skin infections

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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AstraZeneca to invest $100M in R&D site

Sun, 21 Jan 2007 19:01:37 -0500

AstraZeneca is pumping $100 million into its research center in Waltham, MA to boost its R&D efforts for infectious diseases and cancer research. Construction on a 132,000-square-foot facility will begin soon and the facility will open in mid-2009. The expansion will allow AstraZeneca to add 100 more researchers to the 400 it already employs at the research complex.

Since the opening of AstraZeneca R&D Boston, scientists there have discovered three potential drugs that are under development to treat different cancers including breast, ovarian, thyroid and prostate cancer, and two novel-class candidate drugs to potentially treat serious skin infections, serious cases of chronic bronchitis and serious pneumonias. The new development work marks another significant win for the biotech hub in the Boston area, which continues to attract new investment even as public support lags behind other areas in the country.

- see the release for more information

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Press Release: Basilea Announces Positive Top-line Results on Second Pivotal Phase III Ceftobiprole Trial

Maureen Martino — Wed, 10 Jan 2007 12:08:41 -0500

Basilea Announces Positive Top-line Results on Second Pivotal Phase III Ceftobiprole Trial

Basel, Switzerland, January 10, 2007

Basilea Pharmaceutica Ltd. announced today that the second pivotal ceftobiprole phase III study in complicated skin infections met its primary endpoint of statistical non-inferiority versus combination therapy. Ceftobiprole demonstrated high cure rates in patients with complicated Gram-positive as well as Gram-negative skin infections, including diabetic patients with foot infections. A first regulatory submission is planned this year. Ceftobiprole is an anti-MRSA, broad-spectrum cephalosporin developed in collaboration with Cilag GmbH International, a Johnson & Johnson company.

“Complicated skin infections require rapid medical intervention, typically before the causative pathogens are identified. The potent anti-MRSA activity of ceftobiprole, combined with its broad-spectrum activity, provided broad coverage of the clinically relevant pathogens in this important clinical setting. In particular, ceftobiprole, as a single agent, was clearly as effective as a combination regimen of standard broad-spectrum therapy in patients with difficult-to-treat diabetic foot infections,” commented Dr. Rienk Pypstra, Chief Development Officer of Basilea.

This second pivotal double-blind study (STRAUSS II - study of resistant Staphylococcus aureus in complicated skin and skin structure infections) treated 828 patients with either ceftobiprole or the combination of ceftazidime plus vancomycin in a 2:1 randomization. Almost one third of patients had diabetic foot infections of which three quarters were moderate to severe cases.

Ninety-one percent of clinically evaluable patients were cured with ceftobiprole compared to 90% of patients treated with combination therapy. The clinical response in patients with diabetic foot infections was 86% for ceftobiprole and 82% for comparator combination therapy, respectively. Over twenty percent of microbiologically evaluable patients had confirmed methicillin-resistant Staphylococcus aureus (MRSA) infections. The clinical cure rate for ceftobiprole in MRSA patients was 91% compared to 86% for the comparator regimen. One third of patients had infections involving a Gram-negative pathogen. The microbiologic eradication rates in these patients were similar at 84% in both treatment groups. Ceftobiprole was well tolerated. Adverse events were comparable between the two treatment groups.

“These are very strong clinical data. These results show that ceftobiprole monotherapy is non-inferior to standard combination therapy. Ceftobiprole has FDA fast track designation. With two positive phase III trials in complicated skin infections, we plan the first regulatory filing for ceftobiprole this year. We have reached another major milestone on the route to commercialization of ceftobiprole with our partner Cilag GmbH International. We are now closer to providing physicians with a new therapeutic option to treat patients with complicated bacterial skin infections,” said Dr. Anthony Man, Basilea’s CEO.

Products About Complicated Skin Infections

Complicated skin and skin structure infections (cSSSIs) are among the most common infections in the hospital setting. Staphylococcus aureus is the predominant pathogen in skin infections. In recent years resistant strains (MRSA) have become increasingly common and have been associated with increased morbidity and mortality.

Patients with chronic wounds or those who have recently received antibiotics, may also be infected by Gram-negative pathogens. This is frequently the case for diabetic patients with foot infections. Adequate treatment of diabetic foot infections requires hospitalization, surgery and broad-spectrum intravenous antibiotics.

About Ceftobiprole

Ceftobiprole is an anti-MRSA, broad-spectrum cephalosporin that has demonstrated positive results in two phase III trials in complicated skin and skin structure infections. Ceftobiprole has shown a low potential to select for resistance in vitro and exhibits in vitro activity against a wide spectrum of bacteria that cause many hospital and community-acquired infections including those due to resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). Ceftobiprole has received fast track status from the FDA and is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International, a Johnson & Johnson affiliate.

About Basilea

Basilea Pharmaceutica Ltd. is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange (SWX:BSLN). Basilea’s fully integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs. Basilea’s products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. The company owns a diversified product portfolio including three products in phase III clinical development for severe medical indications. Basilea is building a sustainable hospital and specialty biopharmaceutical business. The company is integrating commercialization into its organization, in a first step through co-promoting ceftobiprole in North America and major European countries.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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

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FDA rejects Replidyne's antibiotic

Sun, 22 Oct 2006 20:01:38 -0400

The FDA has issued Replidyne and partner Forest Labs a non-approvable letter for faropenem medoxomil, an antibiotic for acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis and adult skin infections. The FDA called for further trials of the drug, despite the fact that researchers went to the NDA with data from 11 Phase III trials involving 5,000 patients. Replidyne says that it has apparently fallen victim to the FDA's recent preference that drug developers prove that their antibiotics are superior to standard care, not just placebos. They estimate that the additional trials will take two years to complete. No safety concerns were raised by the FDA.

