On June 27, a subsidiary of Horizon Pharma entered into a Settlement and License Agreement with Lupin and Lupin Pharmaceuticals relating to RAVICTI Oral Liquid, 1.1 gm/mL. Specifically, the Settlement Agreement pertains to on-going patent infringement litigation against Lupin in the U.S. District Court for the District of New Jersey, petitions for Inter Partes Review with the Patent Trial and Appeal Board with respect to certain U.S. patents covering RAVICTI and an appeal to the Court of Appeals for the Federal Circuit of a prior finding of the Patent Trial and Appeal Board. In the Litigation, the Horizon Subsidiary has alleged that a generic version of RAVICTI, for which Lupin is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application, infringes certain U.S. patents that are owned by the Horizon Subsidiary. The parties have agreed to file stipulations of dismissal with the court regarding the Litigation and a joint request for termination in the IPRs. Lupin has further agreed to withdraw from the Appeal. The Settlement Agreement also provides for a full settlement and release by each party of all claims that relate to Lupin’s generic version of RAVICTI or the Litigation, the IPRs or the Appeal.Under the Settlement Agreement, the Horizon Subsidiary granted Lupin a non-exclusive, perpetual, royalty-free license to manufacture and commercialize Lupin’s generic version of RAVICTI Oral Liquid in the United States after the License Effective Date and to take steps necessary to develop inventory of, and prepare to commercialize, Lupin’s generic version of RAVICTI during certain limited periods prior to the License Effective Date.Under the Settlement Agreement, the License Effective Date is July 1, 2026; however, Lupin may be able to enter the market earlier in certain circumstances.
Tuesday, July 3, 2018
India asks WhatsApp to stop spread of false messages
India’s IT Ministry has asked Facebook’s WhatsApp to aim to prevent the circulation of false texts and provocative content that have resulted in a series of lynchings and mob beatings across the country in recent months, Reuters reports. “Deep disapproval of such developments has been conveyed to the senior management of WhatsApp and they have been advised that necessary remedial measures should be taken,” India’s IT ministry said.
Food giants, farmers at odds over U.S. GMO labeling
The world’s top food companies, including Nestle (NSRGY), Hershey (HSY), and Unilever (UL) want the U.S. Department of Agriculture to include on labels ingredients from GMO crops, including canola and soybean oils as well as sugar from beets, Reuters reports. Farmers, on the other hand, want the labels to exclude ingredients that have been so refined and processed that they do not contain any trace of the transformed genes when they are used for food, the report says
Monday, July 2, 2018
Merck Performance Materials Gives Strategy Update
- Performance Materials positions itself as a leading provider of solutions for the electronics industry
- After 2019, the business sector is expected to show an average annual sales growth rate of between 2% and 3%
- Lasting EBITDA pre margin of 30% aimed for
Merck KGaA, Darmstadt, Germany, a leading science and technology company, today presented its strategy to secure the future prospects of Performance Materials. The business sector comprises the specialty chemicals business of Merck KGaA, Darmstadt, Germany and supplies solutions for displays, computer chips and surfaces of every kind. After 2019, Merck KGaA, Darmstadt, Germany expects Performance Materials to resume earnings growth.
‘With ‘Bright Future’ we have implemented a transformation program designed to put Performance Materials back on a growth track. We want to further expand our position as a leading supplier of solutions for the electronics industry. To do so, we will align ourselves even more closely with the needs of this key market of the future and drive market-oriented innovations forward,’ said Kai Beckmann, CEO of Performance Materials and Member of the Executive Board of Merck KGaA, Darmstadt, Germany.
In 2017, Performance Materials generated € 2.4 billion or 16% of Group sales. The business sector is currently facing massive market shifts in liquid crystals for display applications. In the coming years, Merck KGaA, Darmstadt, Germany expects to see a continuing market decline, which will also impact sales. However, this development should be more than offset by growth in OLED materials and photoresists as well as in the Semiconductor Solutions and Surface Solutions business units. In particular, Semiconductor Solutions, is expected to be a main driver of this growth. Consequently, Merck KGaA, Darmstadt, Germany assumes that average annual sales growth will range between 2% and 3% in Performance Materials after 2019. The EBITDA pre margin is expected to amount to around 30% in the long run, representing above-average profitability within the specialty chemicals market.
