Amylin Pharmaceuticals Inc. got more than validation for its diabetesdrug candidate on Wednesday _ it got a commitment from partnerJohnson & Johnson to continue the collaboration and $22 million forreaching the first milestone in their alliance.
Johnson & Johnson (J&J) agreed to pay Amylin $7 million inmilestones and option fees and committed another $15 million inequity payments after reviewing interim data from two one-yearPhase III trials of pramlintide, which mimics the hormone amylin andis being developed to improve glucose control in diabetics who needinsulin.
Amylin Wednesday also released Phase II data showing all threedoses tested produced a statistically significant lowering of glucoseconcentrations in those with Type II diabetes.
"This is fantastic, exactly what it's all about," said Tim Wilson, whocovers Amylin for New York-based UBS Securities. "It's nice tohave success" after some of the troubles in biotechnology this year,Wilson said. "Johnson & Johnson looked at two interim analyses thenpressed the button. That pretty much says this drug works."
The market reacted well, pushing Amylin up 56 percent Wednesday.The stock gained $4.88 to close at $13.63 in trading of more thanthree million shares. The stock was trading at $7.75 last year afterJ&J and Amylin announced their collaboration.
Wilson estimated Johnson & Johnson now has committed $72 millionto date in the collaboration that began in June 1995. The NewBrunswick, N.J., paid $5 million up front and had paid another $15million in equity investments. J&J also is paying half of alldevelopment costs and all pre-launch marketing expenses. (SeeBioWorld Today, June 22, 1995, p.1.)
J&J, in the second phase of the collaboration, now is expected tospend another $128 million prior to launch, putting the value of thedeal to Amylin at $200 million, Wilson said.
The two one-year Phase III studies already under way include about400 patients with Type I diabetes and 440 insulin-using Type IIdiabetics. Results of the planned interim analysis were madeavailable only to senior management at Amylin and J&J while thetrial remains blinded.
The $22 million milestone payment includes a $15 million equityinvestment that Amylin can call anytime before completion of thePhase III trials. Johnson & Johnson now holds about 7 percent ofAmylin, or nearly two million of the company's 28 millionoutstanding shares.
The $7 million cash part of the milestone payment includes anelement giving J&J the option until March 1997 to expand thecollaboration to include other amylin agonists. The companies alsoplan to look at other potential uses of amylin agonists.
Diabetics needing insulin treatment have deficiencies of both insulinand amylin, a pancreatic hormone. The goal is to improve glucosecontrol in these patients, thereby reducing the risk of diabeticcomplications such as blindness, kidney failure and amputations,Amylin said.
NDA May Come At End Of 1998
Marjorie Sennett, vice president and chief financial officer at SanDiego-based Amylin, said J&J's milestone payment and continuedcommitment means "everything for our Phase III program iscontinuing full-steam ahead. We will go forward with our plans tostart the remaining four studies of our Phase III program in the fourthquarter this year. That will round out the series of six studies.Assuming clinical success we plan to file a new drug application bythe end of 1998."
Completion of the Phase III program would trigger another $15million investment and an undisclosed milestone payment. A third,undisclosed milestone would be triggered when filings for approvalare made in the U.S. and Europe, Sennett said.
Rachel Leheny, an analyst at Hambrecht & Quist LLC, in New York,described Wednesday's news as "terrific" for Amylin and said thenew Phase II results are promising. "Clearly the program is goingwell," she said.
But Leheny cautioned that the product's eventual utility could comedown to questions about the ease of use for patients, many of whomalready are taking daily shots of insulin. Reducing the number ofinjections needed will be critical, she said.
The Phase II results came from a one-month study in 200 Type IIdiabetics who use insulin. In all three doses (30 and 60 microgramsfour times per day and 60 mcg three times per day) pramlintideproduced a statistically significant lowering of fructosamine, amarker that reflects glucose concentrations over two to three weeks.The glucose control was achieved without an increase in theincidence of hypoglycemia, or low blood glucose reactions.
Next On The Horizon: Testing Lower Doses
Sennett pointed out that three-times-per-day dosing was as effectiveas dosing of four times per day. She said that will allow Amylin tofocus on testing dosing of two or three times per day.
"From an efficacy standpoint we've now demonstrated in seven outof seven Phase II studies the drug produced statistically significantresults in lowering glucose or its surrogate markers," Sennett said.
J&J, through its LifeScan Inc. subsidiary, already has a majorpresence in the diabetes market. Wilson said Amylin and J&J areworking on a formulation that would combine insulin and pramlintidefor delivery in the same syringe, which would reduce the number ofinjections.
Wilson said the potential payoff for pramlintide is huge, which is whyJ&J would invest so much in the program. He said there are 3.5million Type I and insulin-using Type II diabetics in the U.S., andmillions more who have not been diagnosed. There are at least thatmany in Europe, he said.
The market is so enormous that if pramlintide has only 15 percentpenetration at an annual cost of $1,000 it will be a $500 million drugin the U.S. alone, Wilson said. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.