antibiotic

Tetraphase raises $15M for antibiotic work

Maureen Martino — Wed, 06 Aug 2008 11:59:00 -0400

Massachusetts-based Tetraphase Pharmaceuticals has closed the second tranche of its $25 million Series A financing. The $15 million tranche was funded by existing investors, including Mediphase Venture Partners, CMEA Ventures, Fidelity Biosciences, Flagship Ventures and Skyline Ventures. Tetraphase will use the funding to support the advancement of several antibiotic drug candidates.

"Since our inception, we have made significant progress, applying our unique technology to the development of several novel and potent antibiotic drug candidates," said Guy Macdonald, President and CEO. "We are very pleased that our investors share our enthusiasm for and confidence in our programs."

- take a look at TetraPhase's release

Related Article:
U.S. pipeline bone dry for new antibiotics

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
Dry antibiotic pipeline concerns infectious disease experts. Report
Basilea reports positive Phase III antibiotic data. Report
Basilea shares jump on antibiotic data. Report

ALS sees strong data in Phase III antibiotic trial

Thu, 15 Nov 2007 06:59:54 -0500

Advanced Life Sciences is touting data from a recent trial of its antibiotic cethromycin. The therapy produced positive data that it can fight pneumonuia effectively and safely and demonstrated an ability to combat the MRSA superbug as well. ALS officials told the Chicago Tribune that the data was good enough to pursue FDA approval. In the trial, cethromycin essentially matched the efficacy of a standard of care in fighting community-acquired pneumonia. Flavin added that the company planned an NDA next year with marketing to commence in 2009.

"We are very excited to have met all of our endpoints in Trial CL-05, and we are pleased to have successfully completed the clinical development program of cethromycin. The results attained in this trial, along with the positive results achieved in Trial CL-06 reported in June of this year, will form the core of our New Drug Application submission and positions us well with prospective commercial partners," said Dr. Michael Flavin, chairman and CEO of Advanced Life Sciences.

- see the release for more
- here's the report from the Chicago Tribune

Related Articles:
Advanced Life Sciences raises $36M. Report
Clues shed light on fighting lethal MRSA strain. Report

FDA wants more data on Theravance antibiotic

Mon, 22 Oct 2007 06:59:54 -0400

The FDA outlined new information it would need from Theravance and Astellas before it can fully approve telavancin, a new antibiotic that can be used against 'superbug' staph infections. But researchers say that the companies would not need to mount a new clinical trial in order to satisfy the FDA's demands. The FDA's letter includes a request for more clinical data or reanalyzed clinical data, revised labeling and a resolution of good manufacturing practices.

"We are committed to submitting a timely and complete response to this approvable letter," said Rick E. Winningham, the chief executive of Theravance. "We will work with the FDA to resolve the outstanding issues and to ensure a label that accurately reflects the data from our clinical studies, which included the largest group of patients with cSSSI and the largest group of patients infected with MRSA (superbug staph) ever studied." Theravance was a 2003 Fierce 15 company.

- take a look at the release

Related Articles:
Theravance trumpets positive results of mid-stage trial. Report
Astellas take a pass on Theravance's drugs. Report
CDC estimates 94,000 staph infections occurred in 2005. Report

Targanta shares start trading at a discounted price

Wed, 10 Oct 2007 06:59:55 -0400

Shares of Targanta began trading today at $10 a share, a significant discount under the $12 to $14 range it set for itself last month. That discount will cut the company's take from the IPO from a projected $92 million to $57.5 million. Targanta's trouble going public underscores the generally lackluster results biotech companies have been seeing this year on the public markets. Targanta plans to submit its antibiotic oritavancin for FDA approval in early '08. The biotech reported a loss of about $30 million last year. Targanta came in second on our list of the top five VC deals of the first half of 2007.

- see the release on the IPO
- here's the report from Mass High Tech

Related Articles:
Targanta raises $70M in third venture round. Report
Targanta files for $86M IPO to push antibiotics. Report
M&A activity heats up as biotech IPOs struggle. Report

Read more on: Biotech IPOs

Nektar scores $175M pact for pneumonia therapy

Mon, 06 Aug 2007 06:59:57 -0400

Nektar Therapeutics is getting $50 million up front in a $175 million licensing deal with Bayer Healthcare for the successful development of a new therapy for severe pneumonia. Nektar will deploy its pulmonary technology to deliver aminoglycoside antibiotic NKTR-061. The pact includes a rich co-promotion deal for the U.S. market along with a royalty split on sales outside the U.S.

