Replies to post #121094 on Biotech Values

[DewDiligence]

Bayer’s Alpharadin Hits OS Endpoint in Symptomatic CRPC

[The OS HR and p-value of 0.70 and 0.002, respectively, were good enough to meet the threshold for stopping the trial at the interim analysis. Full results were not available in time for ASCO and will be presented at an upcoming medical conference. Bayer’s own PR is at http://www.bayer.com/en/news-detail.aspx?newsid=14775 .]

http://online.wsj.com/article/SB10001424052702304432304576368960935747424.html

›JUNE 6, 2011, 3:12 P.M. ET
By STEN STOVALL and HARRIET TORRY

LONDON—German pharmaceutical company Bayer AG's pipeline got a boost Monday after a trial of its experimental drug Alpharadin was cut short early to allow patients receiving placebo to be offered the new medicine, a move which some analysts said could speed up the approval process for a drug with blockbuster potential.

Bayer said Alpharadin, or radium-223 chloride, which is exclusively licensed from Norwegian partner Algeta ASA, met its primary endpoint by improving overall survival significantly in patients with castration-resistant prostate cancer and symptomatic bone metastases. [The “symptomatic” qualifier is important insofar as the patients have more advanced disease than those in CRPC trials that include asymptomatic or “minimally symptomatic” patients.]

The median overall survival rate was 14 months for Alpharadin users, compared with 11.2 months for those on the placebo. [More important, the OS HR was a very solid 0.70.]

Bayer and Algeta are currently examining the next step in the planned market launch of the treatment, a Bayer spokeswoman said Monday, adding it's too early to give further details.

The complete results from the study will be presented at an upcoming scientific meeting.

Bayer hasn't indicated how much it expects to make in sales from Alpharadin, although a Bayer spokeswoman Monday said Algeta expects sales of "several hundred million euros."

Analysts expect Alpharadin's sales potential to be between €500 million and €1.2 billion for all indications, although Monday's news crucially could speed up the drug's market launch.

"These results have come earlier than we thought," Algeta Chief Executive Andrew Kay said. "We thought we'd file in the second half of 2012. I think filing will still be in 2012 ... we will do every thing we can to accelerate things."

Equinet said in a note to investors that an actual launch of Alpharadin is possible in 2012, while Silvia Quandt Research said Monday's news flow "could save six months" of time for the drug's introduction.

The positive Alpharadin trial data were welcomed by analysts. One said the drug hadn't really been on the radar screen, as the market's focus has been on other big-name Bayer drugs such as Nexavar.

Nexavar had sales of €705 million in 2010, making it Bayer's highest-earning cancer treatment. If Alpharadin sales reach the top end of analysts' expectations however, it could exceed Nexavar.

Bayer's shares jumped after the news and were up 1.5% at €56.26 by afternoon in Europe, while Germany's DAX index was 0.3% lower.

In September 2009, Bayer signed an agreement with Algeta to develop and commercialize Alpharadin.

Under the terms of the agreement, Bayer will develop, apply for global health-authority approvals, and commercialize Alpharadin, while Algeta retains an option for up to 50-50 co-promotion and profit-sharing in the U.S.

Mr. Kay said the company will take its option under the terms of its arrangement with Bayer to build a sales force and infrastructure in the U.S. to commercialize the product with medical marketing and sales there while maintaining and expanding its research and development center in Norway.

Algeta has no products yet but has two pipeline products—Alpharadin, which is also being studied for advanced breast cancer, and Thorium, an early stage antibody targeted therapy aimed at solid tumors.

Prostate cancer is the most common cancer among men northern Europe and the U.S. In 2008, an estimated 903,000 men had prostate cancer and 250,000 died from the disease world-wide.

"We are extremely encouraged by the overall survival benefit shown in this analysis and are hopeful about the potential of Alpharadin to fill a treatment need for men with advanced prostate cancer," said Kemal Malik, head of global development at Bayer's health-care unit.‹

[iwfal]

EXEL

There is a lot of positive here in the bone data, which surprises me that the rest of the data on soft tissues is otherwise underwhelming. But the bone issue is a clear unmet need, and this will be a significant medical advance in that indication if the data holds up clinically in phase III. There is clearly something unprecedented going on here.

Anyone disagree with this?

Yes, I am on record as disagreeing with 'it is surprising that the rest of the data on soft tissues is underwhelming' -g-.

More seriously, I agree with the precise language you used above. But I disagree with what I think you intended to say - that you think 'that there is clearly something that is clinically unpredicidented going on here.'

I think it is possible something very clinically useful is happening. But I wouldn't use the adjective 'clearly'. The pain numbers are fuzzy, the bone scan data is probably driven at least in part by interference with bone processes (and how that restrains the tumor is not clear), the anemia numbers are encouraging but what do anemia number improvements look like for a more typical cytotoxic chemo that doesn't produce anemia, ... ?