Indivior shares drop for second day as hopes for next blockbuster drug dim

Shares of Indivior fell for a second straight day, as prospects for the British drugmaker’s new potential blockbuster drug waned, months after revealing that its former market-leading opioid addiction drug lost market share to a generic rival.

The company sharply lowered guidance for its recently-launched once-monthly injection Sublocade on Wednesday, citing further delays in getting the drug to patients, while also announcing a new set of lower full-year expectations for total revenue and earnings.

Shares, which have almost halved in value this year, fell 7 percent on Thursday, a day after shares slumped 16 percent right after the company announcement.

In July, Indivior scrapped its full-year guidance after saying it lost market share to a cheaper alternative to its blockbuster film-based drug Suboxone, launched by India’s Dr. Reddy’s Pharmaceuticals.

The company, which had hoped that sales from Sublocade would offset the drop in sales of Suboxone, said on Wednesday that its forecast of achieving $25 million (£19 million) to $50 million in Sublocade revenue this year would not be met as it “significantly underestimated” problems related to the new drug launch. It now expects 2018 Sublocade revenue in the range of $8 million to $10 million.

Analysts at Jefferies slashed its long term earnings per share guidance by over 50 percent, and price target by over 50 percent to 250 pence, saying “delayed Sublocade ramp-up significantly impacts a largely fixed cost base despite cost savings.”

In July, the company flagged “some friction” in the distribution and reimbursement model for Sublocade, which made doctors less willing to prescribe the new drug.

“In the near-term, we acknowledge that with respect to Sublocade we have substantially underestimated the lag time associated with the approval of medical benefit coverage of individual patients,” the company said on Wednesday.

https://www.marketscreener.com/DR-REDDY-S-LABORATORIES-9058869/news/Dr-Reddy-Laboratories-Indivior-shares-drop-for-second-day-as-hopes-for-next-blockbuster-drug-dim-27327267/

What Is Driving Biopharma Execs Into Politics?

In February, Bob Hugin, former CEO of Celgene, announced his run for the U.S. Senate to represent New Jersey. After winning the Republican primary to become the party’s candidate, he now faces incumbent Democratic Senator Robert Menendez in the upcoming November election.

Hugin is not the only ex-biotech executive-turned-politician. Alex Azar, currently the Secretary of the Department of Health and Human Services, was the former president of Lilly USA, LLC, the largest division of Eli Lilly and Company.

Making the jump from biotech to politics may not seem like a typical career progression. So, what is driving these executives into politics?

Drug Pricing

People tend to run for office because they feel strongly about certain issues. When thinking about the biotech and pharmaceutical industries, the first issue to come to mind is drug pricing.

Drug pricing tends to be intimately political, whether we want it to be or not. It is a common issue on which candidates define their stance, and access to affordable healthcare is a top voter concern.

Not surprisingly, the campaign between Hugin and Menendez has become a ‘referendum on drug prices.’ Hugin cites his biotech experience as a leg up for him as an advocate for health care reform, stating on his website that he will “promote policies that incentivize bold experimentation and innovation that can find cures and lower costs.”

However, Hugin has come under fire for multiple price increases of Celgene’s top medication Revlimid, a cancer drug, while he was leading the company. In fact, its price was increased three times in 2017, resulting in an almost 20 percent cost increase from 2016 to 2017.

Hugin defended Revlimid’s price increases, citing its increased value as it was approved for use in more patients than originally intended. He told STAT News, “More than 90 percent of the patients that ever took a Celgene cancer drug paid $50 or less per month in copay. And the company invested more than 40 percent of its revenue into R&D, because it’s not good enough where we are in cancer, even though we’ve made good strides.”

Azar even seemed to call out Celgene’s drug price increases, without naming the company outright, in his remarks about President Donald Trump’s drug pricing blueprint in May: “For example, the company that makes one of the 10 most common drugs in [the protected Medicare Part D categories] raised that drug’s price 20 percent in the last 12 months. That particular drug, in 2015, cost $11,500 per month. Under Medicare Part D, that means seniors using the drug will typically owe an extra $115 every month. They just went from paying $575 per month to $690 per month, at a time when the average Social Security check is $1,400.”

Despite Azar’s pharma background, he seems to be adamant about making drugs more affordable. “Drug companies have insisted we can have new cures or affordable prices, but not both,” he said in the same remarks. “I’ve been a drug company executive—I know the tired talking points. I’m not interested in hearing those talking points anymore, and neither is the President.”

