Galvus gets approvable letter
these experts got this wrong. too bad Novartis tried to show how safe their drug was at 30 time the dose and Merck only cared about 3 times the dose. Sometime too much information, is too much information
Galvus is coming. Our physicians were highly confident that Novartis’ (NVS, Not Rated) DPP-IV inhibitor candidate, Galvus would gain FDA marketing approval this upcoming week. They also explained that a possible explanation for the differences in the occurrence of skin lesions seen in the Galvus primate model that were not seen the Januvia primate model was that Novartis tested Galvus at 10 to 30 times the normal dose, while Merck (MRK, Not Rated) only tested Januvia at 2 to 3 times the normal dose. Another possible explanation was that Galvus was tested in the cynomologous monkey while Januvia was tested in the rhesus monkey, introducing a potential species bias. Our experts believe that Galvus will probably contain a warning in its label about potential skin lesions, and in all likelihood Januvia will receive a similar warning.
Recap of Expert Breakfast: “One Sweet Trio of Diabetes Docs”
Michael King, Jr., Senior Biotechnology Analyst (212.430.1750)
KEY POINTS FROM OUR BREAKFAST WITH Drs. Jay S. Skyler, Irl B.Hirsch, and Lawrence Blonde. Also offering their viewpoints were Jane Seley, RN, and Betty Freidel, Diabetes Educator and Patient Advocate.
We hosted an expert breakfast with Drs. Jay S. Skyler, Irl B.Hirsch, and Lawrence Blonde, thought leaders in the field of endocrinology and diabetes as well as Jane Seley, RN and Betty Freidel, Diabetes Educator and Patient Advocate. Jay S. Skyler, M.D., M.A.C.P., is a Professor of Medicine, Pediatrics & Psychology at the University of Miami in the Division of Endocrinology, Diabetes & Metabolism. Irl B. Hirsch, M.D. is a Professor of Medicine in the Division of Metabolism, Endocrinology and Nutrition at the University of Washington School of Medicine. Lawrence Blonde, M.D. is the Director of the Ochsner Diabetes Clinical Research Unit in New Orleans, LA, as well as Associate of the Internal Medicine Residency Program Director. Jane Seley is a registered nurse with NY Hospital Cornell Medical Center. Betty Freidel is a diabetes educator and patient advocate.
Who in our healthcare system is caring for diabetics? Diabetes management continues to challenge the healthcare system as a whole. Due to many factors, most of the more difficult cases seem to end up in a no-man’s land between primary care physicians (PCPs) and endocrinologists. Not only is there a shortage of endocrinologists, with waiting times for appointments of 3 to 5 months, many of the practices are closed to new patients. This especially rings true for complex diabetic patients where the reimbursement to the physician is not commensurate with the amount of time that is required to treat the patient. On the other side, PCPs have a limited amount of time to spend on this complex condition. These patients fall into a gap where they are too advanced for the standard regimens that a PCP can provide, but cannot obtain an appointment with an endocrinologist. By the time a patient reaches an endocrinologist, it is essentially a foregone conclusion that they will be started on injectable insulin therapy.
Byetta samples are filling up the fridge! All of our experts indicated that when they go to the refrigerator for a sample, it is difficult to find whatever it is they are looking due to the extremely large volume of Amylin’s (AMLN, Market Outperform) Byetta 5mcg pen samples. At first glance, this may sound a bit excessive; however, our nurse practitioner (who, we might add, is typically the person involved in training the patient far more so than the physicians) indicated that without samples, the process of prescribing Byetta can be somewhat cumbersome. In fact, the time between the initial decision to choose Byetta, the trip to the pharmacy to get the drug, and the trip back to the physicians office to be trained is often times too overwhelming when given the alternative of the ease of an oral DPP-IV inhibitor. Having in-house samples available to train patients on using the device takes out the trip to the pharmacy and the second office visit to train the patient. While we agree that it may not be necessary to fill up the fridge with Byetta samples, they are clearly driving uptake, or at least curbing erosion to DPP-IVs by making it easier on the patient and the physician/nurse practitioner. Assuming that a patient can tolerate 5mcg, this should then increase the odds the patient moves onto becoming a paying 10mcg patient.
