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For the past several days, the rumor mill has been rampant with suggestions that UK-based Shire may acquire Cubist, a publicly traded Massachusetts-based biotechnology company that sells Cubicin, an antibiotic indicated for the treatment of certain infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Rumor has it that Shire approached Cubist about a month ago with a $44.5-a-share proposal ($2.0 billion) and the pair have been in talks about a deal ever since. Last week, Shire announced that it had entered into a deal to acquire private-held Advanced BioHealing for $750 million. Connecticut-based Advanced BioHealing markets and develops products to enhance wound healing and treat diabetic foot infections in patients with diabetes. Shire’s acquisition of both companies would provide it with a substantial US presence in the antibacterial treatment and diabetes markets.

While Cubist may be a good “fit” for Shire, it is not clear whether or not the company will prevail in its takeover bid. Last month, Cubist settled a patent dispute Teva Pharmaceuticals over Cubicin, which lessened the threat of generic competition by the Israeli drug maker. This sparked speculation among a number of Wall Street analysts that other pharmaceutical companies including AstraZeneca and Johnson & Johnson who are themselves facing generic competition, may consider acquiring Cubist in an attempt to add new antibiotics to their antibacterial portfolios. 

This is not the first time that analysts have speculated that Cubicin may be ripe for acquisition. Almost two years ago, word-on-the-street had it that Novartis may acquire the company. Nevertheless, Cubist is one of the few remaining publicly-traded biotechnology companies that specialize in new antibacterial drug discovery. Its potential acquisition by a big pharma company may signal the end of innovative drug discovery in the antibiotics discovery space. Here’s hoping that Cubist remains independent!

Until next time...

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

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The loss of patent protection and a decline in revenues for a number of blockbuster brand name antibiotics has caused many big pharmaceutical companies to exit the antibacterial drug discovery market. The three remaining big pharma companies still actively engaged in antibacterial research are GlaxoSmithKline, AstraZeneca and Novartis (all European owned companies).

A new report by UK-based Datamonitor entitled “Forecast Insight: Antibacterials” predicts that antibiotic sales revenues will decline from $19.6 billion in 2009 to about $16.4 billion in 2019. Not surprisingly, the report blames the projected decline on generic competition and the lack of new antibiotic launches over the past 10 years.

At present, the top seven antibiotic markets in the world include the US, Japan, France, Germany, Italy, Spain and the UK. According to Datamonitor’s analyses, total sales in these markets have fallen by about 1.6 percent annually since 2005 and will continue to decline by almost 2.0 percent a year through 2019. In 2009, three antibiotics had sales of about or more than $1.0 billion; Johnson & Johnson’s Levaquin (market leader), and Pfizer’s Zosyn, and Zyvox. Interestingly, Pfizer recently decided to shut down its US-based antibacterial drug discovery program and move it to China and Johnson & Johnson recently announced that it was getting out of the antibiotic discovery business. 

Big pharma’s decision to abandon antibiotic research could not have come at a worse time. The incidence of antibiotic resistance among both Gram positive and Gram negative bacteria is rising at unprecedented rates. And while safe and effective treatments for Gram positive infections including MRSA (methicillin-resistant Staphylococcus aureus) still exist, the number of treatment options to treat Gram negative infections caused by Acinetobacter spp, Pseudomonas aeruginosa and enteric bacteria is severely limited. The recent description and rapid spread of a beta-lactamase enzyme called NDM-1 that inactivates the antibiotic carbapenem—the last safe and effective antibiotic to universally treat infections caused by Gram negative bacteria —is extremely troubling and worrisome.

While much of the focus over the last decade was on MRSA, infections caused by untreatable, multiple drug resistant Gram negative bacteria will pose the greatest public health threat over the next 10 years. Unfortunately, it is much harder to develop new antibiotic treatments for Gram negative infections as compared with ones caused by Gram positive bacteria. Further, at present, most of the companies that remain in the antibiotic space continue to focus on new treatment for MRSA and related bacteria. Consequently, new treatments for Gram negative infections may be more than a decade away!

Finally, like MRSA, most infections caused by multiple drug resistant Gram negative bacteria are nosocomial in nature (although the incidence of community acquired infections is also on the rise). This means that the most likely place to become infected with these bacteria is institutionalized healthcare settings including hospitals and nursing homes.

In the past, we have relied on pharmaceutical and biotechnology companies to discover new antibiotic treatments. The decision of many of these companies to leave the antibacterial space for purely financial reasons is unfortunate and regrettable. However, the growing incidence of antibiotic resistance among both Gram positive and Gram negative bacteria suggests that new antibiotics are necessary and that alternate approaches to new antibiotic drug discovery must be implemented. Whether this is through public/private partnerships or strictly through government programs is irrelevant. The bottom line is that we need new antibiotics; and if they are not discovered soon, many patients will die from previously treatable bacterial infections!

Until next time...

Good Luck and Good Job Hunting (start an antibiotic drug discovery company)

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When I saw one of today’s headlines, ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ I immediately dropped what I was doing to read the article. Expecting the worse, I learned that the US Food and Drug Administration (FDA) announced today that it was modifying the label for Pfizer’s antibiotic called Tygacil.

The reason for the label changes was new clinical information that showed that patients with ventilator-associated pneumonia (VAP) and diabetic food infections that are treated with Tygacil are at increased risk of death as compared with those treated with other antibiotic treatments.