- see this release
- read the AFX report on the deal

Related Articles:
Nektar settles university patent fight. Report
Nektar gains fast track for lung infection drug. Report

Press Release: Genzyme Announces Data from First Phase 3 Study of Tolevamer

Maureen Martino — Fri, 06 Jul 2007 11:27:20 -0400

Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea

Genzyme Corp. announced top-line data today from the first of two Phase 3 clinical studies to assess the safety and efficacy of tolevamer liquid, an investigational, non-antibiotic, polymer therapy for patients with Clostridium difficile associated diarrhea (CDAD). The second Phase 3 study of tolevamer liquid is fully enrolled and results are expected later this year.

In this first Phase 3 study known as the Polymer Alternative for CDAD Treatment (PACT) study, tolevamer liquid did not meet its primary endpoint of non-inferiority to the standard prescribed oral dose of the antibiotic vancomycin, as measured by the percent of patients with resolution of CDAD. This result contrasts with the findings from Genzyme’s earlier Phase 2 study of a solid oral dosage formulation of tolevamer that met its primary endpoint of non-inferiority compared to vancomycin.

Consistent with recent published studies, high rates of CDAD recurrences were observed in patients treated with either vancomycin or metronidazole. High CDAD recurrence rates were not observed in patients treated with tolevamer liquid. Tolevamer liquid was generally well tolerated with no unanticipated safety concerns. Data from this first Phase 3 study is expected to be presented at a future medical conference.

“These are disappointing results that alter our expectations about the potential for commercializing tolevamer in the near future,” stated Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. “The results of our second Phase 3 study will be available later this year and will help us determine what contribution tolevamer might be able to make in addressing this serious unmet medical need.”

C. difficile has become one of the most significant infection control concerns in healthcare today. Physicians worldwide are confronting a worsening epidemic, with an alarming rise in the incidence of disease, higher numbers of patients with complications and more frequent failures of standard antibiotic therapy.

Tolevamer is designed to bind and neutralize the toxins released by C. difficile that damage the intestine. A non-antibiotic approach has the potential to treat CDAD and reduce the number of disease recurrences, resulting in improved quality of life for the patient and significant savings to the healthcare system.

About the PACT Study

The PACT study, which involved more than 1,100 patients at approximately 300 sites in North America, Europe, and Australia, is the largest of its kind ever to be conducted for CDAD. In this trial, tolevamer was compared to metronidazole and vancomycin. Aside from testing tolevamer’s efficacy, this was also the first large, rigorously designed, multi-center clinical study that will compare the efficacy of the current standards of care.

About Clostridium difficile

C. difficile proliferates in the setting of altered normal colonic bacterial flora, most commonly due to the administration of broad-spectrum antibiotics. Once established in the colon, C. difficile produces toxins that disrupt the intestinal lining, causing cell death and inflammation that result in diarrhea and colitis.

Earlier studies have shown that even after successful treatment with the current standard of care, approximately 20 percent of patients experience a recurrence of CDAD potentially requiring repeat hospitalization. In addition, a subset of patients with CDAD develop multiple recurrences of the disease, with symptoms that may persist for years.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

This press release contains forward-looking statements, including statements regarding the potential for commercializing tolevamer in the future, when data from this Phase 3 study of tolevamer will be presented and when the results of the second Phase 3 study of tolevamer will be available. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the actual safety and efficacy of tolevamer; the outcome of discussions with regulatory authorities regarding clinical studies and the approval of tolevamer for CDAD and the timing of such discussions; additional analysis of the data from the first Phase 3 study; the results of the second Phase 3 study and whether such results are consistent with this data; the timing of the second Phase 3 study; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending March 31, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.

Press Release: Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data

Maureen Martino — Thu, 05 Jul 2007 12:08:09 -0400

Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea

LAINATE, Italy - July 4, 2007 - Cosmo Pharmaceuticals SpA (SWX:COPN) announced today positive preliminary results from its phase II/III study with CB-01-11 (Rifamycin SV MMX(tm)) in infectious diarrhoea. CB-01-11 is a broad spectrum, semi-synthetic antibiotic that is not absorbed when taken in tablet form. Through the use of Cosmo's MMX(tm) technology, which delivers the active ingredient into the colon, bacteria in the gastro intestinal tract that are important for vitamin synthesis are not sterilized. Given that it is practically not absorbed CB-01-11 is potentially applicable for the treatment of long term infections in the colon.

