Friday, November 9, 2018
FDA to propose menthol cigarette ban, WSJ says
Publicly traded companies in the tobacco space include Altria Group (MO), British American Tobacco (BTI) and Philip Morris (PM).
https://thefly.com/landingPageNews.php?id=2821789
Tesaro reports initial data from AMBER trial of TSR-022, TSR-042 combo
TESARO presented initial data from the Phase 1 AMBER trial of TSR-022 in combination with TSR-042 in patients who have progressed following anti-PD-1 therapy treatment, in an oral session during the 2018 Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, Conference in Washington, D.C. Data presented at SITC included safety and efficacy data from the combination dose-escalation and two expansion cohorts: NSCLC patients that had progressed following anti-PD-1 treatment and melanoma patients that had progressed following anti-PD-1 treatment. At the time of data cutoff, 39 patients with NSCLC who had progressed following anti-PD-1 treatment had received treatment with the TSR-022 and TSR-042 combination, including 14 patients at the 100 milligram dose and 25 patients at the 300 milligram dose of TSR-022. Among the 11 evaluable patients treated with the 100 milligram dose of TSR-022, 1 had a confirmed partial response by immune related RECIST criteria and 3 had stable disease. Among the 20 evaluable patients treated with the 300 milligram dose of TSR-022, 3 had confirmed partial responses and 8 had stable disease. “The initial AMBER data featured at this year’s SITC conference are the first clinical data to be presented for an anti-TIM-3 antibody in combination with an anti-PD-1 antibody and demonstrated that the combination of TSR-022 and TSR-042 is active and generally well tolerated in NSCLC and melanoma patients who have progressed following anti-PD-1 treatment. Additionally, updated results from the GARNET trial demonstrated robust clinical activity of TSR-042 in previously treated, anti-PD-1 naive patients with recurrent or advanced NSCLC, the vast majority of which had TPS less than50%. We look forward to presenting additional data from these studies in 2019,” said COO Mary Lynne Hedley. Additionally, Phase 1 GARNET data of TSR-042 in patients with previously treated recurrent/advanced non-small cell lung cancer and Phase 1 monotherapy dose-escalation data for TSR-033 in a broad range of solid tumors were also highlighted in poster presentations.
https://thefly.com/landingPageNews.php?id=2821791
Merck Keytruda OKd for previoulsy treated liver cancer
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
“Hepatocellular carcinoma is the most common type of liver cancer in adults, and while we have seen recent therapeutic advancements, there are still limited treatment options for advanced recurrent disease,” said Dr. Andrew X. Zhu, lead investigator and director of liver cancer research at Massachusetts General Hospital and professor of medicine at Harvard Medical School. “Today’s approval of KEYTRUDA is important, as it provides a new treatment option for patients with hepatocellular carcinoma who have been previously treated with sorafenib.”
Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.
How can Ironwood fix slowing Linzess sales? Ditch partner Allergan: analyst
Growth for Allergan and Ironwood’s constipation drug Linzess is easing up, Allergan revealed last week. And one analyst thinks Allergan may not be part of the solution.
On Wednesday’s third-quarter conference call, Allergan dropped commentary that was “both new and negative,” as Wells Fargo analyst David Maris put it in a note to clients. Industrywide pricing dynamics will hurt the drug’s pricing power in the future, company marketing chief Bill Meury toldinvestors, adding that Allergan had lowered its growth projections to a low- to mid-single-digit percentage range.
The way Maris sees it, the news was “a good reminder of the issue of being tethered to a partner.” Ironwood’s share slide and underperformance versus the S&P 500 as of late should make the company “revisit its strategic review and really push the question whether Ironwood is better off independent,” he wrote.
Massachusetts-based Ironwood has made some major changes this year, prompted by a little activist intervention. In April, Sarissa Capital Management—the fund run by Alex Denner, one-time protégé of famed proxy brawler Carl Icahn—said it was prepping a boardroom bid for Denner. To keep Sarissa at bay, Ironwood pledged to spin off most of its R&D, hanging onto treatments for GI, gout and abdominal pain, as well as a gastroesophageal reflux disease prospect.
It didn’t take long for Ironwood to realize it didn’t want to keep gout offering Zurampic after all, and it handed that treatment back to partner AstraZeneca to “allocate capital to the highest return opportunities and drive growth,” CEO Peter Hecht said in a statement.
