General information about Multiple Sclerosis existing drugs and drugs under development

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Pharmaceuticals por Mind Map: Pharmaceuticals

1. Teva Pharmaceuticals (Israel)

1.1. laquinimod

1.1.1. não passou phase 3 (outubro/11)

1.2. Copaxone (Glatiramer acetate)

1.2.1. top-selling multiple sclerosis drug in the world (US$ 4 bi)

1.2.2. The drug reduces the annualized relapse compared with placebo by 29%

1.2.3. vai perder a patente em Maio/2014

2. sanofi-aventis (França)

2.1. Campath

2.1.1. vindo da Genzyme, que foi comprada

2.2. Aubagio (Teriflunomide)

2.2.1. falhou em bater o Rebif. Mais fraca, bem tolerada, poderá ser usada para tratamento no início. (jan/2012)

2.2.2. Veio da Genzyme

2.2.3. Passou em 2 testes Phase III, foi feito pedido para vender na Europa (fev/2012)

2.2.4. Foi aprovada pelo FDA (set/2012), o uso é 1/dia.

2.2.5. Aubagio's niche might end up being the patients that can't tolerate the more effective drugs.

2.2.6. harsher warnings in the form of an FDA black box warning label. The warning specifically notes that Aubagio can cause severe liver problems that can lead to death. Additional side effects for the second-line treatment include kidney problems, high blood pressure, and breathing problems.

2.3. Lemtrada

2.3.1. the FDA asked the company to reformat the data in the application. A little embarrassing -- a pharma giant should know what charts and figures the FDA wants -- but it's only a minor delay and certainly easier to fix than running another trial. (ago/2012)

2.3.2. won approval for its multiple sclerosis treatment Lemtrada in the European Union. While the drug has yet to get the green light in the U.S., it is a key addition to Sanofi's multiple sclerosis lineup, which also includes the oral medication Aubagio (sep/2013)

3. Elan (Irlanda)

3.1. Tysabri

3.1.1. co-comercializada com Biogen (ver Biogen Idec)

3.1.2. Direitos comprados pela Biogen Idec, ficando só com 25%

4. Adeona

4.1. Trimesta

4.1.1. treatment of cognitive dysfunction, começou phase II (jan/12). The primary objective of the study is the rate of relapse between the placebo and treated groups at two years.

5. Pfizer

5.1. Rebif

5.1.1. co-comercializada com Merk (ver Merk Serono)

6. Acorda Terapheutics

6.1. Fampyra/Ampyra (dalfampridine)

6.1.1. the only treatment approved by the FDA for MS patients to treat walking impairment

6.2. Zanaflex

6.2.1. short-acting drug that treats central nervous system injuries.

6.2.2. It is used to treat the spasms, cramping, and tightness of muscles

7. GW Pharmaceuticals

7.1. Sativex

7.1.1. treatment of spasticity

7.1.2. GW Pharmaceuticals' only approved cannabinoid drug, Sativex, has been launched in 15 countries and approved in 12 others (mainly in Europe)

7.1.3. is trying to get Sativex approved in the United States (fev/2015)

7.1.4. The company is currently evaluating THC- and CBD-containing Sativex in three phase 3 trials in the United States for treating cancer pain and spasticity from multiple sclerosis, although the drug is already approved in over two dozen countries. Two of the phase 3 trials are identical, with the first having failed to meet its primary endpoint in early January. The second will report results in the second quarter, while the third study, consisting of a more complex design, will announce its findings in late 2015. (jan/2015)

7.1.5. As noted by GW's Pharmaceuticals' press release, Sativex failed to meet its primary endpoint of delivering a statistically significant difference in cancer pain reduction relative to the placebo. Furthermore, the secondary endpoints also missed the mark. The icing on the cake was that 19% of withdrawals were due to adverse events while taking Sativex compared to just 15% for the placebo. Long story short, it was not an encouraging trial in the least. (jan/2015)

8. Questcor Pharmaceuticals

8.1. Acthar (gel)

8.1.1. approved by the FDA in adults with MS for the treatment of acute exacerbations, also known as relapses or attacks.

