Fighting Zika with Germ Warfare

The enemy of my enemy is my friend. That ancient wartime dictum has taken on new meaning in the struggle against infectious disease, as researchers pit one microbial enemy of human beings against another.

Until recently, the strategy has largely trained on using viruses to kill dangerous bacteria. These bacteriophages—or simply, “phages,” as the viruses are known—might be one solution to the increasing problem of antibiotic resistance in a number of worrisome bacterial strains. The phages hijack a specific type of bacteria, injecting their own viral DNA into the microbes. The code instructs a bacterium to make endless copies of the virus until the germ explodes, which spreads the virus to the next target, and so on. (No one said biology wasn’t brutal.)

The approach, believe it or not, is an old one: In the 1940s, before the widespread use of antibiotics, Eli Lilly sold phages that were targeted against germs ranging from staphylococci to streptococci to E. coli. For those inclined, here’s a fascinating mini-review on phage history.

(And in a side note that speaks to the wonder and importance of basic science: It was by studying bacteria’s defense against these ravaging phages that scientists discovered the gene-editing technique, CRISPR Cas-9. For a discussion of that, see our Oct. 26 Brainstorm Health Daily.)

But now, in the fight against Zika, the battle lines are being redrawn—with bacteria going on the attack against the mosquito-carried virus. Scientists are studying how to use a group of bacteria called Wolbachia, which normally prey on insects (and are considered harmless to humans) to infect mosquitoes that carry Zika—homing in on the bugs’ reproductive systems and making them infertile.

The strategy is not without precedent. A research team in Australia has used Wolbachia to limit the ability of certain mosquitoes to carry dengue fever, which sickens more than 50 million people a year. You can find great articles on the effort here and here. Meanwhile, another laboratory group at the University of Kentucky has licensed its Wolbachia-based biotechnology—which targets the reproductive ability of male Asian Tiger mosquitoes—to a company that is awaiting regulatory approval for its product. (The company already has an experimental use permit for a limited trial in California.)

So who gives the nod to these new anti-infective weapons? Not the FDA, mind you, but rather the EPA: the Environmental Protection Agency. Yes, it’s a brave new healthcare world.

More news below.

Clifton Leaf
@CliftonLeaf
clifton.leaf@fortune.com

DIGITAL HEALTH

IBM Watson is trying to figure out why cancers become resistant to drugs. IBM's Watson Health unit seems to announce a new partnership or two every week, and this one is no exception. IBM announced Thursday that it has struck a $50 million partnership with the Broad Institute of MIT and Harvard to study why some cancers become resistant to treatment. The firm notes that there are about 600,000 American cancer patients who die every year because their cancers mutate and stop responding to medication. Under the collaboration, Broad Institute will collect and sequence the cancers of patients who originally did respond to treatment but then became resistant, and Watson's supercomputer will analyze the data to see what genomic trends may help predict if such therapy-nullifying mutations might occur.

Kite Pharma wants to prove the skeptics are wrong about its experimental cancer treatment. Kite Pharma badly wants to become the first company on the market with an approved chimeric antigen receptor T-cell (CAR-T) therapy to treat cancer. The next-gen experimental tech involves taking cancer patients' killer immune cells, reprogramming them to specifically sniff out and destroy cancerous tumors, and then injecting them back into a patient's body. While a number of firms have jumped into the space, including Juno Therapeutics and Novartis, initial trial data underscores both the promises and potential pitfalls of the technology. For instance, Kite presented data earlier this year that showed its CAR-T candidate KTE-C19 was effective in the blood cancer advanced diffuse large B-cell lymphoma, but drew criticism because patients' response rates to the drug declined over time. Now, Kite is saying that it will wait until the first quarter of 2017 to complete filing its application for FDA approval, meaning that more long-term data about efficacy and response rates will be available to support its ambitions. (Endpoints)

BD unveils new syringe exclusively for Eli Lilly insulin. Becton Dickinson has debuted a syringe that's specifically meant for use with Humulin R U-500, a highly-concentrated insulin from U.S. pharma giant Eli Lilly. This particular insulin contains about five times as much insulin compared to certain other products and is meant for diabetes patients with high insulin resistance. But that can be problematic when administering the therapy with standard syringes given that doctors and patients must be extremely careful when converting dosage levels. That's where the new BD syringe comes in—it eliminates the need for dose conversions that might lead to errors and subsequent health complications. "[P]eople with diabetes have diverse needs and that their insulin delivery devices should reflect their individual needs," saidDr. Jeffrey Jackson of Lilly Diabetes in a statement. (FierceBiotech)

