Pfizer’s Eye-Openers: Company Licenses Insomnia, Blindness Agents

Pfizer will establish a 200-rep specialty sales force for Neurocrine Biosciences as part of a copromotion deal for Neurocrine's insomnia drug indiplon.

The sales force will detail indiplon and Pfizer's antidepressant Zoloft (sertraline), focusing on promotion to psychiatrists and sleep specialists.

"Pfizer will help us establish a 200-person sales force that will detail Zoloft under the direction of Pfizer, and under their general marketing direction," Neurocrine CEO Gary Lyons said during a conference call announcing the indiplon deal Dec. 19.

The sales force will be put in place once the indiplon NDA is submitted. Neurocrine anticipates submission will occur in late 2003 at the earliest.

Pfizer will establish the sales force "after NDA filing so that we can build a sales force, have that in place, hopefully contribute to Zoloft's success, and then use that sales force to launch indiplon, and in the future use the sales force to build out a psychiatry presence, hopefully with other internal or partnered products," Lyons said.

The creation of a sales force for Neurocrine is a distinctive feature that Pfizer may have been uniquely positioned to offer in the bidding for indiplon.

Pfizer is in the process of acquiring Pharmacia, which will give Pfizer experience in the sleep-aid category. Pharmacia formerly sold Ambien in partnership with Sanofi-Synthelabo; Sanofi now has sole rights to the drug.

The Pharmacia merger also brings Pfizer a significantly larger detail force that the company may not feel it needs in the current environment.

The sales force arrangement is an example of the kinds of creative features in a partnership deal that Pfizer thinks is becoming more common.

In a recent speech, Pfizer Chairman Hank McKinnell stressed the company's willingness to consider novel arrangements with junior partners - and the importance of ensuring that the arrangements take advantage of each partner's strengths (¹ (Also see "Pfizer Expects Pliant Partners: Deferring To Pfizer Skills And Strengths" - Pink Sheet, 2 Dec, 2002.), p. 14).

Indiplon is a non-benzodiazepine sedative hypnotic that San Diego-based Neurocrine is studying in immediate-release and modified-release formulations.

The two dosage forms are intended to target different aspects of insomnia, such as sleep initiation and maintenance and sleep interruption.

Ambien is expected to lose exclusivity in 2006, Pfizer and Neurocrine noted. The company's hope to launch indiplon before then.

Indiplon was licensed from DOV Pharmaceuticals, which in turn licensed it from Wyeth. Wyeth participates in the insomnia market with Sonata (zaleplon).

Pfizer is paying $100 mil. upfront and up to $300 mil. in milestone payments for rights to indiplon. The deal also includes royalty payments and copromotion fees.

In the U.S., Pfizer and Neurocrine will copromote the product, with Pfizer focusing on general practitioners and expansion of the sleep aid market. Pfizer will have an exclusive license to develop and market indiplon outside the U.S.

Pfizer will be responsible for future development costs for indiplon, including planned Phase IV studies in conditions that commonly occur in conjunction with sleeping disorders, such as depression, anxiety and pain.

During the conference call, Pfizer described insomnia as an "untapped market," and said its physician education program will encourage doctors to ask patients about sleep disturbance.

"The market research shows physicians just don't bother asking," McKinnell said. "Unless the patient brings up an issue of sleep disturbance, the physician typically does not probe for sleep disturbance."

"That is going to be part of our physician education program, and the other part of that of course will be patient healthcare information, which will be a key part of this."

The Pfizer CEO also highlighted the potential "impact of sleep on the comorbid conditions....We expect benefits here well beyond just an extra hour's sleep."

McKinnell noted that Pfizer's contribution in terms of sales support will be much larger than Neurocrine's.

"This clearly is a product which will be in the hands of a GP. Our sales forces now are...800, 780, something like that, [and] this clearly has the potential for multiple sales forces," McKinnell said. "So the Pfizer effort here will be several multiples of the planned Neurocrine sales force."

The indiplon agreement was one of two large licensing deals Pfizer announced in as many days.

On Dec. 18, Pfizer unveiled an agreement with New York City-based Eyetech Pharmaceuticals for joint development and promotion of the age-related macular degeneration and diabetic macular edema drug Macugen (pegaptanib).

The Eyetech deal includes an upfront payment of $100 mil. and up to $645 mil. in milestone payments based on regulatory submissions, approvals and product sales.

The indiplon and Macugen licensing agreements were well-timed for Pfizer: the two deals were signed during a week that also saw a significant setback to one of Pfizer's key brands.

The company's calcium channel blocker Norvasc (amlodipine) was hit with two pieces of bad news on Dec. 17.

First, the National Institutes of Health released the results of the ALLHAT trial concluding that diuretics should be used as first-line therapy for hypertension.

In addition, Pfizer lost a preliminary ruling in its lawsuit seeking to head of the launch of a different salt of amlodipine developed by Dr. Reddy's (see ² (Also see "Pfizer Loses Norvasc Ruling: Rx Patent Extensions Are For Product, Not Use" - Pink Sheet, 23 Dec, 2002.) ).