JPMorgan analyst Jessica Fye upgraded Esperion Therapeutics to Neutral from Underweight and raised her price target for the shares to $47 from $38. The analyst sees a “less bumpy year” for bempedoic acid.
Wednesday, March 13, 2019
Fluidigm price target raised to $14 from $10 at Piper Jaffray
Piper Jaffray analyst William Quirk raised his price target for Fluidigm to $14 from $10 after traveling with management. The analyst is now “incrementally more confident” in Fluidigm’s opportunity to maintain higher mass cytometry growth and opportunistically grow its genomics business. He believes genomics could be the largest source of 2019 upside and that Fluidigm is benefiting from the economies of strong customer relationships such as CareDx. Quirk keeps an Overweight rating on the shares.
https://thefly.com/landingPageNews.php?id=2878271
https://thefly.com/landingPageNews.php?id=2878271
Pyxus opens industrial hemp extraction and purification center in North Carolina
Pyxus International announced the opening of its affiliate, Criticality, LLC’s, industrial hemp extraction and purification facility located in Wilson, North Carolina. The 55,000 square foot state-of-the-art facility was unveiled during a ribbon cutting ceremony and grand opening event on March 12. The facility is designed to follow good manufacturing practices and operate in compliance with dietary supplement standards. The hemp processed at the facility will be used to expertly craft and responsibly produce “Korent,” Criticality’s line of cannabidiol oil products, as well as develop new products in its innovation pipeline.
Inovio’s recent financing paves the way for opportunities, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond kept his Overweight rating and $12 price target on Inovio after its Q4 results, saying the management’s update also gave him “more granularity” on the timing of Phase 3 Reveal 1 and 2 trials. The analyst notes that his current model only accounts for VGX-3100 opportunity in cervical dysplasia, but he sees additional updates for VGX-3100 and immuno-oncology candidates in the second half of 2019 also potentially serving as value-creating catalysts for Inovio stock.
Piper dermatologist survey offers ‘good news/bad news’ for AbbVie
Piper Jaffray analyst Christopher Raymond views his firm’s survey of 101 U.S. dermatologists as “good news/bad news” for AbbVie’s dermatology franchise. On the positive side, due to both AbbVie’s “significant goodwill” as well as risankizumab’s superior clinical profile, dermatologists indicate “significant uptake” of the drug once approved, Raymond tells investors in a research note. On the negative side, Humira continues to lose market share to newer biologics like anti-IL-17s and approved anti-IL-23s at a “rapid pace” that may be accelerated by cannibalization at the hands of risankizumab, adds the analyst. Following the surgery, Raymond remains comfortable with his below-consensus AbbVie revenue estimates this year and next. He keeps a Neutral rating on the shares with a $90 price target.
https://thefly.com/landingPageNews.php?id=2878269
https://thefly.com/landingPageNews.php?id=2878269
Tuesday, March 12, 2019
Maryland House of Delegates approves legalizing medically assisted suicide
Following an intense and emotional debate that brought some lawmakers to tears, the Maryland House of Delegates approved a bill Thursday that would allow terminally ill adults to obtain prescription drugs they could take to end their lives.
It was the fourth attempt to pass the bill; it has failed in three past General Assembly sessions. Thursday’s vote was 74-66 — three votes more than the 71 votes required for passage.
Del. Eric Luedtke choked up as he described how he moved from being an opponent of the idea to a supporter.
The Montgomery County Democrat said he was long opposed to suicide, having had three relatives attempt it. But then his mother fell ill with esophageal cancer in 2014 and lost her independence and control of her body. A few days before she died, he found her in the kitchen, drinking a bottle of liquid morphine in an attempt to end her life.
“I began to ask myself what right I had, as a government official, and even as her son, to dictate to her how her life should end? What right do any of us have to determine that for another individual?”
Struggling to hold back tears, Luedtke said he was voting for the bill because it represented “restoring to people like my mother the ability to make a decision for themselves. A final decision for themselves.”
Luedtke was among several delegates who gave heartfelt, wrenching testimony during the somber debate that lasted nearly 90 minutes. Several shared stories of loved ones who died painful deaths or their own experiences with serious diseases. Others invoked their faith, saying that it’s not up to humans to decide when they die.
At times, delegates wiped away tears. Others bowed their heads or looked skyward in contemplation.
“This is an intensely painful issue for all of us,” said Del. Geraldine Valentino-Smith, a Prince George’s County Democrat who spoke against the bill.
