King Altace Scripts Shift To 10 Mg; Dosage From HOPE Trial Helps Fuel Growth

Prescriptions for King's ACE inhibitor Altace (ramipril) are shifting to the 10 mg strength, the same dose used in the Heart Outcomes Prevention Evaluation study, CEO Jefferson Gregory said.

"The sustained shift of Altace prescriptions to the 10 mg dose is especially significant since the 10 mg dose is the same dose administered to patients in the landmark HOPE trial that resulted in the dramatic findings based on which FDA approved the new indications for Altace," Gregory said during the firm's third quarter earnings call Oct. 28.

Altace received supplemental approval Oct. 5, 2000 for reduction in risk of myocardial infarction, stroke and death from cardiovascular causes (¹ (Also see "King Altace Label Highlights Data Supporting Efficacy In Diabetic Patients" - Pink Sheet, 9 Oct, 2000.), p. 15). The recommended dosage is 2.5 mg once a day for one week, 5 mg once a day for the next three weeks and subsequent increases as tolerated to a maintenance dose of 10 mg, once a day.

Altace is available as 1.25 mg, 2.5 mg, 5 mg and 10 mg capsules, and the 5 mg and 10 mg strengths each represent 38% of the Altace market, King said.

In the third quarter, "total prescriptions for 10 mg Altace increased 67% over the same period of the prior year in comparison to the increase of 50% for all strengths of Altace combined," Gregory said.

The shift towards the 10 mg dose boosts Altace sales; 100 tablets of the 5 mg dose carry an average wholesale price of $133.84; the same count of 10 mg carries an AWP of $153.33.

Sales of Altace increased 71% to $130.5 mil. in the third quarter. Company revenues were $315.7 mil., an increase of 37%. New prescriptions of Altace increased 43% to 901,000 and total prescriptions were up 50% to 2,777,000, King said, citing IMS data. New prescriptions among cardiologists were 21.43% and 16.6% among endocrinologists, the company said.

King is studying a potential new indication for Altace through the DREAM (Diabetes Reduction Approaches with ramipril and rosiglitazone Medications) study, which will investigate the possibility that Altace and/or GlaxoSmithKline's Avandia can prevent type 2 diabetes (² (Also see "King Plans $45 Mil. On Altace DTC Campaign; DREAMs Of Diabetes Indication" - Pink Sheet, 26 Feb, 2001.), p. 11).

King is also considering line extensions for Altace, and plans to talk to FDA about marketing a combination of Altace and the diuretic hydrochlorothiazide; the combination is sold in Europe.

"One of the problems has been going through the clinical portfolio for that product, to try and see whether those [European] clinical trials will meet FDA criteria or not," Gregory said.

Co-promoter Wyeth has not adjusted its Altace detailing following the halt of the Women's Health Initiative study on Wyeth's hormone replacement therapy Prempro, Gregory said.

"It hasn't gone up, but there hasn't been a falloff either. They pretty much market [Altace] not with the women's healthcare products but with their [proton pump inhibitor] Protonix ."

FDA is considering limiting the indications for Prempro after the WHI study showed increased breast cancer and cardiovascular safety signals (³ (Also see "FDA Hormone Therapy Risk Management Options Include Narrower Indication" - Pink Sheet, 28 Oct, 2002.), p. 19).

King is looking to acquire a product complementary to Altace. "There is one product...that could look like it is in a synergistic position with Altace. Whether we get that product or not is another issue, but that is one we are looking at," Gregory said.

King is also seeking acquisitions to drive growth in other areas. On Oct. 21, the company announced a plan to purchase Meridian Medical Technologies in a deal valued at $247.8 mil.

The acquisition will give King access to Meridian's auto-injector franchise, including DiaJect (diazepam) for seizures; approval is expected in the first half of 2003. "Hopefully we can grow our sales force in 2003 and from some of that growth we can be able to promote their product DiaJect," Gregory said.

"We think we can promote DiaJect with a very targeted sales force, even potentially some telemarketing. We have a very sizeable telemarketing force," he added.

King relaunched Ortho-Prefest (estradiol/ norgestimate) in September with its expanded 100-rep women's sales force (⁴ (Also see "From The Quarterly Conference Calls" - Pink Sheet, 5 Aug, 2002.), p. 35). For the week ending Oct. 18, new prescription market share was 3.98% and total prescription share was 3.82%, according to IMS data.