Azar supporters highlight his pharma experience as an ‘advantage in figuring out how to make drugs more affordable,’ although critics are still skeptical of whether actions will actually be implemented to lower drug prices. Some even note the three-fold price increase of insulin during his 10 years at Lilly.

Other Motivations

Drug pricing and healthcare issues don’t seem to be the only motivating factor driving Hugin to run for office. He states his stances on a variety of issues on his website, including his support of LGBTQ rights, protecting the environment, securing the border and immigration reform. Hugin also draws heavily from his military experience, where he served 14 years in the U.S. Marine Corps, and education background, as the first person in his family to attend college, as inspiration for his viewpoints.

Azar began his career in law before becoming the general counsel and eventually deputy secretary at HHS under President George W. Bush. It was only after his time at HHS that he transitioned into the biopharma industry with Eli Lilly and Company. His motivations seem to be based on drug pricing and healthcare issues as his four main priorities are decreasing drug cost, making health insurance affordable, focusing Medicare payments on quality and confronting the opioid addiction epidemic.

With the intertwined nature of drug pricing and politics, it may not be surprising to see more biopharma execs leave their post in pursuit of holding office and impacting healthcare policy.

https://www.biospace.com/article/ip3o-what-is-driving-biopharma-execs-into-politics-/

Canopy Growth investors approve $4B investment by Constellation Brands

Canopy Growth (CGC) is pleased to announce that at the Company’s annual general and special meeting of shareholders held on September 26, 2018, shareholders approved the previously-announced $4B private placement of 104,500,000 common shares and 139,745,453 common share purchase warrants of the company to CBG Holdings LLC, an affiliate of Constellation Brands (STZ).

https://thefly.com/landingPageNews.php?id=2796141

'African swine fever virus does not pose risk to humans'

The ASF pathogen is a virus which infects domestic pigs and wild boar and which leads to a severe, often lethal, disease in these animals. It is transferred via direct contact or with excretions from infected animals, or through ticks. The ASF virus is endemic to infected wild animals in Africa, but there have also repeatedly been outbreaks in southern Europe. The pathogen has been spreading north-westwards since 2007 from Georgia through Armenia, Azerbaijan and Russia. Cases of ASF have been registered in wild boar along with outbreaks in domestic pigs in the Baltic states since 2014. The virus has also been detected in Romania, Hungary, Poland and the Czech Republic. In September 2018, the pathogen was also found in wild boars in Belgium and thus for the first time in Western Europe.

The pathogen is very stable and can remain infectious in food over several months. If unheated food or food scraps from infected animals are fed to non-infected animals, the virus can therefore spread to previously ASF-free regions, thus infecting domestic pig herds too.
Although the ASF virus does not pose a hazard or a risk to humans, the meat of domestic pigs and wild boar should always be prepared under hygienic conditions, just like all other raw meats, as it can also contain other pathogens, advises the BfR. It should be kept refrigerated and prepared separately from other foods before cooking. When heating, a core temperature of 70 degrees Celsius or higher should be reached in the meat for at least two minutes, the BfR recommends.
The BfR has compiled some frequently asked questions about ASF for further information. They can be downloaded at the BfR website.​​

Source:

https://www.bfr.bund.de/en/press_information/2018/28/african_swine_fever__no_risk_to_consumers-205309.html
https://www.news-medical.net/news/20180926/African-swine-fever-virus-does-not-pose-risk-to-humans.aspx

Sarepta Therapeutics (SRPT) PT Raised to $200 at RBC

RBC Capital analyst Brian Abrahams raised the price target on Sarepta Therapeutics (NASDAQ: SRPT) to $200.00 (from $187.00)

https://www.streetinsider.com/Analyst+Comments/Sarepta+Therapeutics+%28SRPT

Medtech Infraredx Sees Data Back ‘Holy Grail’ of Cardiovascular Imaging Tool

A new cardiovascular imaging tool could prevent the possibility of people experiencing a second or third heart attack.

Jason Bottiglieri, president and chief executive officer of Burlington, Mass.-based Infraredx, said cardiovascular disease is the number one killer of men and women globally. Many people who survive the first heart attack have second and third events, Bottiglieri told BioSpace in an exclusive interview.