"The FDA said it looked at 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection comparing the overall mortality for Tygacil with other antibiotics. Overall, the studies showed death occurred in 4% of patients receiving Tygacil, or 150 out of 3788, and 3% of patients, or 110 of 3646, receiving comparator antibiotics."

While I didn’t find the difference in the mortality rates that shocking, it is important to point out that Tygacil is not an FDA-approved treatment for either VAP or diabetic foot infections. Nevertheless, the antibiotic is routinely used by many infectious diseases physicians as a treatment for both infections. This is because many VAP and diabetic foot infections are caused my multiple drug resistant bacteria and physicians are willing to resort to unapproved treatments (like Tygacil) to treat high risk patients. Put simply, there is generally little choice; either use Tygacil or the patient may die! 

Further, the 1% difference in mortality rates between Tygacil and other antibiotics may not be clinically significant because many of the treated patients are seriously ill and near death anyway. Finally, differences in the mortality were based on retrospective results from clinical studies that were designed to assess the safety and efficacy of Tygacil for indications other than VAP or diabetic foot infections. Consequently, it is difficult to conclusively say whether or not Tygacil is less safe than other antibiotics to treat patients with severe bacterial infections like VAP and diabetic foot.

Nevertheless, Tygacil's label has already been updated to warn doctors about the possible death risk. Pfizer sent a letter dated July 26 to health care professionals detailing the new label. The label change is listed below:

"Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:"

The bottom line: the jury is still out on the safety and efficacy of Tygacil as a treatment for VAP and diabetic foot infections. This can only be determined when well controlled, statistically-relevant clinical trials are designed and conducted. While FDA was correct to insist that Pfizer send a note to infectious diseases physicians alerting them of possible increased risks, I don’t think that the label change was newsworthy enough to earn the headline ‘FDA Warns on Increased Death Risk with Pfizer Antibiotic’ It is a shame that journalists continue to insist on publishing sensationalistic and often times inaccurate scientific headlines. While it may garner some additional readers, it does little to instill American confidence in our public health system.

Until next time...

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

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Let me say at the outset of this post that I have a PhD in Bacteriology and admittedly less than objective when it comes to the topic of microbiology education and improving the public understanding of science. However, in today’s New York Times Science Times section there were no fewer than five articles that required some knowledge of microbiology to understand the implications about what was written.

1. Vaccination is Steady, but Pertussis is Surging
2. Really? The Claim: More Sugar Leads to More Cavities
3. Steep Drop Seen in Circumcisions in the U.S.
4. Patterns: Medicare Coverage Drives Antibiotic Use
5. Vital Signs: Nipple Piercings Add to Risk of Abscesses

While it doesn’t require a PhD to decipher the information in this article a basic understanding of microbiology would allow readers to understand the significance and future implications of the material that was presented. For example, in the article about nipple piercings; anybody who has taken an introductory microbiology class knows that bacteria like Staphylococcus aureus and Streptococcus pyogenes can cause pus-laden infections and if left untreated can result in potentially life-threatening abscess formation. Sugar and cavities? Microbiology 101 students all know that bacteria like S. mutans (that live in everyone’s mouths) ferment sugars and produce lactic acid that degrades tooth enamel and can cause cavities. And, most entry level microbiology students understand that the overuse of conventional antibiotics is largely responsible for the emergence of multiple drug resistant bacteria like multiple drug resistant S. aureus MRSA) and vancomycin resistant enterococci (VRE).

The point that I am trying to make is that bacteria are all around us; some do good things like fix nitrogen to improve crop yields and produce oxygen during photosynthesis while others cause devastating acute and chronic infections. Nevertheless, the lay public is largely ignorant about the microbes on and around them. Most of my friends, many of whom have advanced degrees in their fields, don’t know the difference between a virus and a bacterium and believe that it is okay to treat a cold with antibiotics! How can people modify their behaviors to effectuate change to improve their lives if they lack a rudimentary understanding of the factors responsible for conditions that afflict them?

Don’t get me wrong—we don’t need more PhD microbiologists. However, requiring all high school biology students and maybe biology degree students to have a firm understanding of the fundamental principles of microbiology would be a great start toward improving the lives of many Americans!

Until next time...

Good Luck and Good Job Hunting!!!!

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As I noted in a post a couple of days ago, the media frenzy surrounding the identification of a new beta lactamase and erythromycin inactivating enzyme in strains of Klebsiella pneumoniae and Escherichia coli was neither noteworthy nor anything to get all worked up about. For whatever reason, the media reported results of an almost year old research study. If the results of this study had serious public health implications why did it take media outlets so long to report it to the lay public? I suspect that the report was a cleverly crafted promotional campaign underwritten by pharmaceutical companies that are trying to boost sales of their antibiotics. To that end, the Pharmalot Blog reported yesterday about potential conflicts of interests for several of the study’s authors.

According to the Pharmalot post, “The study in The Lancet was funded by the European Union, as well as Wyeth and the Wellcome Trust charity, both of which are involved in producing antibiotics for treating such cases, CNN-IBN reports. Karthikeyan Kumaraswamy, the scientist who headed the study, received a travel grant from Wyeth. And David Livermore, another co-author, received conference support from numerous drugmakers and also holds stock in AstraZeneca, Merck, Pfizer and GlaxoSmithKline, the report continues.”

