Analysis: Amylin’s Symlin Shows Promise

By STEVE MITCHELL

Amylin presented data at the American Diabetes Association meeting suggesting Symlin improves control of diabetes when used in combination with another drug, leading some analysts to forecast a ramp-up in sales.

Jim Reddoch, an analyst with Friedman, Billings and Ramsey, told United Press International the data, combined with a pending approval for a pen delivery, could make investors sit up and take notice of Symlin, a synthetic analog of the human hormone amylin.

Symlin is going to be an important drug, Reddoch said. It’s been maybe overlooked by investors so far, but investors will have a hard time overlooking it when these numbers start next year.

He projected Amylin sales could nearly double, from $78 million this year to $132 million by 2009.

There probably could be upside to that, he said.

Symlin is administered by subcutaneous injection, but Amylin has filed a supplement new drug application for a pen injection, which is anticipated to be approved by the end of the year.

The data presented at the ADA meeting showed Symlin, when used in combination with Sanofi-Aventis’ Lantus, improved glucose control and reduced weight in patients with type 2 diabetes that was inadequately controlled with Lantus and oral agents.

We are encouraged by the results from this study investigating the use of Symlin with an established regimen of basal, or long-acting, insulin, Matthew Riddle, a professor of medicine at Oregon Health & Science University, said in a statement issued by Amylin.

Improved glucose control often is accompanied by weight-gain or increased hypoglycemia, but with this approach, neither of these problems occurred while glucose control improved, Riddle added.

In the 16-week study, one in four patients receiving Symlin achieved reductions in HbA1C levels, post-meal glucose, weight and incidence of severe hypoglycemia. Fewer than one in 10 patients who did not receive Symlin achieved improvements in all four measurements.

Matthew Osborne, an analyst with Lazard Capital Markets, said Amylin’s Byetta LAR — a sustained-release formulation of Byetta — looks to be in good shape.

We have seen a couple of companies detail their own efforts to develop a once-weekly agent … but Byetta LAR so far seems to be the furthest along and could be the best in class for a once-weekly agonist, Osborne told UPI.

Byetta LAR’s approval is anticipated for as early as 2009 and some analysts are projecting it will achieve peak sales of $3 billion.

Other companies developing once-weekly agonists include ConjuChem, Sanofi-Aventis and two smaller companies with candidates that are still in the preclinical stage.

So Byetta LAR shows great promise, but it may not be only one on the market, Osborne said.

He forecasts LAR will surpass Byetta, which requires twice-daily injections.

There’s the opportunity to grow the market outside of twice-daily Byetta, but incrementally it may be 40 to 50 percent more, not a two-fold increase, Osborne said.

The uptake of Byetta LAR may depend on how aggressive physicians and patients are in using it.

The greatest unknown is whether LAR will expand the patient population to those earlier in the course of disease, he said. How aggressive will physicians be in using once-weekly version to prevent the course of progression?

Osborne said another part of the Amylin story that may be getting overlooked is the potential of the company’s obesity pipeline, which includes pramlintide (the active ingredient in Symlin) and PYY 3-36.

We think a lot of the positive news for Byetta and LAR is factored into the stock, but what is not calculated is the obesity pipeline Amylin is focused on developing, he said.

He’s waiting for the release of clinical evidence that is anticipated to be available in the second half of this year to make a more definitive call, but so far, Amylin has indicated it expects big things from its obesity candidates.

Preclinical studies have suggested the agents can overcomes leptin resistance and could generate substantial weight loss, he noted.

They’re taking a different tack to the typical routes of obesity therapies, which are usually oral therapies that target the central nervous system in making patients feel full, he said. This is more of a hormonal approach to treating obesity that may have a different mechanism and greater weight loss.

The drawback, however, is they are injectable agents. But if there’s significant weight loss, there could be a fair number of patients willing to use them, he said.