Lilly/Icos Will Launch Cialis DTC Ads Once Doctors Are “Fully Educated”

Patient preference will be one theme of professional promotions for Lilly/Icos' erectile dysfunction therapy Cialis , Icos CEO Paul Clark indicated Jan. 13 at the J.P. Morgan health care conference in San Francisco.

"Doctors tell us that patient preference is an important factor in helping them choose the right ED treatment for their patients," Clark said.

The CEO described two studies published in the November issue of Clinical Therapeutics that compare patient preference for Cialis (tadalafil) to that for Pfizer's Viagra (sildenafil).

In the first study, patients who were already taking Viagra and switched to Cialis "preferred Cialis to Viagra by a ratio of nine to one."

In the second study, "66% of men starting treatment for ED favored Cialis over Viagra after trying both products for four-week periods," Clark noted. "These were the first published head-to-head preference studies between Cialis and Viagra."

The studies were published the same month that Cialis entered the market. The ED treatment cleared FDA Nov. 21 (¹ (Also see "Lilly/Icos Cialis Clears FDA; 36 Hour Efficacy Claim Applies To Starting Dose" - Pink Sheet, 24 Nov, 2003.), p. 23).

Lilly and Icos are focusing on professional promotions for Cialis first, and will hold off on launching a direct-to-consumer campaign until they feel they have adequately prepared prescribers.

"We will supplement detailing efforts in this country with a focused PR effort that will be followed by a direct-to-consumer advertising campaign starting this quarter after we have fully educated physicians about the product's benefits," Lilly CEO Sidney Taurel said the same day in a separate J.P. Morgan presentation.

Lilly and Icos' promotional strategy for Cialis is in keeping with Lilly's principles for direct-to-consumer advertising. In particular, the company pledged to "educate physicians and other health care professionals about Lilly medications before advertising them to the public" (² (Also see "DTC Principle Statements From Drug Companies Urged By Lilly's Taurel" - Pink Sheet, 18 May, 1998.), p. 25).

Lilly and Icos launched the professional marketing campaign immediately following the Cialis approval.

"Days after approval, we held a nationally broadcast satellite symposium that provided several thousand physicians with information they need for their patients when patients ask about Cialis. We are pleased with the high awareness and enthusiasm about Cialis that we are encountering in physicians' offices," Clark said.

"Our launch execution has been outstanding," he declared. "Sales reps were trained, equipped and meeting with physicians one business day after approval. Shipping from our manufacturing facility began within two days of approval. By the end of the second week, more than 80% of U.S. pharmacies were stocked."

"The Icos and Lilly sales reps have already made several thousand face-to-face visits with physicians in their offices," Clark said. "We achieved 50% share of voice in the physicians' office immediately after launch."

Despite being able to provide investors with positive statistics about the efficiency of the Cialis launch, Clark noted one drawback to the strategy: it is not as transparent to investors as DTC ads will be.

"We recognize that as consumers or investors you didn't see how quickly our sales reps began detailing, how fast we began to ship the product, or that we achieved the highest share of voice in our class with physicians. That would not be visible to you," he said.

"What would be, of course, would be consumer marketing," Clark noted. "Some people are surprised they haven't already been seeing on TV and other direct to consumer advertising that we will have."

"We have not yet begun our direct to consumer program for a good reason. A consumer ad that includes a brand name, an indication and product benefits is typically cleared by the FDA," Clark explained.

"A competitor, approved in August 2003, is still running ads that only give the brand name. While that is permissible, it creates very low awareness because it doesn't connect the patient population and the patient benefits."

Television reminder ads for Bayer and GlaxoSmithKline's Levitra first aired Aug. 26 (³ 'The Pink Sheet' Sept. 1, 2003, In Brief). The ED therapy was approved Aug. 19 (⁴ (Also see "Levitra Clears FDA In Time For NFL Season; Priced At Discount To Viagra" - Pink Sheet, 25 Aug, 2003.), p. 3).

Bayer/GSK launched a second reminder ad for Levitra (vardenafil) Sept. 4 during the opening game of the 2003 National Football League season (⁵ , p. 22).

Lilly/Icos' decision to forgo launching Cialis reminder ads at launch may also relate to its position as the third entrant. Results from a recent study by the Kaiser Family Foundation showed that DTC advertising increases the size of the market for a therapeutic class rather than the share of a particular product (⁶ (Also see "DTC Increases Overall Market Size, Not Specific Product Share – Kaiser Study" - Pink Sheet, 29 Sep, 2003.), p. 31).

"FDA review of the direct to consumer campaign for Cialis is proceeding," Clark noted. "We expect to debut consumer ads for Cialis this quarter. They'll be exciting and you'll see a lot of them."

"While the current category leader has a five-plus year head start on us, we and our partner Lilly are not intimidated," he declared.

"We know that it takes time to change medical practice and consumer behavior," Clark said. "We have the resources and we intend to use every legitimate means to do just that."

Lilly has said the character of the Cialis ad campaign will be similar to that of Viagra and Levitra - "loud" and "frequent" (⁷ (Also see "Cialis DTC Starting In 2004; “Loud” And “Frequent” As Viagra, Levitra Ads" - Pink Sheet, 1 Dec, 2003.), p. 6).

Reserving the right to launch reminder ads for Cialis in the future, Clark maintained the Lilly and Icos "prefer ads that clearly describe Cialis and the distinct compelling benefits that it offers."

The companies will focus on differentiating Cialis based on its 36-hour duration of response, with DTC ads conveying the message that Cialis allows patients to "choose when the moment for intimacy is right for you" (⁸ , p. 32).

Clark noted Icos is "very pleased with the U.S. label." In addition to Cialis' long duration of response, the CEO highlighted the fact that Cialis absorption is not affected by food, "including high-fat meals;" that Cialis patients can also take Boehringer Ingelheim's benign prostatic hyperplasia therapy Flomax (tamsulosin); and the fact that Cialis labeling does not list "visual disturbance" as an adverse event observed in clinical trials.