Group items tagged

Arrowhead Pharmaceuticals on Monday (November 22) entered a drug development deal with GlaxoSmithKline (GSK) under which the British drugmaker will develop and market Arrowhead's potential treatment for patients with fatty liver disease NASH. Under the pact, Arrowhead said it would get an upfront payment of $120 million and is eligible for additional milestone payments including up to $190 million at first commercial sale of the product, and up to $590 million in sales-related milestone payments. The drug candidate, ARO-HSD, is currently in an early-to-mid stage trial for nonalcoholic steatohepatitis (NASH), a fatty liver disease. It is based on RNA interference technology, where genes that contribute to disease are silenced.

The British Generic Manufacturers Association (BGMA) has published a positioning paper which sets out the objectives that need to be delivered through the next Voluntary Pricing and Access Scheme (VPAS) on Thursday (15 June). The paper details how a financially sustainable VPAS can support widened medicines access to patients. VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1% but for 2023 it has soared to 26.5%. Last year, the association had raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent. "The rocketing rate is in large part due to the growth in spend in on-patent medicines since 2019. Looking at the four completed years of the current VPAS scheme, data shows that the average annual growth rate for on-patent medicine sales value from 2019-22 was 18% compared to just 2% for off-patent products," said the association.

Pfizer said on Tuesday it will pay $11.6 billion to buy Biohaven Pharmaceuticals, making a big bet on its ability to boost sales of the top-selling pill in a new class of migraine drugs. The boards of both companies have approved the deal, they said. Biohaven shares jumped 70 per cent to $141.31, while Pfizer was up slightly at $48.83. Pfizer is flush with cash from a once-in-a-lifetime surge in revenue from Covid-19 vaccines and therapeutics and has said it is looking to buy companies or drugs that could add at least $25 billion in annual sales by the end of the decade. "The CGRP oral medications, though still somewhat newer entrants in a deeply entrenched space, continue to make steady inroads in disrupting the broader migraine market in the U.S.," said BioHaven chief executive Vlad Coric. Biohaven forecast Nurtec sales of $825 million to $900 million in 2022. Pfizer said it expects the pills to eventually overtake the shots.

Boehringer Ingelheim UK & Ireland has appointed Vani Manja as its new Country Managing Director and Head of Human Pharma. Manja has been associated with Boehringer Ingelheim for over 11 years, in successful leadership roles in Germany, the United States and most recently as General Manager, India. Her career started as a commissioned officer in the Indian Army Ordnance Corps which preceded leadership roles at Becton Dickinson and McKinsey. She brings extensive experience of strategy, marketing, sales, business development, people management, and cultural transformation and is passionate about tackling healthcare inequalities and advancing sustainable healthcare. Commenting on her new role, Manja said: "It is with great heart that I bring the spirit of conscious leadership to my new role. I look forward to being fully present and partnering with key stakeholders in the healthcare ecosystem in our collective quest to improve health for humans and animals in the UK and Ireland."

Boehringer Ingelheim's UK & Ireland managing director Uday Bose has been elected chair of the European Medicines Group (EMG). Established in 2001, the EMG is a voice for UK operations of continental European headquartered research-based pharmaceutical companies and seeks to promote a dialogue between the UK Government, the NHS and wider stakeholders. "I am delighted to share the news that I have been elected chair," Bose wrote in a LinkedIn post, adding: "I look forward to working with the EMG to help support the ambition set out in the Life Sciences Vision for the UK to be a world leader in life sciences." Bose is a vastly experienced pharmaceutical industry leader who has had over 20 years' experience spanning general management, health economics, sales and marketing roles with national, regional and global accountability.

