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.
Wednesday, May 30, 2018
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?”
Allergan to Sell Women’s Health and Infectious Disease Businesses
Allergan will sell off two non-core businesses following a strategic review of the company’s assets, according to multiple reports.
The move will likely quell misgivings some shareholders have had about the state of the pharma giant. In April a group of shareholders banded together to push for change at the company. That move came days before Chief Executive Officer Brent Saunders said he was committed to the company’s business strategy during a rosy review of the first quarter for 2018. However, during that call with investors and analysts, Saunders noted that the company’s strategic review could bring about some changes, including the buyback of shares, divesting assets, splitting the company, M&A activity to spur revenue or continuing as is.
Selling off assets appears to be part of the plan. Today multiple outlets are reporting that Allergan has made a decision to sell its women’s health business and infectious disease business. Business Insider reported that Saunders himself confirmed the sale of the two assets. This morning Saunders spoke to the Bernstein Annual Strategic Decisions conference and said Allergan’s board of directors wants to focus on the company’s four core businesses — eye care, aesthetics, central nervous system diseases and gastrointestinal conditions. Combined the company’s aesthetics business and sales of its dry eye drug Restasis generate about 40 percent of Allergan’s annual income. The decision by the board to sell those two non-core assets was unanimous, reports said.
“We have a very strong pipeline in all those areas. Having a focus on those four areas will make Allergan a more exciting company,” Saunders said, according to Reuters.
Saunders noted that the sale of the women’s business could be delayed due to an expected safety ruling on the company’s uterine fibroids treatment Esmya, Reuters said. That ruling is expected in August. In his interview, Saunders said it’s likely that potential buyers for the women’s health business would want to “wait out” that decision.
No formal deal or timeline for a sale has yet been announced, but the sale of the two businesses could fetch Allergan between $4 and $6 billion, Seeking Alpha noted, citing analysts at Cowen. The women’s health business is valued at about $4 billion and the infectious disease business has a value of about $2 billion.
Despite the potential boon in revenue from the sale of the businesses, shares of Allergan are down this morning. Shares fell to $147.56 earlier today, but have climbed a bit to $150.39 as of 10:39 a.m. Allergan’s stock has fallen about 33 percent since this time last year when it was trading at $243.05 per share.
The sale of the two businesses may not be enough to satisfy the shareholders who have been pushing for change. RBC analyst Randall Stanicky wrote in a note earlier this month that the sale of those two non-core businesses “would not bring in sufficient proceeds for meaningful redeployment of capital and would fail to change how investors value the company,” Reutersreported.
Eiger target cut by Piper
Eiger BioPharmaceuticals price target lowered to $24 from $28 at Piper Jaffray. Piper Jaffray analyst Edward Tenthoff lowered his price target for Eiger BioPharmaceuticals to $24 to account for dilution from the recent financing. The analyst expects Phase II readouts for exendin in hypoglycemia and ubenimex in lymphedema in Q3. He reiterates an Overweight rating on the shares
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