And as Maris figures, it might want to reconsider its Allergan partnership, too, especially because Allergan is going through some soul-searching of its own. Its shares have struggled badly over the last couple of years, thanks in part to competitive threats to its top products, and asset sales meant to boost investor sentiment so far haven’t panned out.
“With competition headed to the market and a partner going through its own strategic review, slower growth assets may not get the attention they once did. This, combined with pricing pressures, may point [out] that there are options that should be more fully explored than the split already contemplated,” Maris wrote.
Coherus reveals biosimilar launch tactics in battle against Amgen’s Neulasta
Coherus dialed up pressure on Amgen with a recent FDA approval for a Neulasta biosimilar, and now the company has unveiled its bid for a market share steal, using a discounted price and patient and reimbursement services.
Udenyca will carry a list price of $4,175, a 33% discount to Amgen’s key drug, executives said on a conference call Thursday. The price is also lower than Neulasta’s average selling price of $4,422.
Coherus’ senior vice president of marketing and market access Jim Hassard said the “price is attractive to payers without diminishing the value proposition of Udenyca.” On Thursday’s call, Hassard detailed the company’s biosim strategy as offering several strengths.
Besides Udenyca’s price, Coherus sees a market advantage in its patient and reimbursement services, not to mention a solid supply to make sure patients get the drug when they need it. The company’s manufacturing means it has plenty “to enter the broad marketplace,” Hassan said. “And again some competitors that have entered the market maybe haven’t had that same luxury.”
The company plans to launch its biosim Jan. 3, execs said.
Neulasta helps cancer patients receiving chemotherapy boost their white blood cell count to fight off infections. Importantly, Coherus’ SVP of commercial analytics Michael Chen pointed out Thursday that treatment is “episodic with a high degree of patient turnover.”
That’s an advantage for the biosimilar over others that have seen limited success in the U.S. market, such as biosimilar versions of Remicade, a drug for autoimmune diseases that patients use for ongoing treatment. Once new patients find success with a particular drug, doctors are reluctant to switch them, and Johnson & Johnson has managed to secure reimbursement deals that are still snaring those new scripts.
For its launch, Coherus will focus on market segments with “pent-up demand and desire to derive true cost savings for their patients,” such as hospitals, SVP of sales Chris Thompson said on the call. That would include hospitals in the 340B program, where drugs are heavily discounted. And as Thompson noted on the call, the largest group purchasing organization representing hospitals, Vizient, applauded the biosimilar approval.
Mylan launched its own Neulasta biosim, Fulphila, this summer and has been focusing on community oncology clinics and hospital-based outpatient clinics rather than hospitals themselves, Chief Commercial Officer Tony Mauro said on a recent conference call. He said the launch has been “surgical” and that there remains a big opportunity for Mylan, even after a second biosimilar entered the market. On the call, Mylan President Rajiv Malik said Mylan’s “capacity is exactly as we had planned and as we had anticipated” for the launch.
For Amgen, a second biosimilar means more pressure on its stalwart Neulasta, a top biologic that generated $3.9 billion in the U.S. last year. While the company is facing a growing biosimilar threat, Amgen itself is advancing with biosimilars. It has U.S. approvals for biosims to AbbVie’s Humira and Roche’s Avastin, though neither have launched due to patent issues.
Korean wholesaler smuggled Novo’s obesity drug Saxenda into China
Anti-obesity drug Saxenda has been one of Novo Nordisk’s key growth drivers lately—and apparently, a Korean wholesaler noticed. The pharmaceutical middleman allegedly smuggled the popular drug into China, where it’s not yet approved.
Korean regulators are investigating the wholesaler for allegedly hawking Saxenda in China, Korea Biomedical Review reported, citing multiple sources.
A Novo spokeswoman confirmed to FiercePharma that the company was made aware of the incident but declined to comment on the company’s launch plans for Saxenda in China.
“We have been in dialogue with our distributor who has immediately terminated the contract with the wholesaler,” she said.
Novo Nordisk wasn’t aware of the situation before the probe emerged, according to the Korean media outlet. “Frankly speaking, we are dumbfounded,” a Novo official was quoted as saying. “This happened because it was difficult to control sub-distributors. We will do our best not to repeat the same mistake.”
While Saxenda is not available in China, its sister drug, diabetes blockbuster Victoza—which contains the same active ingredient, liraglutide—was approved in China in 2011 and was added to the country’s national reimbursement system last year.
