Ascent Pediatrics acetaminophen controlled-release beads NDA expected by end of 1997.

ASCENT PEDIATRICS ACETAMINOPHEN CONTROLLED-RELEASE BEADS NDA FILING expected by the end of 1997 pending analysis of Phase III trial results, the company states in an April 25 initial public offering prospectus. Under development as an OTC treatment for pain and fever in children, Pediatemp beads would compete against marketed pediatric medications in liquid or chewable tablet forms, the company reports. As designed, the controlled-release product would enable eight-hour dosing, "rather than the four hours required for currently available products," Ascent states.

According to the prospectus, "Ascent is developing Pediatemp beads with a proprietary controlled-release technology that releases the acetaminophen at specific rates over time in order to provide a therapeutic effect (reduction in fever and pain) over eight hours." The company believes the eight-hour dosing "may significantly increase compliance and permit therapeutic coverage for the full 24 hours of each day."

Ascent notes that marketed OTC pediatric products are not available in extended-release formulations and are limited to four-hour dosing. Furthermore, under the tentative OTC final monograph for internal analgesic products, only five doses of acetaminophen are allowed per 24-hour period, the company adds. "Therefore, if the medication requires four-hour dosing, treatment may only be given for 20 hours in each 24-hour period."

Formulated as tiny beads, Ascent's acetaminophen product "can be sprinkled on a food that is appealing to [a] child, such as applesauce, or delivered in a liquid, such as water," the prospectus explains.

Ascent conducted three Phase I pharmacokinetic trials comparing Pediatemp beads to McNeil's Tylenol extended-relief caplets and immediate-release tablets, the prospectus reports. Involving 63 "healthy adults," the studies showed Pediatemp beads to possess "equivalent bioavailability" to the Tylenol products.

Two Phase III trials have been conducted by the company; data from both studies are being analyzed. The first trial, completed in December, tested Pediatemp beads for dental pain reduction. A double-blinded trial, the study involved 125 adults who received either Pediatemp beads or Tylenol extended-relief caplets in a single dose over eight hours.

The second trial, which began in June 1996 and was completed in February, involved 100 febrile children ages two to 11. Designed to evaluate Pediatemp beads for treatment of fever in children, the study compared the product "on a double-blinded basis with an immediate-release presentation of acetaminophen for efficacy (reduction in fever) and safety."

"If the results of these clinical trials are satisfactory, the company plans to file an NDA for Pediatemp beads in the second half of 1997," the prospectus states. Ascent also is developing a Pediatemp acetaminophen controlled-release liquid. Noting that it is "applying its taste masking technology in developing this product," the firm is conducting studies to "optimize" the potential product's "formulation and taste characteristics."

Wilmington, Mass.-based Ascent is attempting to establish itself as a niche company specializing in the pediatric pharmaceutical market. The company is hoping to net $21.5 mil. from the 2 mil. share IPO. Cowen & Co., Volpe Brown and Adams, Harkness & Hill are underwriting the offering.

Proceeds from the offering are earmarked for R&D and acquisition activities and to pay for the March purchase of Upsher-Smith's Feverall line of OTC acetaminophen rectal suppositories.

Ascent agreed to pay $11.5 mil. plus an estimated $300,000 in inventory expenses for the Feverall products, which Upsher will continue to manufacture for five years. The acquisition is expected to be final in July; Ascent plans to take over marketing of the OTC rectal suppositories line "in the second half of 1997," the prospectus states. Under the agreement, Ascent will be allowed to use the Feverall trademark for other acetaminophen products under development.

Introduced by Upsher-Smith in 1989, Feverall suppositories are available in four strengths: 80 mg, 160 mg, 325 mg and 650 mg. Ascent notes that the product line saw net sales of $3.9 mil. in 1996. According to the prospectus, IMS America estimates that the U.S. pediatric market for acetaminophen rectal suppositories was about $5.8 mil. in 1995. Competing OTC acetaminophen rectal suppositories include G&W Laboratories' Acephen, PolyMedica Industries' Neopap and a number of private label brands.

Promotional efforts for the line have included advertising and two-month telemarketing programs conducted in the fall of recent years, according to the prospectus. Ascent will attempt to "increase market penetration" for the Feverall line "through personal sales calls to pediatricians and pediatric nurses, although there can be no assurance" of success, the company states.

Ascent also is hoping to introduce an OTC nasal saline spray, Pediamist, by the second half of 1997. The company notes that the spray is delivered by a metering device "specifically designed to deliver saline solution in a low volume fine mist under low pressure." The firm believes the product will broaden acceptability among children and "assure delivery of a consistent volume of spray."

In addition, Ascent is applying its taste masking technology in the development of a line of "improved flavor" OTC cough/cold products containing guaifenisen, dextromethorphan and pseudoephedrine. In a study of 81 children ages three to six, the company found that the children preferred Ascent's guaifenisen cough syrup to Whitehall-Robins' Robitussin, the prospectus states. Planning to introduce the cough/cold products as a complete line, Ascent says it will wait to launch the guaifenisen syrup until the other products have been developed, which is expected in late 1999.

Other development projects at Ascent include additional OTCs employing the firm's taste masking technology and Rx products including Primsol trimethoprim antibiotic solution, prednisolone sodium phosphate syrup, Pediavent albuterol controlled-release suspension, cromolyn sodium cream and cromolyn sodium controlled-release nasal spray.

Ascent is establishing a "moderately-sized" specialty sales force to promote Feverall, Primsol and Pediamist to pediatricians and pediatric nurses, the prospectus states. The company also is conducting a corporate awareness campaign through direct mail and journal ads.

Ascent was founded in 1989 by former Fisons pharmaceutical research director Emmett Clemente, PhD. Clemente, who also worked at Warner-Lambert in consumer products in the 1970s, is chairman of the company. Former Mead Johnson Europe President Alan Fox joined the firm as CEO in May 1996. Another former Mead Johnson exec, Gregory Vannatter, is VP-marketing. Ascent has 24 employees.