National Editor

With the year inching toward its finish, two more companies filed for initial public offerings.

Memory Pharmaceuticals Corp., of Montvale, N.J., aims to raise up to $86.25 million for its work in treating central nervous system disorders such as Alzheimer's disease, vascular dementia and schizophrenia. And Santarus Inc., of San Diego, intends to raise $85 million to be used mostly for manufacturing and marketing of Rapinex (omeprazole) powder for suspension and to build sales and marketing capabilities

Memory did not say how many shares it will offer or specify a price range, but said the proceeds would be used for clinical trials, working capital and general corporate purposes.

In the pipeline is MEM 1003, a neuronal L-type calcium channel modulator being developed for Alzheimer's disease, for which a Phase II trial design is under way. The drug might also be useful for vascular dementia and mild cognitive impairment, the company noted in a prospectus related to the IPO.

Another drug, MEM 1414, is a phosphodiesterase-4 inhibitor, also for Alzheimer's disease, which is in Phase I trials expected to finish early next year. Expected to enter Phase I trials late next year is MEM 3454, a partial agonist of the nicotinic alpha-7 receptor, being developed for schizophrenia. Another compound, MEM 1917, is another PDE4 inhibitor that has shown promise in preclinical tests against depression.

The company has a pair of deals with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, for development of the PDE4 inhibitors, including MEM 1414 and MEM 1917, and for nicotinic alpha-7 partial agonists, including MEM 3454. (See BioWorld Today, Sept. 19, 2003.)

As of Sept. 30, Memory had garnered $35 million from Roche - the amount of cash and cash equivalents recorded on that date - and stands to receive another $295 million in milestone payments from those collaborations, if the deals reach their full potentials. Memory recorded a net loss of $14.13 million for the nine-month period.

The company would trade on Nasdaq under the symbol "MEMY." Underwriters for the IPO are UBS Investment Bank, SG Cowen Securities Corp., Banc of America Securities and Fortis Securities, all of New York.

Meanwhile, Santarus did not disclose the number of shares to be offered or the price range in its IPO prospectus.

Santarus most recently made news when it disclosed early positive Phase III results with omeprazole for upper gastrointestinal bleeding in critically ill ventilated patients. The treatment performed well enough to reach the primary endpoint in the trial, with a particularly impressive "p" value in a head-to-head study against intravenous cimetidine, a standard of care in the indication, Santarus reported. (See BioWorld Today, Aug. 7, 2003.)

All three of the firm's product candidates are in the Rapinex family: powder for suspension, capsule and chewable tablet. They target a variety of upper GI disorders, including heartburn, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), upper GI bleeding and peptic ulcers.

Rapinex is designed to beat the widely used proton pump inhibitors - omeprazole is one of them - which block stomach acid production by inhibiting the hydrogen-potassium adenosine triphosphate enzyme system. PPIs are available for oral use only in the delayed-release, enteric-coated formulation, which delays the onset of action. The powder-for-suspension version is an immediate-release omeprazole that uses an antacid (sodium bicarbonate) instead of an enteric coating to protect the omeprazole from acid degradation.

Santarus submitted a new drug application for the 20-mg dose of powder for suspension in August, and the FDA is expected to respond in June 2004. The first-sought indications are heartburn and symptoms related to GERD; treatment and maintenance of healing of EE; and treatment of duodenal ulcers. Santarus intends to file the NDA for upper GI bleeding in that patient population in the second half of 2004, asking the FDA to approve the powder-for-suspension version at a 40-mg dose to prevent bleeding in critically ill patients - no PPI is approved for the condition - and in patients with gastric ulcers. Pivotal clinical trials for the other two forms of Rapinex are expected to start in 2004.

Three years ago, Santarus licensed from the University of Missouri the rights to patents related to specific formulations of non-enteric-coated PPIs with antacids for treating upper GI disorders. The initially issued U.S. patents expire in July 2016. Founded in 1996 and starting significant business activity in 1998, Santarus had $52.13 million in cash and cash equivalents as of Sept. 30.

In June 2002, the company signed a sublicense agreement with TAP Pharmaceutical Products Inc., of Lake Forest, Ill., for use of the immediate-release PPI technology with TAP's Pevacid (lansoprazole) and its derivatives. Santarus got an up-front fee of $8 million and could get milestone payments totaling more than $100 million, plus royalties. Fifteen percent of the up-front cash went to the University of Missouri. Milestone payments and royalties also must be shared. (See BioWorld Today, July 10, 2002.)

Santarus would trade on Nasdaq under the symbol "SNTS." Underwriters for the IPO are SG Cowen Securities, of New York; UBS Securities LLC, of New York; Thomas Weisel Partners LLC, of San Francisco; and RBC Capital Markets, of Toronto.