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Gilead Stays on Track

The company continues to look like large-cap biotech's best bet.

BOSTON -- Here are some additional updates from last week's Thomas Weisel Partners Healthcare conference. Today:

Gilead Sciences

(GILD) - Get Gilead Sciences Inc. Report






(CELG) - Get Celgene Corporation Report


Plus, I have another look at

Isis Pharmaceuticals


and its closely watched cholesterol-lowering drug candidate.

The June launch of Gilead's pulmonary arterial hypertension drug, Letairis, is going well, according to Kevin Young, the company's executive vice president for commercial operations.

About 2,000 pulmonary specialists have registered for Gilead's Letairis risk-management plan, which represents about 60% of the doctors who treat patients with pulmonary arterial hypertension, said Young. While not all of these doctors have prescribed Letairis so far, Young said that reports from the field suggest that Letairis is gaining market share in newly diagnosed patients as well as those patients who can't tolerate

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Tracleer, a competing drug.

When Gilead reports third-quarter earnings in October, there will be a lot of investor focus on Letairis. The number of patients on the drug, if Gilead chooses to disclose, will likely be inflated to some extent, because the company is giving away free Letairis samples to smooth out the reimbursement process.

Letairis launched with a very strong label that positioned the drug to be best in class. This plays into the strength of Gilead's marketing team, which has proven in the past (in the HIV drug market, specifically) that it excels at knocking off established competitors.

On the HIV front, the once-daily triple-combo pill Atripla has hit a regulatory delay in Europe, but Young says the company still believes it can receive approval by year's end.

While the Atripla delay stings, the damage is skin-deep for the most part, because the growth of Truvada (Gilead's portion of Atripla) continues to exceed expectations. In other words, whether European HIV patients receive Truvada or Atripla, it matters little to Gilead, because the revenue flowing into the company is essentially the same.

Gilead will present new data on its experimental hepatitis C drug GS 9190 in November. The data to be presented will likely be from a phase Ia study in healthy volunteers, but Young said data from a more important phase Ib study in hepatitis C patients might be ready for presentation.

I've been accused of being a shill for Gilead in the past, especially by some sore-losing

Encysive Pharmaceuticals


shareholders, but biotech investors with a longer-term perspective would be hard-pressed to find a better big-cap pick than Gilead. Not only is the new pulmonary business off to a strong start, the established HIV franchise just keeps growing.

And there's plenty of fuel left in the HIV tank, because the public health trend is toward more testing and earlier treatments.

Affymax Ahoy


(AMGN) - Get Amgen Inc. Report

will obviously benefit if it wins an ongoing legal battle to keep


anemia drug from launching in the U.S. But another winner worth thinking about is Affymax.

The small biotech firm, based just outside San Francisco, is developing a novel anemia drug with many of the extended dosing advantages of Roche's Micera but none of the intellectual property headaches.

Affymax's drug Hematide is a synthetic peptide, not a biologic protein, so it steers well clear of Amgen's patents. And in its current formulation, Hematide is dosed once monthly, and that potentially makes it more convenient than Amgen's drug Aranesp.

Amgen and Roche are battling in a Boston courthouse right now over Micera. If the judge rules that Roche violates Amgen patents, Micera's path to market in the U.S. would be significantly delayed or blocked altogether. That would put Affymax's Hematide in line to potentially be the next anemia drug to market here.

Affymax CEO Arlene Morris wasn't foolish enough to predict an outcome in the Amgen-Roche legal fight, but she's trying to put Hematide in the best position to capitalize if Roche loses. Today, that means pushing ahead with the start of a large phase III clinical trial program of Hematide in patients with chronic kidney failure.

These studies -- there will be four in total, enrolling about 2,200 patients -- will use a noninferiority design with Amgen's Aranesp as the comparator. In laymen's terms, this means that Hematide needs only prove itself "equivalent" to Aranesp in its ability to boost a patient's hemoglobin levels.

The safety hurdle is a bit higher, given all the recent concerns about toxicity associated with these anemia drugs when used in patients with kidney disease. As a result, the Food and Drug Administration has asked Affymax to collect data on cardiovascular adverse events from patients in all four of its phase III trials, said Morris.

Clearly, Affymax has a long way to go before Hematide is ever approved (best case is probably 2010-11), but the stock has been trading near its lows, so an Amgen victory over Roche might also set off some more buying interest in Affymax.

Checking Off Celgene

There wasn't much new to glean from Celgene's presentation to investors last week given by President and COO Bob Hugins. The driver for the stock has been, and continues to be, the cancer drug Revlimid.

No. 1 on Celgene's domestic checklist is to expand the drug's use into front-line, or newly diagnosed, multiple myeloma patients. This task is made easier by the impressive survival data presented during June's ASCO cancer meeting.

The second priority is Revlimid's push into Europe. The drug was granted formal approval in June. Since then, Celgene has been working on final country-by-country approvals and launches. One area of potential concern is Revlimid pricing in Europe, so that's something to watch as the drug rolls out across the Atlantic over the remainder of this year.

After these two items, it's still more Revlimid, but in different cancers. Celgene is moving ahead aggressively with studies in chronic lymphocytic leukemia and non-Hodgkin's lymphoma, with some data possible at next year's ASCO meeting.

Celgene likes to call Revlimid a pipeline in a single drug -- a boast, but one that's not far from the truth. The company historically trades at a premium valuation to its peers, but if Revlimid hits all its marks, it could help deliver a 40%-plus earnings growth for the foreseeable future.

Isis Awaits

Here's a quick update on Isis Pharmaceuticals and its cholesterol-lowering drug ISIS 301012, which I discussed in my Sept. 1

Biotech Mailbag:

On Monday, Piper Jaffray analyst Ed Tenthoff held a conference call for his clients with Dr. John Kastelein, an expert on lipid disorders from the Academic Medical Center of the University of Amsterdam. Kastelein is also a principal investigator in clinical trials using ISIS 301012, which I'll refer to as '012.

Kastelein is a big believer and proponent of '012, which he hailed as having the potential to be a "revolutionary" treatment for patients with uncontrolled high cholesterol.

Isis' drug has been dogged somewhat by safety concerns, specifically its linkage with liver toxicity. Kastelein downplayed such worries, stating that although '012 can cause elevations in certain liver function enzymes, researchers have yet to see concomitant increases in levels of bilirubin, a waste product of normal liver function.

Abnormally high levels of bilirubin would be a cause for concern, but so far, no cases have been reported in '012 patients, said Kastelein.

Look for new data on '012 to be presented at a medical meeting in early October.

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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