Review of New Patent on Lupus (IMMU, HGSI)
Immunomedics, Inc. (NASDAQ: IMMU) has made an announcement that may need to be reviewed by Human Genome Sciences, inc. (NASDAQ: HGSI) investors. This is not a deal-killer or anything like that, but this could be at least get a glance from investors based upon the headline. Immunomedics issued a press release today titled “Potential Lupus Drug Gains U.S. Patent”…. Keep in mind that the company’s investor presentation lists some 141 US patents and 302 worldwide patents.
The company said that its patent for “Immunotherapy of autoimmune disorders using antibodies which target B-cells” has been issued. The USPTO assigned U.S. patent number 7,641,901 covering the use of monoclonal antibodies “that bind to the CD22 antigen on B-lymphocytes for treating autoimmune disorders.”
This covers the use of epratuzumab, Immunomedics’s proprietary humanized anti-CD22 monoclonal antibody, and other anti-CD22 antibodies, alone and in combination with other therapeutics. These other therapeutics are listed as antibodies, cytokines, or drugs, for the treatment of a wide range of autoimmune diseases that include systemic lupus erythematosus. Also noted though, above and beyond lupus, were rheumatoid arthritis, Sjogren’s syndrome, multiple sclerosis, myasthenia gravis, diabetes mellitus, and ulcerative colitis.
The company also noted that its partner, UCB, has recently reported encouraging top-line results from their Phase IIb study of epratuzumab in lupus and is planning to initiate a Phase III program for 2010.
The issue here is that this is still moving from Phase II to Phase III rather than already being in Phase III studies. Human Genome Sciences is up for FDA approval and that decision for or against approval will likely come long before this lupus candidate could even come to market. It is also implausible that the FDA will consider patent issues in its decision.
This morning came an analyst downgrade from Goldman Sachs, cutting Human Genome Sciences to a Neutral from Buy. The downgrade was before the open and not tied to this patent allowance for potentially another lupus drug down the road. It was merely a valuation call now that Human Genome Sciences had become worth more than $5 billion in market cap.
Immunomedics Inc. (IMMU) does not fit the same bill as the other quest for 10-baggers or 1,000% gainers in biotech entirely. Its $290 million market cap is larger than most stocks which suddenly run on strong volume of about 1.5 million shares as of 10:28 AM EST, but even after a rapid 18% pop-up the share price is still only $3.86. The 52-week trading range is $0.84 to $7.17 and average daily trading volume is 823,000 shares.
JON C. OGG
Immunomedics (IMMU) Giving Back Gains
Immunomedics (IMMU) is giving back some of the gains that it made yesterday after positive earnings news. The stock is down 8% to $6.28.
Along with earnings, IMMU reported successful clinical trial results for epratuzumab, a drug Immunomedics developed and licensed to UCB Pharma. In the last quarter, IMMU revenue was $8.3 million compared to $1 million in the same period a year ago. The company made almost $1 million.
Douglas A. McIntyre
Immunomedics (IMMU) Surges 63% On Study Results
UCB and Immunomedics (IMMU) announced today top-line results from UCB’s phase IIb clinical study comparing epratuzumab to placebo in patients with systemic lupus erythematosus (SLE, also commonly known as lupus). The data from the 12-week dose and regimen-ranging study demonstrated clinical meaningful treatment effect of epratuzumab over placebo in SLE patients. The 227 patients in this study had moderately (30%) to severely (70%) active disease in multiple organ systems.
The company’s shares moved up 63% to $6.95, near a 52-week high.
In the third quarter, IMMU made $758,000 on revenue of $8.3 million and had $32 million in cash and cash equivalents.
Douglas A. McIntyre
Early ASCO Winners & Losers (IMMU, ONTY, MEDX, HGSI, EXEL, OSIP)
We have captured the big biotech movers from the ASCO conference over the weekend or related news moving the stocks in the biotech sector this morning. Here these are grouped by name and ticker, and the first price is Friday’s close and the second price is the pre-market price snapshot at 9:00 AM EST. After that is the percentage of the price change and the appropriate volume seen as of the 9:00 AM EST cut-off.
STOCK GAINERS:
Immunomedics, Inc. (IMMU)
$2.49 $2.85 14.46% 13,500
Oncothyreon Inc (ONTY)
$2.61 $2.92 11.88% 212,479
Medarex, Inc. (MEDX)
$7.24 $7.80 7.73% 3,790
Human Genome Sciences, Inc. (HGSI)
$2.47 $2.65 7.29% 49,141
STOCKS TRADING LOWER:
Exelixis, Inc. (EXEL)
$5.55 $5.22 5.95% 123,953
OSI Pharmaceuticals Inc. (OSIP)
$33.80 $32.50 3.85% 22,220
Jon Ogg
Weekend of Cancer and Ocology Data at AACR; semi-preview for ASCO (ALTH, AMGN, ARIA, ARRY, AZN, BIIB, CELG, CRIS, IMMU, IMGN, INFI, MEDX, MNTA, ONCY, PFE, PCYC, SUPG, TELK, THLD)
This weekend will kick off a rather important oncology meeting, and it has a chance of setting the expectations for the highly anticipated ACSO (American Society of Clinical Oncology) annual meeting next month. The American Association for Cancer Research Meeting will take place in Denver, CO. and many of the smaller and larger cancer and disease biotech and drug companies will be presenting data. Amazingly enough, this will be the 100th annual meeting.
Allos Therapeutics, Inc. (NASDAQ: ALTH) will present data from an in vitro study examining the potency of pralatrexate in colon, breast, ovarian, lung, prostate, and head and neck cancer cell lines.
Amgen (NASDAQ: AMGN) had industry news earlier this week about its experimental drug called AMG 479 shows promise against pancreatic cancer. Amgen will also be presenting lung cancer data.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) will offer new preclinical data on deforolimus, its investigational mTOR inhibitor, AP24534, its investigational multi-targeted kinase inhibitor, and its investigational anaplastic lymphoma kinase (ALK) inhibitor.
Array BioPharma, Inc. (ARRY) has eighteen abstracts being presented at the meeting and will disclose findings in 7 new anti-cancer programs. Lung and colon cancer data are in these presentations.
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