outlined its requirements: more information on the drug's impact on diabetic foot infections, more time to assess the data submitted, and a review of the study sites used to test the therapy. Ceftobiprole is intended to treat complicated skin infections, including MRSA.

In a phone call with analysts, Basilea CEO Anthony Man declined to offer a timeline for an approval, but noted that the agency isn't asking for more studies. Researchers are also testing the drug as a possible therapy for pneumonia.

While analysts suggested that a 9 to 12-month delay was likely, at least one was pleased to see that the FDA was willing to go with Basilea's non-inferiority trial, which could have proved to be a sticking point.

- here's the release
- read the article from MarketWatch

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Cepheid cashes in on MRSA trends--for now

Fri, 07 Mar 2008 06:59:56 -0500

With cases of antibiotic-resistant MRSA multiplying and fear of the superbug rising, Cepheid was perfectly positioned when it came out with a rapid genetic screening test. Sales have soared as Cepheid has reaped the benefits of new programs that use the screening test to identify MRSA and isolate patients. But as a profile of the company in The New York Times makes clear, the test has spurred controversy over the best way to combat MRSA. Rather than test and isolate patients, critics contend hospitals would be better off if they stuck with hospital-wide campaigns to ward off the bug with regular hand washing campaigns and other such tactics. Meanwhile, as Times scribe Andrew Pollack points out, companies such as Gen-Probe, Roche and Qiagen are advancing their own tests. Cepheid may not have this market to itself very much longer.

- read the article from the New York Times

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FDA to review Theravance's telavancin response

Thu, 06 Mar 2008 06:59:54 -0500

More news in Theravance's ongoing battle to win approval for its antibiotic telavancin: the FDA has accepted the company's response to the approvable letter Theravance received in October. Telavancin is a once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections, such as MRSA.

The FDA's approvable letter included a request for more clinical data or reanalyzed clinical data, revised labeling and a resolution of good manufacturing practices. Last week Theravance was scheduled to meet with the FDA, but that meeting was canceled because the agency wanted review the monitoring of study sites following data integrity concerns. Further action on the NDA won't be taken until the FDA is finished its evaluation. Theravance was a 2003 Fierce 15 company.

"We are pleased that the FDA has accepted for review our complete response, which we submitted on January 21st," said Rick E Winningham, CEO of Theravance. "We are committed to working with the FDA to resolve the remaining issues on our cSSSI NDA."

- check out Theravance's release

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Blog divines new FDA standard on data integrity. Report
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FDA cancels meeting as hopes rise for Basilea

Wed, 13 Feb 2008 06:59:58 -0500

The FDA has canceled a scheduled advisory board meeting on Basilea's ceftobiprole antibiotic, a move that analysts say makes a quick approval likely. That's what investors wanted to believe, sending shares of Basilea up in hopes that the agency will move swiftly. The FDA, though, gave no reason for the cancellation and the company declined to speculate on what it could mean. The agency granted a standard review of the antibiotic in July.

"Normally, the process takes about ten months," said a spokesperson. "The treatment application was accepted in mid-July." Drug developers have been scrambling to come up with new treatments for MRSA and other infections that have been spreading quickly. But several big companies also exited the antibiotic field several years ago, making it harder to find deep-pocket partners to advance new therapies.

- see this release
- here's the report from AFX

Related Articles:
U.S. pipeline bone dry for new antibiotics. Report
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ALSO NOTED: Ventana and Roche forge confidentiality agreement; Rigel wins $3M payment; and much more...

Wed, 14 Nov 2007 06:59:50 -0500

> Ventana Medical Systems and Roche have made nice over a confidentiality agreement, raising the prospects of a takeover. One analyst says that Ventana would likely fetch more than $87 a share. Report

> Rigel Pharmaceuticals will pocket a $3 million payment with the announcement that Merck Serono has exercised its option to add the Japanese territory to its current Aurora kinase collaboration that includes the lead product, R763/AS703569. Release

> ThromboGenics has launched pre-clinical trials on its cancer antibody VPAC. Report

> A team of researchers from the U.S. and Germany has found that community associated MRSA, a particularly virulent strain of staph infection, creates a peptide that causes immune cells to burst. Report

> Sanofi-Aventis just got slapped with a class-action lawsuit on behalf of an institutional investor over Acomplia's FDA rejection. Report

> A synthetic compound developed in the lab at UT Southwestern Medical Center mimics the cellular protein Smac, broadcasting a message to cancer cells that triggers their destruction. Report

> One foundation isn't please with a spoof of Glaxo's restless leg syndrome ad. Report

And Finally... Scientists at the Oregon National Primate Research Center are on the verge of announcing that they have developed a new technique for cloning embryos from adult monkeys. Report

Dry antibiotic pipeline concerns infectious disease experts

Mon, 05 Nov 2007 06:59:55 -0500

The Infectious Diseases Society of America has been beating the drum over a paucity of new antibiotic approvals. With drug developers lured by bigger margins in other disease categories, drug companies began bowing out of this field years ago, says the society. Between '88 and '92 there was an average of three new antibiotic approvals each year. But since 2003 that number has slipped to an average of one new approval a year as Aventis, Abbott Laboratories, Bristol-Myers Squibb, Eli Lilly, Proctor & Gamble, Roche and Wyeth have dropped out of the field or cut research efforts. As a result, physicians say, there are an increasing number of aggressive infections they can't treat.

- read the report

Related Articles:
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Basilea reports positive Phase III antibiotic data

Tue, 09 Oct 2007 06:59:58 -0400

A late-stage trial of the experimental antibiotic ceftobiprole, which is being jointly developed by Basilea and J&J, has demonstrated significant results, with 86 percent of patients being cured of diabetic foot infections. The therapy, which is under review at the FDA, also demonstrated signs of success against antibiotic-resistant bacteria, or Staphylococcus aureus. Researchers unveiled the data at the Infectious Disease Society of America meeting in San Diego.

"Diabetic foot infections are becoming increasingly difficult to treat," said study author, Gary J. Noel, M.D., with Johnson & Johnson Pharmaceutical Research & Development. "These data suggest that ceftobiprole may be useful as stand-alone therapy for this increasingly common type of complicated skin infection."

- check out the release for more info

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WHO: Infectious disease a growing threat

Fri, 24 Aug 2007 06:59:54 -0400

A new report from the World Health Organization is sounding the alarm on the serious threat the world faces from rapidly spreading infectious disease. New disease are emerging--such as AIDS, Ebola and SARS--and the prevalence of air travel means that localized diseases can be easily transported around the globe within hours. In addition, infectious diseases are becoming more difficult to treat and drug resistance in particular poses a serious threat to world health. "Since 1967, at least 39 new pathogens have been identified, including HIV, Ebola hemorrhagic fever, Marburg fever and SARS. Other centuries-old threats, such as pandemic influenza, malaria and tuberculosis, continue to pose a threat to health through a combination of mutation, rising resistance to antimicrobial medicines and weak health systems," warns the WHO.

- see the WHO report

Related Articles:
The challenges of infectious disease. Report
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