Search This Blog

Tuesday, September 18, 2018

AbbVie used kickbacks to boost Humira sales – CA insurance commissioner


AbbVie (ABBV -1.7%) slips on below-average volume in apparent reaction to a lawsuit filed by the California Insurance Commissioner alleging that the company used a “stealthy” network of nurses and kickbacks to doctors to boost prescriptions of top seller Humira.
Commissioner Dave Jones says that, over a five-year period, the company offered physicians various incentives, including cash, meals, drinks, gifts and trips as well as patient referrals, to boost prescriptions for rheumatoid arthritis. The company also allegedly used registered nurses, hired to act as “ambassadors” to visit patients at home and help with administering the drug, to ensure that prescription were refilled, a tactic called “white coat marketing.”
In California, 274K claims for Humira prescriptions were submitted to private insurers who paid out more than $1.2B, according to the lawsuit.
The allegation were initially raised by whistleblower Lazaro Suarez, an RN who worked for QuintilesIMS (now part of IQVIA) and helped develop the network of nurses.
AbbVie is not alone in using nurses to promote medicines. Gilead Sciences (GILD +1.5%), Amgen (AMGN +1.2%), Eli Lilly (LLY +1.2%) and Bayer Pharmaceuticals (OTCPK:BAYRY +0.8%) have apparently used the same approach.

Clovis, executives charged by SEC with misleading investors about cancer drug


The Securities and Exchange Commission announced that Clovis Oncology, its CEO, and its former CFO will pay more than $20M in penalties to settle charges of misleading investors about the company’s developmental lung cancer drug. The SEC’s complaint filed in federal court in Denver alleges that over a four-month period starting in July 2015, Clovis Oncology and CEO Patrick Mahaffy misled investors about how well Clovis’ flagship lung cancer drug worked compared to another drug. According to the complaint, the company’s investor presentations, press releases, and SEC filings stated that the drug was effective 60% of the time, far higher than suggested by actual results available internally. Clovis raised approximately $298M in a public stock offering in July 2015, and saw its stock price collapse in November 2015 after disclosing that the effectiveness rate was actually 28%. The company stopped development on the drug in May 2016. The complaint alleges that certain data provided to Mahaffy and Erle Mast, the company’s CFO at that time, showed that Roci’s efficacy rate was substantially lower than alleged in an investor presentation. In November 2015, after Clovis disclosed the true efficacy using the methodology required by the U.S. Food and Drug Administration, its stock price dropped approximately 70%. The complaint charges Mahaffy with violating Section 17(a)(2) and aiding and abetting Clovis’ violations of Section 13(a). The complaint charges Mast with aiding and abetting Clovis’ federal securities laws violations. The defendants agreed to the settlements without admitting or denying the allegations and the settlements are subject to court approval. Clovis agreed to a $20M penalty. Mahaffy agreed to a $250,000 penalty. Mast agreed to pay a $100,000 penalty and to provide disgorgement and prejudgment interest of $454,145, attributable to selling Clovis stock during the relevant period at inflated prices.
https://thefly.com/landingPageNews.php?id=2792199

