CIALIS TOGETHER GRANTED OTC REGISTRATION IN UK

According to the UK’s Medicines Health products Regulatory Agency’s latest list of authorisations, published at end-February 2023, Cialis Together (tadalafil 10mg, Opella Healthcare / Sanofi) has been granted P (Pharmacy medicine OTC) registration. This is the second such OTC approval globally, following the world first Rx-to-OTC switch of Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) by Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) in February 2022; it is now available OTC (launched in October 2022) alongside a rival version from Polpharma’s Maxigra, which launched first in June 2022.

OTC activity in the erectile dysfunction category is intensifying globally. Futura Medical, which is aiming for its topical gel formulation MED3000 – branded as Eroxon – to become the first major ED treatment available OTC in USA, said in late 2022 that the FDA had confirmed the dossier was under formal review and “indicated that [it] had successfully passed the initial technical screening”. Granting of US marketing authorisation was said to be on track to be achieved by end-Q1 2023.

^{Polpharma’s Tadalafil Maxigra 36h is claimed to get to work in 16 minutes and last for 36 hours}

Nicholas Hall Writes: I’m interested in our lead story as we’re all keen to know what will happen when Viatris’ Viagra meets stiff competition in its UK lead switch market, where Viagra was first to launch and has attracted no branded competitors, so that it virtually dominates the market. Poland was a different matter as Viagra came relatively late into the marketplace, by which time there were a number of sildenafil brands, sold at lower prices with mass advertising, followed by the first switch anywhere in the world of tadalafil. Not surprisingly, Viagra has had only modest results in Poland.

Now we face the prospect of OTC Viagra meeting strong branded competition in its lead market, with a formulation that might not be as well known, but in medical terms is generally recognised as superior. Will Sanofi launch Cialis Together with saturation advertising, or with a more muted campaign that seeks a secondary position in the market? This is an interesting proposition in its own right, but especially as Viagra in Europe may well change ownership in the next year.

There is still time to save up to GB£1,350 when you pre-order the 2023 edition of our Innovation in CHC report, publishing soon! Drawn from CHC New Products Tracker, this report explores innovation by marketer, region and country. It showcases 10 major ingredient trends, 5 delivery format trends and 100 key innovations from 2022. For more information, or to pre-order your copy with the pre-publication discount, contact melissa.lee@NicholasHall.com.

Poland approves world-first OTC switch of tadalafil

We continue with the theme of Rx-to-OTC switch this week with news from Poland, where the Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) has approved Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) as an OTC medicine, effective 1st February 2022. This will join Adamed’s sildenafil options MaxOn Active (25mg) and MaxOn Forte (50mg), which launched in May 2016 and April 2020, respectively. Tadalafil is claimed to get to work within 30 minutes for up to 36 hours, vs claims for sildenafil that it works within 30-60 minutes for up to five hours.

Poland was again one of the most active Rx-to-OTC switch markets in 2021, with only China ahead of it last year in terms of number of launched products reclassified from prescription to OTC status. Three of the six products launched post-switch in Poland in 2021 were erectile dysfunction treatments, including Hasco-Lek’s Mensil Max, Aflofarm’s Inventum Max and Polpharma’s Maxigra Max (all sildenafil 50mg). In addition, there were two digestive health switches – Teva’s antidiarrhoeal Gastrolit and Polpharma’s antacid Famotydyna Ranigast – and Polpharma’s cold sore treatment Heviran Comfort Max.

^{Source: Nicholas Hall’s CHC New Products Tracker}

Nicholas Hall’s Touchpoints: Last week our lead story was the likely switch of HRT in the UK, which we singled out as a pioneer. The latest news this week is from Poland, another switch centre of excellence and where the ED treatment tadalafil will be available in a non-prescription version for the first time anywhere in the world. Tadalafil was launched as a prescription medicine under the trademark Cialis, and Sanofi later acquired the CHC rights from Lilly, but the switch application in the USA has been held up for many years by the FDA.

