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"Bio-Tech" Buzz - HGSI Human Genome Monthly Bullish Breakout Chart Tech. Analysis
Stock Market Technical Analysis Human Genome (HGSI) Monthly Chart Bullish Breakout Human Genome Sciences "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 the 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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Comment
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Comment by Hot Stocks on January 18, 2011 at 3:06pm
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Comment by Hot Stocks on December 5, 2010 at 3:14pm
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Comment by Hot Stocks on December 5, 2010 at 3:07pm
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Before the Bell - Monday Morning Workshop
http://smfhotstocks.com/profiles/blogs/before-the-bell-mondays-stock
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Comment by Hot Stocks on December 5, 2010 at 2:40pm
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Human Genome Sciences (HGSI) and GlaxoSmithKline PLC (GSK) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for BENLYSTA (belimumab) as a potential treatment for systemic lupus erythematosus from December 9, 2010 to March 10, 2011. After the FDA Arthritis Advisory Committee met on November 16, 2010 to consider the BENLYSTA BLA, the FDA requested some additional information from HGS, which has been submitted.
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Comment by Hot Stocks on November 18, 2010 at 11:31pm
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Glaxo has no Genzyme interest, seeks lower R&D risk
Thu Nov 18, 2010 5:12pm EST
* Glaxo says big acquisitions would disrupt R&D
* Reiterates will not make counter-bid for Genzyme
* Will focus more on rare diseases, streamline R&D
By Toni Clarke
BOSTON, Nov 18 (Reuters) - GlaxoSmithKline Plc (GSK.L a href="http://www.reuters.com/finance/stocks/overview?symbol=GSK.L" target="_blank">http://www.reuters.com/finance/stocks/overview?symbol=GSK.L> ) says it is not interested in making a counterbid for U.S. biotech company Genzyme Corp (GENZ.O a href="http://www.reuters.com/finance/stocks/overview?symbol=GENZ.O" target="_blank">http://www.reuters.com/finance/stocks/overview?symbol=GENZ.O> ) and that an acquisition of such size would be disruptive to its own research and development.
Glaxo has been cited as one of a number of parties contacted by Genzyme to determine its value as it fends off an $18.5 billion hostile takeover bid from France's Sanofi-Aventis SA (SASY.PA a href="http://www.reuters.com/finance/stocks/overview?symbol=SASY.PA" target="_blank">http://www.reuters.com/finance/stocks/overview?symbol=SASY.PA> ).
"Those kind of big deals are incredibly destructive to research and development," said Patrick Vallance, senior vice president of medicines discovery and development, who argued that the process can lead to chaos. "There is an argument for maintaining a stable R&D organization."
Speaking on Thursday to reporters in Cambridge, Massachusetts, not far from Genzyme's headquarters, Vallance and other Glaxo executives outlined their own strategy for drug discovery, and said big acquisitions are not part of the plan.
At a time when many large pharmaceuticals companies are struggling to develop new drugs from their internal research operations, Glaxo is experimenting with business models that could hedge its risk of failure.
One is option-based financing, where, instead of buying a company or an asset outright, it gets an option to buy the asset based on its progress in clinical trials. It is a model that is increasingly being adopted by other pharmaceuticals companies and mid-sized specialty drug companies such as Cephalon Inc (CEPH.O a href="http://www.reuters.com/finance/stocks/overview?symbol=CEPH.O" target="_blank">http://www.reuters.com/finance/stocks/overview?symbol=CEPH.O> ).
"It allows GSK to 'test drive' the technology," said Rob Aboud, vice president, global operations and strategy development. "If GSK doesn't exercise the option, the biotech company keeps the programs."
The company is also moving away from developing drugs to treat diseases such as depression and schizophrenia where results are hard to predict and most drugs fail. The risk does not diminish even as the products move through late-stage clinical trials, Vallance said.
Instead, the company is focusing more on drugs for rare diseases, where patient populations are well defined, the disease can be accurately diagnosed and regulators are a little more lenient given the lack of treatments on the market.
Benlysta, the lupus drug Glaxo is developing with Human Genome Sciences (HGSI.O a href="http://www.reuters.com/finance/stocks/overview?symbol=HGSI.O" target="_blank">http://www.reuters.com/finance/stocks/overview?symbol=HGSI.O> ) meets that profile, Vallance said.
"It's exactly the sort of thing we want to be doing."
On Tuesday, an advisory panel to the U.S. Food and Drug Administration recommended that the agency approve Benlysta, which analysts estimate could generate annual sales of up to $5 billion.
MORE LATE-STAGE TRIALS, FEWER FAILURES
Whether the company's strategy is successful in bringing new products to the market remains to be seen, but Vallance said Glaxo is moving more drugs into late-stage clinical trials and is experiencing fewer failures along the way.
"It's early days," he said, "but our late-stage pipeline is very different from four years ago."
Glaxo held its day-long meeting at the headquarters of Sirtris, a company Glaxo bought in 2008 for $720 million. Sirtris achieved renown for its development of resveratrol, a natural enzyme found in red wine that received much publicity for its potential to lengthen life.
That hype moderated and Sirtris's chief executive, George Vlasuk, who joined the company in 2009, said since then the company, which vigorously fights to maintain its independence within Glaxo, has ret
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Comment by Hot Stocks on November 17, 2010 at 5:44pm
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Barclays reiterates an 'Overweight'
rating on Human Genome Sciences (NASDAQ: HGSI),
PT $40.