After the vote was taken, Del. Shane Pendergrass, the bill’s sponsor, smiled and fist-bumped Del. Kumar Barve.
“I think that the quote that ‘Every person is one bad death away from supporting this bill’ was prophetic. It has been the thing that has resonated most with me over the years,” Pendergrass, a Howard County Democrat, said in an interview.
A companion bill sponsored by Sen. Will Smith is pending in the state Senate.
The legislation would allow a doctor to prescribe drugs to a patient that the person could take to end his or her life. The patient must be at least 18 years old and have a terminal illness with a prognosis of less than six months to live. The patient must request the prescription on three occasions, including once in private and once in writing — provisions meant to prevent patients from being coerced.
Supporters said having the option of medically assisted suicide would allow people to maintain control and die without suffering.
Del. Sandy Bartlett described the excruciating pain she suffered while in treatment for bilateral breast cancer. Having confronted her mortality, Bartlett, an Anne Arundel County Democrat, said she doesn’t want to suffer in death.
“I do not want anyone forcing me to live in pain or in a drugged state or die humanely in starvation in hospice,” she said.
Some delegates used their personal stories to argue the opposite point — that it’s not appropriate to end anyone’s life prematurely.
Del. Cheryl Glenn recounted her sister’s final days after a stroke, when she thinks her sister might have ended her life if she had had the option.
But living a few days longer allowed her sister’s estranged son to travel from overseas, and the two reconciled. Had her sister killed herself, “she would have left this world without making peace with her only son,” said Glenn, a Baltimore Democrat.
Glenn said the experience reminded her: “We don’t know what tomorrow holds, we really don’t.”
Others cited their faith, saying that they believe that life and death are in the hands of God, not human beings.
“Are we becoming above God?” asked Del. Ric Metzgar, a Baltimore County Republican.
Del. Jay Walker recalled the gospel song lyrics: “Lord, lift us up where we belong.”
“It doesn’t say, ‘Doctor, take us where we belong’ or ‘Nurse, lift us up where we belong,’ ” Walker said. “It says, ‘Lord, lift us up where we belong.’ ”
Walker, a Prince George’s County Democrat, said allowing people to end their lives amounts to “overstepping our bounds.”
As on the House floor, the bill has been the subject of lengthy committee hearings full of intimate stories on both sides of the issue. Several hundred people demonstrated against the bill Monday during a March for Life in Annapolis.
Jennifer Briemann, director of the Maryland Catholic Conference, issued a statement praising delegates who had the “courage to stand up to the out-of-state interests pushing this predatory agenda.”
She called on state senators and Republican Gov. Larry Hogan to prevent “this dangerously flawed bill” from becoming law.
Kim Callinan, CEO of Compassion & Choices, an Oregon-based organization that promotes such legislation, observed the debate from the House balcony. She said with baby boomers beginning to reach retirement age, they are dealing with deaths of their parents and peers, causing them to rethink their views on death experiences.
A recent poll from Goucher College found 62 percent of Marylanders support allowing terminally ill patients to obtain medication to end their lives.
Six states and the District of Columbia have laws allowing doctors to prescribe lethal prescriptions to qualifying patients. Seventeen states are considering similar legislation, according to state analysts.
Doctors, too, are becoming more supportive of the bills, Callinan said. MedChi, the Maryland State Medical Society, previously opposed the bill but took a neutral stance this year.
Smith, the lead Senate bill sponsor and a Montgomery County Democrat, said he was optimistic about the legislation’s chances after the House vote.
“It gives us a lot of momentum in the Senate,” he said. “I suspect that the Senate floor will be a very close vote.”
Hogan, a Republican, has not committed to a position on the bill. He has said that it is “one that I really wrestle with from a personal basis” and that he would give it careful consideration if it reaches his desk.
Cowen Conference Spotlight: Biogen, Regeneron and Lilly
With Cowen and Company’s 39th Annual Health Care Conference going on in Boston this week, a lot of stories in the biopharma industry are coming out. Here are a few highlights.
Biogen Emphasizes Pipeline Other Than Aducanumab
Biogen’s chief executive officer Michel Vounatsos participated in an interview with Cowen & Company analyst Phil Nadeau. One of the striking things was that Vounatsos stated almost immediately that “Importantly, we have enriched and advanced our pipeline portfolio very well beyond aducanumab.”