Zealand meets primary, key secondary goals in Phase 3 hypoglycemia trial


  • All primary and key secondary endpoints successfully achieved
  • 99% of patients on dasiglucagon recovered from low blood glucose within 15 minutes
  • Median time to plasma glucose recovery of 10 minutes with dasiglucagon
  • Conference call today, September 18 at 5 PM CET/11 AM ET
Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the successful results in the pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes.
Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal® rescue pen for easy, fast and effective treatment of severe hypoglycemia.
The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. The trial compares the glycemic response observed after administration of dasiglucagon with that of placebo and that of currently marketed glucagon, in powder form for reconstitution prior to injection. The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of >/=20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. 168 subjects were included in the trial: 82 to the dasiglucagon arm, 43 to the placebo arm, and 43 to the GlucaGen® arm. Additional details about the trial are found at https://clinicaltrials.gov/ct2/show/NCT03378635.
  • The primary result demonstrates that the median time to blood glucose recovery was 10 min for dasiglucagon, which was superior to placebo (median: 40 min; p<0.001). The median time to recovery for GlucaGen® was 12 min.
  • 99% of subjects were recovered from the insulin-induced hypoglycemia within 15 min following dosing with dasiglucagon, versus 2% with placebo and 95% with GlucaGen®.
Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with similar numbers for dasiglucagon and GlucaGen® (nausea: 55% and 53%, vomiting: 23% and 19%, respectively).
Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma, commented: “I believe that the Phase 3 results are outstanding, and show that dasiglucagon HypoPal® rescue pen could become the fastest rescue treatment for severe hypoglycemia. I am grateful to the patients and clinical investigators who participated in the trial.”
Professor, Dr. Thomas R. Pieber, Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, said: “The results of this Phase 3 trial are impressive in that all patients had clinical relevant increases in blood glucose level within 15 minutes, with a median time to recovery of only 10 minutes. The rapid onset of action suggests that dasiglucagon could become a very attractive treatment option for diabetes patients having a severe hypoglycemic event.”
This is the second Phase 3 trial with positive results for dasiglucagon. The previous Phase 3 trial confirmed dasiglucagon’s safety profile. Zealand will soon initiate a Phase 3 trial in pediatric diabetes patients, which is expected to complete in mid-2019.
Britt Meelby, President and Chief Executive Officer at Zealand Pharma, commented: “The compelling Phase 3 results bring the dasiglucagon HypoPal® rescue pen a significant step closer to a better treatment for people living with diabetes, addressing one of their biggest fears. I am thrilled about this achievement, which represents an important milestone for Zealand in executing our strategy of bringing fully-owned products through registration.”
Conference call today, September 18 at 5 PM CET/11 AM ET
Zealand’s management will host a conference call today, September 18, at 5:00 PM CET/11:00 AM ET to discuss the results of this pivotal phase 3 trial. Participating in the call will be President and Chief Executive Officer Britt Meelby Jensen, Executive Vice President and Chief Financial Officer Mats Blom, and Executive Vice President and Chief Medical & Development Officer Adam Steensberg. The presentation will be followed by a Q&A session.
The conference call will be conducted in English, and the dial-in numbers are:
Denmark:………………….. +45 35 15 80 49
United Kingdom:………… +44 (0)330 336 9128
United States:……………. +1 929-477-0448
Passcode…………………..  4510337
A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, https://edge.media-server.com/m6/p/khb3xico, and will be accessible on the Investor section of Zealand’s website (www.zealandpharma.com).

India, U.S. closing in on package deal to remove trade irritants


 Indian farmers and U.S. manufacturers of medical devices could be among the main winners in a trade package under negotiation, as Washington and New Delhi look to remove long-standing irritants to ties, sources familiar with the talks said.