Barclays analyst says, "We are reiterating our rating on shares of HGSI following positive recommendation from the FDA Arthritis
Advisory Committee (AAC) panel for Benlysta approval for patients with
SLE. With FDA framing the vote as a vote for having Benlysta on the
market, we believe that there is little question on approvability
although label finalization will likely extend beyond the Dec. 9 PDUFA.
Potential label restrictions on use in severe CNS and renal disease as
well as African Americans is unlikely to impact commercial opportunity
significantly, and we are maintaining our peak sales estimate and $40
price target."
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Comment by Hot Stocks on November 17, 2010 at 5:44pm
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Human Genome Sciences (HGSI) and GlaxoSmithKline PLC (GSK) announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve BENLYSTA (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE). The FDA Arthritis Advisory Committee is convened to provide the FDA with independent expert advice on a broad range of issues related to rheumatology drug products.
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Comment by Hot Stocks on October 28, 2010 at 2:20pm
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Oct. 27, 2010 20:04 UTC
Human Genome Sciences Announces Third Quarter 2010 Financial Results and Key Developments
- BENLYSTA® granted priority review by FDA, with PDUFA target date of December 9, 2010 -
ROCKVILLE, Md.--(BUSINESS WIRE a href="http://www.businesswire.com" target="_blank">http://www.businesswire.com> )-- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial results for the quarter ended September 30, 2010, and provided highlights of recent key developments.
“BENLYSTA has continued to make excellent progress in the third quarter and we look forward to the upcoming FDA advisory committee meeting,” said H. Thomas Watkins, President and Chief Executive Officer. “We have completed the hiring of our BENLYSTA sales force and sales management team for the United States. Their training is now underway, and we are currently building an organization to work alongside GlaxoSmithKline in Europe. Regulatory applications have been submitted in Europe, Australia, Canada and Switzerland, and we anticipate regulatory submissions in a number of additional countries in the coming months. We continue to believe that BENLYSTA could become the first new approved drug for lupus in more than 50 years.”
FINANCIAL RESULTS
HGS reported revenues for the quarter ended September 30, 2010 of $50.8 million, compared with revenues of $18.8 million for the same period in 2009. Revenues primarily included $36.1 million recognized from payments previously received under the ZALBIN™ agreement with Novartis, $7.3 million recognized from sales and deliveries of raxibacumab to the U.S. Strategic National Stockpile, and $5.1 million from manufacturing and development services other than raxibacumab.
The Company reported a reduced net loss for the third quarter of 2010 of $40.9 million ($0.22 per share), compared with a net loss of $49.0 million ($0.32 per share) for the third quarter of 2009.
For the first nine months of 2010, HGS reported revenues of $136.1 million, compared with revenues of $222.8 million for the same period of the previous year. Revenues primarily included $82.8 million recognized from the ZALBIN agreement with Novartis, $34.0 million recognized from the sale and delivery of raxibacumab to the U.S. Strategic National Stockpile, and $13.7 million from manufacturing and development services other than raxibacumab. The reduction in revenues for the current nine months, compared with the same period last year, primarily reflected the higher level of raxibacumab revenue recognized in 2009, $162.7 million, partially offset by increased recognition of revenue from the ZALBIN agreement in 2010.
The Company reported a net loss of $145.6 million ($0.78 per share) for the nine months ended September 30, 2010, compared with net income of $15.4 million ($0.11 per share) for the same period of the previous year. The net loss for the current nine months, compared with the same period last year, primarily reflected the difference described above in raxibacumab and ZALBIN revenue recognized in 2010 versus the same period in 2009, in addition to a gain in 2009 of $38.9 million on the extinguishment of debt.
As of September 30, 2010, cash and investments totaled $1.0 billion, of which $938.6 million was unrestricted and available for operations. This compares with cash and investments totaling $1.2 billion as of December 31, 2009, of which $1.1 billion was unrestricted and available for operations. HGS expects cash and investments at year-end 2010 to total approximately $900-950 million.
“HGS has continued to invest in building the commercial infrastructure and expertise required to support a world-class launch of BENLYSTA,” said David P. Southwell, Executive Vice President and Chief Financial Officer. “With approximately $1 billion of cash and equivalents, HGS is well-positioned financially to support the launch and growth of BENLYSTA and to fund our research and development program.”
HIGHLIGHTS OF RECENT PROGRESS
BENLYSTA®: Granted Priority Review by FDA;
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Comment by Hot Stocks on September 22, 2010 at 1:36am
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Human Genome pops as a newsletter circulates suggesting GSK for HGSI (29.07 +0.22) : Same rumor circulated in mid August. See our Aug 20 10:05 and 12:53 comments. 13-Sep-10 12:14 ET In Play Human Genome at Morgan Stanley analyst conference (29.15 -0.84) : Co commented on 50/50 partnership with Glaxo (GSK) on Benlysta: Should approval be gained "as early as December", HGSI will have 100 sales reps in the US, along with GSK's planned 100 sales reps in the US. The two co's will promote product together... On European plans for Benlysta, HGSI has 3 countries planned and expects that should approval be met GSK, in terms of "effort", GSK will have more than 50%... On commercialization of Benlysta, the co stated that treatment and diagnosis would be almost completely addressed by Rheumatologists, with Primary Care not an option... In the US the co stated that there are 1.5 mln Lupis sufferers, and an initial commercial market of 200,000 for Benlysta... In terms of the size of the market in Europe, HGSI sees it at about the same magnitude as the U.S., though with some country to country differences.
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