Like its peers, Johnson & Johnson faces pricing and biosim threats in the coming years. But thanks to new launches and label expansions for existing meds, the drugmaker believes it can continue to outperform rivals in pharmaceuticals, execs said on a conference call Thursday.
On Thursday’s call, J&J execs highlighted esketamine, recently filed with the FDA in treatment-resistant depression, plus erdafitinib for metastatic urothelial cancer, as future growth drivers. The submission for the latter drug should be completed in the coming weeks, they said. For its already marketed meds, J&J plans to file applications for 50 new uses through 2021, more than 10 of which have a sales potential of more than $500 million.
Over the last several years, J&J has outperformed the branded drug industry in annual sales growth, according to the Thursday presentation, and the company committed to continue the trend through new offerings and add-on uses.
The pipeline developments come as J&J’s megablockbuster immunology med Remicade continues to battle in the market against biosimilars from Pfizer and Merck. Despite the competition, Remicade has held the majority of share thanks to J&J’s contracting. A lawsuit brought by rival Pfizer, which manufactures a biosimilar to Remicade, challenges the aggressive contracting as “anticompetitive.”
Despite J&J’s success defending Remicade, Executive Vice President and Worldwide Chairman for Pharmaceuticals Jennifer Taubert said J&J expects “continued erosion” for the blockbuster, plus further generic erosion for Concerta and Velcade. Additionally, Tracleer and Procrit are expected to face new competition, she said. The generic situation for prostate cancer med Zytiga remains an unknown—for now—following a patent trial that has completed; the company is awaiting a judge’s ruling. Still, J&J execs maintain the company can achieve strong pharma growth even without Zytiga.
Along with biosimilars, J&J executives highlighted pricing pressure from public and private payers as a threat in the coming years. But, they said, J&J has realized 100% of its growth from volume increases in 2017 and the first half of 2018, so the company is well positioned against that challenge.
An options buyer put a sizable hedge against the U.S. exchange-traded fund tracking the marijuana industry in a bet that pot stocks won’t continue to soar.
Shortly before the market closed Thursday, the investor bought 5,000 October $34 puts and 5,000 October $24 puts on the ETFMG Alternative Harvest ETF, which goes by the ticker MJ, while simultaneously selling 10,000 October $29 puts. The move sent total options volume in the fund to more than five times its 20-day average. Put options give investors the right to sell the underlying shares for a set price.
The ETF lost 6.3 percent on Thursday, but has rallied nearly 40 percent over the last 30 days as its largest components — Cronos Group Inc., Tilray Inc. and Canopy Growth Corp. — have soared. Tilray, for example, has more than quadrupled in that time. The fund fell more than 5 percent in early trading Friday, but rebounded and was up 1.5 percent to $35.87.
The wager would pay off if Thursday’s downturn continues. The meteoric climb in marijuana shares was halted, at least temporarily, by reportsthat U.S. authorities may make it more difficult for cannabis industry workers, investors and users to enter the country.
Lupin announced that it has received approval for its Atovaquone Oral Suspension USP, 750 mg/5 mL from the United States Food and Drug Administration (FDA) to market a generic version of GlaxoSmithKline LLC’s Mepron Oral Suspension, 750 mg/5 mL.
Lupin’s Atovaquone Oral Suspension USP, 750 mg/5 mL is the generic version of GlaxoSmithKline LLC’s Mepron Oral Suspension, 750 mg/5 mL. It is indicated for prevention and acute oral treatment of mild-to-moderate Pneumocystis carinii pneumonia (PCP) in patients intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
Atovaquone Oral Suspension, 750 mg/5 mL had annual sales of approximately USD 117.4 million in the US (IQVIA MAT June 2018).
Is aimed at addressing concerns regarding over-dependence on regional supply of pharmaceutical ingredients to the Western pharmaceutical industry
Leverages more than 600m3 chemical capacity at the Visp (CH) chemical complex operating under ISO quality systems
Provides a critical link in Lonza’s end-to-end service offering covering early intermediates, active pharmaceutical ingredients (APIs), drug product intermediates and specialized finished drug product supply
Lonza Pharma & Biotech today announced the launch of its pharmaceutical early-intermediates supply initiative. The initiative leverages chemical production facilities at the company’s Visp (CH) site to address increasing global early-intermediates supply security and quality concerns. Lonza now offers its customers an integrated supply chain from non-GMP early intermediates to cGMP advanced intermediates and APIs.
Lonza will supply ISO-certified early intermediates to customers under customized arrangements in order to simplify supply chains. These arrangements can be based on replacing current sources of non-GMP material, forward processing of basic or specialty chemicals, or back integrating current API supply. The seven ISO-certified plants within the Visp complex provide more than 600m3 of reactor volume and a full range of capabilities across an array of chemical technologies to service customer requirements.