Performance Materials serves attractive growth markets in the electronics, automotive and cosmetics industries. Particularly the electronics sector is benefiting from megatrends such as digitalization, mobility and urbanization, supplies a wide variety of end-user markets and is thus more stable and less susceptible to industry cycles. Merck KGaA, Darmstadt, Germany aims to further expand the leading role of Performance Materials as a supplier of solutions for the electronics industry. The company is also working to establish sustainable success out of the positive trend seen in the growth market of China in recent months. Merck KGaA, Darmstadt, Germany opened an OLED technology center in Shanghai in June.
Over the past year, Performance Materials has replaced almost its entire leadership team and organized itself into the three business units Display Solutions, Semiconductor Solutions and Surface Solutions. An integrated research and development team is steering the entire innovation process, thereby ensuring the efficient deployment of resources. To strengthen its technological leadership in the various markets and to secure long-term growth, Performance Materials will continue to invest heavily in innovations. New business fields and innovations such as liquid crystal windows offer additional growth potential.
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CMS proposes paying home health agencies for remote monitoring
CMS is considering paying home health agencies for remote patient monitoring.
Remote patient monitoring involves the use of digital tools to collect health data such as vital signs, weight, blood pressure, blood sugar, blood oxygen levels, heart rate, and electrocardiograms.
“Today’s proposals would give doctors more time to spend with their patients, allow home health agencies to leverage innovation and drive better results for patients,” CMS Administrator Seema Verma said in a statement released Monday announcing the annual home health proposed payment rules. “The redesign of the home health payment system encourages value over volume and removes incentives to provide unnecessary care.”
That’s especially important as more care is delivered in the home.
In 2016, about 3.4 million Medicare beneficiaries received home health services, and the program spent about $18.1 billion on home health care services. In that year, over 12,200 agencies participated in Medicare, according to the Medicare Payment Advisory Commission.
Studies show remote patient monitoring results in more live-time data sharing which can lead to more tailored care and better health outcomes.
The rule also outlines a new pay model for home health services which was called for in the Bipartisan Budget Act of 2018.
The current system pays for 60-day episodes of care and also sets payment on the number of therapy visits a patient receives. The new Patient-Driven Groupings Model will no longer count therapy sessions and will pay for 30-day periods of care.
The new structure would move Medicare towards a more value-based payment system while also reducing administrative burden on home health agencies. The PDGM model would will launch January 1, 2020 if finalized.
In all, the CMS is proposing a 2.1% or $400 million increase in Medicare payments for home health agencies. That’s a change from the 0.4% or $80 million cut from last year.
Opioid use among Part D members is down but ‘remains concerning’
Data from the Medicare Part D program show fewer beneficiaries are receiving high amounts of opioids, but a watchdog agency says usage “remains concerning,” while urging insurers to further restrict at-risk patients with lock-in programs.
The number of beneficiaries receiving high amounts of opioids through Part D coverage declined 8% in 2017 from just over 500,000 in 2016 to nearly 459,000, according to a report (PDF) by the Office of Inspector General.
The number of beneficiaries that received an “extreme” amount of opioids—defined as a daily dose more than two-and-a-half times the CDC’s recommendation for chronic pain patients over the course of the year—dropped 17% in the last year, from 69,500 to 57,600.
Doctor shopping declined even more precipitously, with 14,800 beneficiaries receiving excessive amounts of opioids at from multiple prescribers or pharmacies in 2017 compared to 22,300 the previous year.
However, 1 in 3 Part D beneficiaries still received at least one prescription opioid, and the overall level of opioid use “continues to raise concerns,” the OIG said.
While OIG has ramped up efforts to identify instances of inappropriate prescribing by partnering with states to identify instances of fraud, the agency called on insurers to implement new lock-in authority under the Comprehensive Addiction and Recovery Act of 2016, which allows Part D sponsors to restrict at-risk beneficiaries to select pharmacies and prescribers.
“We also call on Part D sponsors to work with pharmacies to ensure that the new point-of-sale care coordination alerts are implemented and effective,” the OIG wrote. “Specifically, sponsors should ensure that when these controls are triggered, the pharmacists consult with the prescribers before dispensing additional opioids.”
On the enforcement side, this week the OIG along with the Department of Justice announced charges against 601 individuals with fraud crimes totaling $2 billion. A sizable portion of that national takedown was devoted to opioid fraud, with 76 doctors charged for their role in diversion schemes.
Hemophilia Drug Prices and the Market
Miracles, it seems, have a high price tag. At least, if those miracles are miracle drugs. There’s no doubt that trends in gene therapy and immuno-oncology are producing drugs that are as close to miraculous as we’re likely to get, doing a great job, generally, in beating back diseases that to this point were untreatable or didn’t respond well to other therapies.