Having skirmished for months over tit-for-tat tariffs on steel and some agricultural products, the two sides began talks in June that also cover India’s concerns over U.S. steel tariffs and U.S. problems with Indian tariffs on imported IT equipment.
“We are closely negotiating a discrete package of trade issues. It will amount to a pretty substantive agreement,” said a source with knowledge of the negotiations.
Neither the office of the United States Trade Representative or India’s trade ministry responded to a request for comment.
The source said the two sides expected to close the deal in the next few weeks.
U.S. President Donald Trump, who dislikes multilateral trade agreements, said earlier this month that India had approached the United States to “start doing a trade deal,” without giving any details.
The current discussions, however, are focussed on removing outstanding sources of friction, and are not aimed at creating a bilateral free trade agreement, sources from both sides said.
Having already waded into bigger fights with China and the European Union, Trump has previously called out India for unfair trade practices. At an estimated $126 billion, U.S. goods and services trade with India last year was less than a fifth of its trade with China.
Unlike some other countries India failed to be given a waiver after the Trump administration imposed new import tariffs on steel and aluminium imports in March.
New Delhi retaliated by raising tariffs on a number of U.S. products but has held back from implementing them while it negotiates a package to soothe ties. The tariffs were to go into effect from Monday midnight but the government issued an order saying these had been deferred until Nov. 2.
“Our relationship with the U.S. unlike many other nations has not deteriorated,” said an Indian government official involved in the talks. “But if you think relations have become very friendly with a lot of bonhomie, I don’t think that has happened either.”
CAPPING MARGINS, NOT PRICES
U.S. companies are hungrily watching an Indian economy that is growing at more than 8 percent, as they seek presence in a market that has potential for massive growth.
One of the most prominent trade issues to erupt during Trump’s presidency has involved India’s treatment of medical devices imported from the United States. Last year, U.S. exports of medical devices and equipment to India totalled $863 million.
India last year equated high profit margins of medical device makers with “illegal profiteering”, capping prices for some heart stents – small wire-mesh structures used to treat blocked arteries – and knee implants, to help poor patients. That measure provoked a storm of criticism from U.S. companies, such Abbott Laboratories, Johnson & Johnson (J&J) and Boston Scientific, which said such controls hurt innovation and future investment plans.
In June, India’s federal think tank Niti Aayog invited industry views on a new policy which would cap trade margins, and not prices, to help patients while allowing the industry “reasonable profits”.
Two Indian government sources said the think tank had recommended allowing a maximum 65 percent trade margin — the difference between the price at which a company sells to its stockists, after recovering its operational expenses, and the price paid by patients.
The recommendation has still to be accepted by Modi’s office, another source said.
The new policy proposal, which is favoured by both J&J and Boston Scientific according to company letters seen by Reuters, would help manufacturers who have argued that outright price caps were at times below their import costs and led to losses.
Modi’s office did not respond to a request for comment.
BREAKTHROUGH IN FARM PRODUCTS
One of the main areas where India is likely to benefit will be agricultural trade, with Washington expected to grant concessions making it easier for Indian exporters of products like rice, mangoes, table grapes and lychees the sources said.
Currently, the United States imports just a small fraction of the $5.5 billion of rice shipped annually from India, the world’s top rice exporter. New Delhi wants to sell basmati rice but U.S. agencies have in the past flagged concerns over the presence of chemical residues in the rice. New Delhi is also discussing how to meet stringent U.S. standards to sell bovine meat. India is the world’s biggest buffalo meat exporter but has failed to make much headway in the U.S. market because of Washington’s insistence that a country be free from foot-and-mouth disease.
The two sides are exploring ways to open the U.S. market for certain grades of bovine meat from India, according to the Indian government negotiator and the other sources familiar with the talks.
For its part, the United States wants to sell more almonds to India, the world’s top buyer, cherries and eventually dairy products.
The United States has also been urging India to lower the input costs of components for IT that would allow U.S. companies to manufacture in India as part of Modi’s flagship Make-in-India campaign. These affect firms such as Apple Inc and Qualcomm Inc with plans to set up operations in India.
The United States has complained that India’s tariffs are among the highest in the world, and cover a range of IT equipment, including circuit boards, screens and memory chips.
“In this kind of a package, everything is interlinked even though our mutual concerns are on different issues,” one of the sources said.
“But we need to reach an agreement on everything that’s on the table.”

Glaxo grabs new drug development head from Boehringer


GlaxoSmithKline has hired Chris Corsico from German drugmaker Boehringer Ingelheim to fill the new role of senior vice-president development as the company reshapes its research strategy, a spokesman for the British group said on Tuesday.

Corsico, currently chief medical officer at Boehringer, will start at GSK on January 1, reporting to research head Hal Barron.
Barron himself joined GSK at the start of 2018 in a key appointment for new Chief Executive Emma Walmsley, whose top priority is to improve research productivity in pharmaceuticals.

