Dermatological Drugs Market Forecast 2015-2025: Opportunities for Leading Companies

psoriasis. In April 2014 it was reported that Perrigo had begun the launch of authorised generic Taclonex.

4.10 Soriatane (acitretin) – GlaxoSmithKline

Soriatane is a small molecule systemic therapy indicated for the treatment of severe psoriasis in adults. It is an oral retinoid that inhibits excessive cell growth and skin cell thickening that is seen in psoriasis. It reduces plaque formation and scaling. It was launched in 1996 by Stiefel Laboratories (now part of GSK). Patent protection has since expired for Soriatane, leaving it vulnerable to generic competition.

Soriatane causes a wide range of side effects. These include dryness and cracking of the lips, dryness of the nasal passages and loss of hair as well as more serious side effects such as hepatitis and pancreatitis. The serious nature of these side effects restricts revenue generation; Soriatane is only prescribed after treatment with another therapy has failed and is only given to those patients suffering from severe psoriasis.

4.10.1 Soriatane: Sales Forecast 2015-2025

GSK reported that soriatane sales in 2014 were particularly affected by the generic competition in the US which is said to have affected the company’s dermatology products cumulatively. Dermatology product sales for the company were reported to have decreased by 56% in 2014 compared to 2013. Although GSK has not publicly published individual sales for Soriatane, visiongain have estimated sales for the product at $86m in 2014 (Table 4.13).

We forecast sales for Soriatane to continue its decline over the forecast period. The patents granting the drug exclusivity in the major markets have expired for a number of years. This has allowed generic versions to erode away large portions of the drugs sales since the first US generic version was launched in April 2013. GSK reported in Q1 of 2015 that the sales erosion being witnessed for Soriatane was a major contributing factor to the 56% decline that the company experienced in the dermatological arm of its business.

Table 4.13 and Figure 4.15 show visiongain’s revenue forecast for Soriatane used in psoriasis and psoriatic arthritis between 2015 and 2025.

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Figure 6.6 Solodyn (Valeant): Sales Forecast ($m, AGR%), 2014-2025

Market Size ($m) AGR (%)

250 5

200 0

150 -5 (%) AGR

Revenue ($m) Revenue 100 -10

50 -15

0 -20

Year

Source: Visiongain 2015

Table 6.4 Solodyn (Valeant): Sales Forecast ($m, AGR%, CAGR%), 2014-2025

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Solodyn ($m) 210 217 225 231 192 163 144 128 115 104 96 89 AGR (%) 3.2 3.6 2.9 -17.1 -14.8 -11.5 -11.2 -10.4 -9.1 -7.9 -7.2 CAGR (%) 2014-19 -4.9 2019-25 -9.6 CAGR (%) 2014-25 -7.5

Source: Visiongain 2015

6.5.2 Antitrust Action Over Solodyn Pay-For-Delay Deals

In July 2013, Rochester Drug Co-Operative, a New York-based wholesale drug distributor filed a federal antitrust lawsuit against Medicis and other generic drug manufacturers. The suit alleges that Medicis and the generic companies improperly delayed the market entry of generic Solodyn. This was achieved firstly through Medicis’ filing of a ‘baseless’ petition with the FDA to delay approval of Impax Laboratories’ version of Solodyn, and secondly by Medicis and Impax entering

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Dermatological Drugs Market Forecast 2015-2025: Opportunities for Leading Companies

8.5.3 France

France’s dermatological drugs market was estimated at $888m in 2014, accounting for 23.5% of the EU5 market (Table 8.12).

Table 8.12 The French Dermatological Drugs Market Forecast: Revenue ($m), Rank, Market Share (%) and CAGR (%), 2014-2025

2014 2019 2025 Market Size ($m) 888 995 1,056 Global Market Ranking 5th 6th 7th EU5 Market Share (%) 23.5 22.9 22.2 2014-2025 2014-2025 CAGR (%) 1.6 Market Outlook Positive

Source: Visiongain 2015

8.5.3.1 French Dermatological Drugs Market Forecast 2015-2025

France will retain its position as the second largest market within the global dermatological drugs market. France’s large population size and high levels of healthcare spending means that revenue generated by the sale of dermatological drugs is relatively high. We forecast this trend to continue over the coming years. As novel treatments for dermatological indications are launched unto the market, the high costs associated with these therapies will help to sustain the high dermatological drugs revenue in France.