My colleague Maryna Marriott of the CHC Insight Europe team tells me: “Poland continues to lead the way in switch innovation. The tadalafil approval follows a number of sildenafil 25mg and 50mg switches, with the Polish ED category totalling US$27.7mn in MAT Q3 2021, according to DB6, an increase of 28.5% vs the year-ago period. Men’s health clearly remains high on the consumer health agenda, and it seems likely a number of other tadalafil switches will follow in Poland.”

Switch is an expensive process in the USA, which is why it is subdued there at present. On the other hand, there has been renewed switch activity in Europe and parts of Asia. The problem for the CHC industry has always been that the benefits given to US companies gaining switch status – the cost to the patient-as-consumer drops substantially and there is often three years marketing exclusivity, whereas the ingredient can no longer be prescribed for the same indication – are not available to marketers in the rest of the world. That leads to the curious situation of some switches being regulatory wins but commercial failures. Let’s hope that Adamed is blessed with decent sales for its latest innovation.

Find solutions for success in this competitive CHC landscape with Nicholas and the team in Athens on 4-6 May 2022 for our 32nd European CHC Conference & Action Workshop! Meet with peers and hear from industry experts, including sessions from Bayer, Teva, J&J and many others face-to-face! For more information, or to reserve your seat, please contact elizabeth.bernos@NicholasHall.com.

Switch: 2020 Review and 2021 Prospects

According to our CHC New Products Tracker tool, which covers 20 key markets globally, 2020 was a relatively good year for Rx-to-OTC switch activity, not quite at the level of particularly active years like 2018, but above average in terms of switch-related launch developments, and with some notable breakthroughs such as GSK’s switch of Voltaren Arthritis Pain (diclofenac) in the USA and Glenmark’s Momate Rhino Advance Nasal Spray (mometasone + azelastine) switch in Russia.

Thanks to the Rx-to-OTC reclassification of Voltaren Arthritis Pain, as well as eye allergy itch relief range Pataday (Alcon), the US market led the way in terms of switch developments in 2020, along with Poland, Germany and China. As for category switch trends, looking at Tracker data for the past 8 years (2013 to 2020), allergy remedies has been by far the most active OTC subcategory in producing new products following switch activity, with double the amount of NPD activity as the next nearest subcategory, cough remedies.

Looking ahead to 2021, one of the first switch developments this year will again be an allergy remedy. The UK’s Medicines & Healthcare products Regulatory Agency granted GSL status to Sanofi’s Allevia tablets for seasonal allergic rhinitis (fexofenadine 120mg; 12+ years; 1 tablet per day) in late December 2020. Once Allevia and other OTC fexofenadine products are launched, they will enjoy mass market distribution from the outset (it is more common in the UK for switched ingredients to be granted pharmacy-only OTC status). This is the second Rx-to-GSL UK allergy remedy switch in as many months, following approval for J&J’s Rhinocort Aqua budesonide 64mcg nasal spray in November 2020 (to be marketed as Benacort Hayfever Relief).

In addition, Poland remains at the forefront of global switch activity, with the country’s medicines agency (URPL) recently approving the Rx-to-OTC switch of Famotydyna Ranigast film-coated tablets (Polpharma; famotidine 20mg). Claimed to relieve indigestion, heartburn and hyperacidity for up to 12 hours, this is the first famotidine option available OTC in Poland. Meanwhile, Australia’s TGA is seeking comments until 27th January 2021 on proposed amendments to the Poisons Standard, which will be discussed at the March 2021 meeting of the Advisory Committee on Medicines Scheduling, including adding the following pharmacist-only medicines to Appendix H to permit consumer advertising: prochlorperazine and metoclopramide for the treatment of nausea associated with migraine; and chloramphenicol for ophthalmic use.

