By Matthew Willett

Guilford Pharmaceuticals Inc. sold 2.095 million shares, stock it registered with the SEC in November, for proceeds of $36.32 million to fund its advancing pipeline and commercialization of the reacquired Gliadel Wafer.

Guilford registered 3.5 million shares through a shelf registration in November for just such a situation, said Andy Jordan, Guilford senior vice president and chief financial officer. (See BioWorld Today Nov. 11, 2000.)

"A little over a month ago we put up shares on the shelf, and what we've done is executed under that by selling a little over 2 million shares," Jordan said. "What we're trying to do is utilize that incremental funding to do two things. We're building commercial operations for the recently reacquired Gliadel Wafer and doing the distribution and sales of that product, and this new funding will help to fund the Commercial Operations Group.

"The second thing is that Guilford is transitioning from a company that's predominantly a research company to a development company. In this quarter we'll be putting two different products into the clinic."

Guilford, of Baltimore, reacquired its approved Gliadel Wafer, a biopolymer product for treatment of recurrent primary malignant brain cancer, from Aventis Pharma, the pharmaceutical arm of Aventis SA, of Frankfurt, Germany, in October. Sales of the product in 1999 were $16.3 million. (See BioWorld Today, Oct. 25, 2000.)

This year the company plans to move up to five compounds into the clinic. Jordan said the $36.32 million financing puts the company on solid financial ground for the advancement.

"We entered the year with in excess of $100 million," he said. "So, as to our coffers, this allows us to continue to have a strong balance sheet and as we look at transactions, in-licensing or out-licensing, it gives us a position of strength."

Moving into the clinic will begin within the next 30 days, Jordan said, for two programs.

"This quarter we'll be putting two different products into the clinic in addition to Paclimer, a NAALADase inhibitor, and a propofol prodrug, a general anastethic. So by the end of the first quarter we'll have three products in the clinic."

Paclimer, a controlled-delivery formulation of paclitaxel using Guilford's microsphere technology, is currently in Phase I testing in women with advanced ovarian cancer.

"That's still in dose escalation, and it's moving nicely but we've not reached maximum tolerable dose. I think if we get the dose level high enough Phase I is likely to be over in the first quarter," Jordan said.

NAALADase, a neuroprotectant, is designed to selectively block the excessive release of the neurotransmitter glutamate. Guilford's prodrug is a water-soluble formulation of the top-selling anesthetic propofol, which logged $750 million in sales in 1999.

"Putting [propofol prodrug] in a Phase I trial will certainly give us an indication as to whether we've got a product we can take the rest of the way," Jordan said. "It'll probably be 2004 or 2005 before it's on the market. If it works well and it's safe, the timeline could be accelerated, but a lot has to happen before we could look at an accelerated time frame."

Guilford also is aiming to initiate clinical trials of an extended-release formulation of lidocaine for pain management, further solid-tumor indications for its microsphere paclitaxel, and it has several programs in preclinical development it hopes to advance this year.

"We're looking at other neuroprotectants and other neurotrophic programs, and we still have a number of programs in our research pipeline," Jordan said. "Our strong research side will be well complemented by our development side, and with the addition of the commercial group as we've brought back Gliadel, it gives us, essentially, a fully integrated company. We believe it puts us in the position of being able to be fully integrated."