Xlucane

XBRANE BIOPHARMA’S XLUCANE – Market Potential and Competitors

Summary (also available in Swedish, see bottom of post)

No significant difference of Xbrane Biopharmas biosimilar Xlucane versus the original drug Lucentis.

Apr 17, 2017 – FDA Approves Genentech’s Lucentis for all Forms of Diabetic Retinopathy (DR).

Lucentis will go off patent 2020 in the US and 2022 in Western Europe.

Market size and forecast Lucentis

  • Diabetic Retinopathy (DR) market size: USD 6.5 billion in US alone in 2015. Forecasted growth at 6.9% CAGR from 2016 to 2023. CAGR = mean annual growth rate.
  • The wet AMD (wAMD): USD +8 billion by 2020.
  • Total Market for AMD in U.S., UK, Germany, France, Spain, Italy, and Japan: from $5.1 billion in 2013 to $10.1 billion by 2023

Xlucane is used in the treatment of various eye diseases, mainly:

  • (AMD) wet form of Age related Macular Degeneration
  • (DME) Diabetic Macular Edema
  • (RVO) Retinal Vein Occlusion

Status on Biosimilar Competitors to Xlucane

  • Formycon – is running a phase III trial with their biosimilar candidate to Lucentis called FYB201 in partnership with Bioeq IP AG. They are aiming for H120 data. 
  • Fovista – is not per se a competitor to Xlucane. This is due to the fact that Fovista is about a combination of anti-VEGF’s and Fovista. So it is to be seen as an adjunctive therapy, which means that it is an additional substance, treatment, or procedure used for increasing the efficacy or safety of the primary substance, treatment, or procedure or for facilitating its performance. For further reading, click here and here.
  • Coherus – I cannot really find anything supporting that Coherus are developing a biosimilar to Lucentis or other product for treatment of AMD. There is no information on this in Coherus own website Please let me know if you find support of this.

Introduction

On April 17, 2017, Genentech announced that its product Lucentis had become the first and only FDA-approved medicine to treat diabetic retinopathy (DR) in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye.

Genentech is quite a major player in the Bio Pharma industry. Genentech is among the world’s leading biotech companies and a member of the Roche group.

This is quite major news for Xbrane Biopharma and its product Xlucane. Let me shortly explain why. But first let me clarify what Xlucane is.

Xbrane Biopharma and its Xlucane (originator drug Lucentis)

Xbrane Biopharmas leading product in the biosimilar segment is Xlucane. Xlucane’s originator drug is Genentech’s Lucentis.

Xlucane is a ranibizumab biosimilar used in the treatment of various eye diseases, mainly:

(wAMD) wet form of Age related Macular Degeneration

(DME) Diabetic Macular Edema

(RVO) Retinal Vein Occlusion

No significant difference of Xlucane versus Lucentis

Xbrane Biopharma has performed a comprehensive study of Xlucane versus Lucentis. The study demonstrates no significant difference of Xlucane versus Lucentis on the most important parameters. This proves the quality of the product and gives us huge comfort for ongoing scale up of the production to commercial scale and the upcoming clinical trials and it allows us to accelerate the out-licensing process of the product.

Genentech’s Lucentis and its FDA approval on april 17, 2017

First and only FDA-approved medicine to treat Diabetic Retinopathy (DR)

With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy (DR)  in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye.

The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 74 and affects nearly 7.7 million people in the U.S.

Genentech’s Lucentis FDA-approval History

Date                      Article

Apr 17, 2017       FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy

Jan  5, 2017         FDA Approves Genentech’s Lucentis (ranibizumab) for Myopic Choroidal Neovascularization

Oct 14, 2016       FDA Approves Genentech’s Lucentis (ranibizumab) Prefilled Syringe

Feb  6, 2015        FDA Approves Lucentis (ranibizumab) to Treat Diabetic Retinopathy in People with Diabetic Macular Edema

Aug 10, 2012       FDA Approves Lucentis (ranibizumab) for Treatment of Diabetic Macular Edema (DME)

Jun 23, 2010        FDA Approves Lucentis (ranibizumab) for the Treatment of Macular Edema Following Retinal Vein Occlusion

Jun 30, 2006        FDA Approves Lucentis (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration

Dec 30, 2005       Genentech Submits Biologics License Application for FDA Review of Lucentis in Wet Age-Related Macular Degeneration

Source: https://www.drugs.com/history/lucentis.html

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy and myopic choroidal neovascularization (mCNV).

Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.

Outside the U.S., Lucentis is approved in more than 110 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and visual impairment due to choroidal neovascularization (CNV).

Market Estimates for Xlucane (and competitors)

Here I present a few market estimates from well-renowned sources. They differ only slightly.

As already mentioned, Lucentis is the first and only FDA-approved medicine to treat diabetic retinopathy (DR).

  • USD 6.5 billion

Diabetic Retinopathy (DR) market size alone in 2015 was USD 6.5 billion, it is forecast to grow at 6.9% CAGR from 2016 to 2023.

  • USD +8 billion

The wet AMD (wAMD) segment market is expected to reach more than USD 8 billion by 2020.

  • USD 7.5 billion

The anti-VEGF market is lucrative for biosimilar companies. Lucentis recorded estimated sales of $3.5 billion in 2015 and Eylea more than $2.7 billion. The total market for intravitreal anti-VEGF treatments in 2015 was around $7.5 billion.

  • USD 10.1 billion by 2023

The market for treatments of AMD across seven major countries (U.S., UK, Germany, France, Spain, Italy, and Japan ) will almost double in value from $5.1 billion in 2013 to $10.1 billion by 2023, according to research and consulting firm GlobalData.

GlobalData is a leading global provider of business intelligence in the healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research, and development.

Lucentis Annual Sales of 2016

*CHF: 1 406 000 000

*SEK: 11 795 400 000

*USD: 1 488 220 000

Source: http://www.roche.com/dam/jcr:48a515f7-7fe5-4c21-81f6-b028eed0c844/en/med-cor-2017-02-01-e.pdf

Patents

Lucentis will go off patent 2020 in the US and 2022 in Western Europe.

Lucentis competitor Eylea: comparison and patents

For Eylea, patents expire in 2020 and 2021 in the US and Europe, respectively, according to the journal Nature.

Eylea does not have FDA-approval to treat Diabetic Retinopathy (DR) in people who have been diagnosed either with or without diabetic macular edema (DME)

Studies have shown that there is no significant difference between Lucentis and Eylea in successful treatment of AMD. Here I link to two of them.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4546020/

https://www.brightfocus.org/macular/article/how-effective-are-macular-degeneration-treatments

Important note

Eylea is not a competitor to Xbrane Biopharma’s product Xlucane. Xlucane will primarily be competing against the likes of other biosimilar products when the patents of the origininal drug Lucentis expire. Not against the original products, like Eylea and Lucentis. Xlucane is a very price-competitive biosimilar to Lucentis and applicable in all of the above mentioned treatments.

Biosimilar Competitors

Biosimilars and non-originator biologicals* of ranibizumab approved or in development

Company name, Country
Product name
Stage of development
Coherus, USA CHS-3351 In pipeline [2]
Formycon/bioeq, Germany FYB201 Phase III trial started in October 2015 [3]
Hospira (Pfizer)/Pfenex, USA PF582 Entered into an agreement to exclusively develop and commercialize PF582 in February 2015 [4]. Pilot phase I/II study in AMD ongoing as of February 2015
Intas Biopharmaceuticals, India* Razumab ‘Similar biologic’ launched in India in June 2015 [5]
Xbrane Biopharma, Sweden Xlucane Positive data from in vitro biosimilarity study comparing Xlucane versus Lucentis reported in February 2017 [6]
*It should be noted that similar biologics approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Source: http://www.gabionline.net/Biosimilars/General/Biosimilars-of-ranibizumab

Formycon

Formycon is running a phase III trial with their biosimilar candidate to Lucentis called FYB201 in partnership with Bioeq IP AG. They are aiming for H120 data.

http://www.formycon.com/wp-content/uploads/2017/05/fc-gb-16-en-web.pdf

https://www.investing.com/analysis/xbrane-biopharma—good-manufacturing-status-allows-sales-to-start-200177543)

Fovista

Ophthotech has completed a multicenter, randomized, double-masked, controlled Phase 2b clinical trial evaluating the efficacy and safety of Fovista administered in combination with an anti-VEGF agent for the treatment of patients newly diagnosed with wet AMD.

