Nov 10 (Reuters) – Roche Holding AG (ROG.S), still months away from seeking regulatory approval of its experimental Alzheimer’s drug, is already taking aim at rival Biogen Inc’s (BIIB.O) Aduhelm, saying that its medication would be priced competitively.
Bill Anderson, head of pharmaceuticals at Roche, did not provide pricing details for the company’s treatment for the lethal brain-wasting disease, but indicated in an interview that it could be priced as much as 30% below Aduhelm’s $56,000-a-year cost.
When it launched in June, Biogen’s drug became the first approved medication that targets one of the changes in the brain that occurs with Alzheimer’s. But Aduhelm sales have stalled as Medicare, the U.S. government healthcare program for people over age 65, evaluates coverage.
The delay has opened up opportunities for rivals such as Roche whose drugs are still many months away from U.S. Food and Drug Administration review and their approval is uncertain.
Anderson said Roche has priced new therapies in the United States “at or below the prices of things we replace … even though we had superior results.”
Roche, Biogen and other drugmakers are due to present data this week at the annual Clinical Trials on Alzheimer’s Disease conference in Boston.
Roche’s Alzheimer’s candidate gantenerumab, like Aduhelm, is designed to remove amyloid plaques from the brains of people diagnosed with the disease. Roche has said it will wait for pivotal trial results, due in the second half of 2022, before seeking regulatory review.
Anderson told Reuters that Roche aims to show “unequivocal data on efficacy.”
The FDA approved Biogen’s drug based on evidence that it reduces amyloid brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows the disease’s progression.
Eli Lilly & Co (LLY.N) has begun a rolling FDA application for its own experimental Alzheimer’s drug based on evidence of its plaque-removing ability. Lilly’s drug could get U.S. approval by the second half of next year.
Medicare expects to issue a final decision in April on its reimbursement policy, which will apply to all plaque-reducing agents.
Biogen posted third-quarter Aduhelm sales of just $300,000, far below the $11 million Wall Street had expected. Some neurology centers using the drug have said the company is providing Aduhelm, given as a monthly infusion, free of charge while the insurance claims process is worked out.
Reporting by Deena Beasley in Los Angeles; Editing by Will Dunham and Caroline Humer
Our Standards: The Thomson Reuters Trust Principles.
Taking next-generation motion from concept to reality
~ How free motion can address challenges in the pharmaceutical industry ~
If companies were to take home one lesson from the COVID-19 pandemic, it should be that flexibility is key. This statement is no less true for the pharmaceutical industry, which has been pushing for flexibility for years. With a pandemic almost behind us and the challenges of a rapidly ageing population, flexible manufacturing is needed now more than ever. In this article , Adnan Khan, manager of pharma industries at Beckhoff UK, discusses the challenges of pharmaceutical production lines and how next-generation motion can help.
While there are many tips for creating a more flexible manufacturing process, from plug-and-play robotics to single-use manufacturing, few tips focus on motion control in production lines. Motion control has the power to make production lines more flexible and efficient, but few motion control systems provide the freedom and range to maximise their benefits.
From concept to reality
In interviews conducted by Donna Ritson, president of DDR communications and Paula Feldman, senior director of Business Intelligence, 75 per cent of pharmaceutical manufacturers said they were increasing their level of automation going forward. So for those wanting to invest in optimising their production lines, where should they spend their money?
Over the years, technology has advanced, allowing the pharmaceutical industry to advance with it. However, despite the introduction of sophisticated technology, challenges still occur in the production of pharmaceutical products, such as flexibility and efficiency. The XPlanar, a first-of-its-kind planar motor system, can help address these challenges.
The XPlanar system comprises the mover, tile and control software. The magnetically driven mover is wireless, with six degrees of jerk-free movement, allowing for the technology to effortlessly levitate over the tiles, which can be moved and placed as a facility needs. With each singular mover having a bare load of up to 4.2 kg, a maximum speed of 2 m/s and an easily wipeable surface, the XPlanar is bringing the reality of next-generation motion to the pharmaceutical industry.