Benefit Gains Exceed Wage Growth, New Labor Data Shows


Americans’ compensation is growing, but workers might not notice it in their regular pay.
The value of benefits — including bonuses and vacation time — grew at a faster rate in the 12 months ended in June than wages and salaries, according to data the Labor Department released Tuesday. That extended a long-running but slow shift in compensation toward benefits and away from wages.
The cost of benefits for private-sector employers rose 3% in June from a year earlier, while the cost of wages and salaries advanced 2.7%.
The benefit gain was driven by a nearly 12% increase in bonuses and other forms of supplemental pay. That likely in part reflects bonuses that many large companies, including AT&T Inc. and Comcast Corp., gave to employees after Congress approved a package of tax cuts.
Increased bonus payments could also indicate firms are using one-time payments to recruit or retain workers, rather than raising their base salaries.
While bonus payments were well up from a year earlier, they were unchanged from March, the last time the data was collected. The data aren’t seasonally adjusted, making monthly comparisons potentially misleading, but the lack of movement could suggest that at least some of those payments may not be repeated.
Paid leave, including vacation time, rose 4% in June from a year earlier. The cost of health-care coverage and other insurance rose 2.3% from a year earlier.
Benefits growth outstripping wage gains is consistent with a recent paper from President Trump’s economic advisers that found broader compensation growth was stronger than the gain in average hourly earnings reported in the monthly jobs report.
Most forms of benefits have been growing at a better rate than wages and salaries since the recession ended in mid-2009.

Spire profit sinks on ‘unprecedented’ UK National Health cutbacks

 Core earnings at UK private hospital operator Spire Healthcare Group sank 21 percent in the first half of 2018, driven by belt-tightening at the National Health Service that cut referrals to its big private providers.

Shares of Britain’s largest independent hospital group dropped 12 percent to an all-time low 148.6 pence after the report, which also predicted full-year core earnings would fall by up to a fifth, to 120-125 million pounds.
Spire, BMI Healthcare and Nuffield Health have helped the NHS cope with pressures on services in recent years, but their earnings and revenue have taken a hit as the NHS prioritises emergency cases and makes cuts elsewhere, focusing on essential health services.
Spire shares have now fallen 40 percent this year.
To mitigate the hit from fewer NHS referrals, Spire – founded in 2007 as a network of 25 Bupa hospitals – said it was reducing capital spending further and focusing on self-paying patients and its own general practitioners.
Chief Executive Justin Ash, who took charge last September, told Reuters after the results he was cutting his forecast for full-year investment for the second time in two months, by another 10 million pounds to 80 million pounds.
“We are investing in to what is a relatively difficult market largely because of the NHS,” Ash said, calling the decline in NHS admissions at Spire hospitals and clinics “unprecedented”.
Ash said in the release the company expected other private providers to suffer similarly from the changing environment, and as one of the UK’s big providers saw opportunities in that.
He said revenue from the company’s private business was up 2.5 percent while self-pay revenue at the firm rose 8.3 percent to 87.3 million pounds in the first half.
NHS revenue, by contrast, fell 10 percent to 140.3 million pounds, pulling down overall revenue by 1.1 percent to 445.6 million pounds in the six months ending June 30.
Spire’s first-half earnings before interest, taxes, depreciation and amortisation (EBITDA) dropped to 66.1 million pounds.
The company’s forecast for full-year EBITDA compared to the consensus of 134.8 million pounds estimated by 11 analysts, according to Thomson Reuters I/B/E/S.
In a separate statement, the company named John Forrest, former chief operating officer of pub operator Greene King retail operations, as its new chief operating officer.
The appointment is the latest in a string of top management changes at Spire, as it looks to combat constraints from the NHS-linked business.
Difficult trading conditions and belt-tightening by the NHS led Australian rival Ramsay Health Care to post a 21 percent fall in annual profit last month.