These revelations caused spokespersons from the Indian government to issue the following statement:

“This news has created a misconception and a feeling that the point of origin of the bacteria is in India. We have got the matter examined. We have come to a conclusion that this is not the right statement. After seeing the research paper, I strongly refute that hospitals in India are the source of the strain and strongly condemn naming the bacteria after New Delhi,” Director General of Health Services RK Srivastav tells CNN-IBN. “Intellectual scientific freedom is all very good but there is a conflict of interest in this research. Researchers like these are examined separately according to the code of ethics.”

Back in the day, it was commonplace to assign the city or country of origin to bacterial isolates. And, I see no reason why this should not continue. While I disagree with the Indian government’s claim that the NDM-1 strain designation will interfere with tourism in that country, I still contend that elevation of the study results to the international stage was premature and largely irresponsible. The fact that several of the study’s co-authors were or are funded by pharmaceutical companies and own stock in these companies suggest that the media frenzy may have been “stoked” for personal and corporate gains.

Hat tip to Ed at Pharmalot!

Until next time...

Good Luck and Good Job Hunting (try clinical microbiology)

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I read a post today on Yahoo News entitled “Warning on New Superbugs from S. Asia.” While I initially thought that this article may contain some important news on the real and growing of multiple drug resistant bacterial pathogens, I sadly learned that it was nothing more than an sensationalistic attempt to promote the discovery of a new metallo-beta-lactamase gene bla(NDM-1) in an Indian isolate of Klebsiella pneumoniae, a Gram negative bacterium. The work was performed by a group at Cardiff University in Wales and published almost a year ago in the journal Antimicrobial Agents and Chemotherapy.

There is no question that morbidity and mortality from Gram negative infections is rising and will certainly continue to increase in the future. This is because most of the work in antibacterial drug discovery in the last decade was focused on Gram positive bacteria including methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE). Although new antibiotics have reached the market for these organisms, they are used judiciously, and mainly as a last resort, because of fears of emerging resistance to them among Gram positive clinical isolates. Unfortunately, developing new antibiotics against Gram negative pathogens as compared with Gram positive bacteria is much more difficult. To that end, no antibiotics of note have been discovered in recent years to treat multiple drug resistant strains of Gram negative bacteria. 

While identification of the bla (NDM-1) gene may be scientifically and biologically interesting, it will likely have little effect on the clinical treatment of Gram negative infections. This is because many Gram negative isolates are already resistant to most beta-lactam antibiotics and consequently these antibiotics are used only sparingly to treat many Gram negative infections. Regardless of the implications of the discovery of the NDM-1, what I find most troubling about the article is its title. It leads uninformed persons to believe that the world is in grave danger and that a pandemic of multiple drug resistant strains of Gram negative bacteria may be imminent.  While infections caused by multiple drug resistance strains of Gram negative bacteria are clearly on the rise, strains carrying the NDM-1 gene will not decimate the world population any time soon! In fact, the authors suggest that these strains may cause some problems in India which “already has high levels of antibiotic resistance.”

There is no doubt that informing people about the growing incidence of multiple drug resistant bacteria is a good thing. Maybe, if enough people get frightened they may be able to induce big pharmaceutical companies—many of which abandoned antibiotic drug discovery and development in the late 90s—to reinvigorate their programs. That said, it is not clear why this story got elevated to a lead story on Yahoo News since the discovery was made almost a year ago—maybe today is a slow news day? Nevertheless, the impending doom and sensationalistic tone of the article suggests that reporters who cover the life sciences need some training in microbiology. This is necessary to insure that the stories that they write about antibiotics are kept in the appropriate context and historical perspective. That said, don’t be surprised today if the sales of antibacterial products increase and the stock prices of biotechnology companies involved in antibacterial drug discovery and development spike!

Until next time...

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

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For the past decade or more multiple drug resistant strains of bacteria such as methicillin resistant Staphylococcus aureus (MRSA), enterococci and other Gram positive cocci have been highlighted and showcased in the medical and lay press. While the incidence of infections caused by MRSA and other Gram positive cocci has steadily risen, antibacterial drug discovery experts have long known that the greatest disease threat in the future will be from emerging multiple antibiotic resistant strains of Gram negative bacteria including Acinetobacter baumannii, Klebsiella pneumoniae, Serratia marcescens and Pseudomonas aeruginosa.

Last Spring, in an interview that I conducted with Barry Eisenstein, MD, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals and an antibacterial drug discovery expert, he indicated that there are currently no drugs in development to treat infections caused by antibiotic resistant Gram negative bacteria. He warned that this, coupled with the loss of interest in antibiotic development by large pharmaceutical companies, will cause infections caused by multiple drug resistant Gram negative bacteria to become a serious unmet medical need in the not so distant future. The appearance of an article in the New York Times this past Saturday chronicling the rise of infections caused by antibiotic resistant Gram negative bacterial suggests that the not so distant future may have already arrived! For the record: would newspaper and television reporters please refrain from identifying bacteria as “germs.” It is an anachronistic term which was coined in the 19^th century before bacteria and viruses were conclusively identified as the cause of most infectious diseases.

Despite the media hype about antibiotic resistant Gram positive bacteria, a variety of new drugs have been developed to treat infections caused by these bacteria. Interestingly, because of greater public awareness about MRSA infections and improved hospital infection control and surveillance programs, the incidence of disease caused by MRSA and other Gram positive bacteria is finally beginning to wane. Unfortunately, the same is not true for infections caused by antibiotic resistance Gram negative bacteria.

