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12:00 AM
Nov 05, 2007
 |  BioCentury  |  Finance

Ebb & Flow

Three highly anticipated sets of Phase III data were announced last week: for exenatide LAR to treat Type II diabetes, for Viveta treprostinil to treat pulmonary arterial hypertension and for Orplatna satraplatin to treat prostate cancer.

One was a blow up, with predictable results for GPC (FSE:GPC; GPCB). Of the two successes, only United Therapeutics (UTHR) was rewarded by the market, while Amylin (AMLN) was penalized for not rewarding expectations.

The problem for AMLN's trial of once-daily exenatide LAR, versus its twice-daily counterpart Byetta, was that LAR wasn't as superior as investors had hoped.

In the 30-week trial in 295 patients, patients who received LAR showed a statistically significant improvement from baseline (1.9%) in HbA1c vs. those who received Byetta (1.5%). After 30 weeks, both treatment groups lost an average of 8 pounds. The incidence of nausea was about 30% lower for exenatide LAR than for Byetta.

But investors had expected more.

"It seems like it's only marginally superior, so the only benefit that you have is the convenience," noted Maxim Jacobs of Ridgemark Capital.

"The expectation for the delta between the two arms was that it would be larger," said Evan McCulloch of Franklin Templeton.

On a conference call, AMLN President and CEO Daniel Bradbury said the Byetta arm performed better than in previous studies, which was likely due to the open-label design as well as high retention and compliance rates.

"The bottom line is that we saw the best results that we've ever seen with Byetta in this study, both in terms of glucose control and weight loss," he concluded.

According to Byetta's label, in a 30-week trial a high dose resulted in a 0.8% improvement in HbA1c from baseline. Last week's outcome was nearly twice that. Similarly, weight loss in the label study was 2.8 pounds, less than half that in the data presented last week.

An NDA submission is planned for 1H09. With LAR not expected to be on the market until at least 2010, both McCulloch and Jacobs suggested the lack of a clear treatment advantage leaves the door open for once-daily competitors.

Each mentioned BIM 51077, a glucagon-like peptide-1 (GLP-1) analog to treat Type II diabetes from Roche (SWX:ROG) and Ipsen (Euronext:IPN), with Japanese marketing rights shared by Teijin Pharma.Phase IIb data for the compound are expected by year end. The subcutaneously injected candidate is being tested in once-daily, once-a-week and once-every-two weeks regimens.

LAR uses Medisorb drug delivery technology from Alkermes (ALKS). AMLN was off $4.03 to $43.15 on the week. ALKS was down $3.03 (18%) to $14.19, despite reporting earnings that beat consensus estimates (see "EPS Watch," A21).

AMLN and Eli Lilly(LLY) market Byetta.

UTHR exhales

While expectations were high for LAR, there were many more skeptics on Viveta, an inhaled formulation of treprostinil from UTHR. That helped give the company a big boost on both its earnings and the Viveta results: UTHR gained $25.67 (38%) to $94.11 on Thursday and finished the week up $29.37 (40%) to $102.85.

The company reported 3Q diluted EPS of $0.66, up 94% from $0.34 in the same period last year. Revenues rose 46% to $59 million from $40.4 million during 3Q06.

Viveta also met the primary endpoint of a statistically significant change in six-minute walk distance at week 12 in the Phase III TRIUMPH-1 trial to treat pulmonary arterial hypertension (PAH). Viveta showed a 20-meter improvement vs. optimized patients given placebo.

A subcutaneous formulation of treprostinil is already marketed by UTHR as Remodulin, which improved median change from baseline in the 6MW test by 10 meters, according to pooled results from a pair of 12-week studies listed on its label.

There are three other drugs to treat PAH on the market: Pfizer (PFE) markets Revatio sildenafil, and Tracleer bosentan is from Actelion (SWX:ATLN) and Gilead Sciences' (GILD) Letairis ambrisentan.

Revatio improved 6MW scores by 45-50 meters in the 277-patient Phase III trial included on its label, while the label for Tracleer states that patients showed an improvement of 35 meters in the 125 mg arm of the Phase III BREATH-1 study.

Letairis ambrisentan is a once-daily oral selective endothelin A receptor antagonist for which GILD reported additional Phase III data late last month. At week 12, patients with idiopathic disease (IPAH) improved by 58 meters from baseline, while there was a 19-meter improvement in patients with PAH associated with connective tissue disease (see BioCentury, Oct. 29).

McCulloch told Ebb & Flow that based on last week's data, Viveta looks like an approvable drug, although the magnitude of benefit was less than he was anticipating. He had been looking for 6MW data more in the 25-30 meter range.

He thinks UTHR's big uptick was driven partially by short covering and probably some takeout speculation.

Orplatna's bad news

On the downside, Germany's GPC lost more than half of its market cap last week after Orplatna plus prednisone failed to significantly increase overall survival in the Phase III SPARC trial in hormone-refractory prostate cancer (HRPC) patients vs. prednisone alone.

GPC was depending on positive survival data to reinvigorate Orplatna after FDA's Oncologic Drugs Advisory Committee recommended in July that the agency wait for overall survival data before deciding if the oral platinum compound is eligible for regular approval. GPC subsequently withdrew...

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