This strong performance reflects continued momentum across the core European markets. The company is pleased with the steady progress with ZETIA in Japan since its launch last June. There is a two-week prescribing restriction imposed on all new product introductions in Japan during their first year. Despite this, ZETIA has already captured more than a 5% value share, on par with other major country launches in its first year. As of July 1st, physicians now have the flexibility to prescribe ZETIA more freely to help get patients to their LDL cholesterol goal.
REMICADE sales increased 41% to $557 million.
With this record quarter, REMICADE has now delivered sales of nearly $1.1 billion during the first half of the year, and is currently annualizing past the $2 billion mark. REMICADE continues to be an important growth driver. Despite increasing competition, REMICADE has now delivered more than 25% growth in each of the past 10 consecutive quarters.
As new competition has entered the market, overall utilization of biologics continues to increase, particularly in Crohn''s disease and ulcerative colitis.
Anti-TNF have provided important treatment advances and the company is proud of the pioneering role that REMICADE has played in changing the treatment paradigm for these debilitating conditions.
With the potential addition of golimumab as early as next year, the immunology franchise is well positioned for long-term growth.
While REMICADE may already be perceived as one of the most efficacious products in its category, golimumab has the potential to be seen as the best subcutaneous injectable with its once a month dosing. Schering Plough has two products in this large and growing biologic market, with expected exclusivity for golimumab until 2024.
In allergy, global NASONEX sales increased 6%, driven by solid growth across international markets.
In the US, NASONEX sales declined 5%, driven by a mild spring allergy season, as well as continued competitive pressures. NASONEX has now been approved in Japan, representing another important milestone in its life cycle. Schering Plough anticipates the Japanese launch this fall.
Sales from the women''s health care franchise, including fertility and contraception grew to over $500 million during the quarter. NUVARING, CERAZETTE, and IMPLANON are important products that provide women more contraceptive options than just the traditional birth control pill.
Earlier this month, Schering Plough announced promising Phase III results for its next generation fertility treatment.
Patients treated with corifollitropin alfa achieved a 39% pregnancy rate, on par with existing therapies but offering patients the added benefit of less frequent injections. The company is exited about the potential to expand this franchise and the category, helping more couples to become families.
Global PEGINTRON sales declined 2%, despite continued strong performance in emerging markets.
Final results of the IDEAL study were presented at the Annual Meeting of the European Association for the Study of the Liver. Important insights were discussed among physicians that may help shape worldwide clinical practice in treating this serious disease. Although SPR rates and safety profiles were found to be similar between PEGINTRON and Pegasus, IDEAL demonstrated predictability of response and lower relapse rates for PEGINTRON.
Earlier this month, results of a significant Phase III trial with PEGINTRON in melanoma were published in The Lancet.
This cooperative group trial was the largest positive adjuvant trial ever conducted in patients with stage 3 melanoma. Treatment with PEGINTRON for up to five years provided a sustained increase in relapse free survival. And if approved, PEGINTRON may provide an important treatment option for physicians and patients in a very challenging disease.
Last month the EMEA issued a positive opinion for sugammadex.
Sugammadex, by rapidly and safely reversing the effects of shallow and profound muscle relaxation, has the potential to modernize the use of anesthesia around the world. Sugammadex is a good strategic fit with the current portfolio, leveraging the company’s experience in the hospital channel.
Key questions and answers from the second quarter fiscal 2008 earnings call conducted by Schering Plough Corp. (SGP) on July 22, 2008.
Tim Anderson (Sanford Bernstein):
What''s your confidence level on your asenapine PDUFA? You just mentioned introducing sugammadex later this year, PDUFA date is next month. You are very close to launching, but your comments seem to suggest it might be a little farther off?
