WASHINGTON, July 2 (UPI) -- Wall Street likes Akorn's recent moves, including the filing of a new drug application, or NDA, for its ophthalmic gel and its agreement with India-based Cipla to develop a generic drug for the prevention of organ transplant rejection.

Akorn said Friday it filed a NDA with the U.S. Food and Drug Administration for Akten, a topical, anesthetic gel intended for various eye operations, including Lasik, cataract surgery, and intravitreal injections. Akten is the company's first internally developed brand-name drug product.

Robert Uhl, an analyst with Friedman, Billings and Ramsey, reiterated his outperform rating of Akorn, saying the drug's potential is more than $100 million annually.

"We estimate a potential addressable market of roughly $125 million per year," Uhl stated in a research report.

Uhl forecasts Akten, which he expects to be approved and launched in the second quarter of 2008, could generate sales of $10 million its first year and ramp up to $20 million in 2009.

He also liked the Cipla deal, noting that the agreement covers a generic version of an undisclosed, oral, organ transplant rejection drug with $750 million in annual sales.

Under the terms of the deal, which Akorn announced last week, Cipla will develop, manufacture and supply the drug. Akorn will conduct the bioequivalence studies, file the abbreviated new drug application, or ANDA, and distribute the product in the United States and Puerto Rico.

In addition, Akorn will pay Cipla undisclosed milestone fees for the ANDA development of the product.

Akorn will get 60 percent of the net revenues, which Uhl estimates could be $20 million to $50 million.

Akorn said it anticipates launching the drug in late 2009, but Uhl said he was delaying adding the product to his forecast until the timing of its launch was more definite.

Overall though, he likes the deal because "it represents another example of management's ability to strike deals with external companies on attractive financial terms to boost its new product pipeline."

Uhl also likes Akorn's existing pipeline, saying several products could be approved by the FDA over the next year-and-a-half.

"We continue to forecast sales for Akorn of $204 million in 2008, a jump from our estimate of roughly $80 million in 2007," he stated. "The growth arises due to the full pipeline of new product opportunities that we expect will receive FDA approval in the next 12-18 months."

Akorn's pipeline includes its tetanus vaccine, which could launch by September 1. Uhl forecasts the vaccine will generate $10 million this year and increase to $45 million in 2008.

Akorn also anticipates introducing a generic ophthalmic formulation of diclofenac in early October and an oral generic vancomycin by the end of the year that could generate $30 million in 2008.

Friedman, Billings and Ramsey did not respond to United Press International's request for comment from Uhl.

Akorn shares rose Friday after the company announced it was filing the Akten NDA to more than $7 and closed at $6.99. However, the stock slipped slightly on Monday and closed down .072 percent at $6.94 per share.

Akorn did not return a call from UPI seeking comment, but the company said in a statement its Akten NDA was supported by a trial involving 209 patients that met the primary endpoints in all three dosing arms.

The company, which projected it would launch Akten in the first half of 2008, said the market size for the drug is approximately 6 million procedures annually.

"This is a very important milestone in our company's history," Arthur S. Przybyl, Akorn's president and chief executive officer, said in a statement. "Akten is our first internally developed NDA drug product."

The Cipla deal represents Akorn's second agreement with the Mumbai, India-based firm and there may be more to come.

"This exclusive drug development and supply agreement reinforces our commitment to expanding our business relationship with Cipla," Przybyl said.

Last year, the companies entered into a 10-year agreement to develop an undisclosed generic, oral anti-infective with a market potential of approximately $100 million.