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Tuesday, January 22, 2019

UnitedHealthcare, fueled by fed probes, sues generics makers for price fixing


Thanks to groundwork laid by state AGs—who’ve been going after generics companies for alleged price fixing—UnitedHealthcare is suing dozens of copycat drugmakers for essentially the same thing. And the insurance giant is trying to claw back money it spent on allegedly overpriced drugs.
In a 355-page lawsuit, UnitedHealthcare sued the companies for collusion, naming a group of “core conspirators” that includes Teva and Mylan, as well as dozens of other drugmakers. UnitedHealthcare, the largest insurer in the U.S., aims to claw back financial losses it says it suffered because of the inflated prices.
Filed in Minnesota federal court, UnitedHealthcare’s suit leans on government evidence and press reports detailing an industrywide effort by generic drugmakers to artificially jack up prices. The insurer claims the core conspirators directed other generics companies to price their drugs in accordance with their scheme.
The evidence backing its claims is “well established at this point,” the new lawsuit says, pointing to guilty pleas from former execs at small generic drugmaker Heritage Pharmaceuticals, plus a lawsuit from dozens of state attorneys general and an ongoing federal probe.
“Unprecedented price increases” for drugs named in the suit came with the “absence of any reasonable economic or market explanation for these price increases other than collusion,” the suit says. To decide on pricing, the generic drug execs talked by telephone, email and text, and met in person at trade association meetings, the suit claims.
As industry watchers know, UnitedHealthcare’s lawsuit is far from the first of its ilk. Rival insurer Humana, for instance, already sued generic drugmakers making the same allegations.
And meanwhile, federal investigators have issued subpoenas to Mylan, Teva, Actavis, Sandoz, Endo, Par Pharmaceuticals, Sun Pharmaceuticals, Impax, Lannett, Mayne, Dr. Reddy’s, Sandoz, Aurobindo and Taro, according to company disclosures. The Department of Justice executed search warrants at offices for Perrigo, Mylan and Aceto, according to the lawsuit.
All in all, UnitedHealthcare argues the conspiracy was “effective and is still ongoing.” It’s seeking damages, an injunction and more.
Government officials have been investigating generic pricing collusion since 2014. Last month, Connecticut Assistant Attorney General Joseph Nielsen told the Washington Post the probe had expanded to 300 drugs. As the new lawsuit notes, the investigation so far has yielded guilty pleas from two former executives of Heritage Pharmaceuticals who are now cooperating with investigators.
Connecticut Attorney General Jepsen and dozens of other attorneys general have also sued generics makers for alleged collusion. The states say the companies referred to the generic drug market as a “sandbox” where they were supposed to “play nice” with one another. Meanwhile, the Department of Justice has its own investigation underway, and criminal charges could come from that effort.

Discounting hit J&J’s Xarelto hard. Can a new launch turn things around?


Competition and discounting are understandably plaguing Johnson & Johnson’s older drugs. But its cardiovascular blockbuster Xarelto is also on that list.
The New Jersey drugmaker reported a 14.4% dip in fourth-quarter sales for the anticoagulant, which competes against Pfizer and Bristol-Myers Squibb’s hotshot Eliquis and Boehringer Ingelheim’s Pradaxa. J&J attributed the ding to U.S. discounting in the competitive market.
But that’s not to say J&J doesn’t have plans to counteract that trend. With a recent blockbuster nod in coronary and peripheral artery disease in hand, though, company leaders hope they can soon reverse the trajectory.
“We would expect the CAD and PAD indications to be a differentiating factor moving forward” and to “expand not only market share for the brand but also the market itself, as it’s going to reach a broader base of patients,” execs said on the company’s earnings conference call.

Johnson & Johnson is certainly hoping so, as it’s already dealing with declines for its elderly treatments. Generics to prostate cancer med Zytiga triggered a 12.7% drop in U.S. sales, while hypertension giant Tracleer declined by 25.7% worldwide as follow-up Opsumit gained ground and European generics picked up steam. Meanwhile, anti-inflammatory blockbuster Remicade is clinging to a whopping 93% of its market despite biosimilar competition, though discounts brought its U.S. sales down by 21.4% for the quarter.
Q4 pharma sales still grew by 5.3% worldwide despite those hurdles, though, thanks in large part to the company’s cancer and immunology units. Sales of multiple myeloma-fighter Darzalex skyrocketed by nearly 60% globally, and based on Q3 data, the drug recorded a six-point increase in U.S. market share across all lines of therapy, said Chris DelOrifice, J&J’s VP of investor relations. Fellow cancer treatment Imbruvica saw sales climb by 34.7%, gaining four points of U.S. share as of Q3 and taking the title as new patient and total patient share leader in chronic lymphocytic leukemia.

