UBS analyst Navin Jacob started Eli Lilly with a Buy rating and $131 price target. The analyst’s analysis suggests the company’s diabetes franchise growth, Verzenio adjuvant trial success and operating margin expansion are not fully appreciated in the stock or estimates
Wednesday, January 23, 2019
Bayer requests that CA judge limit evidence in Roundup trial
Bayer’s Monsanto has asked a California judge in the litigation over Roundup, the company’s glyphosate-based weed killer that allegedly causes cancer, to limit evidence by dividing an upcoming trial into two phases, Reuters reports. The same request was previously successful with a different judge, the report notes
BMO Capital Downgrades Merck (MRK) to Market Perform
BMO Capital analyst Alex Arfaei downgraded Merck (NYSE: MRK) from Outperform
Tuesday, January 22, 2019
Thermo Fisher Blood Test Helps ID Life-threatening Ara h 6 Peanut Sensitization
A new test from Thermo Fisher Scientific helps allergists and other medical providers better predict which patients may be at risk for life-threatening sensitization to Ara h 6, a protein component in peanuts that can cause severe allergic reactions in certain individuals. Thermo Fisher’sImmunoCAP Specific IgE blood test for Ara h 6, part of a line of assays for detecting specific peanut allergen components, has been cleared by the U.S. Food & Drug Administration for in vitro diagnostic use.
Results from Ara h 6 ImmunoCAP testing can act as an aid to help specialists and other clinicians better understand patients’ risk factors as part of tailored allergy treatment or management plans. In some cases, it could reduce the need for oral food challenges, a testing method where a healthcare professional feeds a patient food in measured doses to see if it triggers an allergic reaction.
‘Testing a patient’s sensitivity to Ara h 6 can play a critical role in understanding the likelihood of a future life-threatening reaction,’ said Rebecca Rosenberger, MMSc, PA-C, senior manager, clinical affairs and education, Thermo Fisher Scientific. ‘Adding the Ara h 6 test to the existing ImmunoCAP peanut component assays enables us to provide a more complete view of a patient’s overall peanut sensitization, including whether a patient is at risk for cross-reactivity.’
Advanced diagnostic capabilities for peanut allergies can contribute to better outcomes for allergy sufferers, especially young children. Patients should consult with their healthcare professional or healthcare provider to get tested for individual peanut components. This knowledge helps the clinician understand potential risks, leads to more informed allergy management, and provides renewed peace of mind for patients and parents.
The newest addition to the ImmunoCAP line of component allergy tests also includes assays for cross-reactive carbohydrate determinants (CCD) and profilins, which are both allergens contained in various plants, pollens and foods. Sensitization to CCD and/or profilin usually does not cause any symptoms but is due to cross-reactivity with certain plants and pollens.
ImmunoCAP blood testing is the most widely used specific IgE blood test, and its accuracy has been documented in more than 4,000 peer-reviewed publications. The tests can identify allergic sensitization to common environmental allergens – seasonal and perennial, indoor and outdoor – as well as common food allergies such as peanuts, eggs and milk. ImmunoCAP tests, which are available in most major U.S. laboratories, can be ordered for patients of any age regardless of skin condition, current medication, symptom, disease activity or pregnancy status.
For more information on allergies, symptoms and diagnosis, please visit www.allergyinsider.com.
Johnson & Johnson 2019 revenue forecast misses views
Johnson & Johnson on Tuesday forecast 2019 sales that fell short of analysts’ estimates as the healthcare conglomerate faces increasing competition for some of its older drugs.
The company’s prostate cancer drug Zytiga, an important growth driver, is expected to be pressured by generic competition, while sales of its rheumatoid arthritis drug Remicade has been slipping due to competition from cheaper biosimilar versions.
The company said it expects full-year sales in the range of $80.4 billion (£62 billion) to $81.2 billion, compared with the average analyst estimate of $82.69 billion, according to IBES data from Refinitiv.
In the fourth-quarter, sales rose about 1 percent to $20.39 billion, topping the average Wall Street estimate of $20.20 billion, helped by double-digit percentage growth in sales of Crohn’s disease treatment Stelara and cancer drugs such as Darzalex and Imbruvica.
Strength in the company’s pharmaceuticals business also offset higher costs. In the quarter ended Dec. 31, the company’s litigation expense doubled to $1.29 billion. J&J did not provide a specific reason for the surge in litigation costs and a spokesperson was not immediately available for comment.
The healthcare company is facing more than 11,000 lawsuits over the safety of talc in its products, including baby powder, alleging that its use caused cancer.
Reuters on Dec. 14 published a special report detailing that the company knew for decades that cancer-causing asbestos could be found in the product.
J&J has repeatedly defended the safety of its talc products, saying that decades of studies have shown them be asbestos-free and that they do not cause cancer.
Darzalex and Imbruvica sales saw a double-digit rise in sales to $584 million and $703 million, respectively, in the fourth quarter. Sales of Stelara, also used to treat psoriasis, rose 33.6 percent to $1.44 billion.
While J&J has huge medical device and consumer health divisions, its pharmaceuticals unit has been its main growth driver in recent years.
J.P. Morgan analyst Chris Schott said the positive pharma outlook was tempered by ongoing growth challenges to the company’s medical device and the ongoing talc litigation.