Fovista is not per se a competitor to Xlucane. This is due to the fact that Fovista is about a combination of anti-VEGF’s and Fovista. So it is to be seen as an adjunctive therapy, which means that it is an additional substance, treatment, or procedure used for increasing the efficacy or safety of the primary substance, treatment, or procedure or for facilitating its performance. For further reading, click here and here.

Coherus

I really can’t find anything supporting that Coherus is developing a biosimilar to Lucentis or other product for treatment of AMD. There is no information on this on Coherus own website either. Please let me know if you find support of this.

Pfenex

Pfenex has continued to make progress on the strategic review for the PF582 program and will provide an update when appropriate.

– Pfenex Second Quarter 2017 report

This is what Pfenex declares on its PF582 in their Second Quarter 2017 report:

“In August 2016, Pfenex regained full rights from Pfizer to PF582, Pfenex’s biosimilar product candidate to Lucentis (ranibizumab) for the treatment of retinal diseases, and announced positive results from the phase 1/2 trial which showed that PF582 was pharmacologically active and had a safety profile that was consistent with that of Lucentis. Pfenex has continued to make progress on the strategic review for the PF582 program and will provide an update when appropriate.”

Further reading on Xbrane Biopharma:

https://robertveritas.wordpress.com/2017/09/07/xbrane-biopharma-redeye/

Sammanfattning

Ingen signifikant skillnad på Xbrane Biopharmas biosimilar Xlucane jämfört med det ursprungliga läkemedlet Lucentis.

17 april 2017 – FDA godkände Lucentis för alla former av DR (DiabetesRetinopati).

Patentet för Lucentis löper ut 2020 i USA och 2022 i Västeuropa.

Marknadsstorlek och prognos Lucentis

DR (DiabetesRetinopati): USD 6,5 miljarder år 2015.

Genomsnittlig årlig tillväxttakt till 2023: 6,9%.

AMD (Age-related Macular Degeneration): USD +8 miljarder år 2020.

Förväntad totalmarknad för AMD i USA, Storbritannien, Tyskland, Frankrike, Spanien, Italien och Japan: från 5,1 miljarder dollar 2013 till 10,1 miljarder dollar år 2023.

Xlucane används för behandling av olika ögonsjukdomar, främst:

(AMD)

(DME)

(RVO)

Status på konkurrenter till Xlucane

Formycon – pågånde fas III-studie med sin biosimilarkandidat till Lucentis. Formycon strävar att presentera sin data H1 2020.

Fovista – är inte i sig en konkurrent till Xlucane. Detta beror på att Fovista ges i en kombination av anti-VEGF och Fovista. Så Fovista är en kompletterande substans som används för att öka effektiviteten hos den primära substansen (Lucentis).

Coherus – Jag kan inte hitta något som stödjer att Coherus utvecklar en biosimilar till Lucentis eller annan produkt för behandling av AMD. Det finns ingen information om detta på Coherus egen webbplats. Vänligen meddela om du hittar annan information.

Pfenex – I augusti 2016 återgick de fullständiga rättigheterna till PF582 från Pfizer till Pfenex. Pfizer valde att hoppa av. PF582 är Pfenex biosimilarkandidat till Lucentis. Pfenex har meddelat positiva resultat från fas 1/2-studien som visade att PF582 var farmakologiskt aktiv och hade en säkerhetsprofil som stämde överens med Lucentis. Pfenex meddelar i sin Q2-rapport för 2017 att man kommer att ge en uppdatering när så är lämpligt.

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