Gilead assumed with an Overweight at Piper Jaffray. Piper Jaffray analyst Tyler Van Buren assumed coverage of Gilead Sciences (GILD) with an Overweight rating and $85 price target. The analyst, after speaking with management, has a “high level of conviction” that pricing for the hepatitis C virus franchise has finally stabilized. It is inconceivable that AbbVie (ABBV) will continue to be irrational on pricing, Van Buren tells investors in a research note.
Wednesday, May 30, 2018
Gilead, Galapagos NV announce Phase 2 study meets primary endpoint
Gilead (GILD) and Galapagos NV (GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at Week 16, as assessed by the American College of Rheumatology 20% improvement score. There was an ACR20 response of 80% for filgotinib versus 33% for placebo. The ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib versus placebo 48% for filgotinib versus 15%; ACR70: 23% versus 6 percent. Filgotinib was generally well-tolerated in the EQUATOR trial, with no new safety signals observed and similar laboratory changes compared to those reported in previous trials with filgotinib in rheumatoid arthritis patients. The adverse event rate was similar in both groups with mostly mild or moderate events reported. There was one serious infection in the filgotinib group, a patient who experienced pneumonia with a fatal outcome. One other patient receiving filgotinib developed herpes zoster. There were no cases of opportunistic infection, tuberculosis, thromboembolism, or malignancy.
Five Prime, Roche collaborate to develop companion diagnostic assays
Five Prime Therapeutics (FPRX) announced it has entered into a collaboration with Roche (RHHBY) to develop immunohistochemistry companion diagnostic assays for use with Five Prime’s first-in-class investigational drug candidates, bemarituzumab, an anti-FGFR2b antibody, and FPA150, a B7-H4 antibody. Five Prime and Roche are collaborating to develop, validate and commercialize a tissue-based IHC companion diagnostic assay to help identify patients whose tumors overexpress FGFR2b and are eligible for treatment with bemarituzumab. The CDx assay will be used in Five Prime’s global registrational study of bemarituzumab in combination with 5-fluorouracil, leucovorin, and oxaliplatin, a regimen known as mFOLFOX6, as front-line treatment in patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification that Five Prime expects to start in the second half of 2018. Five Prime plans to use the Roche IHC assay along with a circulating tumor DNA test in the FIGHT trial to identify the estimated 10 percent of patients with gastric and gastroesophageal junction cancer who would be eligible for treatment with bemarituzumab. Five Prime and Roche will also collaborate to develop and validate a tissue-based IHC diagnostic assay for use as a laboratory developed test to help identify patients whose tumors overexpress B7-H4. Five Prime plans to use this IHC assay in the expansion portion of the ongoing Phase 1 clinical trial of FPA150 to identify patients with advanced or metastatic breast, ovarian, endometrial and bladder cancers whose tumors overexpress B7-H4. Financial terms of the agreement were not disclosed.
Agios started at buy by Piper
Agios Pharmaceuticals initiated with an Overweight at Piper Jaffray. Piper Jaffray analyst Tyler Van Buren started Agios Pharmaceuticals with an Overweight rating and $125 price target. The analyst believes both Idhifa and Tibsovo will experience commercial success while AG-348 for pyruvate kinase deficiency could represent a $750M-plus opportunity. He sees “no shortage of potential opportunities for future value creation.”
Incyte started at buy by Piper
Incyte assumed with an Overweight at Piper Jaffray. Piper Jaffray analyst Tyler Van Buren assumed coverage of Incyte (INCY) with an Overweight rating and $85 price target, stating that he expects Jakafi to produce durable, high-margin revenues approaching $2.5-$3B over the next ten years and predicts Incyte and partner Lilly (LLY) will receive an approval for baricitinib next week.
DOJ Report Claims Purdue Executives Knew OxyContin Was Being Abused
Purdue Pharmaceuticals has named a new head of corporate social responsibility as it continues to grapple with negative attention due to the rampant opioid crisis across the United States.
On Tuesday the company named Lisa C. Miller to the newly created position as the company seeks to “devote greater resources” to initiatives to combat the opioid crisis. The appointment came one day before a scathing Justice Department report showed that executives within the company knew about the abuse of its lead opioid drug, OxyContin in the late 1990s and early 2000s, despite assertions that it was unaware. In a long and detailed report, CNBC noted that the DOJ report showed that federal prosecutors found that the executives at the company know about “’significant’ abuse of OxyContin in the first years after the drug’s introduction in 1996 and concealed that information.”
According to the report officials at the company knew the OxyContin pills were being crushed and snorted as abusers sought to get high faster. Citing internal reports from Purdue sales representatives, the DOJ said the words “street value,” “crush,” or “snort” were used 117 times between 1997 and 1999.
Additionally, the federal report said that the company was aware that its product was being stolen from pharmacies and that some doctors were being charged with selling prescriptions, CNBC reported. Despite that knowledge, the DOJ report said that Purdue Pharma continued to market OxyContin as “less prone to abuse and addiction than other prescription opioids.”
A Purdue spokesperson told CNBC that the company is making strides to address opioid abuse. But, the spokesperson also criticized the DOJ report.
“Suggesting that activities that last occurred more than 16 years ago are responsible for today’s complex and multifaceted opioid crisis is deeply flawed,” the unnamed Purdue spokesperson told CNBC in a statement.