In the placebo controlled, randomized, double blind trial 120 patients in 8 sites in South Africa were treated with a 200mg tablet, 4 times per day for 3 days. The trial assessed non-inferiority versus Normix® (rifaximin) and the primary endpoint was the time from first ingestion of tablet to the last unformed stool. According to the preliminary reports CB-01-11 met this primary endpoint.

Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: "We are very encouraged about these preliminary results since many of the needs of patients are not adequately met with products currently on the market. Infections of the colon affect many more persons than colon inflammations and this is consequently a substantially larger market. We believe that our proprietary MMX(tm) technology will enable us to improve a range of products in colon infections and thus better meet patients' requirements."

Further analysis of the data is ongoing.

About Cosmo Pharmaceuticals

Cosmo is a speciality pharma company that aims to become a global leader in optimised therapies for certain gastrointestinal diseases. The company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections. Cosmo's first MMX(tm) product that has reached the market is LIALDA(tm) / MEZAVANT(tm), a treatment for IBD that is licensed globally to Giuliani and Shire Pharmaceuticals. Cosmo's proprietary MMX(tm) technology is at the core of the company's product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. For further information on Cosmo, please visit the Company's website: www.cosmopharmaceuticals.com

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

Cosmo shares buoyed by successful antibiotic data

Thu, 05 Jul 2007 00:01:36 -0400

Shares of Italy's Cosmo Pharmaceuticals were buoyed by news of positive preliminary data from a Phase II/III trial of Rifamycin for infectious diarrhea. The antibiotic hit its primary goal of the time from taking a dose to the last unformed stool. Analysts immediately leaped on the news, citing the likelihood that the company would soon take several strides forward on its development. Lehman Brothers pegged potential annual sales at $120 million.

"We believe these positive data could now enable the product to be partnered in Europe and filed in selected European countries," said Lehman Brothers. "In addition, Cosmo will now likely commence a Phase III study for U.S. regulatory filing."

- see the release
- here's the AFX report for more data

MicuRx gains $10M in financing

Mon, 25 Jun 2007 00:01:35 -0400

Union City, CA-based MicuRx Pharmaceuticals has closed a $10 million round of financing. The Morningside Group led the round of investment. MicuRx discovers and develops advanced antibacterial and antifungal drugs. "MicuRx has established a strong pipeline of research projects targeting optimization of validated antibiotic classes such as protein synthesis inhibitors," Mike Gordeev, Ph.D., executive vice president and chief scientific officer of MicuRx, said in a statement. "We are aggressively moving forward to implement our proprietary approach and expect to identify our first development candidates with significantly improved therapeutic potential on an accelerated timeline."

- see MicuRx's release for more on the financing

Basilea shares jump on antibiotic data

Tue, 09 Jan 2007 19:01:38 -0500

Shares of Switzerland's Basilea jumped to record heights after the drug developer announced positive results for a late-stage study of its experimental antibiotic, ceftobiprole. Overall, 91 percent of patients responded to the drug compared to 90 percent receiving a combinational therapy. About 86 percent of volunteers with a diabetic foot infection responded compared to 82 percent taking a comparative therapy. The cure rate for MRSA patients was 91 percent for ceftobiprole compared to 86 percent for a separate therapy. Analysts say that the drug has a good chance of quickly becoming a blockbuster therapy with more than a billion dollars in annual revenue. Antibiotics begin losing their effectiveness as soon as they're marketed and health officials are particularly concerned about the growth of MRSA and other superbugs.

- check out the press release
- here's the report on Basilea from MarketWatch

Related Articles:
Basilea gets fast track for antifungal drug. Report
MRSA-CA danger to healthcare workers. Report

SPOTLIGHT: FDA panel votes to restrict Ketek

Sun, 17 Dec 2006 19:01:33 -0500

An FDA advisory panel has voted to restrict the use of Sanofi-Aventis' controversial antibiotic Ketek. Panel members said that the risks outweighed the benefits of using Ketek against acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis. Report

ALSO NOTED: Elan, Biogen submit Tysabri for Crohn's; Affymax prices IPO;and much more...