Communication breakdown: the endos clearly favor Byetta, but where is the disconnect with PCPs? The clear treatment algorithm from all of our guests is to begin a patient on metformin before introducing Byetta. If there is still a lack of efficacy, a long-acting insulin, such as Lantus or Levemir, can be added before bed. However, this has clearly not played out for the vast majority of PCPs as is indicated by prescription trends. There are two potential reasons for the disconnect: first, as mentioned above diabetes treatment has become increasingly costly in the physician office and poorly controlled diabetes patients can be a money-losing proposition for the physician. When the costs of such items as training patients to use Byetta and answering phone calls related to its use are added, the variable cost of treatment becomes incrementally larger. Second, PCPs do not always have time to learn about the benefits of Byetta. As the diabetes epidemic has grown, poorly controlled patients who previously may have received an immediate referral to an endocrinologist no longer have that option. As mentioned above, many endocrinologists are refusing to accept new patients because their offices are completely booked. Also, due to severe time constraints, the free communication between endocrinologists and PCPs has steadily decreased. The result is PCPs with very little time to learn about the benefits of Byetta from sales reps and endocrinologists, if available, who have limited resources to train patients to use Byetta. From a practical perspective, the expedient decision for the PCP is to try Januvia first before moving to Byetta. Our physicians indicated that when patients are presented with the option of a twice daily injection or a once daily pill, 50% of the time they choose the once daily pill (Januvia). This opinion was quite surprising, given that we were hosting three key opinion-leading endocrinologists who view Byetta as the better drug. So one can surmise that in the average PCP practice, the percentage of patients who choose Januvia will be even larger. However, our experts believe that, over time, as many patients experience poor efficacy with Januvia, there is a potential that they will soon switch to the “real Byetta”. If this prediction in fact comes to pass, we may begin to see this bear out in the weekly prescription data sometime in the near future as many patients have already been on Januvia for two months.
Byetta room temperature storage means more than the street gives it credit for. Byetta has many factors working in its favor, with the obvious weight loss benefit, potential pancreatic beta cell preservation, and most recently, room temperature storage. The latter is important when one considers a patient’s lifestyle; for example, many people do not come home for dinner and thus might miss an injection. Patients with busy schedules may opt out of taking Byetta because they know they will frequently have a difficult time taking their second injection, especially if they do not have easy access to a refrigerator. In this respect, Januvia may appear to be the more attractive alternative. However, with the recent approval of room temperature storage, this effect is reduced or eliminated entirely.
Galvus is coming. Our physicians were highly confident that Novartis’ (NVS, Not Rated) DPP-IV inhibitor candidate, Galvus would gain FDA marketing approval this upcoming week. They also explained that a possible explanation for the differences in the occurrence of skin lesions seen in the Galvus primate model that were not seen the Januvia primate model was that Novartis tested Galvus at 10 to 30 times the normal dose, while Merck (MRK, Not Rated) only tested Januvia at 2 to 3 times the normal dose. Another possible explanation was that Galvus was tested in the cynomologous monkey while Januvia was tested in the rhesus monkey, introducing a potential species bias. Our experts believe that Galvus will probably contain a warning in its label about potential skin lesions, and in all likelihood Januvia will receive a similar warning.
What’s so hard about inhaled insulin? In terms of Pfizer’s (PFE, Not Rated) Exubera, the physicians who know the most about the drug – the endocrinologists – are the least likely to prescribe it. In fact, of the three physicians at our breakfast, none have prescribed Exubera at this time – nor will they anytime soon. The principal reason behind this reluctance is that the process of commencing Exubera therapy is too difficult. For example, patients are required to receive pulmonary function testing (PFT), interpretation of the PFT test results is required, and then retrieval of the device from the pharmacy is necessary. These steps must be taken before patient education on using the device is provided by the nurse practitioner. In addition, considerations of reimbursement for service provided come into play. Even an issue as simple as administration of the PFT testing becomes complicated. Endocrinologists most often do not have spirometry available in their offices. It may not be reimbursed by insurance, and the results of the test can vary from patient to patient, lab to lab, and reader to reader. While many PCPs often have in-office spirometry, reducing some of the difficulty, it still remains a multi-step process. Our physicians felt that, while injectible insulin is still complicated to initiate in a diabetic patient, it is a far simpler process in comparison to Exubera. The docs were also of the view that the endocrinologist was the wrong audience for Exubera, and that Pfizer should direct its marketing message to the PCP and, perhaps, to patients directly (although most of them were not fans of pharmaceutical companies engaging in direct-to-consumer advertising).
Missteps in marketing At this time, Exubera has not been marketed to primary care physicians. As PCPs become more familiar with the drug, there will definitely be uptake by some patients. Our experts indicated that the reasons for patients’ hesitancy in beginning insulin therapy are multifactorial. Apparently, one study showed that on average, patients had three reasons for not wanting to start insulin. Remember, to many patients, insulin is seen as an act of desperation and the tendency is to try and hold out as long as possible. Thus, while concerns of injections are definitely real for some patients, there are numerous additional issues that cause hesitation. In order to see adoption on a larger scale, a great deal of education will need to be done. However, there are many obstacles to getting the message across. For example, it is very difficult for pharmaceutical reps to have face time with physicians and the opportunities to market to PCPs are almost non-existent. In this regard, DTC marketing may be the step required to bring more awareness to newer drugs. In diabetes treatment, patients often times drive the decision process. Should they bring up their interest in inhaled insulin, all else being equal, the physician is likely to prescribe Exubera. In fact, one study showed that of the patients who were hesitant to start insulin, the availability of an inhaled insulin increased the interest in starting therapy three-fold.
<<Diabetes Breakfast 02-23-07.pdf>>
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