Biotech Stock Mailbag: ASCO, Celldex, Obesity Drug Game-Changer

Yes, I am, and I believe my divergent views on Celldex and Galena are professionally consistent. While an imperfect measure for sure, the enterprise values of the two companies (Celldex $170 million; Galena $50 million), suggests "the market" sides with me.

The mechanism of CDX-011 makes sense and is validated; Neuvax does not and is not. Celldex conducted a small, but well-designed phase II study (no data mining!); Galena's phase II study was sloppy, imbalanced and data-mined all to hell.

Peter G is mad again, so mad that he forgot to check his spelling and grammar:

"Adumb, You managed to do it again with GALE. I am afraid you have step over the line this time with GALE. After all should we believe you or Dr. Peoples??? Thats a dumb question even you can answer. Oh by the way who was shorting prior to your BS article? I think the SEC stock watch will like to know. Good luck your gonna need it this time."

A nicer note from Ken L.:

"I very much enjoy and appreciate your thoughtful articles, your balanced approach and communication, as well as your active engagement with your readership. I've also always been impressed by your maturity in dealing with (more accurately -- NOT dealing with) the vocal community of conspiracy theorists -- true believers rather than truth seekers. Couldn't believe your measured response to these zealots--you're a better man than I!

Seems like it's getting to you recently. Let me encourage you to stay above it and not get frustrated! I'm certain the vast majority of your readership appreciates your work immensely and would be sorry to lose it! I'm a bit too much on the inside to participate actively in the conversation, but please know that reasonable people around the world are behind you."

Thank you, Ken. Good advice.

Lastly, I spent an hour this week with Tom Hughes, CEO of Zafgen, developer of the weight-loss drug beloranib. Zafgen is a small, privately held company so you'll probably never get the chance to invest in it. Hughes and his venture capital backers want to sell Zafgen to Big Pharma instead of going public on its own.

Still, Zafgen is a company worth following because beloranib may fundamentally change the way obesity is treated -- perhaps more so than the current crop of publicly held companies like Vivus (VVUS), Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX).

What makes beloranib different is its mechanism of action. I'm simplifying here, but as Hughes explained to me, the drug works in the liver to reset or normalize a patient's metabolism. Obese people, especially those who are morbidly obese, have livers that work overtime converting food into stored fat instead of energy to be burned off by muscle. When these obese patients are treated with beloranib, their livers stop making fat and instead start converting food into energy, like the metabolism of a lean person.

This is different from the way drugs like Vivus' Qnexa or Arena's lorcaserin work, which is by altering brain chemistry so that obese people feel satiated or have less of a desire to eat.

Beloranib-treated patients lose weight and they feel less hungry. In two phase I studies to date, patients lost about 1 kilogram of weight per week over the course of a one-month trial. The studies only enrolled a handful of patients, but they all lost weight.

Hughes says Zafgen is now gearing up to start a larger phase II study of about 120-150 patients that will dose beloranib for 12 weeks. The study will take about a year to complete.

Beloranib requires twice-weekly injections just under the skin so it's not as convenient as pills. But Zafgen is developing the therapy for patients with potentially life-threatening obesity -- BMIs in the mid 30s to as high as 50. These are the same patients who are eligible for bariatric, or stomach-reducing, surgery. The numbers are big: 400,000 bariatric surgeries are performed in the U.S. every year; 15-18 million people eligible for the surgery.

Hughes is hopeful that beloranib can produce sustained 25-50% weight loss, which is on par with what doctors achieve with bariatric surgery. Obviously, Hughes' hopes need to be borne out in longer and larger clinical trials that have yet to be conducted.

Still, belonarib is a really interesting drug and perhaps the first clinically meaningful medical treatment option for obesity. Watch to see if Zafgen is acquired by Big Pharma in the next year or two.

--Written by Adam Feuerstein in Boston.



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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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