BMS to sell French subsidiary?

According to an exclusive report in Reuters, BMS is looking to sell its French OTC subsidiary, Upsa, in a potential deal which could exceed €1bn (US$1.2bn). Deutsche Bank and Jefferies are said to be preparing the auction process, which will begin after the summer. It is rumoured that potential bidders may include Stada, Zentiva, Mylan and P&G, while Recordati could also decide to make a play for the company.

Upsa has been in operation for over 80 years and the company itself is a well-established brand in France, by far BMS’s key OTC market. According to DB6, BMS generated global OTC sales of US$477mn in 2017, 60% of which were generated in France (US$285mn). BMS’ next two biggest OTC markets are Belgium and China.

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Upsa’s key brands are Dafalgan and Efferalgan analgesics (both paracetamol), as well as the paracetamol-based Fervex systemic cold & flu line. According to the latest OTC DASHBOARD trend report, Upsa is the No.2 OTC marketer in France behind Sanofi but sales there fell by 4.8% in 2017, with mid-single digit declines for Dafalgan and Efferalgan.

Price cuts for reimbursed semi-ethical painkillers like Dafalgan and Efferalgan have contributed to the decline in France, causing marketers like Upsa to shift focus from reimbursed options to pure OTCs; reimbursed Efferalgan SKUs were rebranded as Efferalganmed in October 2015. In December 2017, the marketer also rebranded Fervex medical device options as Les Élémentaires, in response to rising concerns about the use of umbrella branding which could confuse consumers.

With M&A activity in the CHC industry rapidly increasing, it might be the right time for your business to explore interesting and suitable growth opportunities coming from M&A. Our specialist M&A boutique is working with a number of strategic and financial partners to assess potential opportunities — for buyers and sellers — and is well placed to discuss the current business climate and possible synergies. To find out more, please contact ammar.basit@NicholasHall.com.

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Hollywog unveils smartphone-controlled pain device

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As revealed by our recently published MAT Q2 2017 info, global sales of topical analgesics (+8.2%) fast outpaced systemic analgesics (+3.8%), owing to higher levels of product innovation. This trend was particularly noticeable in North America, where sales of topical analgesics were up 16.2% in the year to end-June 2017.

One specific area of dynamism has been topical pain relief devices, specifically TENS machines, with a variety of smaller marketers and established OTC players launching such products in recent years. For example, Bayer launched TENS device Aleve Direct Therapy in summer 2016.

The innovation stakes have now been raised higher with the launch of a smartphone-controlled TENS device by US marketer Hollywog. The WiTouch Pro Bluetooth TENS Therapy device is paired with the WiTouch Pro App to provide stimulation pain therapy to the lower back.

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According to Chuck Thomas, CEO of Hollywog: “This launch signals an important innovation for Hollywog, where our new patented pain management solution, the WiTouch Pro, offers a drug-free digitally-enabled alternative to block pain and keep moving. People are looking for a discrete solution that is personalised for their pain and with this launch we deliver on that need.”

This trend is likely to accelerate, with marketers like Purdue Pharma already looking at how to deliver pain therapy via smartwatches too.

Belfast scientists say aspirin could reverse tooth decay

Aspirin has long been prized for its painkilling properties, while low-dose aspirin is a popular systemic cardiovascular treatment, but new research shows that it could also reverse tooth decay.

According to a BBC report, the effects of tooth decay could potentially be reversed by the use of aspirin and lead to fewer fillings being needed in the future, researchers in Belfast have said. Tooth decay, the most common dental disease, leads to the inflammation of the tooth nerve, causing toothache.

Initial research at Queen’s University found aspirin stimulates stem cells in teeth, enhancing tooth regeneration. Current treatment for tooth decay involves fillings, which may need to be replaced many times during the lifetime of the tooth.

The British Dental Association reported in 2016 that 72% of 15-year-olds in Northern Ireland have dental decay. That figure compared to 44% in England and 63% in Wales.

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Teeth naturally have limited regenerative abilities. They can produce a thin band of dentine, the layer just below the enamel, if the inner dental pulp becomes exposed, but this cannot repair a large cavity.

The research findings, to be presented later this week at the British Society for Oral and Dental Research annual conference, show that aspirin can enhance the function of those stem cells, thus helping self-repair by regenerating lost tooth structure.

The researchers collated large amounts of previous research data to identify aspirin as a compound that can induce the gene signature needed to generate new dentine.

 

Ibuprofen associated with blood pressure rise in arthritis patients at CVD risk

According to the European Society of Cardiology, ibuprofen is associated with increased blood pressure and hypertension compared to celecoxib in patients with osteoarthritis or rheumatoid arthritis and increased risk of cardiovascular disease.

Nonsteroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but are now linked with increased blood pressure and adverse cardiovascular events.

NSAID labels include warnings about potential increases in blood pressure but there is little data on the effects of individual drugs. Maintaining or achieving blood pressure control in patients with arthritis and concomitant hypertension could avoid more than 70,000 deaths from stroke and 60,000 deaths from coronary heart disease each year.

The study which found the results, PRECISION-ABPM, was a prospective, double blind, randomised, non-inferiority cardiovascular safety trial. It was conducted at 60 sites in the US and included 444 patients, of whom 408 (92%) had osteoarthritis and 36 (8%) had rheumatoid arthritis. All patients had evidence of, or were at increased risk for, coronary artery disease.