Kelso Pharma, the growing UK based specialty pharma business, has announced its first product launch with the release to the UK prescription medicines market of Acepiro (Acetylcysteine) 600mg effervescent tablets. Acepiro 600 mg effervescent tablets are indicated in adults only and are being made available to hospital and community prescribers in 20 and 30 day packs, with the 30 day pack consistent with monthly prescribing. The NHS List Price for the 30 day pack is £4.40, with the 20 day pack priced at £3.65. Acepiro is being launched by Stirling Anglian Pharmaceuticals (SAP), which was acquired by Kelso Pharma one year ago, providing a new UK platform and springboard for future sales growth for the business. The new product complements SAP's existing portfolio of three medicines: CosmoCol (macrogol 3350 plus electrolytes) powder for oral solution - an osmotic laxative indicated for the treatment of chronic constipation and faecal impaction. Stirlescent (naproxen) 250mg effervescent tablets - containing naproxen, which is a non-steroidal anti-inflammatory drug (NSAID).

Britain's biotech firm Avacta Group on Monday (January 10) announced halting sales of its Covid-19 rapid antigen lateral flow test AffiDX to replace antibodies in the device and increase its ability to diagnose the Omicron variant. The company stated that AffiDX is capable of detecting Omicron when the virus is present in high numbers in samples, but the sensitivity of the test reduces at lower viral loads. The performance of all rapid antigen tests came under scanner in wake of a large number of mutations in the Omicron variant. AffiDX contains both a proprietary Affimer reagent and a commercially available antibody. The Affimer reagent detects the Omicron variant with the same sensitivity as the Delta variant, and performance of the antibody is paired with the Affimer reagent in the test. This has been affected by the additional Omicron mutations, the firm said. Alastair Smith, chief executive of Avacta Group, said: "Our determination to only provide high quality, high performance diagnostic tests has led us to the correct decision to pause all marketing of the AffiDX® lateral flow antigen test. We have, of course, been unable to market the product in the UK since October 2021, as the product continues to await approval under the new CTDA regulatory process.

The Royal Pharmaceutical Society (RPS) has called for a 'firm commitment' to prosecuting those making profits through the sale of DNP (2,4-Dinitrophenol). It has also urged the social media companies to 'remove content promoting or selling DNP to further reduce harm'. Legislation to regulate DNP will come into effect on 1 October 2023. On Monday (23 January) it was announced that DNP will be included in the 1972 Poisons Act. President of RPS Professor Claire Anderson said: "DNP is unfit for human consumption and its main use is in the manufacture of explosives and pesticides. It is sold by unscrupulous dealers to vulnerable individuals wanting to lose weight but has a dangerous effect on the metabolism and has led to 32 deaths since 2007 in those taking it as a 'diet drug'. "Including DNP in the Poisons Act is a positive move as it will restrict its availability, but what's really needed is an outright ban to reduce the risk to the public. Australia has already classified DNP as a substance of such a danger to health as to warrant prohibition of sale and we'd like the UK to follow suit.

Covid-vaccine maker AstraZeneca said Friday that profits fell sharply in the first half on ballooning costs linked to its takeover of US biotech firm Alexion. The pharmaceutical group added that sales of its Covid-19 vaccine Vaxzevria slumped 49 percent in the second quarter. Net profit slumped 64 per cent to $746 million compared with the first six months of last year, AstraZeneca said in a statement. Operating expenses jumped 33 percent, "reflecting the addition of Alexion, and continued investment in new launches and the pipeline" of drugs, the group said. That offset a 48-percent jump in revenue to more than $22 billion. Revenue rose strongly thanks to sales of Alexion medicines. The group said annual revenue from Covid-19 medicines is anticipated to be broadly flat compared with 2021.

Superdrug has reported more than 400 per cent spike in sale of the chickenpox vaccines in the UK. To protect children against the disease during chickenpox season, nearly nine out of 10 patients (87 per cent) have taken their wards under the age of five for vaccination in the last eight weeks. Chickenpox can be a seasonal disease with children usually catching it in the winter and spring, with UK peaks often between March and May. The last two years of spending time in and out of various lockdowns have meant less interaction between people, and so less transmission across the general population. Caris Newson, head of healthcare services at Superdrug, said: "One of the knock-on effects of Covid is that people have a greater awareness and understanding of the benefits that vaccines can offer. "We launched the chickenpox vaccination service five years ago in 2017 and it's now that we're beginning to see greater interest in how it can support family health. In fact, our fully qualified nurses have told us that they've had more parents ask about the chickenpox vaccination service, and word of mouth has then spread amongst parents and schools."