For those of you who may not know, the cell wall architecture of Gram negative bacteria (and a multitude of antibiotic resistance mechanisms) makes it much more difficult and costly to develop new antibiotics to treat Gram negative infections. Consequently, research in this area has been largely ignored for the past 15 years or so. This means that in the future the morbidity and mortality associated with infections caused by antibiotic resistant Gram negative bacteria is certain to rise. With this in mind, persons at the greatest risk of developing these infections include patients in hospitals and long term care facilities and individuals receiving implantable medical devices.

Because most large pharmaceutical companies abandoned antibiotic drug discovery in the mid to late 1990s, it is unlikely that new Gram negative antibiotics will come from the pharmaceutical sector. While there are several small biopharmaceutical start ups working on antibiotics for Gram negative bacteria (KaloBios Pharmaceuticals, Calixa Therapeutics and Novexel) the increasing regulatory scrutiny and rising development costs suggests that these companies may have trouble bringing new antibiotics to market. Sadly, this places the onus of new Gram negative antibiotic discovery squarely on the shoulders of the US government. To that end, as much as it pains me to say this, it will likely take the death of government official or family member before sufficient resources are allocated to address this rapidly growing unmet medical need. Maybe the Obama Administration ought to think about allocating stimulus monies to begin to address the problem!

Until next time...

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

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Theravance Inc. announced Thursday US Food and Drug Administration (FDA) regulators are not satisfied with new data on its infection drug candidate telavancin (Vibativ), and indicated that further clinical studies may be required to win marketing approval.

Approval of Vibativ has been held up for three years, as the Food and Drug Administration asked the company for more data about the drug, and about studies Theravance has conducted in support of its application to the FDA. Theravance said Thursday the FDA told it the data so far is not enough to prove Vibativ works.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA). Theravance submitted an NDA to FDA for review in December 2006.

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Company representative said that they do not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required ( I guess it may be time for a meeting to discuss these issues?).

In response to the FDA’s previous requests for more data on telavancin, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

While getting new antibiotics are the market are important, clinical studies must be carefully designed with appropriate endpoint to address potential safety and efficacy issues. Although Theravance believes that it has done that, the agency, as always, will be the final arbiter of a decision on telavancin.

Until next time...

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

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For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with Steve Projan— a well known and highly respect maven on bacterial antibiotic resistance—who told me that the physician story was an urban legend and that the main reason for the emergence of antibiotic resistance was directly related to the use of antibiotics as growth enhancers in livestock feed. Not surprisingly, shortly after my conversations with Dr. Projan, papers began appearing in the literature that corroborated the claims.

Despite a growing body of convincing scientific evidence, the Bush administration did nothing to regulate or reduce the use of antibiotics in live stocks feeds in the US for almost a decade. Last year it is estimated that 35 million pounds of antibiotics were used in the US. Interestingly, 70% were used in cows, chickens and pigs. It is important to point out that the US isn’t the only culprit; recent estimates suggest that 50% of the global antibiotic supply is used by the livestock industry. Recognizing a growing problem, the European Union and other developed countries (not the US) have adopted strong limits on the use of antibiotics for livestock purposes.

Thankfully, the pressure against the use of antibiotics in agriculture and livestock production is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health — the Food and Drug Administration (FDA), CDC and U.S. Department of Agriculture — declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And, this past summer, FDA deputy commissioner Dr. Joshua Sharfstein told Congress that farmers need to stop feeding antibiotics to healthy farm animals.

Pharmaceutical companies and agricultural lobbyists argue that antibiotics keep animals healthy and meat costs low, and have successfully help to defeat a series of proposed limits on their use. To that end, in 2009, drug makers spent $135 million and agribusiness companies another $70 million, lobbying against new limits on the use of antibiotics as livestock growth enhancers. FDA official say that without new laws the agency’s options are fairly limited. Ironically, the agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. And, the only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

Previous attempts by FDA to limit antibiotic usage have consistently met with limited success. For example, in 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups. In 2000 FDA ordered the antibiotic Baytril (used in the poultry industry) off the market. Five years later, after a series of failed judicial appeals, poultry farmers finally stopped using the drug as a growth enhancer. Finally, in 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration — in an FDA note in the federal register — reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Luckily, we now have a President who believes in regulation of big business to protect the health and welfare of Americans and is smart enough to make the scientific connections between emerging antibiotic resistance in animals and human. Maybe some real change will be coming soon....one can only hope!!!!!!!!!!

Hat tip to Ed at the Pharmalot Blog

Until next time...

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

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Johnson & Johnson today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The agency requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&J’s New Drug Application (NDA) for ceftobiprole was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.  The company received an approvable letter in March 2008 and submitted what it thought to be the necessary information necessary to garner approval of the new antibiotic

Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas. The antibiotic was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. 

The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada, Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.

J&J intends to discuss the best path forward with the FDA as soon as possible. New antibiotics are necessary to combat the growing trend of multiple drug resistant strains of bacteria that are responsible for an increasing amount of bacterial infections.

Until next time...

Good Luck and Good Job Hunting!!!!

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Last week, I took a group of Seattle researchers to task about issuing a press release about isolating methicillin resistant Staphylococcus aureus (MRSA) from sand samples taken from public beaches in Washington State. Their findings were neither remarkable nor news worthy and likely did more harm than good. Sadly, another article about MRSA—designed to alarm rather than inform and educate the American public—appeared in today’s Science section of the NY Times.

