Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

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!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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)

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On episode #6 of the podcast This Week in Microbiology, Vincent, Cliff, Michael and Elio review the use of bacteriophages to manage infections, and the presence of antibiotic resistance genes in bacteriophages from urban sewage and river water.

Hosts: Vincent Racaniello, Cliff Mintz, Michael Schmidt, and Elio Schaecter.

Subscribe to TWiM (free) on iTunes,  Zune Marketplace, via RSS feed, by email or listen on your mobile device with the Microbeworld app.

Links for this episode:

• Potential bacteriophage applications (Microbe)
• Revived interest in bacteriophages (Current Biology)
• Pulmonary bacteriophage therapy for Pseudomonas infections (PLoS One)
• Bacteriophage therapy for chronic otitis (Clin Otolaryngology)
• Aggregatibacter actinomycetemcomitans bacteriophage capable of lysing biofilm (AEM)
• Clinical trials using bacteriophage
• Antibiotic resistance genes in environmental bacteriophages (PLoS One)
• Letters read on TWiM #6

The model of bacteriophage T4 shown in the photo is described here.

Send your microbiology questions and comments (email or mp3 file) to twim@twiv.tv , or call them in to 908-312-0760. You can also post articles that you would like us to discuss at microbeworld.org and tag them with twim.

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

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!!!!

• Email This
• Print
• Comments (3)
• Trackbacks
• Share Link

Despite the brouhaha surrounding the publication of an article about new South Asian strains of antibiotic resistant bacteria that carry the NDM-1 gene, some good may actually come from it. The Pharmalot Blog reported today that an article entitled “Are You Ready for a World without Antibiotics” appeared in the UK’s Guardian newspaper just two days after the first report about NDM-1.

While the Guardian piece is a little heavy handed in parts, it does a good job accurately portraying the growing lack of antibiotics left in the armamentarium to treat infections caused by many drug resistant Gram positive and Gram negative bacterial pathogens. As I have noted numerous times before, large pharma, for the most part, quietly exited antibiotic drug discovery and development in the late 1990s. 

Only a handful of biotechnology companies are developing new drugs to combat infections caused by antibiotic resistant bacteria. Unfortunately, many of these companies have hit regulatory snags for these drugs and the likelihood of approval is questionable. And if something isn’t done soon e.g. government funded initiatives, people may begin to succumb to bacterial infections at rates that haven’t been seen since the pre-antibiotic era which ended in the 1940s.

Until next time...

Good Luck and Good Job Hunting!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

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!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!)

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

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)

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Optimer, a San-Diego, CA-based biopharmaceutical company, reported positive Phase III clinical trial results for OPT-80, its lead treatment for Clostridium difficile gastroenteritis. C. difficile gastroenteritis is caused by exotoxins secreted by clostridia that have colonized the colon following prolonged antibiotic treatment for other bacterial infections. If left untreated, patients can die from a pseudo-membrane that forms in the colons of C. difficile-infected people. The incidence of C. difficile gastroenteritis has drastically increased over the past decade because of prolonged treatments with multiple antibiotics that are often necessary to eradicate infections caused by multiple drug resistant bacteria.

Historically, CHO-based drugs (with a few notably exceptions like heparin) have not fared well as therapeutic agents. To my knowledge, OPT-80 is the first synthetic carbohydrate (CHO)-based antibiotic to demonstrate anti-bacterial efficacy in a Phase III clinical trial. Having worked for Transcell Technologies (now defunct) and Alchemia,Pty—both of which attempted to develop CHO-based antibiotics—Optimer’s clinical success with OPT-80 is certainly noteworthy. I wish the company continued success in the future—mostly because I have always thought that carbohydrates would make good antibiotics!

Until next time…

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

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Sinus infections are diagnosed in about 31 million Americans each year and are among the most common reasons for doctor visits. The infections affect the air spaces (sinuses) around the nose and in the lower forehead. Inflammation and excess mucous can cause nose congestion, headaches and eye and face pain. Causes include bacteria, viruses, fungal infections and allergies.

A study published in the December issue of the Journal of the American Medical Association (JAMA) showed that patients with sinus infections treated with antibiotics did not get better more quickly than those treated with placebo, And, that most sinus infections would resolve themselves over time without treatment. The lack of effectiveness of antibiotic treatment could be explained by the inability of many antibiotics to reach the site of infection in the sinuses. Also, it is important to point out, that antibiotic treatment is ONLY EFFECTIVE when treating bacterial infections; not those caused by viruses or fungi. To that end, infectious disease experts issued guidelines in 2001 advising against using antibiotics for most sinus infections in otherwise healthy people, blaming overuse for contributing to the growing problem of antibiotic resistance.

Critics of the study questioned whether all the patients in the study had true bacterial sinus infections. Although patients were recruited to the study by family doctors, the results were based on patients' self-reported symptoms rather than medical exams that confirmed actual cases of sinus infections. So it goes….

BTW, recent studies suggest that yellowish or greenish mucous doesn't always mean the infections are bacterial–another urban legend bites the dust.

Until next time….

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

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link