An ongoing area of intense interest is Biogen’s aducanumab for Alzheimer’s disease, which in a desert wasteland of failed clinical trials, aducanumab sometimes feels like the sole survivor, with big expectations for its clinical trials in the next year or two. But Vounatsos’ discussion emphasized the company’s many efforts and pipeline projects other than aducanumab, saying, “Beyond aducanumab and the leading AD (Alzheimer’s disease) portfolio, Biogen certainly has ALS compounds, has PSP compounds. So, beyond, MS, SMA, we have now neuromuscular franchise opportunity, we have ophtha franchise opportunity, we have AD franchise opportunity, movement disorders and stroke where we are now in Phase III. So, this opportunity to bring forward this pipeline in the early 2020 is actually what this team was able to deliver, while at the same time, continue to deliver on the current base.”
Regeneron’s Praluent Grows Despite Patent Battles
Regeneron Pharmaceuticals’ senior vice president, Portfolio Management, Jay Markowitz, and executive vice president, Finance, and chief financial officer, Robert Landry, spoke with Cowen analyst Yaron Werber. The discussion was wide-ranging, and of course, the company’s relationship with Paris-based Sanofi came up because of their long-term development and commercialization partnerships. The two companies have been engaged in patent lawsuits with Amgen over their Praluent versus Amgen’s Repatha, both for hard-to-treat cholesterol. A recent court decision in Germany went to Amgen, there’s an injunction in Japan, and there was an appeal decision in the U.S. recently, with the U.S. Supreme Court refusing to hear Amgen’s case. As a result, Werber asked about Regeneron’s strategy and outlook for the drug.
Landry responded, “I would say with that product, everything is on the table. What we’re trying to do with our Sanofi friends are to ensure that the OpEx (operating expense) pertaining to that product right now is in a space where we continue to maintain some share of voice because we’re going against a pretty big competitor with regards to Repatha. So we want to maintain some share of voice but yet have it very monitored in such a way that if it’s only going to develop X amount of sales, that we’re able to make profitability off of that product. So currently, it is wait-and-see, and we continue to look at options in terms of how this is going to play out.”
Which seems to be a way of saying they don’t plan to abandon it, but they’re working on ways to keep it profitable.
And Markowitz notes that, considering cardiovascular disease is the leading cause of death in the developed world and the class of drugs that Praluent and Repatha belong in are safe and effective, “It’s stunning to me that the class of drugs is not used more broadly and more widely and that these—and that the whole focus of this has been on what’s the IP position in the patents.”
Which is a tiny bit disingenuous, given that the PCSK9 inhibitors like Praluent and Repatha run about $14,000 per year compared to the standard-of-care, statins, which run about $600 per year.
For all the IP issues, Praluent sales grew about 40 percent in the U.S., bringing about $300 million globally.
Eli Lilly Closes Elanco Separation, Digs into Oncology and Focuses Diabetes
Eli Lilly’s executive vice president and chief financial officer Josh Smiley was interviewed by Cowen’s Steve Scala. It began with the recent news on the Elanco separation, which was announced last year, and made up about 15 percent of Lilly’s topline. Smiley said, “We IPOed 20 percent of the shares in September of last year, and then we concluded that exchange this morning and announced that it was successful. We actually had about a little bit more than five times the oversubscription. So, the Proration factor was about 13 percent for people who chose to participate.”
He noted that some of the company’s debt will drop because of Elanco, but that will be offset by the debt the company incurred when it acquired Loxo Oncology for about $8 billion. That led to a discussion of the Loxo deal, with Smiley saying, “What got us the most excited was as we looked at that LOXO-292 data and understood the patient population around the world … we felt quite confident that there is a big enough patient base and the efficacy and safety data that we see so far is compelling that there is a significant commercial opportunity. So, we think the 292 is derisked clinically. We’re confident that we’ll have enough data before the end of the year to submit and be ready to launch the product in 2020.”
LOXO-292 is a first-in-class oral RET inhibitor granted Breakthrough Therapy designation by the FDA for three indications.
They also discussed the diabetes drug Trulicity, particularly as it faces competition from other GLP-1 analogs. Smiley said “We see lots of opportunity in the GLP space overall. From an overall patient population perspective, our data still says that only about 3 out of 10 patients who get a first injection are getting a GLP versus a basal insulin, I think that that data should be much closer to 100 percent. So, there’s a lot of room for patient growth in the class. Now, what we see with Trulicity is we think a very well-positioned product to help continue to enable that growth.”
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