"Based on the filing packages we included in our NDA submission, particularly for ABS and CAP, we are disappointed that the FDA is requiring additional clinical trials," said Kenneth J. Collins, President and CEO of Replidyne in a release. "However, we believe that at the doses studied faropenem has a clearly demonstrated favorable safety profile. Replidyne is in a strong financial position to continue the development of faropenem with our partner Forest and to advance our promising pipeline." As you might recall, Replidyne was chosen as a 2006 Fierce 15 company.

- see this press release from Replidyne
- read the Houston Chronicle report

Related Article:
Replidyne files for $100M IPO. Report

Theravance declares success in antibiotic trial

Tue, 22 Aug 2006 20:01:39 -0400

Theravance shares were on the decline this morning despite some upbeat news from its pivotal trial on the antibiotic telavancin. Studies involving more than 1,800 volunteers demonstrated that the injectable antibiotic for skin infections is just as effective as vancomycin while demonstrating greater bacteria death (telavancin 89.9 percent versus vancomycin 85.4 percent) and cure rates (telavancin 90.6 percent versus vancomycin 86.4 percent). "With the data from this program, telavancin has the opportunity to become an important new medicine for the treatment of serious Gram-positive infections," said Rick E. Winningham, CEO of the South San Francisco-based Theravance.

"With the incidence of methicillin-resistant Staphylococcus aureus infections on the rise, it is imperative that clinicians have effective alternatives in the treatment of these difficult infections," said Dr. Sef Kurstjens, head of research and development at Astellas Pharma, which has signed on as a marketing partner for the drug.

- read the report on the trial data from TheStreet.com

Replidyne files for $100M IPO

Wed, 05 Apr 2006 20:01:37 -0400

Replidyne has filed for a $100 million IPO. The Louisville, CO biotech company has been backed by George Soros' venture group. Replidyne hit an important milestone when the company filed an NDA for its new antibiotic last December. The FDA accepted it in February. Replidyne is looking for FDA approval for faropenem medoxomil as a therapy for acute bacterial sinusitis, community-acquired pneumonia, chronic bronchitis and adult skin infections. Researchers went to the FDA with data from 11 Phase III trials involving 5,000 patients.

- read the release on the IPO

Theravance, Astellas ink $65M deal

Mon, 07 Nov 2005 19:01:37 -0500

Theravance and Astellas Pharma have signed a deal to develop and market Theravance's antibiotic telavancin, an drug currently in phase III trials for skin infections and Hospital-Acquired Pneumonia (HAP). Astellas will make an initial payment of $65 million and will also pay Theravance up to $156 million in clinical and regulatory milestones. If the drug is approved, Theravance will receive royalties on global sales of the antibiotic.

- read this press release for more details on the deal

ALSO NOTED: Canada drafting bulk drug rules; Topamax approved for new indication; Schering-Plough wins FDA OK; Neurochem NDA un

Wed, 29 Jun 2005 20:00:50 -0400

> As expected, Canadian health officials say they have begun to draft new regulations that would stop bulk drug shipments going south. But the move is unlikely to threaten the online pharmacies currently in operation. Article

> The FDA has approved Johnson & Johnson's Topamax as an initial monotherapy for epilepsy. Release

> The FDA has approved Schering-Plough's Avelox for certain skin infections. Release

> The FDA has agreed to review Neurochem's NDA for Fibrillex, an investigational product candidate for the treatment of Amyloid A (AA) Amyloidosis. Release

> The FDA has accepted two BLAs from Merck for two of its investigational vaccines: Rotateq and Zostavax. Release

> The first Vioxx trial is set to start in less than two weeks in Texas. Story

> The FDA has sent Endo Pharmaceuticals a warning letter over its Lidoderm direct mail pieces. Release

And Finally... Canada's MDS has agreed to refund up to 2 million claims for work that was either covered or already paid by insurers. Article

Cubist seeks expanded label for Cubicin

Mon, 27 Jun 2005 20:01:38 -0400

Touting a late-stage trial that highlights the effectiveness of Cubicin in reducing heart valve and blood infections caused by Staph bacteria, Cubist Pharmaceuticals says it will ask the FDA for an accelerated review to expand its use. Cubicin is currently approved to prevent skin infections caused by Staph bacteria.

- read this article from the AP for more

ALSO NOTED: FDA rejects Risperdal for Alzheimer's; Elan CEO bullish on Tysabri's return; Myogen, Novartis expand pact; and much

Wed, 25 May 2005 20:00:50 -0400

> Johnson & Johnson says the FDA has turned thumb's down on Risperdal as a treatment of psychosis in Alzheimer's. Release

> Elan CEO Kelly Martin told reporters that the return of the company's MS drug Tysabri is a question of when "and not a question of if." Article

> Myogen and Novartis are expanding their drug pact to include another heart disease therapy. Story

> Metric: Within months of receiving prescriptions for drugs to lower high blood pressure and reduce cholesterol, large numbers of patients stop taking the pharmaceuticals as prescribed. Article

> The FDA has approved AstraZeneca's Merrem for skin infections. Release

> GlaxoSmithKline Pharmaceuticals and Japan's Eisai have struck a deal to market Eisai's ulcer drug in India. Story

> India's Alchemist has bought Delhi-based Valiant Healthcare for 45 million rupees. Alchemist is also planning to build a drug-making plant in Uttaranchal. Story

> Toronto's Generex Biotechnology has been allowed additional time to meet Nasdaq's listing requirements. Release

And Finally... Sen. Arlen Specter (R-Penn.) says he has enough votes in the Senate to override a presidential veto on stem cell legislation. Story