Novartis on Wednesday (February 1) predicted that core operating income would grow in a "mid single digit" percentage range in 2023 following stagnation last year, as the Swiss drugmaker prepares to spin off its Sandoz generics business. Full-year core operating income was broadly flat at $16.7 billion, it said in a statement, coming in slightly below market expectations of $16.8 billion. Adjusted for overall negative currency effects, group sales in 2022 advanced 4 per cent to $50.5 billion as gains from heart failure drug Entresto and multiple sclerosis (MS) drug Kesimpta were partly offset by competition from cheap generic copies of established MS drug Gilenya. Novartis said it was on track to spin off its generics unit Sandoz in the second half of the year as part of its effort to sharpen its focus on its patented prescription medicines. Analysts have welcomed a programme unveiled in 2022 to trim costs and cut 8,000 jobs and plans to focus on fewer therapy areas and drug technologies. But the market has been underwhelmed by prospects for medium-term growth from new drugs.

The Federation of Small Businesses (FSB) on Thursday (4 December) announced a new strategic partnership with the Bank of England to protect small businesses from the risks associated with accepting counterfeit banknotes. Cash is still the number one customer payment method for 25 per cent of small high street businesses, and cash payments are expected to increase during the festive period, according to FSB. By becoming a Strategic Partner of the Bank of England's Banknote Checking Scheme, the organisation is trying to help its members become aware of the use of counterfeit notes, which has reputational and financial impacts. The FSB is encouraging its members to sign up to the Scheme, which offers training materials to staff so they can identify a counterfeit note at point of sale and know what to do with it, as well as stay up to date with best practice and bank note developments.

A man has been sentenced to three and a half years in prison for illegally importing and distributing unlicensed medicines from India, the Middle East, and the Far East. Antoine Christopher Kolias, 31, received his sentence at Southwark Crown Court on 28 June after being found guilty of criminal activities in May. The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) led the investigation, dubbed Operation Bentley. Kolias was discovered to be acting both as a distributor for an established unlicensed medicines dealer and running his own illicit business. He was involved in the sale of sildenafil citrate, the active ingredient in Viagra, as well as Class C drugs including tramadol, zopiclone, and pregabalin between 2018 and 2019, and again between 2020 and 2021.

Olbas has announced the launch of its new TV ad campaign which will debut across the country this October. The TV campaign, which will be supported by a £1.5 million pound media investment, has been directed by commercial film director, Anthony Farquhar-Smith. The latest Olbas advertising creative will feature a new animated character, Lauren who is suffering with congestion caused by a cold. Lauren will be seen at home as the house begins to fill with balloons causing Lauren to feel uncomfortable and restricted, mimicking the 'bunged up' feeling of a heavy head cold. Olbas then saves the day as we see Lauren reach for a bottle of Olbas Oil to ease the symptoms of congestion, and as a result, the balloons deflate and the house returns to normal. Along with the large media investment, the campaign will also benefit from a strong PR programme to ensure the brand and retail sales are well supported throughout the peak cold and flu season. Owned by family-run health business, Lanes Health, Olbas Oil continues to be manufactured at their Gloucester based factory. Olbas uses only natural essential oils to provide a gentle but effective formulation to ease congestion and enhance breathing passages. The product offer includes Olbas Oil, Olbas For Children, Olbas Inhaler, Olbas Nasal Spray, Olbas Menthol Pastilles and Olbas Bath.