Saxenda was approved by the FDA in late 2014 and introduced in Korea last July. The obesity drug has been posting fast growth recently, alongside Novo’s overall GLP-1 franchise. For the first nine months of 2018, sales jumped 53% in local currencies to 2.64 billion Danish krone ($402 million); its business in Japan and Korea chipped in on that growth, said Novo in its third-quarter report. According to Korea Biomedical Review, huge demand often depleted supply in Korea, and the sentiment, if not the drug itself, has spread to its neighbor China.
The drug’s Korean distributor, Zuellig Pharma, is one of the largest healthcare services groups in Asia. It has distribution and logistics collaboration deals in the region with some of the biggest international biopharma companies, including Roche, GlaxoSmithKline, Pfizer, and Merck & Co., known as MSD in Asia. In 2010, its Chinese operation was scooped up by Cardinal Health, which wanted to expand its Chinese business, and it in turn was sold to Shanghai Pharma last November for $557 million.
Drug smuggling has become a hot topic in China, thanks to a dark comedy movie, Dying to Survive, which was based on the true story of a leukemia patient who illegally sneaked in cheap Indian-made generics to Novartis’ Gleevec. But prescription drug smuggling in China is mainly associated with providing alternatives to high drug prices, rather than seeking personal gain on demand for an unapproved drug.
In China, all unapproved drugs are considered “counterfeit,” and those selling them could face sentences as high as three years in prison, and if casualties were involved, the penalty could go all the way up to a death sentence.
Quest: New Data at the American Heart Association 2018 Scientific Sessions
Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, announced today that it will present results of three studies at the 2018 American Heart Association Scientific Sessions in Chicago.
Researchers from Quest Diagnostics and the company’s recently acquired Cleveland HeartLab performed the studies. The research covers topics ranging from best practices in laboratory testing for aiding the detection of non-functioning HDL (good cholesterol) to identifying individuals through employee wellness programs who may benefit from cholesterol reduction efforts.
Additional research, presented in an oral presentation, evaluates the effectiveness of genetic risk scores in aiding the identification and management of atrial fibrillation (AF) in high-risk patients in the prospective REVEAL study. These individuals are undergoing continuous monitoring with an implantable cardiac monitor. The study also identified the patient characteristics most predictive in developing AF.
“Heart disease is the leading cause of death for both men and women in the United States, but it is often preventable with appropriate prevention and intervention efforts aided by diagnostic insights,” said Jake Orville, General Manager, for Quest Diagnostics Cardiometabolic and Endocrinology Franchise, which includes Cleveland HeartLab. “Our research at this year’s AHA Scientific Sessions demonstrates the essential value of genetic and other forms of laboratory diagnostics in helping patients at risk for cardiometabolic disorders achieve the best possible health outcomes.”
Quest is a leader in cardiovascular diagnostic information services. In 2017, Quest announced the creation of its Cardiovascular Center of Excellence through the acquisition of Cleveland HeartLab. The Center of Excellence, based in Cleveland, combines Cleveland HeartLab’s personalized evaluation of heart disease risk based on inflammation and other markers with Quest’s Cardio IQ® portfolio of lipid particle analysis and genetic and metabolic testing leadership.
Conventional laboratory tests to assess cardiovascular and metabolic diseases, such as lipid panels, may not identify risk in all patients. New inflammation, genetic and other biomarkers may help physicians identify at-risk patients and guide treatment protocols to improve outcomes.
Abstracts can be accessed on the AHA 2018 Scientific Sessions website at: http://www.abstractsonline.com/pp8/#!/4682
The Quest Diagnostics data being presented at this year’s annual meeting are:
Sunday, November 11, 2018
7:45 a.m. – 7:55 a.m.:
- “Genetic Risk Score Associated With Atrial Fibrillation Detected by Insertable Cardiac Monitoring in High Risk Patients: A Reveal AF Trial Sub-Study” (Oral: 215)
2 p.m. – 3:15 p.m.:
- “Employee Wellness Program Can Identify Those Who May Benefit From Cholesterol Reduction Efforts” (Poster: Su1173 / 1173)
Monday, November 12, 2018
10:30 a.m. – 11:45 a.m.:
- “A Novel Proteomic Predictor of Cholesterol Efflux Capacity Demonstrates Inverse Association With Cardiovascular Disease” (Poster: Mo3114 / 3114)
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