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http://www.StockMarketFunding.com Stock Market Technical Analysis Human Genome (HGSI) Monthly Chart Bullish Breakout Human Genome Sciences Bullish “Options Activity” $1 Million in options contracts purchased at the $30 Strike Price Weekly Chart Trend Analysis Video News & HGSI Trend Commentary. It’s not lupus. It’s never lupus.” The words of Dr. Gregory House in the hit TV drama House M.D. probably did more to burn the complex autoimmune disease on the public consciousness than any medical awareness campaign.But there’s a serious point: While frequently put forward, a diagnosis of lupus rarely seems to turn out correct. And despite some very bullish forecasts, decisions on deal making and financing have so far been taken almost blindly because no one really knows just how large the lupus market is, or how big it could become in future.This could soon change. On November 16, Human Genome Sciences Inc. and GlaxoSmithKline’s Benlysta will be reviewed by a U.S. FDA advisory committee, and a positive verdict should pave the way to it becoming the first new treatment for lupus in 50 years. This, in turn, could spur deal interest in a number of companies developing earlier-stage projects, such as Sweden’s Active Biotech, Germany’s Biotest, the French micro cap Neovacs and private U.S. start-up Argos Therapeutics Inc.Meanwhile, key projects that have already been licensed to large partners, such as Zymogenetics Inc’s atacicept, Trubion Pharmaceuticals Inc’s SBI 087 and ImmuPharma’s Lupuzor, should find a surer footing towards funding and approval, although given the historic risks inherent in lupus drug development, it’ll be some time before any big pharma partners pull the M&A trigger and decide to buy their junior partners outright.Defining the actual size of the lupus market will be one of Benlysta’s most important roles. Current estimates of lupus incidence vary widely, and there’s little hard evidence to go on as the condition has a relapsing nature, a bit like multiple sclerosis, and is currently treated only symptomatically with a range of off-patent drugs.Without accurate estimates of prevalence and incidence it’s impossible to make hard and fast decisions on drug pricing or estimate peak sales, and by implication decide whether to strike a licensing deal, and, if so, for how much.Nevertheless, most analysts are cautiously penciling in peak sales for Benlysta of more than $1 billion. Another important point is that the drug, should it be approved, will be marketed by GlaxoSmithKline, whose selling prowess should ensure that physician and patient awareness of the disease increases, meaning that subsequent treatments could have a bigger market to take aim at. Many of the molecules in development–including Benlysta as well as Biotest’s BT 063 and Neovacs’ kinoid vaccine–are complex biologicals; the importance of this in terms of withstanding generic pressure cannot be overstated.

As far as potential partners are concerned, big pharma players like Pfizer, Roche and AstraZeneca have long held an interest and should be active in deal making, especially if current development projects encounter setbacks. Israel-based Teva Pharmaceutical Industries, already a partner for Active Biotech’s laquinimod, is an obvious partner for the latter’s related project paquinimod.

It will also be interesting to see whether Merck & Co. Inc, the only big pharma company without a significant presence in lupus at present, decides to take the plunge after the first drug approval.

Of course, analysts’ forecasts could be way out, and if the market size is significantly smaller that could spell the end of some drug developers’ efforts, or a switch into alternative autoimmune disease for others. In any case, the route to developing a drug for lupus is notoriously tricky, a fact to which management of La Jolla Pharmaceutical Co, which was almost wiped out when its drug Riquent failed in Phase III, can testify.

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