8.1.2. custa US$ 23.000 por frasco

8.1.3. pode ser usado quando o tratamento para a recaída (relapse) não está funcionando. Casos graves

8.1.4. "selling this drug at an extremely high price point. The interesting thing is that this drug has been around for 50-plus years"

9. Bayer AG

9.1. Betaseron

10. XenoPort

10.1. Arbaclofen Placarbil

10.1.1. was unsuccessful in delivering a statistically significant benefit compared to the placebo. XenoPort's management noted that the company plans to cease development of AP

10.2. XP23829

10.2.1. very similar to current FDA-approved MS drug Tecfidera, which is made by Biogen Idec, but could be even better given its favorable safety profile.

10.2.2. XP23829 definitely bears close watching, but it's also years away from making a difference

11. Apitope

11.1. ATX-MS-1467

11.1.1. Acabou o segundo Phase I com sucesso: MRI results showed a decrease in the number of contrast-enhancing brain lesions

11.1.2. is aimed at working with the immune system to treat the underlying cause of disease and restoring immunological balance, rather than just treating the symptoms or suppressing the complete immune system

11.1.3. ATX-MS-1467 is being developed under an agreement between Apitope and Merck Serono, under which Apitope has carried out the Phase I clinical trial, while Merck Serono will be responsible for all development activities from the beginning of Phase II clinical trials.

12. AbbVie

12.1. Co-desenvolve Daclizumab com a Biogen

13. Alkermes

13.1. developing the next-generation Tecfidera

13.2. Early-stage studies of its MMF drug are expected by mid-2014.

13.3. announced the initiation in July (2015) of a phase 1

13.4. The idea for Alkermes is to develop a non-inferior MS product in terms of efficacy that potentially has an improved safety profile relative to Tecfidera.

14. MediciNova

14.1. MN-166 (Ibudilast)

14.1.1. Jul/13: has announced the initiation of a cooperative Phase IIb trial of MN-166 in patients with progressive multiple sclerosis

15. Bionure (EUA)

15.1. BN201

15.1.1. Fast Forward will provide funding to Bionure for the late-preclinical development of BN201 to enable IND filling to support the Phase 1 clinical study in Acute Optic Neuritis (AON).

15.1.2. Bionure's BN201 is a New-Chemical Entity, first-in-class neuroprotective candidate in development for AON and has been recently granted with orphan designation status by the FDA.

15.1.3. Bionure to file the IND by Q2 of 2015"

16. Receptos

16.1. RPC1063

16.1.1. RPC1063 reported positive results from the Phase 2 portion of the RADIANCE study in RMS (fev/2015)

16.1.2. (fev/2015) The Phase 3 portion of RADIANCE, which is currently enrolling patients ... In addition, we have initiated the SUNBEAM Phase 3 trial of RPC1063 in patients with RMS

16.1.3. In the phase 3 portion of the RADIANCE study, which was actually begun in late 2013 under a special protocol assessment with the Food and Drug Administration, RPC1063 will be pitted head-to-head against Biogen Idec's Avonex. With strong efficacy and safety in its phase 2 study, this is certainly a drug for relapsing MS patients

17. Arena

17.1. APD334

17.1.1. APD334 is a modulator of sphingosine 1-phosphate subtype 1, or S1P1. Drugs such as Novartis' (NYSE: NVS ) Gilenya, which is in this class, are thought to work by retaining lymphocytes in the lymph nodes so they don't attack other tissue. Lowering patients' lymphocyte counts in the blood is clearly a sign APD334 is doing what it's supposed to.

17.1.2. sucesso phase 1b em jan/2015

18. Ipsen (comprou Canbex)

18.1. VSN16R

18.1.1. designed to treat spasticity

18.1.2. acabou Phase IIa (jan/2015) com sucesso

19. Biogen Idec (EUA)

19.1. Avonex (Interferon beta-1a)

19.1.1. Vendeu US$ 2.9 bi em 2012

19.2. Tysabri (Natalizumab)

19.2.1. informação importante

19.2.2. arguably the best drug available

19.2.3. problemas com PML

19.3. Fampyra

19.3.1. acordo com Acorda, ver Acorda

19.4. Tecfidera (BG-12)

19.4.1. Destruindo a competição, fez as ações da Biogen subir 60% em 6 meses, começou a ser vendida no início de 2013.

19.4.2. The drug reduced the annualized relapse compared with placebo by 44% or 51%, depending on whether it was dosed twice or three times a day.

19.4.3. was studied in two different clinical trials known as Confirm and Define. In its Confirm study, Biogen noted that its pill, administered twice daily, reduced the rate of MS relapses by an impressive 49%, and was associated with a 71% to 99% drop in new or expanding lesions in both trials.

