Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



Human Genome Advances

Yesterday, development-stage biopharma Human Genome Sciences (Nasdaq: HGSI  ) announced its second-quarter financial results following a quarter full of developments with its two lead drugs.

In June, Human Genome released phase 2 data on potential hepatitis C treatment Albuferon and lupus-fighting compound Lymphostat. Albuferon is being tested as a potential first-in-class longer-acting form of interferon alpha that will compete with existing interferon therapies from Schering-Plough (NYSE: SGP  ) and Roche.

In the phase 2 data, Albuferon produced mixed results when compared to Roche's Pegasys. Efficacy in the intent-to-treat Albuferon arms was comparable to Pegasys, but there wasn't any apparent dose-dependent response in patients taking the higher bimonthly dose of Albuferon.

By far the worst issue to crop up in the study is that patient dropout because of adverse events was significantly higher in all three of the Albuferon arms compared to Pegasys. Even at the lowest 900-mcg dose of Albuferon, discontinuation in patients taking the drug was 9.3%, compared to only 6.1% for Pegasys-treated patients.

This increased rate of patient drops thanks to adverse events is not going to be looked upon favorably by regulatory agencies if it continues in the phase 3 study, considering that the efficacy of Albuferon doesn't appear stronger than existing treatments and its other benefits, the easier dosing schedule and potential quality-of-life improvements, likely won't be enough to make up for this big issue.

The good news is that a subgroup of heavier patients appears to benefit more from Albuferon than existing patients. How well this translates into improved efficacy and safety in the ongoing phase 3 studies is not known.

Speaking of which, all four of the phase 3 studies for Albuferon and Lymphostat are currently under way. The two Albuferon trials are expected to complete enrollment in 2007, with data arriving in 2009. Development partner Novartis (NYSE: NVS  ) is also planning a new phase 2b study to evaluate treating patients with higher doses of Albuferon.

Human Genome ended the second quarter with $700 million in cash and investments. On the conference call, management said that this would be sufficient for it to continue operations without the need for another cash infusion until at least the announcement of phase 3 data for Albuferon and Lymphostat. Hopefully for Human Genome investors, an infusion of positive clinical trial data will also be coming up.

Looking for more Foolish drug-stock coverage? Check out the Fool's market-beatingRule Breakers newsletter. You can check out all our recommendations, as well as get access to our message boards and exclusive content, with a 30-day free trial.

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.

Read/Post Comments (0) | Recommend This Article (10)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 533234, ~/Articles/ArticleHandler.aspx, 10/25/2016 1:23:37 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated Moments ago Sponsored by:
DOW 18,178.62 -44.41 -0.24%
S&P 500 2,144.12 -7.21 -0.34%
NASD 5,283.36 -26.47 -0.50%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

12/31/1969 7:00 PM
HGSI.DL $0.00 Down +0.00 +0.00%
Human Genome Scien… CAPS Rating: **
NVS $72.85 Down -2.60 -3.45%
Novartis CAPS Rating: ****
SGP.DL2 $28.15 Down +0.00 +0.00%
Schering-Plough Co… CAPS Rating: ****