It’s also true that many of these drugs have astoundingly high price tags. The most expensive drug in the U.S. is Horizon Pharma ’s Actimmune for a rare disease, chronic granulomatous, which runs about $52,321 for a single month’s treatment, for example. Sarepta Therapeutics’Exondys 51 for Duchenne muscular dystrophy has a yearly price tag of about $300,000.
One disease that is getting some attention lately for its costs is hemophilia. It is a rare bleeding disorder. A gene mutation prevents blood from clotting properly. It is generally passed from mother to son.
But according to a 2015 Express Scripts report, the drugs to treat hemophilia cost more than $270,000 annually on average. And that’s for patients who don’t have complications from their disease, where the annual price can climb above $1 million.
In the U.S., there are about 20,000 patients, but AllianceBernstein, an investment research firm, estimates the hemophilia market in the U.S. is worth about $4.6 billion.
There are currently 28 different hemophilia drugs available in the U.S., with another 21 in development. They are typically biologics, with no current biosimilars available. Biologics are notoriously expensive. One of the peculiarities of the hemophilia market is that with so much competition, the prices haven’t come down. Jerry Avorn, a professor at Harvard Medical School, told NPR, that this hasn’t brought prices down in the way someone “operating at the level of undergrad Econ 101 would expect.”
NPR points out, “The problem is that companies have no incentive to lower prices. Patients generally don’t push back because insurers pay the bulk of the cost. And insurers tend not to object because the market for the drugs—expensive as they are—is small and the patients are especially vulnerable.”
Acorn noted to NPR, “It’s a magical formula: Lifesaving drug, child at risk of bleeding to death—it kind of casts anybody who looks at costs into the role of some evil Scrooge-like person. The insurers don’t want to end up on the front page of the newspaper saying Little Timmy bled to death because his drug wasn’t covered.”
And, of course, no company wants to be the first one to cut prices in a potential drug war.
The first products to treat hemophilia came out in the mid-1960, were which derived from human blood plasma. But in the 1980s, when HIV emerged, these products, unfortunately, spread HIV into the blood supply, infecting about 4,000 hemophilia patients.
In the 1990s, cloning human clotting proteins in animal cells using recombinant DNA technology took over, which is difficult to make. Bayer, for example, has a factory in Berkeley, California that produced the drug Kogenate. When at full capacity, it produced less than a pound of clotting factor annually. But when diluted with other ingredients, it is used to treat thousands of patients in 80 countries.
But it’s still an area of interest for many companies, no doubt because of the profitability related to a lifetime chronic disease whose medications justify six-figure price tags, but also because the technology is advancing where therapies are improving. Here are a few examples.
On May 22, 2018, BioMarin Pharmaceutical announced an update to its previously reported Phase I/II trial of valoctocogene roxaparvovec, a gene therapy for severe hemophilia A. The company has six clinical studies ongoing in its comprehensive gene therapy treatment of severe hemophilia A. There are two Phase III trials, a Phase I/II trial, and two additional and separate studies, one to evaluate seroprevalence in people with severe hemophilia A and one non-interventional study to evaluate baseline characteristics in hemophilia A patients.
In the 6e13 vg/kg cohort, the trial to date showed continued and substantial decrease in bleeding requiring Factor VIII infusions with a 97 percent reduction in mean Annualized Bleed Rate (ABR), with no spontaneous bleeds and elimination of all bleeds in targets joints in the second year.
Also on May 22, Spark Therapeutics, along with Pfizer, released data from an ongoing Phase I/II clinical trial of SPK-9001 for severe or moderately severe hemophilia B. The companies reported that all 15 participants had discontinued routine infusions of factor IX concentrates, none of them experienced serious adverse events, and there were no thrombotic events or factor IX inhibitors.
“We are pleased to see all 15 participants, notably including the first four participants who have been followed for more than two years, continue to show that a single administration of SPK-9001 has resulted in dramatic reductions in bleeding and factor IX infusions, with no serious adverse events,” said Katherine High, Spark Therapeutics’ president and head of research & development in a statement at the time.
And on June 4, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors. A decision will be made by October 4, 2018. The therapy was approved in November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. It was also approved for the same population by the European Commission in February 2018.
Hemlibra is a bispecific factor IXa- and factor X-directed antibody designed to bring together factor IXa and factor X, proteins needed to activate the natural coagulation processes and restore the blood clotting process for hemophilia A patients.
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