InfraredX has developed the Makoto Intravascular Imaging System and Dualpro catheter as a tool to help in the prevention of subsequent heart attacks. The system uses intravascular ultrasound and near-infrared spectroscopy (IVUS+NIRS) to identify vessel structure and composition of lipid plaque. The pools of lipid plaque in the arteries can lead to thrombotic events, said Bottiglieri, who assumed the role of CEO at InfraredX in 2015.

Using the IVUS+NIRS technology has the potential to change the field of interventional cardiology, Bottiglieri said. The combination of two modalities in one catheter is capable of providing cardiologists double the information of other imaging catheters, he said. With this, physicians can select which therapies are best for patients in order to prevent future heart attacks, Bottiglieri said.

The InfraredX device is used similarly to the way physicians used a balloon and stent, Bottiglieri said. Images gathered from the Makoto Intravascular Imaging System and Dualpro catheter show a localized segment of a coronary artery. With the combination of IVUS+NIRS, physicians can determine the chemical composition of lipid pools and use that to gauge treatment options.

Bottiglieri said it’s critical that physicians have the right tool to prevent heart attacks in patients and he believes InfraredX is on the cusp of having a device that will be able to do just that.

“We think this will be meaningful for the field. This could be the Holy Grail for cardiology,” Bottiglieri said.

Whether or not InfraredX has found the key tool for cardiologists remains to be seen. The company though is expecting data from a clinical trial that could support Bottiglieri’s bold prediction. Results from the Lipid-Rich Plaque (LRP) Study could pave the way for a U.S. market launch of the Makoto Imaging System and Dualpro catheter. Data from the trial will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 Scientific Symposium on Sept. 24. The LRP Study is designed to identify a correlation between lipid core plaque (LCP) and the occurrence of major adverse cardiovascular events (MACE) within two years.

Bottiglieri said this will be the definitive trial for the system.

“We never had the data, it was all anecdotal but now will have the definitive trial,” he said.

Bottiglieri said they’ve “long believed” that because of the anecdotal evidence will bear out in the data study. If the data bears out as he expects, Bottiglieri said the company is already eyeing potential clinical studies that pair the system with drugs or prophylactic stent.

Infraredx released the results of that study on Sept. 24. The results show that the company’s technology has the capabilities to successfully identify patients and coronary plaques as vulnerable to future major adverse cardiovascular events (MACE), such as heart attacks. The study met its co-primary endpoints, which included the association of patient-level of max-lipid core burden index (LCBI) with a vulnerable patient, as well as the association of plaque-level maxLCBI with vulnerable plaques, lesions within a pre-imaged segment likely to cause a future MACE in that specific segment.

The company has already commercially launched the system in Japan, where imaging plays a significant part of the Japanese angioplasty procedure, Bottiglieri said.

Bottiglieri said that getting patients to comply with medical recommendations isn’t as easy as it should be. He noted that a physician can tell a patient who is diabetic to quit smoking because of the hazards to their health. For many patients though, the advice falls on deaf ears. Now though, Bottiglieri said the Makoto Intravascular Imaging System and Dualpro catheter can provide a snapshot of the coronary artery that could show those patients there are lipid pools and how that can lead to a heart attack.

“This could help them be more compliant,” he said.

With the data readout close, InfraredX is planning its next steps. The company signed a long-term lease for a space that is about 50 percent larger than its current digs. Bottiglieri said this will allow them to conduct all research and development under one roof in Burlington, Mass.

https://www.biospace.com/article/cp8r-medtech-infraredx-anticipates-trial-data-will-support-holy-grail-of-cardiovascular-imaging-tool/

‘Model Towns’ Treating Dementia Set for Abandoned Big-Boxes, Strip Malls

Senior Helpers, a major provider of in-home senior care services, has launched a nationwide franchise concept called Senior Helpers Town Square.

The concept involves the adaptive reuse of older commercial properties being transformed into specialized treatment centers for dementia. The spaces evoke an earlier period in a dementia patient’s life. Namely, midcentury America.

Toward that end, the George G. Glenner Alzheimer’s Family Centers created the prototype Town Square in Chula Vista, California, in partnership with the San Diego Opera Scenic Studio.

The development, which opened this summer, occupies 9K SF of otherwise unremarkable warehouse space on the town’s Main Street.

A second location is under construction near Baltimore in a former Rite Aid in White Marsh, Maryland, Citylab reports. Senior Helpers will own that facility, which will open in early 2019. A third location is planned for the Chicago area.

https://www.bisnow.com/national/news/healthcare/old-industrial-and-retail-space-gets-new-use-as-places-that-look-old-93244#0