Thu, 14 Dec 2006 19:01:30 -0500

> Shares of Elan and Biogen Idec were on the rise this morning after the two developers announced that they had submitted Tysabri as a therapy for Crohn's disease. Report

> Affymax priced its IPO of 3.7 million shares at $25 a share. Release

> Advancis Pharmaceutical has filed for FDA approval of its antibiotic, Amoxicillin Pulsys, 18 months after it was pummeled by investors following the drug's failure in clinical trials. The company's Pulsys technology provides patients with doses of therapy throughout the day. Advancis--which mounted a new trial for the therapy--wants the FDA to approve the antibiotic as a once daily therapy for strep throat, compared to the standard treatment of amoxicillin three times a day. An approval could come in October. Report

> Chutes & Ladders: Sanofi-Aventis has named research director Gerard Le Fur as its new CEO. Report

> The Committee for Medicinal Products for Human Use has reversed its stand on Tarceva and recommended Roche's therapy for metastatic pancreatic cancer in combination with gemcitabine chemotherapy. Report

> Lipoxen has agreed to license its PolyXen technology to Baxter International to boost the effectiveness of its hemophilia drug Factor 8. Lipoxen gains a million dollars up front and up to $75 million in milestones. The CEO of Lipoxen also said he expects to sign more of these drug pacts. Release | Report

> Merck has blueprinted a $100 million expansion of its North Carolina vaccine operation. Report

> Omrix has priced its offering of 2.25 million shares at $32 a share and expects to raise $44.4 million from the offering. Release

> Schering-Plough has reformed its corporate governance rules, ending the board's right to launch a poison pill defense against a hostile takeover and changing the way directors are elected. Report

> Canada's MethylGene announced that after reviewing its recent R&D successes in its small molecule oncology programs, it will not pursue additional clinical trials for MG98, its second generation antisense compound targeting DNA methyltransferase. Release

> Antisoma has raised £26.3 million in an offering. Report

> A University of Minnesota Cancer Center study has found that children who beat leukemia are living longer lives. Report

> Does the FDA do enough to regulate drug ads? The GAO doesn't think so. Report

And Finally… U.S. breast cancer rates plunged 15 percent from mid-2002 to the end of 2003, and experts believe that the sudden reversal in cancer rates could be attributed to the sudden drop in the use of hormone therapy for menopause. Article

Forest buys Cerexa in $480M deal

Wed, 13 Dec 2006 19:01:38 -0500

Forest Laboratories has joined the lineup of drug developers bidding their way to new prospects with its agreement to buy the antibiotic developer Cerexa for $480 million in cash. Forest gains development and marketing rights for three antibiotics, including one--ceftaroline acetate--which is poised to begin a late-stage trial for skin infections. It could be launched in 2010 or 2011. If its sales break the $500 million mark in any 12-month period after the five years it is launched, Cerexa's investors will get an additional $100 million payday.

"Ceftaroline is an important late-stage development product that can address serious and life-threatening infections in the hospital setting including MRSA," said Howard Solomon, chairman and CEO of Forest. Cerexa was a 2006 Fierce 15 company.

- see this release on the deal
- here's the AP report on the buyout

Related Articles:
Forest halts enrollment as researchers study safety signal. Report
Forest to pay Mylan $75M for nebivolol rights. Report
Cerexa raises $50M, plans Phase II trials. Report

ALSO NOTED: FDA staffers back Ketek; Abbott gains a majority of Kos shares; and much more...

Tue, 12 Dec 2006 19:01:30 -0500

> In advance of an FDA advisory committee meeting on the controversial antibiotic Ketek, agency staffers have concluded that the data on the Sanofi-Aventis therapy demonstrates that it is safe and effective. Report

> Abbott's cash tender offer has won a majority of Kos Pharmaceuticals' shares. Report

> Amgen plans to repurchase up to $5 billion of its stock. Release

> Biomira has arranged $13 million in financing. Release

> Athenagen has begun a Phase II clinical study of the company's lead compound, GTS-21, in patients with Alzheimer's disease. Release

> OncoMethylome Sciences has licensed its prostate cancer test to a subsidiary of Johnson & Johnson. Report

> Eden Bioscience has received a delisting notification from Nasdaq. Report

And Finally… A new study says that a sleep apnea therapy also improves memory. Release

FDA's showdown with Grassley to delay nomination

Thu, 30 Nov 2006 19:01:35 -0500

Acting FDA commissioner Andrew von Eschenbach is refusing to turn over information on the antibiotic Ketek to Senator Charles Grassley. According to von Eschenbach, giving the senator everything he asked for would make it difficult for the agency to conduct independent investigations. From Grassley's perspective, the FDA is not being compliant with a subpoena. It all adds up to a further delay for von Eschenbach's nomination, which is now being blocked by Grassley, a powerful Republican senator who has often been harshly critical of drug companies as well as the FDA.

