Replies to post #48247 on Biotech Values

[DewDiligence]

The Baltimore Sun chimes in on the Albuferon not-so-positive data:

http://www.baltimoresun.com/technology/bal-bz.humangenome08jun08,0,676332.story

>>
Hepatitis C Drug Tests ‘Encouraging’ to HGS

[I confess! I’m the one who put the quotation marks around “encouraging” :-)]

By Tricia Bishop
June 8, 2007

Human Genome Sciences Inc. reported clinical trial data yesterday showing that Albuferon, a hepatitis C drug the Rockville biotech is developing, is comparable to a current therapy and may do less damage to patients' quality of life during treatment.

It also had a benefit of particular interest in the United States, where a large percentage of patients are overweight: The drug appeared to work better in heavier people than its alternative, a drug called Pegasys made by Hoffmann-La Roche Inc.

But Albuferon, one of two drugs the company is relying on for eventual revenue, also had higher rates of patient discontinuation because of adverse events - particularly at the higher dosing levels.

Even though Albuferon requires fewer injections than Pegasys, 18 percent of the patients given 1,200 micrograms of the drug every two weeks chose to stop taking it. That compares with 6 percent in the group of people being treated weekly with Pegasys in the midstage trial involving 458 patients.

That led analyst Terence Flynn of Lazard Capital Markets to conclude that may not be enough of an improvement to differentiate it from Pegasys, which Human Genome was using as a comparison.

The company, which has yet to bring a drug to market, said it will adjust dosing levels in further tests to minimize the discontinuation rates. [HGSI has said that the phase-3 trials, which have an SPA, allow for dosing reductions on the fly without unduly punishing the statistical integrity; they haven’t disclosed how this will be accomplished, however.]

Yesterday's trial results showed Albuferon worked as well as Pegasys when 900 micrograms were given once every two weeks. In that Albuferon group, working patients also reported missing fewer days of work to recover from side effects, which include severe flu-like symptoms.

At the biweekly 1,200 microgram level, Albuferon was slightly less effective than the weekly Pegasys, but it met its efficacy point 68 percent of the time in heavy patients, compared with Pegasys' 53 percent. [This is an obsolete dosing regimen; HGSI and NVS know that a higher amount is than 1200mcg is needed for monthly dosing.] Administered once a month at 1,200 micrograms, Albuferon was effective in 51 percent of patients, compared with Pegasys' 58 percent.

Human Genome Sciences shares closed down 63 cents, or 6 percent, to $9.83 on the Nasdaq yesterday.
<<

[microcapfun]

Comments on ... Human Genome Sciences Announces Positive Final Results of Phase 2b Trial of Albuferon

Dew said: Clinical results are not automatically positive just because a PR says so, and I would characterize these data as middling.

Yeah. And compared to the previous update, they suck.

To summarize, at 12 weeks post treatment, SVR12 rates for Albuferon minus Pegasys were
5%, 2% and -1%.
But at 24 weeks post treatment (which as you say is the only thing that counts) SVR rates were
0.6%, -2.4% and -7.0%.

Yechh. The key is that SVR for the Pegasys arm actually went up w/o treatment, from 54% to 57.9%! I wonder how that happened.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_H/threadview?m=tm&bn=8514&tid=6...

(If interested, read the entire Yahoo thread for context.)

micro

[Preciouslife1]

Human Genome Sciences Announces $40 Million Milestone Payment Related to Albuferon Development

PR Newswire Europe (inc. UK Disclose) - Aug. 28, 2007
http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1483919&contenttype=sentryarticle...

ROCKVILLE, Md., Aug. 28 /PRNewswire-FirstCall/
Human Genome Sciences, Inc., today announced that it will receive a $40 million payment from Novartis in September 2007 for the previously reported successful completion of a Phase 2b trial of Albuferon(R) (albinterferon alfa-2b) in treatment-naive patients with chronic hepatitis C.

"This $40 million payment will bring the total milestone payments received from Novartis under our Albuferon co-development and commercialization agreement to $132.5 million," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Novartis and HGS are also sharing clinical development costs equally. From a strategic perspective, our collaboration with Novartis is proceeding very well. Our companies are jointly committed to the highest quality of clinical development, and we are working closely together to bring Albuferon to market as rapidly as possible."

HGS also reported in a separate press release issued earlier today that it has completed enrollment ahead of schedule in the first of two pivotal Phase 3 trials of Albuferon in chronic hepatitis C, and now expects to have Phase 3 data available by the spring of 2009, with filing of global marketing authorization applications anticipated by the fall of 2009.

Under a co-development and commercialization agreement entered into in June 2006, HGS and Novartis will co-commercialize Albuferon in the United States and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $92.5 million received to date and the $40 million payment expected in September 2007.

About Albuferon

Albuferon is a novel long-acting form of interferon alpha created by HGS using its proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for more than 20 days. Research shows that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a number of cancers.

About Hepatitis C

Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. An estimated 170 million people worldwide are infected with the virus, including nearly 4 million people in the United States. When detectable levels of the hepatitis C virus persist in the blood for at least six months, a person is diagnosed as having chronic hepatitis C. The hepatitis C virus can cause serious liver disease in a significant proportion of people who are infected, leading to cirrhosis, primary liver cancer and even death.

About Human Genome Sciences

The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer and other immune-mediated diseases. The Company's primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both drugs are under way.

In June 2006, HGS announced that the U.S. government exercised its option under an existing contract to purchase 20,000 doses of ABthrax(TM) (raxibacumab) for the treatment of anthrax disease. Other HGS drugs in clinical development include two TRAIL receptor antibodies for the treatment of hematologic and solid malignancies.

For more information about HGS, please visit the Company's web site at http://www.hgsi.com/. For more information about Albuferon, please visit http://www.hgsi.com/products/albuferon.html. Health professionals or patients interested in Albuferon clinical trials or other studies involving HGS products may inquire via the "Contact Us" section of the Company's web site, http://www.hgsi.com/products/request.html, or by calling [phone], extension 3550.

HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.