‘Lonza’s Visp site is well positioned to help address our customers’ concerns over their API supply chain. As a world leader in API development and manufacturing, we have been diversifying and replacing our early-intermediates supply base with internally produced material,’ said Michael Banks, Vice President Early Intermediates, Lonza Pharma & Biotech. ‘We are now able to offer this early-intermediates supply option directly to customers under flexible arrangements that meet their specific needs.’
Lonza has a well-established base for chemical synthesis at its Visp site with more than 40 years’ track record in the production of APIs and their intermediates. The Visp infrastructure includes a vast array of development, clinical scale and manufacturing capacity, capabilities and expertise for both small molecules and biologics.
Lonza’s second small-molecule site in Nansha (CN) was built and operates to ICH* standards for the development and manufacture of APIs, providing additional supply chain capability and flexibility to a global customer base.
‘We are dedicated to the high-quality, secure supply of intermediates and APIs for ensuring uninterrupted supply of life-saving medicines. We are also focused on innovation – across our technologies, services and business models – to help bring new medicines to market,’ said Gordon Bates, President Chemical Division, Lonza Pharma & Biotech. ‘The launch of our early-intermediates initiative is another important chapter in pursuing this mission.’
Allergan Plc (AGN.N) said revenue from its medical aesthetics business could double by 2025, even as it faces increasing competition for its blockbuster wrinkle treatment, Botox.
The drugmaker announced earlier on Friday the acquisition of Bonti Inc, which makes a shorter-acting neurotoxin than Botox.
Allergan is also doubling its investment in direct-to-consumer ad spending and beefing up its sales force as companies like Revance Therapeutics Inc (RVNC.O) and Evolus Inc (EOLS.O) vie to wrest market share with rival treatments to Botox. The company made the announcements at its Medical Aesthetics Day in New York.
Chief Commercial Officer Bill Meury said Allergan expects revenue at its medical aesthetics unit to grow to $7 billion to $8 billion. That compares with revenue of $3.8 billion from the business in 2017.
Beyond Botox, the unit includes dermal filler Juvederm, the CoolSculpting fat-freezing systems, and other treatments.
He said the forecast implied an 8 to 10 percent compound annual growth rate.
Meury said the Bonti acquisition would allow the company to market a new “starter toxin.” Patients could test drive the treatment, which lasts for two to four weeks, to help them decide if they want to use longer-term Botox.
Approximately twenty percent of employees with insurance had at least one out-of-network claim for inpatient care, according to a Peterson-Kaiser Tracker analysis. Employees with out-of-network provider bills may experience increased stress due to the cost of healthcare because they are largely responsible for out-of-network costs.
In 2016, 15.5 percent of all inpatient admissions claims that took place within in-network facilities included services from an out-of-network provider, indicating that choosing an in-network care site is not necessarily a predictor of what costs a payer will cover.
Overall, 17.6 percent of claims related to inpatient admissions involved out-of-network services.
The research team inferred that the high prevalence of out-of-network billing may stoke employee concerns about the affordability of medical services. In recent years, employees have experienced an increase in their cost sharing commitments for employer-sponsored coverage, leading to concerns over affordability.
Employees enrolled in limited network employer plans, such as an HMO or exclusive provider organization (EPO) plan, typically experience high-cost out-of-network bills, according to KFF researchers. HMOs and EPOs typically do not cover any form of out-of-network care.
Even employees in PPO plans, which are benefit packages that may provide coverage for out-of-network care, also face significant out-of-network costs.
“The [PPO] plan may have somewhat higher cost-sharing amounts (for example, it may have a separate or higher deductible) for services from out-of-network providers,” KFF explained. “Second, and more importantly, the providers they use may ask them to pay any difference between what the plan reimburses and the amount that the provider charges for its services.”
KFF found that employees sometimes face surprise medical bills when an in-network provider refers the employee to an unknown out-of-network provider for services.
“Other instances of out-of-network service use may be inadvertent, such as where an enrollee encounters an out-of-network provider (maybe an anesthesiologist) in the course of treatment at an in-network hospital or surgical center, or when their in-network provider refers them to an out-of-network provider for services such as laboratory testing or radiology,” KFF explained.
Surprise medical bills can create significant financial challenges for employees. A separate KFF survey found that seven out of ten with unaffordable medical bills did not realize the bills were for out-of-network care.
The team explained that the practice of balance billing can also make employees vulnerable to out-of-network costs.
Balance billing is when the provider asks the patient to pay the difference between the costs covered by their insurance plan and the out-of-network costs. Employer health plans rarely have cost-sharing policies that protect employees from balance billing, the team added.