The article, “Ties to Pets Has Germ Jumping To and Fro” in which the word “germ” appeared several times, reports on the possible transmission of MRSA between humans and their pets, most notably dogs and cats. Much of the article focuses on the “strong link between animal to human transmission,” offers several frightening examples of serious zoonotic cases that have been recently reported and suggests that cats are eight times more likely than other pets to transmit MRSA to their owners. After reading the first part of the article, readers would rightfully believe that we are in the midst of a massive zoonotic MRSA epidemic with family pets at its epicenter.  However, on the second page of the article the author mentions an epidemiological survey study conducted by Dr. J. Scott Weese, a veterinarian from the University of Guelph in Ontario Canada which showed  that only “two to three percent of pets carry MRSA on their fur or skin or in their saliva.” Further, the study suggests that healthy animals that are transiently colonized by MRSA eliminate them “in a manner of weeks.” Compare the 2 to 3 per cent carrier rate in pets with an almost 70% human carriage rate of MRSA. While I am a PhD-trained infectious disease microbiologist, I don’t think it requires a PhD to quickly realize that pets really aren’t a major source or cause of MRSA infections for humans. That said, raising awareness among veterinarians about MRSA might aid in the development of appropriate disease surveillance, diagnostic testing, andinfection control to lessen the impact of MRSA on smallanimals.

I have no doubt that many people will look at and possibly treat their pets differently after reading the Times article. Further, many will unnecessarily spend money to have their pets tested for the presence or absence of MRSA. While informing the American public that pets (like humans) might unknowingly transmit MRSA is a good thing, turning the rare transmission of MRSA from animals to humans into a major epidemiological brou-ha-ha is misleading, scientifically disingenuous and reckless. Good journalism should inform and educate, not alarm and frighten people by presenting misleading and wrong-headed information. 

Until next time....

Good Luck and Good petting your pets (it will do more good than harm)

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Last week, in a post about the antibacterial properties of cinnamon oil, I mentioned a concoction consisting of cinnamon bark, lemon oil and eucalyptus called “thieves oil” that was used by grave robbers in the Middle Ages to prevent bacterial infections from routinely handling dead bodies. Interestingly, my local New York NBC affiliate filmed a video with an infectious disease physician who demonstrates how to make and use thieves oil. 

Check it out!

Until next time....

Good Luck and Remember to wash your hands!!!!

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The 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) is currently taking place in San Francisco. For those of you who may not know ICAAC, is an annual meeting mainly attended by infectious disease physicians and researchers where the latest and most cutting edge research on infectious agents is reported. Things must have been a little slow at this year’s meeting (except for H1N1 of course) which led the newswires to pick up a story about the isolation of methicillin resistant Staphylococcus aureus  (MRSA) at public beaches in Washington State. While MRSA infections are certainly a public health concern, particularly among infants, older adults and immunocompromised individuals finding MRSA at public beaches isn’t particularly surprising nor newsworthy.

S. aureus is an opportunistic pathogen that isn't particularly virulent and is incapable of causing disease unless it is accidentally introduced into a wound, surgical incision or similar environment. In humans, the bacterium colonizes mainly the nasal passages, but it may be regularly found in most other anatomical locales, including the skin, oral cavity and gastrointestinal tract. Epidemiological studies have demonstrated that over 70% of people transiently carry S. aureus in their nasal passages at one time or another in their lives. This means that S. aureus is very common and ubiquitous in human populations. Consequently, I wasn’t surprised when I learned that Seattle researchers had isolated S. aureus at public beaches in Washington State. Nor was I shocked to learn that some of the isolates were MRSA strains!  After all, the incidence of methicillin-resistant S. aureus has been steadily increasing in the US and elsewhere for the past 20 years. And, healthy people who carry MRSA (and regularly shed it from their bodies) do like to go to beach and lay in the sand when the weather is warm. That said, I would have flabbergasted if the researchers didn't isolate MRSA from the beach sand samples that they surveyed. As an aside, I want to let my readers know that I isolated S. aureus from a soil sample while an undergraduate microbiology  major at Cornell University. Finally, while some MRSA infections can be fatal, those that are diagnosed correctly and early are usually easy to eliminate with conventional antibiotic regimens.

Because the work mentioned in the ICAAC press release hasn’t been published, it is  difficult to evaluate the results and implications of the study's findings.  Nevertheless, I don’t think it was prudent for the scientists who conducted the research to issue a press release about finding MRSA at public beaches—especially when the American public is already jittery about infectious agents like H1N1. If the authors’ intent was to make a big splash (pun intended) by mentioning the “dreaded MRSA” in their press release, they were successful—the story is all over the news. However, in my opinion, we are obliged as scientists to accurately inform the lay public about important scientific and public health issues—not play into its worse fears and misconceptions about them.

Until next time...

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

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There are many natural products from animals, plants, fungi and bacteria that possess antibacterial properties. This makes complete sense from an evolutionary standpoint. Therefore, it should comes as no surprise that spices like cinnamon and natural products like honey possess inherent antibacterial properties. Nevertheless, despite my over 30 years as a card-carrying bacteriologist, I always pleased and pleasantly surprised when I learn that a common substance like cinnamon oil has potent antibacterial activity against antibiotic-resistant bacterial pathogens.