- read the Washington Post report on the showdown

Related Articles:
Senator makes dramatic demand in Ketek probe. Report
Two Senators block von Eschenbach. Report
FDA safety official called for halt to Ketek trial. Report

Pfizer, Teva settle lawsuits

Tue, 21 Nov 2006 19:01:36 -0500

Pfizer and generic drug giant Teva Pharmaceuticals have come to an agreement over three drugs, ending two lawsuits over Pfizer's cancer drug Idamycin and antibiotic Zithromax. "Under the settlement, Teva will pay Pfizer $70 million and agrees not to contest the validity of the respective drug's patents. Teva will be able to continue selling its generic version of Idamycin and Zithromax." Teva also gains the right to manufacture and market a generic version of another Pfizer cancer drug, Ellence.

- read this Ynetnews article for more on the settlement
- check out Teva's press release on the agreement

ALSO NOTED: Wall Street waits on new Pfizer CEO; HGS touts Phase II hep C trial; and much more...

Sun, 15 Oct 2006 20:01:30 -0400

> Wall Street is waiting to see how Jeff Kindler, the new CEO at Pfizer, will handle his role on Thursday as he announces the company's third quarter performance. Analysts want some idea of what new directions he has in mind for Pfizer. Report (WSJ sub. req.)

> Omrix Biopharmaceuticals says that its Phase III non-inferiority study of human thrombin compared to bovine thrombin met its primary endpoints. Both thrombins had similar results in stemming bleeding. Report

> Human Genome Sciences is touting positive data from Phase IIb trials of Albuferon for hepatitis C. Report

> Germany's Evotec will collaborate with Japan's Daiichi for medicinal chemistry and compound profiling. Report

> A Chinese antibiotic maker had its license revoked after an antibiotic it makes was blamed for the death of six people and multiple injuries. Report

> Cambridge Antibody Technology and The Debiopharm Group have entered into an exclusive worldwide licensing agreement to develop and commercialize SC-1. SC-1 is a fully human monoclonal IgM antibody SC-1 that targets CD55SC-1, a cell surface receptor that is specifically expressed on gastric carcinoma cells. Release

> J&J has won a round in federal court in its patent fight against a generic version of Risperdal. A judge has ordered that sales of the generic be held up to the end of 2007. Report

> Hana Biosciences has acquired the rights to develop Menadione, a preclinical therapy intended to prevent skin rash associated with epidermal growth factor receptor inhibitors in certain cancer treatments. Report

> Vical is selling $12.5 million in stock to fund operations. Report

> India's Wanbury will buy the generic drug business of Spain's industrial Farmaceutica Cantabria. Report

And Finally… The U.S. government is creating a new cord blood bank to provide life-saving stem cells needed for therapies. Cord blood contains the same stem cells as bone marrow, but doesn't need the same kind of genetic match to be effective in patients. Article

Schering-Plough pulls its garenoxacin app

Sun, 20 Aug 2006 20:01:36 -0400

Schering-Plough has withdrawn its application to the FDA for approval of the antibiotic garenoxacin, a drug that was developed by Japan's Toyama. Toyama announced the move, which will take a bite out of its projected earnings. Toyama had expected the agency to approve the antibiotic, clearing the way for the Japanese drug developer to start earning revenue on U.S. sales. Schering-Plough dropped the application because it did not have a sub-licensee for the U.S. market, officials said. But Toyama also added that Schering-Plough plans to file again. In order to make up for the lost revenue, Toyama now plans to accelerate licensing talks for the experimental Alzheimer's drug T-817MA, T-5224 for rheumatoid arthritis and the antiviral agent T-705.

- see the report on garenoxacin from Asia News

Advancis' new antibiotic formulation hits endpoints

Thu, 10 Aug 2006 20:01:39 -0400

A year after undergoing a painful restructuring, Advancis Pharmaceutical announced that its once-daily formulation of the antibiotic amoxicillin--its lead product--met its primary endpoints in a Phase III trial. The news led to a sharp jump in the company's stock price, which was pummeled a year ago after executives announced that its trial on the new formulation had failed to achieve its endpoints. After laying off half of its staff, Advancis went back to the drawing board and mounted a new trial, changing the treatment period from seven days to 10. The data indicates that the once-daily formulation is not inferior to penicillin and is 85 percent effective in treating strep throat. Advancis now will tackle of market that saw 59 million prescriptions for Amoxicillin Pulsys last year, earning $640 million. Advancis now plans to begin hiring up staffers to handle the launch.

"If approved for marketing, we believe our once-daily version of amoxicillin would represent a major advance in the most widely used antibiotic in the U.S. and would be the first and only once-daily amoxicillin therapy approved for marketing in the United States," said Edward Rudnic, president and CEO of Advancis.

- here's the report on Advancis from The Washington Post