Pharmaceuticals

General information about Multiple Sclerosis existing drugs and drugs under development

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Pharmaceuticals by Mind Map: Pharmaceuticals

1. Biogen Idec (EUA)

1.1. Avonex (Interferon beta-1a)

1.1.1. Vendeu US$ 2.9 bi em 2012

1.2. Tysabri (Natalizumab)

1.2.1. informação importante

1.2.2. arguably the best drug available

1.2.3. problemas com PML

1.3. Fampyra

1.3.1. acordo com Acorda, ver Acorda

1.4. Tecfidera (BG-12)

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

1.4.2. 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.

1.4.3. 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.

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

1.4.5. $50,000-$55,000 annual price tag

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

1.5. Plegridy (Peginterferon Beta-1a)

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

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

1.5.3. 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.

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

1.6. Daclizumab

1.6.1. Co-desenvolvida com AbbVie

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

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

1.6.4. Provável aceitação pelo FDA no final de 2014.

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

1.7. anti-LINGO-1

1.7.1. for acute optic neuritis

1.7.2. 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)

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

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

2. Novartis (Suiça)

2.1. Gilenya (fingolimod)

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

2.1.2. 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

2.1.3. A primeira pílula aprovada para o tratamento.

2.1.4. 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.

2.2. M356

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

2.3. Siponimod

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

2.3.2. is in Phase III testing in the secondary progressive form of MS (jan/2015)

2.3.2.1. The secondary progressive study won't read out for another two to three years, at least.

2.4. Secukinumab

2.4.1. remédio para tratar psoríase

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

3. Teva Pharmaceuticals (Israel)

3.1. laquinimod

3.1.1. não passou phase 3 (outubro/11)

3.2. Copaxone (Glatiramer acetate)

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

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

3.2.3. vai perder a patente em Maio/2014

4. sanofi-aventis (França)

4.1. Campath

4.1.1. vindo da Genzyme, que foi comprada

4.2. Aubagio (Teriflunomide)

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

4.2.2. Veio da Genzyme

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

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

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

4.2.6. 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.

4.3. Lemtrada

4.3.1. 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)

4.3.2. 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)

5. Elan (Irlanda)

5.1. Tysabri

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

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

6. Merk Serono (Alemanha)

6.1. Rebif (Interferon beta-1a)

6.1.1. Rebif Approved for Early MS

7. Adeona

7.1. Trimesta

7.1.1. 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.

8. Phases

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

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

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

8.4. 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

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

8.6. 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

9. Pfizer

9.1. Rebif

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

10. Acorda Terapheutics

10.1. Fampyra/Ampyra (dalfampridine)

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

10.2. Zanaflex

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

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

11. Legenda

11.1. Injeção

11.2. Oral

11.3. Intra-nasal

11.4. Droga de apoio

12. GW Pharmaceuticals

12.1. Sativex

12.1.1. treatment of spasticity

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

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

12.1.4. 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)

12.1.5. 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)

13. Questcor Pharmaceuticals

13.1. Acthar (gel)

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

13.1.2. custa US$ 23.000 por frasco

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

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

14. Bayer AG

14.1. Betaseron

15. Eficácia

15.1. BG-21 > Aubagio

15.2. Rebif > Aubagio

16. Segurança

16.1. Aubagio > Gilenya (?)

17. XenoPort

17.1. Arbaclofen Placarbil

17.1.1. 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

17.2. XP23829

17.2.1. 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.

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

18. Apitope

18.1. ATX-MS-1467

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

18.1.2. 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

18.1.3. 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.

19. AbbVie

19.1. Co-desenvolve Daclizumab com a Biogen

20. Alkermes

20.1. developing the next-generation Tecfidera

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

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

20.4. 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.

21. MediciNova

21.1. MN-166 (Ibudilast)

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

22. Bionure (EUA)

22.1. BN201

22.1.1. 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).

22.1.2. 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.

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

23. Interessante

23.1. http://www.fool.com/investing/general/2015/02/01/this-could-be-game-changing-news-in-the-battle-aga.aspx

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

23.2. http://www.fool.com/investing/general/2015/03/08/could-this-study-help-lead-to-a-cure-for-select-mu.aspx

24. Receptos

24.1. RPC1063

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

24.1.2. (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

24.1.3. 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

25. Arena

25.1. APD334

25.1.1. 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.

25.1.2. sucesso phase 1b em jan/2015

26. Ipsen (comprou Canbex)

26.1. VSN16R

26.1.1. designed to treat spasticity

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

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