Allendale Pharma Today Sponge Relaunch $3 Mil. PR/Ad Campaign Planned

The U.S. relaunch of the Today Sponge is on the horizon, with an FDA inspection of the manufacturing facility for the OTC nonoxynol-9 contraceptive slated for the week of May 22. The product's marketer, Allendale Pharmaceuticals, submitted a supplemental NDA Jan. 23.

Allendale plans to support the reintroduction with a $3 mil. promotional campaign, consisting for the most part of a public relations push. Advertising in women's magazines also is anticipated. The PR agency of record is Williams Whittle Rothstein (New York City); the ad agency is Williams Whittle Associates (Alexandria, Va.).

Allendale anticipates difficulty in meeting strong, immediate demand for the sponge, which was discontinued in 1995 by then-owner American Home Products due to quality control shortcomings and a decision by AHP not to devote more resources to upgrading its manufacturing facility.

Allendale acquired the brand from AHP in December 1998; the product will be manufactured by Accupak Inc. in Mainland, Pa. The supplemental NDA was necessitated by the change in manufacturing site.

In addition to its popularity - approximately 20 mil. sold each year - the sponge has gained pop culture notoriety as the subject of storylines on such TV shows as "Seinfeld" and "Third Rock from the Sun."

In an attempt to counteract anticipated consumer demand, Allendale plans to slowly roll out the product, one retailer at a time, ensuring each retailer is adequately stocked before introducing the item through another seller.

While rollout could begin within days or several weeks following FDA approval, Allendale hopes to achieve full-scale distribution in 90 to 120 days.

The firm already is lining up e-commerce and bricks-and-mortar retailers to carry the item. The OTC contraceptive will be available via the Internet on drugstore.com and Rx.com. Retail chains that have expressed strong interest in the product include Wal-Mart, Rite Aid and Eckerd.

Despite its current state of abeyance, the sponge is being previewed on drugstore.com, which features a section explaining what the product is and how it works. Allendale's Web site, www.todaysponge.com, also provides a clinical summary, safety information and directions for use.

The item is expected to retail for $2-$2.50 per sponge and will be packaged in three-, six- and 12-count boxes. While Internet retailers are opting for the 12-counts, stores are expected to sell the smaller sizes.

The Accupak manufacturing facility is producing the sponge for sale in Canada, where it is expected to reach store shelves shortly. Allendale has signed a distribution agreement with a major pharmaceutical company to introduce the product in Canadian food, drug and mass channels.

The Web site for the official Canadian online distributor of the sponge, birthcontrol.com, says that due to the large number of customers interested in the product, "we are going to have to limit the quantities in the beginning." Allendale also plans to begin sales, on a smaller scale, in the U.K. in 90 to 120 days.

In the U.S., Allendale will introduce Today Personal Lubricant simultaneously with the sponge relaunch. The company is expected to emphasize the lubricant's inclusion of vitamin E and aloe to distinguish it from similar products - such as Johnson & Johnson's K-Y and BioFilm's Astroglide.

While the sponges and lubricant likely will not be shelved together, packaging will emphasize the lubricant as part of the Today line, and Allendale could incorporate lubricant coupons in sponge packaging.

On April 24, Washington, D.C.-based Associated Pharmacologists & Toxicologists filed a citizen petition asking FDA to ban OTC sale of the sponge. APT, which has filed three previous petitions on the subject, contends the sponge, when used as directed, "is likely to cause damage to vaginal and cervical tissue more frequently than any other non-prescription contraceptive," increasing the risk of toxic shock syndrome and HIV infection.

Allendale, which will file a formal response to the petition, maintains the sponge is safe and effective; the firm does not anticipate an adverse FDA decision.