A recent study showed that a cinnamon oil solution was capable of killing a variety of nosocomial bacterial pathogens including Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus (MRSA). Moreover, the cinnamon oil appeared to be as effective as several antiseptics and disinfectants widely used in many hospitals. And, this isn’t the first report on the antibacterial effects of cinnamon oil. In a 2008 study, French researchers showed cinnamon oil solutions of 10% or less were effective against S. aureus, Escherichia coli and several antibiotic resistant strains of bacteria.  Further, there is a precedent for the use of cinnamon-derived products as an antiseptic. In the Middle Ages thieves who stole jewelry from dead bodies and used “thieves oil”—a concoction consisting of cinnamon bark, lemon oil and eucalyptus—rarely got ill. Finally, cinnamon oil when topically applied to the skin is generally safe. However, in some people it can cause an allergic reaction.

This is good news for a country that has grown increasingly obsessed with chemically-based antibacterial soaps and sanitizers whose overuse may actually be selecting for the emergence of strains of multiple antibiotic resistant bacteria. Nevertheless, the use of natural antiseptics like cinnamon and other plant oils as sanitizers may help to reduce the growing incidence of  drug resistance among nosocomial bacterial pathogens.

Until next time....

Good Luck and Remember to Wash Your Hands (with plain soap, not antibacterial-containing products!)

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Rumors are rife that Novartis is going to purchase Lexington, MA-based Cubist for $1.6 billion. Wall Street analysts are speculating that Novartis may announce the deal as early as Monday.

Cubist manufactures Cubicin (daptomycin), one of only a handful of new antibiotics brought to market in the past 20 years that is effective against many infections caused by Gram-positive bacteria, most notably methicillin-resistant Staphylococcus aureus (MRSA). The company is developing new lipopeptide antibiotics similar to Cubicin and also has an active anti-viral drug discovery program.

Over the past 10 years, big pharma companies largely abandoned antibiotic research and placed all discovery efforts in the hands of only a few smaller public companies and startups. Cubist is the only independent biopharmaceutical company that successfully brought a new antibiotic to market. 

Novartis’ possible acquisition of Cubist signals, that at least one major pharmaceutical company sees opportunities and upside in the antibiotic drug discovery market. Several years ago, Pfizer acquired another antibiotic discovery company, Vicuron (formerly Versicor) but to date the acquisition has not yielded any new antibiotics. While Novartis’ acquisition of Cubist is yet another sign of consolidation that is taking place in the life sciences sector, it may bolster new efforts in the antibacterial drug discovery area. Unlike Cubist, Novartis has enough money and marketing muscle to increase Cubin sales and develop some of the exciting new molecular entities in Cubist’s drug development pipeline.

Until next time…..

Good Luck and Good Job Hunting!!!!

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That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.

Beginning in the early 1990s, Dr Anderson noticed a rapidly rising incidence in the number of community acquired skin infections caused by MRSA among his patients. Most of Dr Anderson’s patients were swine farmers—the predominant industry in Camden. At first puzzled by the growing incidences of MRSA outbreaks, Dr. Anderson began to suspect that his patient’s pigs may be the source of growing number of cases of MRSA skin infections. He was reluctant to alert public health officials about his suspicions because any hint livestock-related health issues might jeopardize the livelihood of many of his neighbors and friends. By last fall, however, Camden’s MRSA epidemic had grown so large that Dr. Anderson could no longer remain silent. Rather than alert the authorities himself, he decided to invite Mr. Kristof, an investigative reporter, to visit him in Camden and break the story. Unfortunately, before Mr. Kristof could visit, Dr. Anderson died abruptly at age 54. There was no autopsy, but a blood test suggested he may have died from a heart attack or aneurysm. And—this is where the story gets interesting—a recent Dutch study has linked porcine MRSA isolates to a case of human endocarditis. Dr. Anderson had himself suffered at least three bouts of MRSA infections.

In another Dutch study conducted in 2004, MRSA strain ST398 (which caused the endocarditis in the more recent study) was isolated from three family members, three farm workers and 8 of 10 pigs from a single farm. Since then, strain ST398 has spread rapidly through the Netherlands — especially in swine-producing areas— and pig farmers there are 760 times more likely than the general population to carry MRSA. More recently, a study conducted by public health officials in Ontario, Canada showed that 20% of pig farmers were colonized by strains of MRSA genetically identical to those isolated from European pigs. Finally, a 2008 study conducted in Iowa, reported that strain ST398 was isolated from 45 percent of pig farmers and 49 percent of hogs that were tested. Together, these studies suggest that colonization of swine by MRSA and pig farmers is very common and that swine (and possibly other agricultural animals) could become an important reservoir for strains of MRSA.

While not conclusive, most infectious diseases experts believe that the emergence of MRSA and antibiotic resistant bacteria can be directly linked to the widespread and rampant use of antibiotics as growth enhancers in livestock feed. Despite the alarming emergence of multiple antibiotic resistance bacteria, livestock producers in the US and elsewhere continue to add antibiotics to livestock feeds. This led Mr. Kristof to lament that “we as a nation have moved to a model of agriculture that produces cheap bacon but risks the health of all of us.” Not surprisingly, as is frequently the case, big business has chosen to place profits before the health and safety of society.

Until next time...

Good Luck and Good Reading (look for Mr. Kristof’s Sunday column on the emergence of antibiotic resistant "superbugs")

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A team of researchers at the University of Wisconsin-Madison (my alma mater) genetically engineered a strain of Streptomyces platensis to overproduce the antibiotics platensimycin and platencin. They accomplished this by deleting a regulatory gene (ptmR1, whichencodes a putative GntR-like transcriptional regulator) in the antibiotic synthetic pathway that controls production. The newly engineered strain has been reported to overproduce platensimycin and platencin with yieldsof 323 ± 29 mg/L and 255 ± 30 mg/L, respectively. This represents a 100-fold increase in the yields observed with corresponding S. platensis wild type strains.