Flexible and efficient
Flexibility has always been an issue in the pharmaceutical industry, as traditional plant layouts make it hard to switch over or adjust equipment to produce different products. Due to a large number of sensitive chemical processes in pharmaceutical manufacturing, moving equipment around requires equipment recalibrations and strategic positioning. However, with new methods such as modular manufacturing, allowing for multiple different drug productions in one facility, these challenges are slowly being addressed.
Modular manufacturing refers to a type of manufacturing where there is no fixed equipment, meaning facilities can be broken down and rearranged as needed. As modular manufacturing is embraced, new techniques will be needed to achieve a modular facility. The XPlanar system elevates this manufacturing method to a more efficient, flexible and long-lasting one. Like with many of the equipment used for modular manufacturing, the XPlanar system can be laid out freely in a multitude of arrangements to suit the pharmaceutical facilities’ requirements.
The XPlanar system provides the pharmaceutical industry with the production flexibility needed to not only create a modular manufacturing facility but a more efficient manufacturing facility. The XPlanar system allows manufacturers to create a flexible production line with movements of 360 degrees, allowing for easy and efficient product inspection, alignment or processing.
The easy adaptability of the movers and tiles ensures the technology can last in an ever-evolving technological landscape. Using this free-moving system the pharmaceutical industry can see the benefits of next-generation motion becoming reality.
Keeping pets protected during heatwaves this summer
We’ve been lucky to have been hit with some great weather this summer, however, some days have been exceptionally hot and causing us discomfort to the point where we don’t want to leave the house! Our pets can also struggle in this heat and if not looked after correctly, can lead to life threatening issues for them.
Dr. Sarah Machell, Medical Director for Vetster, has shared her top five top tips to ensure that our pets can enjoy the summer days as much as we can.
Vetster, is a digital platform that connects licensed vets with pet owners virtually, with 24/7 online appointments, launches in the UK this summer.
1. Provide adequate rest, shade, and ventilation
Coping with high temperatures and humidity is tough enough on its own, but it’s even more difficult for pets who are exercising in direct sunlight and don’t have adequate ventilation. Limit outdoor activities to early mornings and late evenings when it’s cooler. When walking your pet, choose shady routes off the pavement. Ensure outdoor pets have shady, ventilated places to escape the heat. Keep in mind that pets also rely on evaporation for cooling, regardless of if they sweat like horses or pant like dogs, and high humidity decreases the effect of evaporation. This means your pet needs you to keep an eye on the heat index for them as well as for you. Be sure your pets have easy access to a steady supply of clean water. Pets are naturally wired to stay hydrated as long as they are healthy and avoid heavy exercise in the heat, so there’s no need to try to encourage your pet to drink more. Just make sure the water supply is in easy reach and doesn’t run dry.
2. Be wary of paws on the hot pavement!
When the weather gets extremely hot, so does the pavement—asphalt, in particular. If you’re taking your dog out for a walk, try to remember that they don’t have shoes to protect against the heat. Even though paw pads are extremely tough, hot surfaces can burn them. Consider using padded booties for their paws to create a barrier between paw pads and the hot concrete. Better yet, try to steer clear of the streets and walk on the cool grass instead. If there’s an opportunity to wade through some clean water or catch the spray from a sprinkler, that’s even better. Remember that pavement retains heat and you still need to be aware of the risks when you go for walks in the evening.
3. Look out for signs of heatstroke
Heatstroke is a very serious condition and one to look out for in your pets. As a pet parent, it’s important to be aware of your pet’s fitness level and avoid overexertion when the weather’s too hot or humid. Less athletic dogs, dogs with underlying illnesses, and brachycephalic breeds are at higher risk for developing heatstroke, so keep an extra close eye on them. Heatstroke is life-threatening, but it can be avoided if you take action to cool your pet when they show early signs of heat stress. If your dog doesn’t want to keep walking, lies down in the shade, or digs up cool dirt to lie in, those are clues they’re getting too hot. Excessive panting that doesn’t improve after a short rest is another indicator. Get out of the heat and offer water to keep the threat of heatstroke from escalating. Splash down hot ears, paws, and bellies with water to achieve more rapid cooling.