19.4.4. The most common side effects exhibited by patients on Tecfidera were flushing and gastrointestinal events.

19.4.5. $50,000-$55,000 annual price tag

19.4.6. sales are running at an annualized $3.6 billion pace exiting 2014

19.5. Plegridy (Peginterferon Beta-1a)

19.5.1. This is a longer-lasting, and therefore less-injected (1 vez/2 semanas), version of the company's flagship product Avonex.

19.5.2. pediu aprovação para FDA em maio/13, já fez 1 ano de Phase 3. Só deve ser aprovada em 2014.

19.5.3. Reusltados 1o ano da Phase 3: significantly reduced disease activity such as relapses, disability progression and brain lesions compared to placebo, in addition to demonstrating favorable safety and tolerability profiles at one year.

19.5.4. Já está sendo comercializada (jan/2015): To date, roughly half of Plegridy prescriptions have come from Avonex switches.

19.6. Daclizumab

19.6.1. Co-desenvolvida com AbbVie

19.6.2. Atualmente em Phase III (set/13), poderá ser comercializada em 2 anos se tudo der certo.

19.6.3. demonstrated a 54% and 50% reduction in annualized relapse rates compared with the placebo in the 150mg and 300mg dosages

19.6.4. Provável aceitação pelo FDA no final de 2014.

19.6.5. AbbVie and Biogen should submit for regulatory approval of daclizumab in the first half of 2015.

19.7. anti-LINGO-1

19.7.1. for acute optic neuritis

19.7.2. Overall, the actual trial results were a mixed bag, although Biogen reported them as "positive." Biogen's chief medical officer pointed out that it was the first clinical trial to provide evidence of biological repair in the central nervous system. I see that as encouraging, since Biogen's major hope for the drug is that it could reverse damage to the brain caused by multiple sclerosis, where it is also being tested. At the moment, multiple sclerosis can be managed but not cured -- but Biogen may now be a step closer. (jan/2015)

19.7.3. pode ser usado para MS além de neurite ótica. Falhou alguns testes, mas ainda está sob análise (jan/2015)

19.7.4. Data from SYNERGY is expected sometime in 2016. (SYNERGY is the name of one phase 2 trial)

20. Novartis (Suiça)

20.1. Gilenya (fingolimod)

20.1.1. passou phase 3 (dez/11) estranho, esse medicamento já não estava sendo vendido?

20.1.2. jan/2012: Health agencies on both sides of the Atlantic are investigating reports of 11 deaths in multiple sclerosis patients taking Gilenya - por problemas cardíacos

20.1.3. A primeira pílula aprovada para o tratamento.

20.1.4. has the potential to cause serious cardiovascular problems through slowing a patients' heart rate, can lower lymphocyte counts (similar to Tecfidera), and can potentially lead to macular edema or liver problems.

20.2. M356

20.2.1. Versão genérica do Copaxone, co-desenvolvido com a Momenta Pharmaceuticals.

20.3. Siponimod

20.3.1. another S1P modulator that's somewhat different from Gilenya

20.3.2. is in Phase III testing in the secondary progressive form of MS (jan/2015) The secondary progressive study won't read out for another two to three years, at least.

20.4. Secukinumab

20.4.1. remédio para tratar psoríase

20.4.2. teste prova de conceito foi feito para mostrar que pode ser usado para tratar MS

21. Merk Serono (Alemanha)

21.1. Rebif (Interferon beta-1a)

21.1.1. Rebif Approved for Early MS

22. Phases

22.1. Phase 0 - exploratory, first-in-human trials

22.2. Phase I - assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug

22.3. Phase II - assess how well the drug works, as well as to continue Phase I safety assessments in a larger group

22.4. Phase III - randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is

22.5. Phase IIIB - enquanto a solicitação submetida está pendente para aprovação, testes podem continuar para coleta de mais dados sobre a droga

22.6. Phase IV - postmarketing surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold

23. Legenda

23.1. Injeção

23.2. Oral

23.3. Intra-nasal

23.4. Droga de apoio

24. Eficácia

24.1. BG-21 > Aubagio

24.2. Rebif > Aubagio

25. Segurança

25.1. Aubagio > Gilenya (?)

26. Interessante


26.1.1. Nova técnica de tratamento, mas eficaz apenas no início da doença!


27. Sorry about the info in Portuguese. I'll translate & update if I see some interest in my map.