Wednesday, January 23, 2019
Biohaven allowed to proceed with BHV-3241 Phase 3 clinical trial
Biohaven Pharmaceutical (BHVN)announced the FDA has notified the company that it may proceed with its clinical investigation of BHV-3241, a novel myeloperoxidase, or MPO, inhibitor, which Biohaven is developing as a potential treatment for multiple system atrophy, or MSA. The FDA May Proceed Letter was received following Biohaven’s reactivation of the investigational new drug, or IND, application initially filed by AstraZeneca (AZN) prior to licensing the compound to Biohaven.
https://thefly.com/landingPageNews.php?id=2852065
Teva upgraded to Neutral from Underweight at Piper Jaffray
Piper Jaffray analyst David Amsellem upgraded Teva Pharmaceutical to Neutral and raised his price target for the shares to $16 from $15. The analyst says that while the “reality of the erosion” of Copaxone is not lost on him, he no longer perceives downside risk that is “significantly greater than that of other major U.S. generics companies.” He sees a more balanced risk/reward on the shares after removing the risk of further “dramatic erosion” of EBITDA going forward. UBS this morning also upgraded Teva.
https://thefly.com/landingPageNews.php?id=2852081
Boston Scientific Backs Stents in Wake of JAHA Article and FDA Investigation
The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death. In a January 17, 2019 letter to health care providers, the U.S. Food and Drug Administration (FDA) indicated it was evaluating available long-term follow-up data to determine if there were any long-term risks associated with the devices, but had drawn no conclusions as of yet.
Boston Scientific is defending their products, indicating it will work with the FDA. “Patient safety is our highest priority,” the company said in a statement to the Boston Business Journal. “We will continue to advance the clinical evidence of our (drug)-eluting technologies, and work in partnership with the FDA to reinforce safety and efficacy profiles.”
The device, Eluvia, launched last year for peripheral artery disease (PAD). It was approved by the FDA in September 2018. This is an illness where plaque accumulates in the arteries in the legs and decreases blood flow, which causes swelling, ulcers and possible limb amputation. According to Boston Scientific, it affects about 8.5 million people in the U.S.
The device is coated in or releases a chemotherapy drug, paclitaxel. The drug is used to prevent tissue from regrowing that might block the stented artery.
JAHA analyzed 28 different clinical trials and found that patients implanted with the devices had a mortality rate a year after surgery that was the same as patients who did not receive the devices. However, five years later, there was a 14.7 percent death rate compared to 8 percent in the placebo group.
Boston Scientific, in its defense, also raised the FDA’s statement that the benefits of the devices outweighed their risks.
One study, which lasted a year, found Eluvia to be safer and more effective a year after surgery compared to a competitive drug-coated product from Cook Medical, based in Bloomington, Indiana.
In its letter to physicians, the FDA recommended they continue to observe their patients who received the paclitaxel-coated balloons and paclitaxel-eluting stents, discuss the risks and benefits of all available treatments with their patients, and report any adverse or suspected adverse events related to the devices.
“The FDA is currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products,” the FDA wrote. “This will include an evaluation of long-term follow-up data from studies that supported approval of paclitaxel-coated balloons or paclitaxel-eluting stents in the U.S. and other available data sets. This review will focus on causes of death, the paclitaxel dose delivered, and patient characteristics that may impact clinical outcomes. Additional statistical analyses will be performed to clarify the presence and magnitude of any long-term risks. We are working with manufacturers of paclitaxel-coated balloons and paclitaxel-eluting stents to better understand this issue.”
FDA also noted there were a number of such devices approved or being studied in the U.S. “Currently, the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications or use.”
Companies Continue to Develop Treatments for Opioid Addiction
Opioid abuse and overdose deaths saw a sharp spike in the late 1990s through today. From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids, according to the U.S. Centers for Disease Control and Prevention (CDC).
Countless lawsuits have been brought against opioid manufacturers by local governments as part of an effort to regain some compensation for the public resources spent battling opioid overdoses and addiction. It’s important to note that many of those issues facing communities across the United States are not fully laid at the feet of prescription opioids. Illegal opioids such as heroin and fentanyl play a significant role. Still, the CDC noted that overdose deaths involving prescription opioids were five times higher in 2017 than in 1999.
In August, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing medication-assisted treatments (MAT) for patients battling opioid addiction. Medication-assisted treatment (MAT) includes popular drugs such as buprenorphine, methadone and naltrexone. The medications are prescribed to curb the euphoric effects of opioids and reduce the body’s cravings.
Companies have certainly been focused on developing treatments to combat addiction and withdrawal symptoms. Last year, the U.S. Food and Drug Administration (FDA) approved a generic version of Suboxone (buprenorphine and naloxone) developed by India-based Dr. Reddy’s and co-developer Mylan NV. Buprenorphine and naloxone are both used to treat adults who are dependent on or addicted to opioids. Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs. Naloxone reverses and blocks the effect of opioids.
Also last year, the FDA approved US WorldMeds, LLC’s Lucemyra (lofexidine hydrochloride), the first non-opioid treatment for management of opioid withdrawal symptoms in adults. Lucemyra was approved for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. The medication is only approved for a 14-day treatment cycle.
When Lucemyra was approved, FDA Commissioner Scott Gottlieb said the regulatory agency has been developing processes to accelerate the development of better treatments for opioid addiction, including those that help manage opioid withdrawal symptoms.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms,” Gottlieb said in a statement.
