The company offered the following summary of recent developments that have previously been announced, including:
- Entered into an expanded agreement with OraSure Technologies, Inc. to include worldwide rights to develop and promote a rapid oral hepatitis C virus (HCV) test.
- Announced submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application for ZEGERID (omeprazole/sodium bicarbonate) as a branded over-the-counter product to treat frequent heartburn.
- The FDA''s Advisory Committee on Anesthetics and Life Support unanimously recommended approval of sugammadex, which if approved would be the first and only selective relaxant binding agent for use with surgical anesthesia.
- Announced with Centocor, Inc. submission of a Marketing Authorization Application to the European Medicines Agency requesting approval of golimumab as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
- Announced the launch of two new sunscreen products with an SPF of 70+, the highest protection rating available to consumers in a continuous spray.
- Gained FDA approval of label revisions for PEGINTRON (peginterferon alfa-2b) and REBETOL (ribavirin, USP) combination therapy for chronic hepatitis C, recommending weight-based dosing of REBETOL based on patient body weight.
- The Merck/Schering-Plough joint venture announced results of the ENHANCE ultrasound imaging trial.
- Announced a major new Productivity Transformation Program (PTP) to reduce and avoid costs and increase productivity to generate a total of $1.5 billion in targeted annual savings and synergies.
- Announced adoption of a new governance requirement to strengthen the alignment of executives with the interests of shareholders: a two-year holding period for shares acquired by Executive Management Team members upon the exercise of stock options.
- Announced initiation of a Phase II clinical study with vicriviroc, an investigational CCR5 antagonist, for use in first-line therapy of adult treatment-naive HIV-infected patients with R5-type virus only.
Key questions from the first quarter earnings call conducted by Schering Plough Corporation on April 23, 2008.
Catherine Arnold (Credit Suisse): Is it plausible that the cholesterol script trends already show the most negative response to enhance an ACC and that further downside although not impossible is less likely from here?
Fred Hassan: The open science discussion that we are hoping for at the ACC never occurred, and there has been confusion in the market. We are working with it; it is difficult to go to any previous models to make a prediction on how the market share might recover here. We are working hard and we are engaged and we are pleased that temperate voices have surfaced that are again advocating the importance of lowering LDL and getting people to goal.
Catherine Arnold (Credit Suisse): There are some concerns that your $1.5 billion target for PTP is too aggressive. Can you share your argument to why this number is achievable and does not have risk?
Fred Hassan: It is achievable; it is 10% of our 2007 cost base. It is 10% of our combined headcount. This company has a difficult attitude to costs. It is deep into our D&A, and we are at the same time having this ambitious goal of growing the top-line and growing our R&D pipeline. The reason we are being selective with our cost cuts is to make sure that we do not hit our growth areas which have made this company so strong. We were an $8.3 billion company in 2004, we are now in the $20 billion zone, and we are proud of our growth rate; we would like to keep growing. At the same time, we do feel that we can not be much more productive and we can be more precise with our overhead costs as well as some R&D programs and sales and marketing programs. We also do assume some natural growth in costs. There will be opportunities that will come our way and we will go after those opportunities.
Roopesh Patel (UBS): Could you discuss the potential figures that could get VYTORIN and ZETIA franchise growing again prior to release of the IMPROVE-IT trial results in 2012 and then internationally what impact if any are you seeing post the ACC meeting?
Fred Hassan: I will make a general comment that ""lost in the noise"" is an important statement that came from the American Heart Association on the great advance that we have made in our country in reducing heart attacks and strokes over the last several years and one reason that has happened is because people are more carefully about their lifestyle. There is much more care being placed to diet and exercise. But also the new medicines have greatly helped in that regard. We know that 90 million people in our country are candidates for cholesterol management. Only half of them even know that they should be aware of their issues and of those half who are being treated only half are getting medicines. The other half know they have an issue but they are not being treated. From that half that is being treated, only half are at their LDL goals. There is a huge opportunity to improve public heath and to improve cholesterol care and it just happen that when it comes to getting people to their LDL targets, especially the patients at risk are at high risk. VYTORIN and ZETIA are the best tools that doctors have to get patients to their targets. As we look at the landscape around us, we do not see any new molecules or any new major approaches that might be there for the next several years. So ZETIA was a major advance when it came along in 2002 and VYTORIN was a major advance when it came along in 2004. We do believe strongly in the opportunity that exists here.
Carrie S. Cox: We have seen good work done with our sales forces focusing on where this issue needs to be addressed which is in the physician''s office. We are encouraged that average practicing physicians understand the need to get their patients to their LDL cholesterol goals and the big thing to take away from this is more than have other patients who are not reaching goal even prior to these events. The concern that we have going forward is that even fewer patients may be reaching their goals right now. Our job is to continue to do the work that these extraordinary products give us the opportunity to do which is making sure that patients get the opportunity to get to their LDL cholesterol goals and not have the additional risk that can come from a raised LDL level.
Roopesh Patel (UBS): It appears that this quarter''s results demonstrate meaningful SG&A leverage. What is so unique about this quarter that may not carry through in two subsequent quarters?
Robert J. Bertolini: We had 2 cents benefit from that 123R adjustment so that was 2 cents in the quarter as a benefit that came through. When you think about our second quarter, it tends to be a seasonal quarter with promotion spending in our consumer business and in our allergy business. We are seeing the hiring freeze that is having an impact on us. So we are getting some leverage in the business. We are starting to see some of the OBS synergies come through. I would say those are the points going forward.
Tim Anderson (Sanford C. Bernstein): How do you see Merck''s Coadaptive impacting VYTORIN and ZETIA, their producer date I think is Monday?
Carrie S. Cox: We are always watching the other opportunities in the market and while the niacin component is an interesting one in the marketplace, those products do tend to be relatively niched because of the difficulty the patients continue to have with flushing and side effects in taking the niacin compound. They can be important options to add to overall therapy but the niacin portion of the market is unlikely to become a major portion of the overall cholesterol management market.
Tim Anderson (Sanford C. Bernstein): Will you restart at some point your DTC for VYTORIN and ZETIA?
Carrie S. Cox: We are committed to continuing to provide full support for VYTORIN and ZETIA and continue to evaluate when is the right time to consider what to do next with DTC. We are committed to patient education and do provide substantial support to physicians for patient education materials as well. At this point is that there has been little impact of the entire ENHANCE issue outside the United States where the media did not pick it up with the same rigor that it was addressed here and we find that there is good scientific dialogue and discussion and it is being seen more in the right perspective without the impact in the U.S.
Tim Anderson (Sanford C. Bernstein): Do you have a producer date coming up on SINGULAR/CLARITIN?
Thomas P. Koestler: It is under regulatory review, and there was a long history on this product, some challenges based on the early trials, and we did take a different approach with this. We have conducted some additional trials. We are working with FDA and it is under review. We should be hearing something in the near term from FDA on this application.
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