Showing posts with label phase II. Show all posts
Showing posts with label phase II. Show all posts

Friday, November 18, 2011

The Motley Fool preaches pragmatism to potential Achillion suitors...

This Biotech Stock Rose for All the Wrong Reasons
By Brian Orelli | More Articles
November 18, 2011

Achillion Pharmaceuticals (Nasdaq: ACHN ) might get bought, according to an article by Bloomberg. Shares jumped by as much as 17% today in response to the report, although it's pulled back a little since then.

And this is news because?

Achillion has three drugs in the clinic, which all treat hepatitis C, a disease that's quickly moving toward cocktail therapies as a standard of care. Pharmasset (Nasdaq: VRUS ) has separate partnerships with Johnson & Johnson (NYSE: JNJ ) and Bristol-Myers Squibb (NYSE: BMY ) to test its drug in combination with the big pharmas. Roche just bought Anadys Pharmaceuticals for its hepatitis C drug to be used in combination with its drugs and with drugs developed by Merck (NYSE: MRK ) , with which it has a partnership. Vertex Pharmaceuticals (Nasdaq: VRTX ) licensed compounds from Alios BioPharma. And the list goes on.

I'd expect Achillion to be talking with potential partners, and I'd expect that many of those companies would entertain the idea of purchasing the company at the right price.

What I don't expect is for a company's CEO to go blabbing to the media about it. There's just no reason for it.

And there's no reason for investors to jump onboard expecting that a sale is imminent. BioSante Pharmaceuticals' (Nasdaq: BPAX ) CEO made similar comments to the same news organization, causing its shares to spike in July, but shares have since fallen 40% from the high set that month.

Achillion expects to report interim phase 2 data by the end of the year for its lead compound ACH-1625. Most -- dare I say all -- potential buyers would want to see that data before making a purchase. And unless the purchase price was out of this world, Achillion's board would be crazy to agree to a sale with the data on the horizon. Assuming it's positive, the data will only make the company more valuable as a potential takeout target.

If you're going to purchase shares of Achillion, I'd consider looking for a pullback before jumping in. You might not get one -- sometimes rumors are true, and the phase 2 data will be available soon -- but I don't see how Achillion is more valuable after the Bloomberg report than it was yesterday.

Monday, December 20, 2010

Idera Pharmaceuticals reports positive antiviral results from phase 1 study for Hep C drug

Idera Pharmaceuticals (Nasdaq: IDRA) announced Monday positive preliminary results from a phase 1 study for IMO-2125, the company's investigational drug treatment for chronic hepatitis C infection.

Hep C is an infectious disease affecting the liver. It is often asymptomatic, but once established, chronic infection can progress to scarring of the liver. In some cases, people will go on to develop liver failure or other complications, including liver cancer.

During the 4-week dose-ranging trial, the IMO-2125 drug was tested in combination with ribavirin, in 60 patients with the virus. The results indicated a "substantial decline" in virus levels at two days after the first dose of IMO-2125, and after four weeks of treatment, the company said.

In addition, liver enzymes decreased during the treatment period and were within the normal range by the end of the fourth week in the majority of IMO-2125-treated patients.

"In this study, IMO-2125 plus ribavirin was well tolerated with no treatment-related discontinuations, and demonstrated substantial antiviral activity," said vice president of clinical development, Robert Arbeit.

Idera develops drug candidates that act by modulating immune responses through specific Toll-like Receptors (TLRs).

TLRs, a family of immune system receptors and the immune system's first line of defense, recognize pathogens, or infectious agents, and initiate an immune response.

IMO-2125 is designed to stimulate the immune system, causing the body to generate natural interferons and other antiviral cytokines, or protein regulating molecules.

The company said it is now planning a 12-week phase 2 trial of the drug, which it expects will determine optimal dosing and provide longer term safety and antiviral activity data. Recruitment for the study is anticipated to begin in the first quarter of next year.

Idera was up more than 7% on Monday morning, trading at $2.53 as of 11:30am EST