Top 5 Life Sciences Market Stories of June 2017

Top 5 Life Sciences Market Stories of June 2017

This month the FDA took steps for the first time to remove an opioid from the market because of its risk for abuse. Struggling drugmaker MannKind pinned its hopes on sponsoring a reality television show about diabetes. Magellan Diagnostics expanded its recall for venous blood lead tests, Bristol-Myers Squibb and Qiagen partnered on companion diagnostics, and researchers created a ‘living diagnostic’ with engineered bacteria. These are some of the top life science news stories in June 2017.

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“Living Diagnostics” a possibility for future life sciences market

In a letter published online May 29 in Nature Biotechnology, researchers described a successful effort to colonize mice with engineered bacteria that can diagnose gut inflammation.

The bacteria were a common strain of E. coli engineered to retain memory of exposure to tetrathionate, a marker the scientists are developing for inflammation. Bacteria that had been exposed to tetrathionate could easily be detected in fecal samples.

This work moves such non-invasive diagnostics strategies closer to translation to humans, the researchers said.

While bacteria have been engineered for diagnostics in the past, synthetic genetic circuits are vulnerable to mutating or losing function within a mammalian host, the researchers write. Their work shows that it is possible to keep an engineered organism alive and functioning for an extended period of time. Their bacteria remained stable and functional within the mouse hosts for six months.

“Synthetic bacterial devices can colonize the complex host mammalian gut and be used to monitor and analyze the course of a disease over an extended timeframe,” they wrote.

The technology could eventually be used for therapeutics, as well, they said.

FDA asks maker to pull Opana ER due to abuse risk

The FDA announced June 8 it wants Endo Pharmaceuticals to stop selling reformulated Opana ER (oxymorphone hydrochloride) because the benefits to patients no longer outweigh the risk of abuse.

“This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” the FDA press release said.

Post-market data showed that following a 2012 reformulation, in which a coating was added to make the drug harder to crush and snort, people began abusing Opana ER by injection. Injection abuse was linked to a serious outbreak of HIV and Hepatitis C, the FDA said.

Endo Pharmaceuticals did not immediately agree to stop selling Opana ER.

“Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward,” said a June 8 Endo Pharmaceuticals press release.

The company’s stock price has declined since the FDA’s announcement, but the loss of Opana ER would “probably not have a huge negative impact on the company,” a Seeking Alpha report concluded.

Opana is a top-selling product, generating $160 million in sales, according to Seeking Alpha, but “it is hardly the cornerstone of the company.”

Drug maker sponsors reality TV show

A new reality television show called Reversed debuts this summer, featuring Type 2 diabetes patients who were flown to a tropical resort to learn to conquer their illness with lifestyle changes.  The show, which airs on Discovery Life Channel, has an unusual sponsor, MannKind Corp., the California-based maker of Afrezza, an inhalable insulin.

MannKind is struggling financially due to lower than expected sales of Afrezza since its FDA approval in 2014, reports. Insurance companies have classified Afrezza as at Tier 3 drug, leading to high co-pays. Last year, Sanofi terminated its license deal for Afrezza because of lower-than-expected sales.

MannKind has taken steps to stay financially solvent, including selling its headquarters, doubling its in-house sales team, replacing its chief executive officer, and create a direct-to-consumer marketing plan.

MannKind’s sponsorship agreement with the reality show includes advertising spots during commercial breaks and possibly a brief mention of Afrezza on the show, reports STAT. A STAT reporter who previewed the show called it “The Real World: Diabetes,” and said it focuses more on the drama of the participants living together than on the realities of healthful living to combat diabetes.

The first episode is set to be released July 17.

Lead test recalled due to inaccurate results

Magellan Diagnostics is recalling four lead testing systems as a result of an FDA safety alert May 17 notifying labs that Magellan’s systems may underestimate the blood lead levels when processing venous blood samples.

The company recalled the LeadCare Plus and LeadCare Ultra Testing Systems on May 25, and expanded the recall on June 6 to include LeadCare and LeadCare II Blood Lead Testing Systems. The recalls involve more than 8 million devices nationwide.

“The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan,” the agency said in a statement announcing the recalls. “We are conducting studies with the Center for Disease Control and Prevention (CDC) to identify the cause and better characterize the extent of the problem.”

The testing systems may still be used with capillary blood; inaccuracies were found only with venous samples.

While the CDC advised health professionals to retest at-risk children who had low lead levels in venous blood, officials said that heel sticks and finger sticksare the most common method of testing and the vast majority of children will not need retesting.

Bristol-Myers Squibb and QIAGEN partner on NGS, creating a force in life science markets

Bristol-Myers Squibb and QIAGEN announced this month they have signed an agreement to collaborate on companion diagnostics for immuno-oncology therapies.

Their plan is to use Qiagen’s next generation sequencing technologies to create gene expression profiles that can be used as tools to complement several of Bristol-Myers Squibb’s immuno-oncology molecules.

The two companies have been partnering since 2009, according to the press release. The Therascreen KRAS companion/complementary diagnostic assay that they developed together was FDA approved in 2012.