Anavex Life Sciences Corp (AVXL)

[XenaLives]

Is Epilepsy actually our best partnering option, even more proximate than an MS deal?

Pressure is mounting in this space:



https://anavex.com//wp-content/uploads/ANAVEX-2-73-as-a-Potential-Treatment-for-Rett-Syndrome.pdf

Epilepsy is a brain disorder characterised by spontaneously occurring and recurrent seizures with a prevalent population of 5.7 million in 2016 and expected to rise to 6 million in 2026.

According to GlobalData, sales of anti-epileptic drugs totalled $6.1bn in 2016 across the EU5, Japan and US markets. The sales of anti-epileptic drugs are expected to rise to $7.5bn by 2026 at a Compound Annual Growth Rate of 2.1% across the 7 major markets. The US will remain the leading market throughout the ten year forecast period with estimated sales of $5.9bn in 2026.

The Epilepsy market has been dominated in the past by a handful of drugs including the most recent UCB’s Keppra and GSK’s Lamicta. However main drivers of the forecast and growth of sales will be due to the launch of rare orphan disease drugs currently in the late-stage pipeline including Epidiolex and Fenfluramine which are expected to be approved for Lennox-Gastaut syndrome and Dravet syndrome.

https://www.pharmaceutical-technology.com/comment/epilepsy-drug-sales-hit-7-5bn-2026/


This is Kepra:

Image result for keppra manufacturer patent expiration
Levetiracetam was approved for medical use in the United States in 1999. The immediate release tablet has been available as a generic in the United States since 2008, and in the UK since 2011. The patent for the extended release tablet will expire in 2028.
License data: EU EMA: by INN; US FDA: Levet...
Elimination half-life: 6–8 hrs
Levetiracetam - Wikipedia
https://en.wikipedia.org/wiki/Levetiracetam

Google header box is the source


This is Lamictal:

LAMICTAL XR (lamotrigine - tablet, extended release;oral)
Manufacturer: GLAXOSMITHKLINE LLC
Approval date: May 29, 2009
Strength(s): 25MG [RLD] [AB], 50MG [RLD] [AB], 100MG [RLD] [AB], 200MG [RLD] [AB]
Manufacturer: GLAXOSMITHKLINE LLC
Approval date: April 14, 2010
Strength(s): 300MG [RLD] [AB]
Manufacturer: GLAXOSMITHKLINE LLC
Approval date: June 21, 2011
Strength(s): 250MG [RLD] [A

Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Formulations and method of treatment
Patent 8,637,512
Issued: January 28, 2014
Assignee(s): Glaxo Group Limited
A sustained release formulation of lamotrigine or a pharmaceutically acceptable derivative thereof and methods of treatment and uses thereof.

Patent expiration dates:

June 14, 2028
?
Drug product
Oral dosage form for controlled drug release
Patent 9,144,547
Issued: September 29, 2015
Assignee(s): Glaxo Group Limited
An oral dosage form comprising, (i) an erodable core, which core comprises a pharmaceutically active weak base or a pharmaceutically acceptable salt or solvate thereof; and (ii) an erodable coating surrounding said core, which coating comprises one or more openings extending substantially completely through said coating but not penetrating said core and communicating from the environment of use to said core; characterized in that release of the pharmaceutically active weak base or a pharmaceutically acceptable salt or solvate thereof from the dosage form occurs through the said opening(s) by the erosion of said erodable core and through erosion of said erodable coating under pre-determined pH conditions; a process for preparing such a dosage form and the use of such a dosage form in medicine.

Patent expiration dates:

September 22, 2023
Drug product

https://www.drugs.com/availability/generic-lamictal-xr.html

22 AUGUST 2017 RESEARCH REPORTS
AEDs targeting rare epilepsy syndromes set to shoot to top of the market
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Figure1: the anticipated top selling AEDs by 2026 in the 7MM


AED = antiepileptic drug

According to GlobalData’s upcoming report 'PharmaPoint: Epilepsy', the 2016 market was worth $6.11bn in the seven major pharmaceutical markets (7MM), with more than 20 antiepileptic drugs (AED) on the market.

The late-stage pipeline has six new products including novel classes and reformulations, which have been developed to address longstanding unmet needs in the market. These pipeline products are expected to be the major drivers of growth in the epilepsy market, and by the end of the forecast period for 2016, all six are anticipated to make it into the top ten selling AEDs, as seen in Figure 1.

By 2026, the two top selling AEDs are expected to be GW Pharmaceutical’s Epidiolex (cannabidiol) and Zogenix’s flenfluramine, with Epidiolex expected to reach blockbuster status in 2024. Both of these drugs have shown efficacy in patients that suffer from rare, orphan epilepsy syndromes, particularly Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome.

Epidiolex and flenfluramine will be premium-priced. If these drugs are successful in these patient populations, it is likely GW Pharmaceutical and Zogenix will apply for label expansions, allowing them to be used in a broader spectrum of patients.

SK Biopharmaceutical’s cenobamate is forecast to become the third highest-selling AED in the epilepsy space by the end of the forecast period. This drug is aimed specifically at refractory patients who have failed to respond to anywhere from one to three AEDs. This population represents 30% of epilepsy patients, which means that the drug will have a considerable patient pool. However, the price of cenobamate must be low enough to keep it competitive with other branded AEDs, which will limit its sales. (see note below)

The remaining three drugs in the pipeline are expected to generate up to $300m each by 2026 because they partly address some longstanding unmet needs in the epilepsy market. Neurelis and Upsher-Smith Laboratories are both developing nasal sprays for the treatment of acute repetitive seizures (ARS). This formulation is favorable to the rectally administered Diastat and buccal midazolam, and thus is expected to increase compliance in patients.

SAGE Therapeutics’ brexanolone is being indicated for patients suffering from super refractory status epilepticus (SRSE). While this is patient population is particularly small, the high annual cost of therapy (ACOT) will drive sales. If successful in this patient population, SAGE will likely look for a label expansion that allows brexanolone to be used earlier in the treatment algorithm.

The remaining four drugs anticipated to be top sellers in the epilepsy space are branded versions of recently marketed drugs, specifically Union Chimique Belge’s Keppra (levetiracetam), Vimpat (lacosamide) and Briviact (brivaracetam), and GlaxoSmithKline’s Lamictal (lamotrigine). While all of these are expected to have their patents expire by the end of the forecast period, physicians are still likely to prescribe them, as these four branded drugs have been shown to have the best efficacy profiles out of the currently marketed AEDs.

https://www.pharmaceutical-technology.com/research-reports/researchreportaeds-targeting-rare-epilepsy-syndromes-set-to-shoot-to-top-of-the-market-5908092/

SK Biopharmaceuticals is prvately held, a division of:

SK Group (Korean: SK??, ??????), also known as SK Holdings, is one of the largest conglomerates (chaebol) in South Korea. SK Group is composed of 95 subsidiary companies that share the SK brand and culture named SKMS (SK Management System).
Headquarters: Seoul, South Korea
Key people: Chey Tae-won, Chairman & CEO; ...
Products: Energy & Chemicals, Telecommunic...
Number of employees: Korea: 83,645 (2016); ...
SK Group - Wikipedia
https://en.wikipedia.org/wiki/SK_Group