Platensimycin is the first of a new class of natural product antibiotics (with a novel mode of action) to be discovered in the past 40 years.  It exhibits strong, broad-spectrum Gram-positive antibacterial activity by selectively inhibiting cellular lipid biosynthesis. Treatment with platensimycin eradicates Staphylococcus aureus infection in mice. Because of its unique mode of action, platensimycin shows no cross-resistance to other key antibiotic-resistant strains tested, including methicillin-resistant S. aureus, vancomycin-intermediate S. aureus and vancomycin-resistant enterococci.

Platencin, also a natural product, is chemically and biologically related but different from platensimycin. Like platensimycin, it exhibits a broad-spectrum Gram-positive antibacterial activity through inhibition of fatty acid biosynthesis. And, it doesn’t exhibit cross-resistance to methicillin-resistant Staphylococcus aureus, vancomycin-intermediate S. aureus, and vancomycin-resistant Enterococci. Moreover, platencin shows potent in vivo efficacy without any observed toxicity.

Both antibiotics show promise for commercialization. While we need new antibiotics, both platensimycin and platencin target only Gram positive bacteria. Infections caused by multiple drug resistant Gram negative bacteria are threatening to overtake those caused by Gram positive in the very near future. At present, to the best of my knowledge, there are no new antibiotics in the pipeline directed against multiple drug resistant Gram negative strains.

Until next time...

Good Luck and Good Antibiotic Hunting!!!!!!!!

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News Day reported today that Wegmans Food Markets, a grocer with 72 locations in New York, Pennsylvania, New Jersey, Virginia and Maryland is giving away “free generic antibiotics” for customers (with a prescription). Wegmans joins a growing list of supermarkets pharmacies including Giant Food and Publix that are giving free generic antibiotics to its customers.

I first learned about the “free generic antibiotic give away offers” several weeks ago after reading a post on the Wall Street Journal (WSJ) Health Blog. I took the WSJ health blog to task for posting the story without editorial comment on the potentially dangerous practice of “hawking free antibiotics” to drive business at regional and nationwide grocery store pharmacies. Luckily, in today’s WSJ Health Blog post about the Wegmans program, the author (Sarah Rubenstein) did suggest that the practice may lead to unnecessary promotional  use of antibiotics.

As you all should know by now, we are in the midst of bacterial antibiotic-resistance epidemic. People are beginning to regularly die from bacterial infections that were easily treatable a decade ago. Ironically, we are slowly approaching the morbidity and mortality rates for bacterial infections that previously existed in the pre-penicillin era. Moreover, there are no new, orally bioavailable, broad spectrum antibiotics on the horizon. A lack of new antibiotics coupled with rapidly emerging resistance to extant ones is wreaking havoc on the healthcare system in both community and hospital settings.

The “free generic antibiotics” advertising and marketing programs concocted by Giant, Publix and Wegman’s are egregious examples of how a lack of or unwillingness to understand science poses a serious public health threat to all Americans. I have no doubt that the marketers who devised the give away programs have nary a clue about the relationship between antibiotic use and the emergence of antibiotic resistance strains of bacteria. Further, while physicians may be aware of increasing rates of antibiotic resistance, many are reluctant to not prescribe antibiotics to patients who request them. After all, these physicians are running a business and if they don’t write the script, the patient will take his/her business elsewhere. The potential public health implication of these free antibiotic programs begs the question: Why not give away generic ace inhibitors, generic statins or other generic medications whose profits margins are also negligible but don’t carry any public health risks?

Put simply, the promise of free generic antibiotics is a marketing strategy that is in my opinion, reckless, dangerous and may have serious public health implications in the future. Make no mistake about it, I am a capitalist but not when profits are placed before human lives.

Hat tip to the WSJ Health Blog

Until next time…

Good Luck and Good Job Hunting (try antibiotic drug discovery—we need new ones)

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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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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

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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!!!!!! 

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Pfizer announced today that it would withdraw marketing application being considered at FDA and the European Medicines Agency (EMEA) for Dalbavancin an antibiotic it was developing for complicated skin infections caused by bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Pfizer acquired Dalbavancin after it purchased California-based Vicuron Pharmaceuticals for $1.9 billion in 2005. At that time, Vicuron had filed an NDA with FDA and had expected approval for the novel antibiotic. Instead, after acquiring Vicuron, Pfizer received an approvable letter from FDA that requested additional studies before the agency would approve the drug. Based on the agency’s comments, Pfizer decided to withdraw the original US and European applications filed by Vicuron and conduct addition Phase III clinical trials for the complicated skin and soft tissue infection and pediatric indications. I suspect that results from these trials will determine whether Pfizer files new applications with FDA and EMEA for Dalbavancin.

For those of you who may not know, Vicuron Pharmaceuticals was formerly called Versicor, a company founded by Eric Gordon, Mickey Gorman and others. In 1996, I was recruited to interview for a Vice President of Biology position at the company.  At that time, Versicor had about 15 employees — Eric was CEO and Mickey was a consultant.  Although Eric, Mickey and I became fast friends, I didn’t get the job (they never hired anybody for the position). 