A recent report noted that the more marketing dollars were spent on doctors led to a higher rate of opioid prescriptions being written. That, of course, helped contribute to the levels of abuse and addiction and, ultimately, overdoses. Opioid dependency has become a focus for some drug manufacturers. There are certainly some treatments currently available, such as Suboxone or methadone, which are used to help addicts break their addiction. Also, Opiant’s Narcan (naloxone) has been instrumental in saving the lives of countless overdose victimsacross the United States.
As the opioid crisis became national news, prescribing rates of the medication have fallen off. That has happened in part due to some states passing laws regarding limits of opioids that can be prescribed, as well as the rise of other options available for acute pain.
Theranos Documentaries Unveiled as Attorneys Wrangle On Criminal Charges
The story of Elizabeth Holmes and her failed biotech Theranos has become something of a cautionary tale for entrepreneurs. Holmes has been charged with massive fraud for her role in securing hundreds of millions of dollars from investors through lies and deceit about the company’s products.
But even as Holmes and her former partner Ramesh “Sunny” Balwani, who served as company president and chief operating officer, face potential prison sentences of more than a decade for fraud, their stories have become the subject of Hollywood. Hollywood star Jennifer Lawrence signed on to play Holmes in a big-screen adaptation of “Bad Blood,” the book by The Wall Street Journal’s Pulitzer Prize-winning investigative journalist John Carreyrou. Additionally, two documentaries are planned that will tell the story of Holmes and her Svengali-like ability to raise money from investors and curry favor with powerful political leaders, such as former Secretary of Defense Gen. James Mattis and former Secretary of State George Schultz, both of whom served on the company’s board of directors.
This week at the annual Sundance Film Festival, documentarian Alex Gibney will unveil “The Inventor: Out For Blood In Silicon Valley,” a story that looks at the rise and fall of Holmes and Theranos. Gibney, who won an Academy Award in 2008 for his documentary “Taxi to the Dark Side,” teamed up with HBO Documentary Films to tell the story of Theranos. Last year, Gibney said the documentary will include “never-before-seen footage of key company insiders” to tell the story of Theranos. In an interview with the Associated Press last year, Gibney said it will examine how the company flourished and the “psychology of deception.”
Also this week, ABC News will unveil its documentary on Holmes called “The Dropout.” The ABC documentary will air on Jan. 23 on ABC’s “Nightline.” According to Reuters, “The Dropout” will include an interview with Balwani’s attorney, along with “never-before-aired deposition tapes of Balwani, Holmes, three former members of the Theranos board, and others.” After charges were filed against Balwani last year, his attorney Jeffrey Coopersmith told BioSpace that his client was innocent of the charges and that he did not defraud customers or investors.
Both Holmes and Balwani have pled not guilty to the criminal charges filed against them. The criminal fraud charges allege the two engaged in a multi-million dollar scheme to defraud investors, and a separate scheme to defraud doctors and patients. According to the indictment, Holmes and Balwani used advertisements and solicitations to encourage and induce doctors and patients to use Theranos’ blood testing laboratory services, despite the fact that Holmes and Balwani knew the company’s proprietary device was “not capable of consistently producing accurate and reliable results for certain blood tests,” the government said.
While Holmes has pled not guilty to the criminal charges, last year, after the U.S. Securities and Exchange Commission brought charges against the duo, she agreed to pay a $500,000 fine.
The criminal case has not yet gone to trial. That may take a while, as Law360 reported the U.S. Department of Justice and the former Theranos executives “have been bogged down in a prodigious discovery battle involving access to roughly 17 million pages of documents.”
In addition to the criminal charges against Balwani and Holmes, a class action lawsuit against Theranos could be going forward in Arizona. The proposed lawsuit is not only aimed at Theranos, but also its former partner Walgreens, which had a deal with the company. That potential lawsuit though has been affected by the fact that Theranos has shut down and has no funds, Law360 reported.
Intercept initiated at UBS
Intercept initiated with a Buy at UBS. UBS analyst Navin Jacob started Intercept Pharmaceuticals with a Buy rating and $130 price target. The company’s Phase III Regenerate study of Ocaliva in nonalcoholic steatohepatitis, with a readout in Q1 of 2019, is a “true binary event” with a potential valuation swing of 60% in either direction, Jacob tells investors in a research note. The analyst sees a 65% chance of success for the trial. Jacob says Intercept shares have “significant risk but with potential for high reward.”
https://thefly.com/landingPageNews.php?id=2852051
Mizuho sees ‘significant upside’ in Nektar shares, reiterates $81 price target
While shares of Therapeutics (NKTR) have performed strongly year-to-date, “significant upside remains,” Mizuho analyst Difei Yang tells investors in a research note. A recent Nature article on IL-2 immunotherapy and new players in the field provide support for Nektar’s approach to immuno-oncology, says Yang. Further, she believes the company’s collaborations with large pharma, including Bristol-Myers Squibb (BMY) and Pfizer, underscore the “strong potential” of NKTR-214. With multiple data readouts expected in 2019, Yang sees “significant value” in Nektar shares. She reiterates a Buy rating on the name with an $81 price target. The stock closed yesterday down 3% to $44.76.
https://thefly.com/landingPageNews.php?id=2852049
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