Despite significant sales growth in the quarterly results, high street chemist Boots is moving forward with its plan to close 300 stores in the UK. The move, aimed at improving profit margins amid rising costs and competition, will reduce the chain's portfolio from around 2,200 to just 1,900. Last month, the U.S.-based Walgreens Boots Alliance, the parent company of Boots, announced upcoming store closures within the next year. However, the company assured that there will be no job losses as all employees will be given the opportunity to be redeployed to nearby shops. The following sites are confirmed for closure on the specified dates: Heathside Rd, Woking (end of July) UEA campus (end of July) Hamlet Ct Rd, Westcliff-on-Sea (August 1) Windhill Road, Wakefield (October 6) Upper Warrengate, Wakefield (October 7) Glastonbury (October 13) Guildford Road, Woking (end of October) Boots stores at Salford Shopping Centre in Greater Manchester, Church Street in Malvern, The Port Arcades Shopping Centre in Ellesmere, and King William Street in London have already closed since spring.

The Manchester Crown Court on Friday (9 December) sentenced three men, Cleave Lewis (35) and brothers, Denis Sutherland (58) and David Sutherland (59), to a total of three years in jail after they pleaded guilty to the illegal sale and supply online of prescription-only medicines and controlled Class B and Class C drugs, worth more than £1.5m. They were found in possession of nearly 1.3m tablets of prescription-only drugs, including powerful sleeping pills, painkillers and anti-anxiety meds, when officers from the Medicines and Healthcare products Regulatory Agency (MHRA) and Greater Manchester Police searched their residential homes and business premises in October 2017. Following investigations by the agency, they also pleaded guilty to illegally making these medicines available online on three different websites for the public to purchase without prescriptions. The officials also recovered controlled medicines, over half a million (525,737) erectile dysfunction, slimming and herbal tablets, with an estimated value of approximately £500k, from them.

The NHS is on track to miss out on savings of over a billion pounds as patents for a new lineup of 85 biologics are set to expire within the next five years, the British Generic Manufacturers Association has revealed in its new study. The government's Voluntary Scheme for Branded Medicines Pricing and Access is expected to lead to a cost of more than £1 billion for the NHS in the coming years. The BGMA research found that more than 85 biological medicines will experience loss of exclusivity during the upcoming VPAS Scheme period from 2024 to 2028. "This includes blockbuster products like the cancer medicine Keytruda and wet macular product Eylea, which together generate approximately $25 billion in global sales," BGMA said. "The molecules coming off-patent also cover other disease areas including oncology, diabetes, arthritis, and asthma." While biological medicines dominate the medicines budget, constituting the largest cost and cost growth sectors, NHS England aims to expedite biosimilar availability, yielding substantial savings and expanding patient access to vital treatments. Yet, the report found that "this is jeopardised by the influence of the VPAS Scheme".

The British Generic Manufacturers Association (BGMA) has warned of the significant implications for future supply as a result of the crippling VPAS rate. The warning comes after the association's judicial review into the Government's decision to bar it from being a full part of the negotiations for the next five-year VPAS period was dismissed. The voluntary scheme for branded medicines pricing and access (VPAS) is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1%, but in 2023 it has soared to 26.5%. All biosimilars and a proportion of the generics market falls into the scheme.

Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year. It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S. government's Medicare plan for people age 65 and over, potential side effects and cost. One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000 per year. "Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer. Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain swelling and brain bleeding.

Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an industry body said on Monday. Companies are increasingly arguing that it is no longer possible to justify the UK's "voluntary scheme" to global boardrooms and investors as repayment rates in 2023 have surged to 26.5 per cent of revenue, the Association of the British Pharmaceutical Industry (ABPI) said in a statement. "The current scheme has harmed innovation, with costs spiralling out of control, and the UK falling behind other major countries to be left as a global outlier," said Laura Steele, president and general manager for Eli Lilly's Northern Europe division. ABPI said it was seeking early talks with the government to set out a new future settlement. In December, the industry body had said the government raised the amount manufacturers of branded medicines within the voluntary scheme will be required to return to almost £3.3 billion in sales revenue from an earlier amount of £1.8 billion.