On the immunology side, Stelara’s worldwide sales leapt by 33.6% on the back of a solid launch in Crohn’s disease, while execs praised the launch of Tremfya, a drug that’s nabbed a 6.6% share of an ultracompetitive U.S. psoriasis market since its July 2017 debut.
J&J is going to need those drugs to keep up their contributions, especially as it “plans for continued price decreases on a net basis into the future.” But considering the $3 billion to $3.5 billion headwind generics and biosimilars threw its way last quarter, the pharma giant’s execs said they feel like it’s in good shape.
“It’s a great testament to just the strength of the innovative portfolio we have in the pharmaceutical segment,” they noted, adding, “we’re still talking about growth. Most companies would be talking about contraction.”
But J&J doesn’t have great expectations for 2019 overall—or at least not as strong as analysts expected. Its sales forecast for the year amounted to 1% growth at most, or flat at the least.

eHealth sees FY19 revenue $290M-$310M, consensus $265.9M


https://thefly.com/landingPageNews.php?id=2851950

Boston Scientific announces Vici stent meets primary endpoint in VIRTUS trial


Boston Scientific announced positive 12-month data demonstrating that patients who were treated with the Vici Venous Stent System for iliac and femoral vein obstructions exhibited a high rate of patent, or open, target lesions. Primary safety and efficacy results from the VIRTUS trial were presented as a first-time data release at the Leipzig Interventional Course, or LINC. The VIRTUS trial evaluated the Vici stent in patients with clinically significant obstructions in the illiofemoral venous outflow tract resulting from Post Thrombotic Syndrome, or PTS, or compressive diseases such as May-Thurner syndrome. These conditions impact the veins located deep in the pelvis and if left untreated, can impair blood flow back to the heart and cause blood to pool in the legs, resulting in pain, swelling and ulceration. In the VIRTUS trial, the Vici stent met its primary effectiveness endpoint with a primary patency rate of 84% at 12-months, which was greater than the pre-defined performance goal, or PGE, of 72.1%. Nearly all the patients treated with the VICI stent, 98.8%, were free from major adverse events at 30 days post-procedure, thus surpassing the pre-defined safety performance goal of 94%.

Zimmer Biomet price target cut to $135 from $150 at Stifel


Stifel analyst Rick Wise lowered his price target for Zimmer Biomet to $135 from $150 after revisiting his Buy thesis. In a research note to investors, Wise says that he remains confident in his long-term Buy thesis, and believes management will continue to execute on critical turnaround initiatives in 2019, driving steadily-improving top-line results and facilitate continued, substantial debt pay-down. He sees significant value in shares at current levels.

Concert completes enrollment of 12 mg cohort in CTP-543 Phase 2a trial


Concert Pharmaceuticals announced that it has completed patient enrollment of the final cohort evaluating 12 mg twice daily of CTP-543 in its Phase 2a trial for the treatment of moderate-to-severe alopecia areata. The trial previously enrolled patients to receive 4 mg and 8 mg twice daily compared to placebo. Data from the Phase 2a trial including the 12 mg cohort is expected in the third quarter of 2019.

Medtronic announces new data shared on IN.PACT Admiral DCB


Medtronic announced new data shared on the IN.PACT Admiral drug-coated balloon in patients with peripheral artery disease in the superficial femoral and popliteal arteries. Outcomes from the IN.PACT DCB Paclitaxel Safety Analysis, an independent, patient-level survival analysis inclusive of all IN.PACT DCB clinical programs, were presented at the Leipzig Interventional Course in Leipzig, Germany. A manuscript detailing outcomes from the IN.PACT DCB Paclitaxel Safety analysis was also accepted and is in press with the Journal of the American College of Cardiology. At five years there was no statistically significant difference in all-cause mortality between the DCB and plain balloon angioplasty arms. Data found no correlation between paclitaxel dose and long-term survival. Patients treated in the DCB arm were classified by upper, mid, and lower dose ranges. Freedom from all-cause mortality based on Kaplan-Meier estimates was 91.7 percent in the upper range, 90.6 in the mid-range, and 90.0 percent in the lower range. Data demonstrated no difference in mean nominal dose of paclitaxel between overall survival in patients treated with DCB and those who died. Mean nominal paclitaxel doses were 11,829.8ug +/- 7,347.6ug and 11,419.6ug +/- 7,414.8ug respectively.