Both Eric and Mickey left Versicor a couple of years later. Eric went on to start Sunesis, a very successful Bay area oncology company and Mickey retired to his home in Key West, FL. From time to time, I would run into Eric at BIO meetings and Mickey and I would meet up at my all time favorite Vietnamese restaurant (Hy Vong) in Little Havana in Miami, FL. Eric has since retired after 30 years in the pharma/biotech biz and Mickey unfortunately passed away from cancer in the early 2000s.

After meeting Eric and Mickey, I knew that Versicor would be a success one day—the $1.9 billion that Pfizer paid for Vicuron tends to validate that notion. While I didn’t benefit financially from Versicor, I was lucky and fortunate to meet two, really smart, fascinating and genuine individuals who helped me to establish my credibility in the biopharmaceutical industry.  As the saying goes “Money isn’t everything!”

Hat tip to Ed at Pharmalot.

Until next time…

Good Luck and Good Job Hunting!!!!!

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A friend of mine accidentally gashed his leg on an open dishwasher door and thought nothing of it for several weeks until he noticed that the wound wasn’t healing and it hurt really badly. He eventually went to the emergency room at a local, where the ER docs cultured the wound and sent him home with a prescription for oral antibiotics. The antibiotics stopped working several days later and he wound up in another local hospital–this time he was admitted and the spent the next 5 days on a variety of intravenous antibiotics. Despite the treatment (they could not find the right antibiotic combination at first because  they never recultured the wound) his leg turned black from his ankle to his knee and they almost had to amputate. He is back at home now and will be treated with a regimen of iv antibiotics for the next 6 weeks or so. I talked with him last week and I learned that his leg wound is still not completely healed and the infectious disease docs are worried!

My friend almost lost his leg because of a lack of understanding about bacterial infections and antibiotic resistant bacteria and— unfortunately— because of substandard wound care treatment. With this in mind, I am posting what I think are useful tips (from the June issue of the Mayo Clinic Women’s Health Source) about how to prevent, manage and treat wound infections to minimize the emergence and spread of multiple, antibiotic- resistant bacteria.

• Wash your hands: This simple procedure, done properly, remains the best defense. Carry alcohol-based hand sanitizers for times when hand washing isn’t possible.
• Keep personal items personal: Don’t share towels, soap, sheets, razors, clothing or athletic equipment.
• Sanitize linens: If you have a cut or abrasion, wash towels and sheets with hot water and added bleach. Wash gym and athletic clothes after each use.
• Get infections tested: If an infection requires treatment, ask your care provider to take a culture to confirm what bacteria are present before you are given an antibiotic. (Editor’s note: Unfortunately, this is no longer standard practice—most infections are treated empirically which is partly responsible for the increasing frequency of antibiotic resistant bacteria.) If you test positive for a Staphylococcus (Staph) infection, ask that a culture be tested specifically for MRSA in case you need a special antibiotic.
• Use antibiotics appropriately: When you take antibiotics, take all doses even when you start feeling better. Don’t demand antibiotics for viral illnesses; antibiotics don’t work with viruses. Taking too many antibiotics over time could become a detriment because the medication’s effectiveness can be compromised by overuse.
• Use antibacterial products sparingly: Antibacterial soaps and cleaning products probably don’t prevent infections at home and may make these products less effective in hospitals.
• Take precautions in the hospital: Ask all hospital staff and visitors to wash their hands or use an alcohol-based hand sanitizer before touching you. Ask care providers to wipe stethoscopes and other equipment with alcohol. Don’t set food or utensils directly on tables or beds. Make sure that intravenous tubes and catheters are inserted under sterile conditions.

I hope that these tips will help to keep you out of the hospital with potentially life-threatening, antibiotic resistant bacterial wound infections!

Until next time….

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

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Novartis announced today that it intends to purchase Malvern, PA-based Protez Pharmaceuticals for $400 million. Protez is developing a novel spectrum carbapenem antibiotic that is active against variety drug-resistant Gram positive (most notably MRSA )and Gram negative bacterial pathogens. Its lead compound, PZ-601, is in Phase II human clinical testing. Protez acquired PZ-601 (formerly SMP-216601) in 2005 from Dainippon Sumitomo Pharmaceuticals.   

Novartis is buying Protez to sure up its antibacterial drug pipeline. Novartis already sells Cubicin, (manufactured by Massachusetts-based Cubist Pharmaceuticals Inc.,) in Europe and is developing other antimicrobials including Aurograb and Tifacogin to treat infections.

Like many of the newly marketed antibiotics, PZ-601 is injected and not orally bioavailable. Nevertheless, it is likely that PZ-601 will provide much needed help against the ever increasing number of drug resistant bacterial isolates. Swiss companies Basilea Pharmaceutica AG and Arpida Ltd. are also working on experimental medicines to treat MRSA.

It is not clear how the acquisition will affect Protez employees.  I suspect that most of the employees will keep their jobs except for Company officers.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Basilea Pharmaceutica Ltd announced yesterday that the U.S. Food and Drug Administration issued an Approvable Letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections. Results from two Phase III studies involving 1600 patients with complicated skin and skin structure and diabetic foot infections showed that ceftobriprole was as effective and safe as other cephalosporin antibiotics.

The Approvable Letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections. Ceftobiprole is currently being reviewed by regulatory authorities in Canada, the European Union and in Switzerland. The antibiotic is being co-developed and marketed with Johnson and Johnson.

Until next time…

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

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The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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