At one time Purdue was highly aggressive in the way it marketed OxyContin. Company tactics have been so aggressive that lawsuits have been filed against Purdue. The state of West Virginia filed a lawsuit against Purdue and Abbott Labs, which marketed OxyContin from 1996 to 2002. The lawsuit highlighted incentives that were used to boost sales. More than a decade ago Purdue Pharma was forced to pay more than $600 million in fines after the company pleaded guilty in 2007 to a criminal charge of misbranding OxyContin in an effort to mislead doctors and consumers.
Earlier this year Stamford, Conn.-based Purdue announced it was cutting its sales force in half as the company changes its marketing strategy for its chronic pain pill that for many has become the poster child of opioid abuse. Purdue said it will no longer be promoting opioids to prescribers. In a statement on its website, Purdue said there are too many opioid prescriptions that are now in the medicine cabinets of people across the United States. Purdue said it supports initiatives to limit the length of first opioid prescriptions.
With the appointment of Miller to the newly created role, Purdue it attempting to address some of the mistakes the company made in its past with OxyContin. Craig Landau, president and chief executive officer of Purdue, said the idea of corporate social responsibility has become an increased priority for Purdue as it continues to work to address the opioid crisis that claims the lives of an estimated 116 people in the United States each day.
“Our commitment to devote even greater resources to this area closely follows our recent decision to discontinue sales representatives’ promotion of opioids to prescribers and speaker programs associated with our opioid products,” Landau said in a statement.
Sanofi Quick to Keep its Distance from the Roseanne Barr Scandal
Oddly enough, one of the biggest news stories this week was how a TV star was fired for making a racist tweet. In this case, Roseanne Barr, who had been out of the spotlight and relatively free of scandal since her original “Roseanne” TV show went off the air in 1997, only took two months after the show rebooted this year, to get in hot water—and lose her job.
Since coming back into the spotlight two months ago with the successful relaunch of “Roseanne,” she courted controversy with comments concerning immigration, the Parkland school shooting, and various racist and anti-Semitic conspiracy theories.
The straw that broke the camel’s back, or at least forced the hand of ABC and its parent company, Disney, was a tweet about Valerie Jarret, an advisor to President Barack Obama.The tweet, since deleted, read: “muslim brotherhood & planet of the apes had a baby=vj.”
She later apologized, but ABC had enough. ABC President Channing Dungey, herself African-American, said in a statement, “Roseanne’s Twitter statement is abhorrent, repugnant and inconsistent with our values, and we have decided to cancel her show.”
In addition, ICM Partners, Barr’s talent representatives, parted ways.
Not long after, perhaps in an attempt to back-pedal or merely rationalize, she blamed her use of sleep medication Ambien, manufactured and marketed by France drug company Sanofi. She tweeted, “guys I did something unforgiveable so do not defend me. It was 2 in the morning and I was ambien tweeting—it was memorial day too—I went 2 far & do not want it defended—it was egregious indefensible. I made a mistake I wish I hadn’t but…don’t defend it please.”
Sanofi was quick to respond on their own Twitter account, stating: “People of all races, religions and nationalities work at Sanofi every day to improve the lives of people around the world. While all pharmaceutical treatments have side effects, racism is not a known side effect of any Sanofi medication.”
It’s not as if Roseanne Barr wasn’t controversial during the first run of the show or even afterwards. In 1990, she performed a mock Star-Spangled Banner performance and grabbed her crotch at the end, which then-President George HW Bush called “disgraceful.”
Barr, who herself is Jewish, in 2009 did a photoshoot for the satirical Jewish magazine Heebwhere she dressed up like Adolph Hitler, shown pulling burned people cookies out of an oven.
And those are just to name two prominent scandals over the last almost 30 years.
Several of Barr’s co-stars were also quick to criticize Barr as she was ushered out the door, even though Barr took a few hours before lashing back. One was Sara Gilbert, who was an executive producer on the show instrumental in bringing the reboot back on the air. She tweeted, “Roseanne’s recent comments about Valerie Jarrett, and so much more, are abhorrent and do not reflect the beliefs of our cast and crew or anyone associated with our show. I am disappointed in her actions to say the least.”
There is speculation that Gilbert’s “and so much more” hints that there may have been other contributing factors to the cancellation of the show, which would be consistent with stories of turmoil behind the scenes on the show’s first run.
Many observers were waiting for President Trump to voice an opinion on the Barr scandal, because she has been an outspoken supporter of his policies and statements. One of her pet topics were accusations that billionaire financier and philanthropist George Soros was a Nazi. In one well-known Twitter tirade, Barr claimed that Chelsea Clinton, daughter of former President Bill Clinton and Secretary of State Hillary Clinton, had married a nephew of Soros. In part of the Twitter exchange between the two women, Barr tweeted, “By the way, George Soros a nazi who turned in his fellow Jews 2 be murdered in German concentration camps & stole their wealth-were you aware of that?”
President Trump’s son, Donald Trump Jr., retweeted the message.
President Trump, on his part, recently did wade into the controversy, apparently ubnable to resist, tweeting, “Bob Iger of ABC called Valerie Jarrett to let her know that ‘ABC does not tolerate comments like those’ made by Roseanne Barr. Gee, he never called President Donald J. Trump to apologize for the HORRIBLE statements made and said about me on ABC. Maybe I just didn’t get the call?”
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