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Patients were randomised in a 1:1:1 fashion to receive celecoxib (100–200mg twice a day), ibuprofen (600–800mg three times a day), or naproxen (375–500mg twice a day) with matching placebos.

Principal investigator Prof Frank Ruschitzka, professor of cardiology and co-head, Department of Cardiology, University Heart Centre, Zurich, Switzerland, said: “PRECISION-ABPM showed differential blood pressure effects between the different NSAIDs, ibuprofen and naproxen, and the COX-2 inhibitor celecoxib. While celecoxib and naproxen produced either a slight decrease (celecoxib) or a relatively small increase (naproxen) in blood pressure, ibuprofen was associated with a significant increase in ambulatory systolic blood pressure of more than 3mmHg.”

“Patients receiving ibuprofen had a 61% higher incidence of de novo hypertension compared to those receiving celecoxib,” Prof Ruschitzka continued.

These results support and extend the findings of the PRECISION trial, demonstrating non-inferiority for the primary cardiovascular outcomes for moderate doses of celecoxib compared with naproxen or ibuprofen.

Esomeprazole, Ibuprofen OTC Changes Take Effect In Canada

In February this year, Health Canada announced its intention to make two changes to the Prescription Drug List (PDL). Specifically, it was proposed that the PDL be amended to allow an OTC version of esomeprazole for heartburn and to make technical changes that would permit modified-release ibuprofen products available for self-care.

While this announcement was not a surprise as the six-month period for comment elapsed on 5th August, the delay in making the change effective (18th August) was more likely owing to administrative matters than anything therapeutic in nature. The two changes to the federal list are as follows:

  • Esomeprazole or its salts except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg
  • Ibuprofen or its salts except:
    1. An oral dosage form that provides 400mg or less per dosage unit; or
    2. A modified-release oral dosage form that provides 600mg or less per dosage unit

While the Federal decision had no further restrictions attached, the provincial scheduling of these products do take on some further limitations as decided by the National Association of Pharmacy Regulatory Authorities (NAPRA).

Now that the federal switches are finalised, the interim decision made by NAPRA becomes effective. Specifically, the provincial decision on these two items were:

  • Ibuprofen or its salts, when sold in a modified-release oral dosage form that provides 600mg or less per dosage unit would be placed into Schedule III (sold only where a pharmacist is present)
  • Esomeprazole or its salts, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg, in package sizes of no more than esomeprazole 280mg would be assigned to Schedule II (available only from a pharmacist directly)
  • Esomeprazole or its salts, EXCEPT when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg in package sizes of no more than esomeprazole 280mg will not be switched provincially (it will remain in Schedule I – Rx only)

The ibuprofen decision was notable since the regular dosage form is available as an unscheduled item (available through any outlet when sold in package sizes of up to 18,000mg) while the modified release product is restricted. The esomeprazole decision matched the decision made for omeprazole in 2014.

UK press misreports paracetamol’s autism / ADHD links

Paracetamol is the most widely used analgesic in the world and was once deemed the only painkiller that is safe for mothers-to-be.

However, women who take paracetamol during pregnancy “risk having a child with autism or ADHD”, the Mail Online reported last week. Other UK newspapers, The Times and The Daily Telegraph, are also ‘guilty’ of publishing headlines that could potentially cause unnecessary worry for pregnant women.

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The Spanish study that reported on the matter actually provided no direct link or solid evidence to ADHD or autism. Over 2,000 pregnant women using paracetamol, before and during pregnancy, were assessed between 2004 and 2008. Various developmental and behavioural tests on the children at the ages of one and five were then conducted.

Links were found between paracetamol use and hyperactivity / impulse symptoms at age five, and autism symptoms in boys. There was however no direct link to ADHD or autism symptoms, nor a link to intellect or development in the children being affected.

The study will most likely contribute to the long list of pregnancy “dos” and “don’ts” owing to its media focus. Most importantly, the NHS has confirmed that there was no link with the full diagnostic criteria for attention deficit hyperactivity disorder (ADHD) or autism; highlighting that the study cannot prove that using paracetamol in pregnancy caused these symptoms.

OTCs in Action Episode 64: Relieving Zika pain

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OTCs are in Action treating minor symptoms of the Zika virus, which has spread to 66 countries, according to the World Health Organization’s April 21 status report. In fact, the insect-borne disease has become so prevalent that OTC brands are investing in TV advertising detailing their benefits for symptom relief. For example, Nicholas Hall’s OTC INSIGHT Latin America reports this month: GSK’s A+P campaign in support of paracetamol-based Dolex systemic analgesic (known globally as Panadol) highlights its efficacy against symptoms of vector-borne viruses such as zika, chikungunya and dengue.

Nicholas Hall Events will host its 2nd Latin American OTC Conference, From Recession to Recovery: Analysing Latin America’s Return to Growth, on 9-10 June in Miami. Nicholas Hall will be joined by senior professionals with intimate knowledge of the local OTC environment, to offer delegates ways of navigating this dynamic yet unpredictable region.

Following the theme ‘From Recession to Recovery’, our speakers will analyse Latin America’s return to growth showcasing examples of local and global brands, highlighting ways in which they have found success in this region and what lessons can be learned. For more information, please click on the link:
Latin American OTC Conference: From Recession to Recovery