We are delighted to announce that our annual European e-Conference 2021 will take place online on 28 & 29 April! With options for individual and corporate site or global access, take the chance to keep up with what’s happening in consumer healthcare today and contact elizabeth.bernos@NicholasHall.com

OTC Innovation Report 2018

Lamenting the fact that Scott Gottlieb is stepping down as FDA Commissioner, Nicholas Hall commented in Friday’s OTC.Newsflash that: “Although producing few tangible results so far, FDA under Gottlieb has displayed a greater openness to finding new switch models at a lower cost and with shorter lead times, including the use of new technologies.” Nicholas Hall also said that “government support is vital to our industry” and that “more liberal regulations are at the heart of a successful self-care sector”.

A drop-off in switch activity over the past year is part of the explanation for lower levels of high-quality OTC innovation. In 2018, OTC New Products Tracker awarded just six products with 4 stars – eye care brands Lumify (USA) and Zabak Eye Drops (Poland), antacid Reza Band (USA) and antispasmodic Scopolan Compositum (Poland), plus Viagra Connect (UK) and allergy remedy Talerc (Brazil). Compared to previous years, this marked a falling-off in terms of 4-star innovations.

The number of total OTC innovations (3,747) in 2018 was roughly in line with the previous year, and still much higher compared to 2014, 2015 and 2016. However, the number of 2* (528), 3* (94) and 4* (6) innovations was much lower, while the number of 1* innovations (3,119) was at an all-time high.

VMS continues to be a major source of innovation, with three of the Top 5 subcategories in 2018 – probiotics, multivitamins and hair & beauty supplements. Derma is another key source of innovation, with three of the Top 10 – acne remedies, eczema & psoriasis and lip care. The three other innovative subcategories which complete the Top 10 are sedatives & sleep aids, topical analgesics and sore throat.

Please contact us for the full report. You can also review 17,000+ new launches and innovations with OTC New Products Tracker, the ultimate competitive intelligence tool! Products are given a star rating, with “me too” items ranked 1*; launches / line extensions in a new category / adjacency 2*; major launches / line extensions with strong new benefits / positioning 3*, and 1st Rx-to-OTC switches in a category, creation of a new OTC class or other major leaps in innovation 4*. With a recently-released major update including eye-catching new graphics and powerful search filters that help you visualise and explore the vast archive according to your exact requirements, now is the ideal time to set up your free trial. For a demo or more information, contact waisan.lee-gabell@NicholasHall.com.

OTCs in Action: OTC for ED in Poland

This week, OTCs are in Action in Poland, where Adamed is launching MaxOn Active (sildenafil 25mg, the active ingredient in Pfizer’s Viagra), the second market for legitimate OTC access to erectile dysfunction drugs. The first de facto OTC market for the ED category was New Zealand, where Douglas Pharma switched Silvasta in October 2014.

Of course, Rx drugs and dietary supplements for ED can be quite easily available “under-the-counter” (pharmacists dispensing without a prescription) or online in many markets around the world. However, some of these dietary supplement products can have serious and even deadly side-effects, and many feature unsafe ingredients from unscrupulous marketers looking to meet the product demand. Additionally, in many Emerging Markets, pharmacists are often the only healthcare providers accessible to consumers, so the “under-the-counter” trade is widely accepted.

In Poland, where MaxOn is available only in pharmacies, men are asked to take a test to determine safe use of the OTC when they purchase a 2-count pack for about $10.00. It’s estimated that about 1.7mn men in Poland experience ED, so OTC competitors will surely be keeping an eye on this first European OTC ED market.

It’s intriguing that the test to ensure consumer compliance is a like a first KISS (Keep it Simple, Stupid). The test asks consumers several questions regarding their use of drugs and about previous diseases. A man will have three possible answers to each question: yes, I don’t know or no. If the question is marked “yes” or “don’t know”, the patient should consult the doctor about use of the medicine.

Click the link below to see how men will self-test for MaxOn Active:

Take the Test