Artificial cells: The drug delivery devices of the future? Researchers in the Netherlands have created artificial cells that could, theoretically, one day be used as nano vehicles to deliver medicines to highly specific targets in the human body. The researchers were able to direct the movements of these nanoparticles by filling them with enzymes in order to mimic a real human cell. Use of tiny machines to deliver drugs could have a number of advantages, including lowering the risk of side effects from powerful medicines and boosting the power of treatments by getting them to exactly where they need to go. (FortuneDrug Delivery Business News)

INDICATIONS

Hit Pfizer breast cancer drug gets European approval. Pfizer's Ibrance, for the treatment of breast cancer in patients who don't have HER-2 protein related cancer, has won the green light from European regulators, setting up a significant market expansion for a drug that's projected to cross $2 billion in sales for 2016 (the treatment was approved in the U.S. in early 2015). Ibrance's unique action mechanism sets it apart from certain other breast cancer medicines and has soared in popularity since its debut. And the EU approval gives Pfizer yet another leg up in the space over Novartis, which has a rival therapy called ribociclib in clinical trials. The Novartis drug candidate has shown promise in studies but won't be filed for regulatory clearance until later this year. (Reuters)

Bristol-Myers Squibb is gunning for the liver disease space. The pharmaceutical giant announced Thursday that it's struck a licensing deal with Japan's Nitto Denko Corporation in which BMS will have exclusive rights to develop and commercialize a number of Nitto Denko's experimental treatments for Nonalcoholic steatohepatitis (NASH). NASH is a fairly common liver disease in which fat accumulation can lead to permanent damage in patients who don't drink much alcohol. It affects about 2% to 5% of Americans (and a far higher share of obese Americans) and currently has no approved therapies on the market. And BMS isn't the only big pharma that wants to score a winner in the potentially lucrative space—in September, Allergan shelled out an unusually high premium to snap up the California biotech Tobira, which has a late-stage experimental NASH treatment. Allergan chief Brent Saunders believes the market potential could be huge given the worldwide obesity epidemic. (Fortune)

Pfizer may be getting ready to sell off its consumer business. Sources tell Reuters that Pfizer is considering either selling or spinning off its consumer health unit, whose flagship product line includes Chapstick and Advil. That would be a significant transformation for Pfizer, which has been making a number of M&A-related restructuring moves following the collapse of its attempted mega-merger with Allergan. The consumer health business could be valued as high as $14 billion and brings in yearly sales of about $3.5 billion. If Pfizer does decide to sell the unit, it would be following in the footsteps of fellow pharma giant Merck, which sold its own consumer business in 2014. (Reuters)

THE BIG PICTURE

Could a top Celgene exec become a Trump administration cabinet secretary? Politico is out with a list of what President-elect Donald Trump's incoming cabinet may look like—and one (admittedly unlikely) candidate to lead the Department of Health and Human Services (HHS) is Rich Bagger, the former EVP of corporate affairs and market access at biotech Celgene. Bagger, who has previously served as chief of staff to New Jersey Governor Chris Christie (a top Trump surrogate and potential Attorney General pick), stepped away from his role at Celgene in order to take a position on Trump's transition team. The biopharma vet is a longtime Republican party activist and served as a New Jersey state senator. (Politico)

Valeant gets subpoenaed over pharmacy activities. The drama never seems to stop with Valeant Pharmaceuticals and Wednesday was no different. One day after posting a disastrous earnings report and guidance, the firm revealed that it has once again been subpoenaed, this time by the California Department of Insurance, over its relationship with the now-defunct specialty pharmacy and Valeant distributor Philidor Rx. Philidor set off a string of regulatory and legal headaches for Valeant over questions about its distribution and marketing practices, and presaged former chief J. Michael Pearson's departure from the company. (Fortune)

Mylan posts a loss on Medicaid settlement, EpiPen sales drop. The embattled Mylan posted a net loss of nearly $120 million in the third quarter of 2016 that was driven by its planned $465 million settlement with the federal government over allegations that the company had overcharged Medicaid for its flagship EpiPen device. That settlement could be finalized soon, according to Mylan—but the firm also said that it forecasts EpiPen sales to make up about 6% of overall sales in 2017, a drop from previous years. Mylan's market share in the space is massive, covering about 90% of epinephrine sales, but has been seeing modest declines in the wake of the controversy over substantial EpiPen price hikes. CEO Heather Bresch also announced that the company plans to introduce a much cheaper authorized generic version of the EpiPen in December. (Fortune)

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