This post of mine from the ymb ties in with what LeRoux Joostes' talking point.
jab9
Formula: MTX + Medi-Jet = ATRS (+TNF alpha) = ATRS delivery of Biologics for the treatment of DMARD’s
MTX = methotrexate
Medi-Jet = Antares delivery device
TNF alpha = tumor necrosis factor (Currently available biologic agents act as inhibitors of the cytokines IL-1 or TNF. Cytokines are messenger molecules made by many of the body's cells that act to excite other immune system cells. Interleukin-1 (L-1) and tumor necrosis factor (TNF) are made in large amounts in rheumatoid arthritis and other forms of inflammation)
DMARD = Disease Modifying antirheumatic drugs
MTX is considered the first line therapy for the treatment of rheumatoid arthritis (RA) and a top line therapy for poly-articular-course juvenile RA and moderate to severe psoriasis.
Antares has the first and only Subcutaneous, MTX single use, once weekly disposable device (the Medi-Jet) capable of administering MTX doses from 10, 15, 20 to 25 mg.
I’m going to argue, this avenue of MTX delivery by Antares is unique, forward thinking and a potential “trend setter” for the delivery of future biologics when used in combination with MTX.
The biologics listed below, are agents the may be used alone, but are often given in conjunction with other DMARD’s
The predicted top 10 best-selling medicines in 2014 included 3 treatments for arthritis.
1. Humira (adalimumab) by Abbott with 2010 sales of 6.8 billion.
2. Enbrel (etanercept) by Pfizer(Wyeth) with 2010 sales of 7.1 billion.
3. Remicade (infliximab) by Merck/J&J with sales of 7.4 billion.
The three above are biologics that are facing patent loss protection and lets not forget about biosimilars and 2013 biggest patent expiry Amgens Neupogen (filgrastim) for the treatment of Neutropenia with sales 2010 sales of 4.8 billion.
Insert Teva / Antares collaboration:
Two pen injectors (disposables) products – Global programs
– One Generic (ANDA) and One Branded (505B2) product – $1.5 Billion in current sales
– ANDA filing anticipated within 12-18 months – Pen 1
– 505B2 program has completed PK work – Pen 2
I will further argue ( assuming approval and success of Antares Otrexup) that the path of biologics delivery (particularly for the 3 mentioned above) will find their way into an Antares delivery device.
Footnotes:
Dosing
For rheumatoid arthritis, the starting doses have been established by large clinical trials and are shown in Table 2. Biologic agents must be given by an injection under the skin (etanercept (brand name Enbrel), adalimumab (brand name Humira) and anakinra (brand name Kineret)) or by intravenous (IV) infusion (infliximab (Remicade)). These medications must be stored in a refrigerator and warmed to room temperature prior to use. Patient education information and videos are available for the self injectable medicines. A nurse or physician can teach you about the medicine and how to give the injections. It often helps to bring a spouse or friend with you to learn how to do the injections.
Major biologicals facing loss of patent protection include Amgen and Pfizer’s rheumatoid arthritis drug Enbrel (etanercept), Roche’s blood cancer and rheumatoid arthritis medicine Rituxan (rituximab), and Merck and Johnson & Johnson’s anti-inflammatory drug Remicade (infliximab). These three drugs alone are reported to have worldwide sales of more than US$12 billion in 2010 [2].
From GaBi online are these notes:
Biologicals boom Posted 15/02/2013
Researchers predict that the present list of top 10 blockbuster drugs will change dramatically by 2014. The predictions are that by 2014 biological drugs will topple the present market leaders Pfizer’s Lipitor (atorvastatin) and Sanofi’s Plavix (clopidogrel), both of which are small molecule chemical entities [1].
By 2014 at least six out of the top 10 best-selling drugs are expected to be biological drugs, mainly for treating cancer and rheumatoid arthritis. This compares to five drugs making it into the top 10 during 2008 and just one in 2000, see Table 1.
Table 1: Top 10 best-selling medicines 2010
The situation is predicted to change dramatically by 2014, see Table 2. At least six, and as many as eight, of the top 10 best-selling drugs are expected to be biological drugs. Moreover, biological drugs are predicted to account for 75% of sales, an almost two-fold increase in the relative contributions of biological drugs to the pharmaceutical sector.
Table 2: Predicted top 10 best-selling medicines 2014
The reason for this expected change is generics competition for small molecule drugs that will be off patent by 2014, including current bestsellers Lipitor (atorvastatin), Plavix (clopidogrel), Advair (fluticasone/salmeterol) and Diovan (valsartan).
There is also an opportunity here for biosimilars, with an estimated US$17 billion worth of sales in biologicals in the US alone set to lose patent protection between 2011 and 2015.
Major biologicals facing loss of patent protection include Amgen and Pfizer’s rheumatoid arthritis drug Enbrel (etanercept), Roche’s blood cancer and rheumatoid arthritis medicine Rituxan (rituximab), and Merck and Johnson & Johnson’s anti-inflammatory drug Remicade (infliximab). These three drugs alone are reported to have worldwide sales of more than US$12 billion in 2010 [2].