The Peterson-Kaiser Tracker found that ED claims are the most likely to result in an out-of-network provider bill. The team estimated that 27.2 percent of all inpatient admissions with an ED claim were from out-of-network providers.
Patients that receive inpatient mental health treatment are the more likely to receive out-of-network bills from providers than patients using other inpatient services outside of emergency care.
Source: Peterson-Kaiser Tracker
In 2016, a third of all inpatient mental health services were billed by out-of-network providers. Twenty percent of inpatient surgical services and 18.9 percent of inpatient medical services were also billed by out-of-network providers or facilities.
Outpatient service claims (7.7 percent of claims) and outpatient facility charges for emergency and surgical care (9.2 percent of claims) were less frequently billed by out-of-network providers.
The Kaiser Family Foundation explained that many employees may seek out-of-network services because they prefer a specific provider outside their network due to the provider’s reputation, familiarity, or convenience. Employees also are likely to seek out-of-network care when services like mental healthcare are not offered by in-network providers.
Employers may want to design benefits that address mental health to keep employees from using in-network services that are cheaper than out-of-network services. Employers may also want to explore new contracting options with providers to ensure beneficiaries are able to use more affordable healthcare services.
“In many instances, it is doubtful that enrollees could reasonably anticipate or control their use of out-of-network providers,” KFF said. “For inpatient admissions, enrollees using only in-network facilities still have at least one claim from an out-of-network provider in over 15 percent of admissions. For both inpatient and outpatient services, enrollees using emergency rooms have a much higher likelihood of having an out-of-network claim, even when they use in-network facilities.”
High out-of-network costs can add onto an employee’s other stressful cost commitment including premiums and deductibles. Employers offering benefits may want to reduce their employees’ financial burdens by redesigning cost sharing or by assessing providers to develop high performance networksthat lead to lower care costs in general.
Without a doubt China has become one of the most important markets for pharma companies, given the vast patient population and the rising cancer rates. And it seems that western pharmaceutical companies are making greater inroads there.
According to an August report in the Financial Times, since 2012 research and development cooperation between U.S. companies and China are up 70 percent. The Chinese biopharma market is booming as more and more companies eye breaking into that rich market. With that increase in cooperation, there has also been an increase in patent approval in China – but the majority of those have been made by western companies in the Chinese market or were made by Chinese universities without an eye for commercialization. A recent report by IAM, an organization that tracks intellectual property news, noted that Chinese biotech innovation “has yet to make its stamp on the global market.” But that may be slowly changing as companies like BeiGene and WuXi Apptec make inroads into the western markets.
Earlier this month, China’s BeiGene teamed up with SpringWorks Therapeutics to develop therapeutics that will target advanced solid tumors that contain RAS mutations, as well as other MAPK aberrations. BioSpace reported that the companies will combine BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) and SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901 in patients with advanced solid tumors. The first Phase Ib trial is expected to begin in the first quarter of 2019.
That’s not the only good news that BeiGene has posted. Earlier this summer BeiGene reported positive preliminary topline results from its Phase II trial of tislelizumab, the company’s investigational checkpoint inhibitor for relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL). BeiGene’s investigational Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib also snagged Fast Track designation by the U.S. Food and Drug Administration (FDA)for the treatment of patients with Waldenström macroglobulinemia.
In August, WuXi’s subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd., a contract development and manufacturing organization,secured a physical toehold in the United States, opening an operation site in San Diego that will provide process research and development as well as API manufacturing services for early phase clinical studies.
Not only is WuXi establishing a toehold for its CRO, the company has formed several partnerships with U.S. companies, including through investments, such as startups like Unity Biotechnology and Ideaya Biosciences, Inc. WuXi has also formed partnerships with western companies to do business in China. In April WuXi formed a partnership with Seattle-based Juno Therapeutics to develop treatments for cancer with the formation of a new Chinese company called JW Biotechnology Co., Ltd. The new Chinese company’s mission will be to build a cell therapy company in China through using Juno’s chimeric antigen receptor (CAR) and T cell receptor (TCR) technologies in combination with WuXi AppTec’s R&D and manufacturing platform.
Juno isn’t the only company to grab its own toehold in China. In July, Roivant Sciences launched Sinovant Sciences in China with an aim at developing innovative treatments for some of China’s most pressing medical concerns. The company launched with four therapies suitable for Phase III clinical trial application or registration in China, including Derazantinib, a fibroblast growth factor receptor (FGFR) inhibitor in Phase III development for the treatment of intrahepatic cholangiocarcinoma (iCCA), a form of liver cancer with high incidence in Greater China and no approved therapies globally.
Also in July, Takeda noted that its China program is its second-biggest business behind the United States. Takeda’s goal is to launch their medications in China as the same rate as they attempt in their other markets, including the U.S. and Europe. Takeda now regards China as a core country to its business practice.