Visiongain forecasts the French market for dermatological drugs to rise from $888m in 2014 to $995m in 2019, at a CAGR of 2.3% between 2014 and 2019 (Table 8.13 and Figure 8.17). Economic pressures will limit increases in government spending, but a growth in the elderly population will raise patient populations for some dermatologic conditions. Growth will also slow towards the end of the forecast period as a result of increasing competition and market saturation. Nonetheless, we expect the market for dermatological drugs in France to grow to $1,056m in 2025 (Table 8.13), rising with a CAGR of 1.0% between 2019 and 2025.

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In Europe, GSK has withdrawn its marketing application for combined Mekinist/Tafinlar after regulators requested additional information. The company was reported to be looking to re-submit its filing once it has additional results from its Phase 3 trial. However, in July 2014, GSK reported that a Phase 3 study of its Tafinlar and Mekinist combination compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma may be stopped early.

9.5.4 GlaxoSmithKline (GSK): Dermatological Drugs Development Pipeline, 2015

Table 9.8 provides an overview of GSK’s pipeline dermatology drugs in 2015. Further discussion of the leading drugs may be found in Chapter 10.

Table 9.8 GlaxoSmithKline: Dermatological Drugs Pipeline, 2015

Generic name / Name Indication Pha se Description clindamycin/benzoyl Duac low dose Acne 3 peroxide Toctino alitretinoin Chronic hand eczema 3 ofatumumab (anti-CD20 Arzerra Pemphigus vulgaris 3 mAb) GSK2894512 NSAID Atopic dermatitis 2 Stearoyl CoA desaturase 1 1940029 Acne 1 inhibitor (topical) muscarinic acetylcholine Umeclidinium hyperhydrosis 1 antagonist (topical)

Source: GlaxoSmithKline 2015; Visiongain 2015

9.6 Pfizer

Pfizer is regarded as the leading research-based pharmaceutical company globally. Its business segments include: Primary Care, Specialty Care and Oncology, Established Products and Emerging Markets (generics) and Consumer Healthcare (OTC products and dietary supplements). The company was established in 1849 and is headquartered in New York.

Table 9.9 provides an overview of Pfizer’s business.

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evaluated in patients with Grade I-II actinic keratoses. The study is predicted to be completed in August 2015.

10.6.1.2 Ameluz (5-ALA photodynamic therapy) - Biofrontera

Ameluz (BF-200 ALA; 5-aminolevulinic acid photodynamic therapy) is a treatment for AKs which gained approval in the EU in December 2011 and launched first in Germany in August 2012. The treatment remains in clinical trials in the US after the FDA requested further studies to support approval. It was reported recently that the company was to submit approval dossier for Ameluz in the US in March 2015. US FDA approval is expected in around 2015. Four studies were registered for Ameluz under the NIH’s clinical trial database in May 2015 when visiongain enquired:

• A trial to compare Ameluz with Metvix (methyl aminolevulinate photodynamic therapy) in basal cell carcinoma • A trial of Ameluz treatment in entire fields of the skin surface and using Biofrontera’s own PDT lamp BF-RhodoLED • A trial testing the sensitising (allergic) potential of Ameluz, requested by the FDA • A maximal-use pharmacokinetics study in which an entire tube of Ameluz is applied to maximally damaged skin to observe its absorption and elimination

10.6.1.3 Keytruda (MK-3475, Pembrolizumab) - Merck

Keytruda (Pembrolizumab) is a human PD-1-blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab or a BRAF inhibitor (if BRAF V600 mutation positive).

Keytruda’s efficacy was investigated in a multicentre, open-label, randomized, dose-comparative, activity-estimating trial, where eligibility criteria were unresectable or metastatic melanoma with progression of disease. Patients taking part in the trial were randomised to receive 2mg/kg or10mg/kg of Keytruda every 3 weeks until unacceptable toxicity or disease progression. The tumour status in these patients was assessed every 12 weeks. The results of the trial indicated an overall response rate (ORR) of 24% in the 2mg/kg arm, consisting of 1 complete response and 20 partial responses.

The FDA evaluated Pembrolizumab in advanced melanoma under its Breakthrough Therapy program and granted accelerated approval based upon this clinical trial results showing an overall response rate of 24%. Multiple clinical trials are currently under way exploring pembrolizumab

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