4 Never leave your pet unattended in a hot vehicle
Heatstroke can happen in the blink of an eye—it cannot be stressed enough that you should never, ever leave your pet unattended in a vehicle. This is true even if you leave the windows down for fresh air or if you think you’ll only be gone for a few minutes. Studies show that even if the outdoor temperature is 72℉ (22°C), a car can rise up to 117℉ (47°C) in only an hour. Imagine how quickly a car can become dangerously hot when outdoor temperatures are a balmy 86℉ (30°C). Even if you’re leaving your car unattended for a minute or think that leaving a window open will help – the life-or-death gamble you’re taking isn’t worth it.
Why dosage matters in menopause treatment
By Rizvan Faruk Batha MPharm, PGDip GPP, IPresc, MRPharmS, Superintendent Pharmacist of Specialist Pharmacy.
Bioidentical Hormone Restoration Therapy (BHRT) is an alternative option to traditional synthetic HRT, using bioidentical hormones to treat hormonal conditions in both men and women. BHRT is compounded medicine and put simply, means that the individualised ingredients are mixed together under the direction of a qualified prescriber’s prescription to meet the tailored needs of a patient.
For women going through menopause, compounding treatments are often prescribed later down the line, when a woman has been unable to settle on the appropriate dose of HRT with a General Practitioner, often experiencing severe side effects from either too much or too little HRT. In short, compounded menopause medication offers another route for those patients where the licensed preparation is not appropriate or hasn’t worked.
Patient-led care plays an important role in compounded menopause medicine because the patient is involved throughout the process; during the consultation with the prescribing practitioner, and with the pharmacist developing the customised dosage.
One of the biggest challenges faced by compounding pharmacies is the drugs being classified as unlicensed. For drugs to be licensed, it involves research and clinical trials to assess the efficacy, quality, and safety of the medicines, and because of this process, more often than not it is the recommended route to prescribe licensed medicines. That being said, prescribing unlicensed compounded menopause medicines may be necessary, especially when it comes to the patient’s specific need and interests and where licensed medicines have been unable to satisfactorily meet the needs of the patient or are unsuitable for them.
Utilising compounded menopause medicine as a method to enhance patient care could be beneficial for the many patients that need specific dosing or formulation requirements, but sadly more often than not we see delays to patient needs and treatment, as the rise of mass manufactured licensed medicines have grown in popularity. Compounding menopause medicine could offer huge potential for many, but prescribing practices have moved towards evidence-based medicines because of the responsibility imposed on prescribers for prescribing compounded therapies. Clinicians need to understand that even licensed products are not safe or effective for all patients particularly if the product is being used in a population that were not part of the original clinical trials for the drug.
It is important to know that compounding pharmacies and pharmacists in the UK are also regulated and licensed by the General Pharmaceutical Council (GPhC). The GPhC set standards for pharmacists and pharmacies to meet to remain on their register with the aim to protect the public and give them assurance that they will receive safe and effective care when using pharmacy services.
So even though compounded medicines are ‘unlicensed’, there is a lot of due diligence exercised by the pharmacists to ensure the products meet the safe and effective care criteria. This is generally demonstrated through the purchase of medical grade active and inactive pharmaceutical ingredients (with certificates of analysis and safety data sheets), trained staff, following and updating SOPs, audits, traceability of ingredients and products during recalls, as well as continuous learning and error reporting being supported in the pharmacy.
Ultimately, how compounded menopause medicine is viewed will depend on the knowledge and experience of the patients and professionals involved. Although the medicine is unlicensed it is important to understand that experienced clinicians and pharmacists involved in the process of making the decisions are regulated, and patients are consistently monitored during their response to the medicine. If compounded menopause medicine was integrated in the healthcare system, it could change and improve the quality of life of many patients suffering with debilitating menopause symptoms, and we hope as a pharmacy that in the future we will see a shift in how compounded medicine is viewed.