The company posted net profit of $3.04 billion, or $1.12 per share, for the fourth quarter, compared with a loss of $10.71 billion, or $3.99 per share, a year earlier, when it recorded a $13.6 billion charge related to changes to the U.S. tax law.
Excluding items, the company earned $1.97 per share, beating analysts’ average estimate of $1.95 per share.
The company said it expected adjusted 2019 profit in the range of $8.50 per share to $8.65 per share, compared with analysts’ expectation of $8.60 per share.
Walgreens pays $269.2 million to settle U.S. civil fraud lawsuits
Walgreens Boots Alliance Inc will pay $269.2 million to settle two whistleblower lawsuits accusing it of civil fraud for overbilling federal healthcare programs over a decade, the U.S. Department of Justice said on Tuesday.
The pharmacy chain will pay $209.2 million to resolve claims it improperly billed Medicare, Medicaid and other federal programs from 2006 to 2017 for hundreds of thousands of insulin pens it dispensed to patients it knew did not need them.
Walgreens will also pay $60 million to resolve claims it overcharged Medicaid from 2008 to 2017 by failing to disclose and charge the discount drug prices it offered the public through its Prescription Savings Club program.
The Deerfield, Illinois-based company said it “admits, acknowledges, and accepts responsibility” for conduct alleged by the federal government, according to the settlement agreements.
In a separate statement, Walgreens said it “has admitted no wrongdoing,” and that the settlements were in the best interests of customers, patients and other stakeholders.
It also said it set aside enough money for both settlements as of Nov. 30, 2018.
The company recently had more than 9,400 drugstores in the United States.
Walgreens’ settlements resolve claims under the federal False Claims Act, which lets private whistleblowers sue on the federal government’s behalf and share in recoveries.
The accords were respectively approved last week by U.S. District Judges Paul Crotty and Paul Oetken, who both sit in Manhattan.
About $200 million of the payout will go to the federal government, and the rest to state governments.
Walgreens also entered a corporate integrity agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services to ensure future compliance with federal healthcare programs.
Two pharmacists filed the original complaint concerning the insulin pens in July 2015. A copy of that complaint could not immediately be obtained on Tuesday.
Marc Baker, who worked for Walgreens for a decade as a pharmacy manager in Florida, filed the original complaint concerning the drug price discounts in January 2012.
Both lawsuits had been filed under seal.
The cases are U.S. ex rel Rahimi v Walgreens Boots Alliance Inc, U.S. District Court, Southern District of New York, No. 15-05686; and U.S. ex rel Baker v Walgreens Inc in the same court, No. 12-00300.
Sorrento shows fast, durable arthritis pain relief with ‘spicy’ med in early study
A phase 1b study of a nonopioid, nerve-ablating painkiller from Sorrento Therapeutics showed rapid relief of osteoarthritic knee pain that lasted for nearly three months at its lowest dose, prompting the company to begin planning pivotal studies for this year.
Sorrento’s resiniferatoxin injection, or RTX, is 1000 times stronger than pure capsaicin—the compound that gives chili peppers their heat—with an eye-watering score of 16 billion on the Scoville scale. Jalapeño peppers, for example, only range between 3,500 and 8,000 Scoville units, while some of the world’s hottest peppers only break 3 million.
After being injected into the joint, RTX selectively binds to and burns out the nerve endings responsible for transmitting pain signals, while sparing other nerves. In the phase 1b dose-ranging study of about 30 treated patients, pain while walking was reduced by an average of 4.7 points on a 10-point scale compared to the control group after 84 days, with benefits seen as early as the day after the injection.
In addition, there were no dose-limiting toxicities or notable adverse events, the company said in a statement, with doses ranging from 5 to 30 micrograms. Patients will be monitored for one year after injection, according to the study, which is being expanded into phase 2.
“We believe this drug has the potential to rival the best-selling nonopioid pain drugs on the market, and make Sorrento an industry leader in nonopioid pain management,” said Sorrento Chairman and CEO Henry Ji. “We look forward to discussing our phase 1b data with the FDA and plan the final phase of our RTX knee osteoarthritis pain development program.”
RTX was brought up through Sorrento’s pain-focused subsidiary, Scintilla Pharmaceuticals, and is also being studied in treating intractable terminal cancer pain, as an epidural. In 2016, Scintilla had planned to spin out into its own, independent company, following the completed acquisitions of the pain biotechs Semnur Pharmaceuticals and Scilex Pharmaceuticals. However, in October 2017, the deal with Semnur fell through, according to Sorrento’s SEC filings.
Several arthritis drugs have run into trouble in late-phase trials, including Anika Therapeutics’ Cingal and Regeneron’s anti-NGF antibody fasinumab.
Anika’s phase 3 miss in 2018 for its lead candidate, which combines cross-linked hyaluronic acid and the steroid triamcinolone hexacetonide, was unable to outperform the steroid alone after 26 weeks. However, the company does have a positive trial comparing Cingal to a placebo, and is angling for an FDA approval this year.
Regeneron, meanwhile, had to halt the higher-dose arms of a phase 3 study last year, following safety concerns. Fasinumab is being studied in osteoarthritis of the knee or hip, as well as chronic low back pain, across multiple phase 3 trials, the most advanced of which has already enrolled thousands of patients. Regeneron has been testing multiple regimens, but will now focus on the lower doses.
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