Epogen Pediatric Use & Neupogen Cable Ads Expand Major Amgen Franchises

New cable TV ads to identify new cancer patients for Neupogen and a recently approved expansion of Epogen indications to the pediatric population are examples of Amgen's increasing efforts to support its flagship franchises.

The Neupogen cable ads are part of a program called ACCESS, the Amgen Cancer and Chemotherapy Educational Support System. Recently launched ads for the program feature a woman who had breast cancer whose "real-life" employment is in Neupogen (filgrastim) marketing.

A toll free number in the ad prompts patients to provide information about their condition and prescribed course of chemotherapy.

Using information collected from the calls, Amgen delivers "targeted mailings" during the course of patient treatments. Mailings cover a range of topics including nutritional counseling, working with cancer and "Neupogen's role," Amgen Senior VP-Finance & CFO Kathryn Falberg said at CIBC World Markets Healthcare Conference Oct. 26.

The pediatric indication for Epogen (epoetin alfa) was approved by FDA in late July but just now is beginning to be promoted by Amgen. The indication, for use in patients down to one-month in age, makes Epogen available on-label for about 5,200 children on dialysis in the U.S.

Perhaps more importantly in the future, the pediatric indication based on two clinical trials could provide Amgen with a way to seek six months of extra exclusivity.

While biologicals do not currently qualify for patent extensions based on pediatric trials, there is a nascent move to add the incentives for biological products (¹ (Also see "FDAMA Pediatric Incentives Should Apply To Biologics, PhRMA Testifies" - Pink Sheet, 25 Oct, 1999.)). With clinical trials completed on 128 children and an FDA pediatric approval, Amgen may be able to ride that legislative extension effort by seeking retroactive application to approvals during 1999.

A primary vehicle for the promotion is a book written by a 14-year-old dialysis patient titled Justin's Journey: My Life as a Kid with Kidney Disease. The book is cosponsored by the American Kidney Fund and the American Society of Pediatric Nephrologists.

The 32-page, illustrated book profiles the life of its author Justin Hill. Amgen sales reps will distribute the book to pediatric nephrologists and kidney dialysis centers and AKF will make the book available through a toll free number.

In the book, Justin describes "amazing facts about the kidneys," discusses the importance of eating right and explains dialysis, anemia treatment and kidney transplantation. Epogen is highlighted as a way to "avoid" blood transfusions and "jump start" red blood cell production.

In a section entitled, "What Every Parent Should Know About Anemia Treatment," Epogen's clinical study data is summarized. In addition, product labeling and "Information for Home Dialysis Patients" is glued inside the back cover of the book.

There is no "increased risk" to pediatric chronic renal failure patients on dialysis compared to the safety profile of Epogen in adult CRF patients, according to labeling. Since its initial approval, Epogen labeling has contained a caution about benzyl alcohol as a preservative in the multi-dose preserved vial.

As part of the new pediatric labeling, Amgen has added a single-dose, preservative free vial which does not contain benzyl alcohol. The recommended starting dose for pediatric patients is 50 units/kg twice weekly, IV or subcutaneous.

Epogen continues on a dramatic growth pattern for a drug in its tenth year on the market. Epogen sales increased 28% to $449 mil. in the third quarter; total Amgen product sales increased 20% to $769 mil. The company said total sales growth for 1999 will "be close to 20% and that implies total sales of about $3 bil." Third quarter net income increased 36% to $300 mil.

In 2000, Epogen sales are expected to grow at a "mid-teens" rate and Neupogen, Amgen's other lead product, should grow at a "high single digit" rate, Falberg said.

As Amgen takes on more support for Epogen and Neupogen, the company plans to increase its marketing spend and sales forces by about 25%-35%.

Reflecting that increase, SG&A expenses will trend up "quite significantly," Falberg told the CIBC meeting. "To put that in dollar terms, this year SG&A will be roughly $650 mil. and next year our guidance for SG&A is between $800-$850 mil.," she said. R&D spending as a percent of sales will trend down in 2000 with the shift to marketing and sales support.

The SG&A increase is "driven not only by the desire to expand sales of [Epogen and Neupogen] but also to begin building the market and laying the groundwork for follow-on products NESP and SD/01," Falberg noted. As Epogen and Neupogen age, Amgen's current bet to protect the company's position in those fields of treatment focuses on longer acting versions.

NESP (novel erythropoiesis stimulating protein) is the "follow-on molecule" to Epogen. "The primary benefit from NESP is its longer half-life and fewer injections," Falberg said. "We think it can deliver the full benefit of Epogen with less frequent dosing."

In a Phase III clinical trial, recently presented at the American Society of Nephrology, NESP patients safely maintained hemoglobin levels as effectively as recombinant epoetin alfa with less frequent dosing (weekly or once every two weeks compared to 1-3 times per week), the company said.

Trials were conducted in Europe and Australia on 522 hemodialysis and peritoneal dialysis patients. Ninety-seven percent of NESP patients assigned to once weekly dosing and 95% of NESP patients assigned to once every other week dosing maintained Hgb effectively, the study demonstrated. Adverse events, withdrawals and deaths did not differ among NESP and EPO treated patients, the company said.

Amgen plans to file the NDA in the next several months, the company said. A NESP oncology program is in Phase I.

Through Amgen's extensive chemotherapy surveillance program (ChemoInsight), the company has collected data from over 10,000 patient records in their national database, Falberg reported. The data suggests "21% of patients do not get more than 85% of their dose on time" and "about 41% of patients are under-dosed [on Neupogen] by weight." In addition, about two-thirds of patients get less than seven days of Neupogen even though the package insert recommends ten days of treatment.

Noting the "sheer inconvenience" of going to the doctor ten days in a row, Falberg stressed the potential of pipeline product SD/01 to improve both patient care and revenues. The sustained duration G-CSF molecule, currently in Phase III trials in breast cancer patients, is expected to deliver the "full benefit" of ten daily doses of Neupogen with one injection.