I've been lurking at the Lupus forum for a while. Not easy reading, which I guess is nothing compared to what many endure.
The reason for posting is I keep an eye on the research in this area (primarily as an investor rather than out of medical interest) and feel that there is some hope, in terms of new treatments, in the pipeline, and I'd thought I'd post about it.
An investor research company in the UK has today put out a note about Lupuzor. However, it also goes into some detail on it's views of other treatments in the pipeline. (As it's mainly about Lupuzor, it's heavily biased) however, I thought it might be of interest to some. My apologies if anyone feels I've intruded!
BenlystaI/II – This treatment was developed by Human Genome Sciences and licensed GlaxoSmithKline (GSK) which eventually acquired Human Genome Sciences for $3.6bn when the drug was approved. Benlysta is the only Lupus treatment that has been approved by the US FDA in the past fifty years. We see four major advantages for Lupuzor over Benlysta. Firstly, we would expect the manufacturing costs for Lupuzor, a peptide based drug, to be much lower than Benlysta, which is antibody based. This could potentially allow Lupuzor to gain market share through stronger margins combined with a lower sales price. According to the National Centre for Biotechnology Information, Benlysta treatment costs c.$35,000 per patient per annumIII. We understand that Lupuzor on the other hand could feasibly be priced at half this level. Secondly, we believe Lupuzor‟s safety record to be superior, and while not directly comparable or proven given the relative stages of development, Lupuzor has not shown any significant adverse drug-related effects on patients dosed. However, Benlysta‟s website says that Benlysta “can cause serious side effects”. Thirdly, patients have demonstrated an improvement in their condition within three months when taking Lupuzor, whereas we understand that Benlysta can take circa one year to have an effect. Lastly, Benlysta is delivered through IV Infusion and therefore needs to be administered within a hospital. Lupuzor on the other hand can be taken by the patient through a simple injection (in a similar way to insulin) just once a month.
Initiation of Coverage │ ImmuPharma Plc
LaquinimodIV/V – On 12th June Teva announced the results of a Phase IIa study of its drug, Laquinimod. This drug demonstrated “an additive effect in improving renal function when combined with current standard of care for active lupus nephritis” when compared with standard of care alone. This suggests that kidney function improved in patients with Lupus Nephritis. However, we note that as this release describes Lupus Nephritis as a manifestation of Lupus that can cause chronic kidney failure. This implies to us that at present this drug has shown effectiveness in treating only the manifested form of Lupus, Lupus Nephritis, and not the overall disease. The Lupus Foundation of America says that Lupus Nephritis usually develops within five years after the symptoms of Lupus begin, with up to 40% of Lupus patients developing kidney complications. Therefore, as Lupuzor has demonstrated effectiveness in halting the progression of Lupus, we interpret this as suggesting that it could halt the progression of patients before they develop Lupus Nephritis. We do not believe that Laquinimod has demonstrated itself as a treatment for Lupus (SLE) as a whole, whereas Lupuzor has already shown that it can treat Lupus rather than a manifestation of it, and as such we do not see Laquinimod as a major threat at present.
Other Candidates – While this list is not exhaustive, we briefly describe some additional potential Lupus treatments here:
EpratuzumabVI/VII (UCB and Immunomedics) – This compound demonstrated a treatment advantage of 25% points over a placebo in a Phase IIb trial comparable to Lupuzor, or a total response rate of 46%. Lupuzor demonstrated superior total efficacy in its trial, with 62% of a major sub-group of the trial (90% of the population) responding to treatment (21% points higher than the placebo).
AtaciceptVIII/IX (Merck Sorono) – Atacicept recently completed a Phase II/III efficacy study for the treatment of SLE. However, this drug failed to meet its primary end point in a Phase II rheumatoid arthritis study.
TabalumabX (Eli Lilly) – Tabalumab is currently progressing through a Phase III trial for SLE, however in February 2013 Lilly announced that a Phase III study of the drug for rheumatoid arthritis will be discontinued due to lack of efficacy.
AbataceptXI/XII (Bristol-Myers Squibb) – This potential candidate failed a trial to treat SLE as it failed to prevent flares of the condition relative to a placebo. We understand that a Phase II efficacy study for the treatment of Lupus Nephritis is ongoing.
We have shown that there is some level of competition in the marketplace, yet with the exception of Benlysta, all candidates are either in the testing phases or have not been approved. Accordingly, the market for approved Lupus treatments contains very few candidates. In addition, we know of no other drug candidate that attempts to combat lupus in a similar way to Lupuzor – through a specific peptide-based treatment approach. Most other drugs in development have broader mechanisms for immunosuppression, which is why they have been tested in other indications such as rheumatoid arthritis. We therefore believe that given Lupuzor‟s low production costs, relative safety, and its speed of action (positive patient responses seen within twelve weeks), it is well placed to enter a relatively uncompetitive market with strong USPs.