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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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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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