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Datamonitor attended this year's International Federation of Gynecology and Obstetrics World Congress in Cape Town to assess the state of the women's healthcare market. The overwhelming presence of Bayer-Schering at the conference confirms the company's strength in the contraceptives field and its commitment to maintaining its market-leading position.
At the International Federation of Gynecology and Obstetrics meeting (FIGO 2009), Bayer-Schering sponsored a whole symposium for each of its leading contraceptives, and all data presented showcased the effort that the company is undertaking to expand the indication usage of its leading brands. This is consistent with Bayer-Schering's ongoing strategy to differentiate its products from other hormonal contraceptives in order to maintain its leading position in the market.
Mirena positioned as drug of choice in menorrhagia
On October 5, Bayer-Schering hosted a symposium during which it presented pivotal Phase III data of Mirena (levonorgestrel) for the treatment of menorrhagia (heavy and prolonged menstruations). The FDA only recently approved Mirena for this indication, making it the first drug to have this label in the US. While Datamonitor's research showed that Mirena was already widely used for such conditions in the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK), regulatory approval will legitimize this use of the drug. Mirena has been available in the EU for more than a decade and in the US since 2001, achieving sales of $397m across the seven major markets.
Bayer-Schering showed data that were presented to the FDA for drug approval of Mirena for menorrhagia. In the large multicenter randomized open label trial, women receiving Mirena were compared to those women receiving the active comparator medroxyprogesterone acetate. The median blood loss reduction was by far greater in patients receiving Mirena than those receiving the control. Moreover, while by the end of the study the median blood loss in the Mirena patients was below 10ml, in patients receiving medroxyprogesterone acetate it was still above the 80ml which is considered to be the cut. This means that the percentage change in menstrual blood loss from baseline with Mirena was -71%, and with the control, -22%. In conclusion, the results showed that Mirena is an effective first-line treatment for menorrhagia.
Furthermore, the company presented new data which demonstrated the safety and efficacy of the consecutive use of Mirena for both contraception and menorrhagia. Data presented by Dr Gemzell-Danielsson showed that 56.5% of patients did not experience pain at all during the removal and 41.7% experienced mild pain during the immediate reinsertion of the second intrauterine device. Moreover, those patients experiencing bleeding episodes with the first Mirena were likely to experience a greater reduction in bleeding after the insertion of the second. This is only the second study to provide evidence that women returned to amenorrhea rapidly after the insertion of the device (within two weeks).
Yaz/Yasmin equivalence demonstrated
Bayer-Schering presented data from a study in which it compared the cycle control of an oral contraceptive containing ethinylestradiol 30mcg/drospirenone 3mg (Yasmin) administered in a 21/7 regimen versus a lower-dose oral contraceptive containing ethinylestradiol 20mcg/rospirenone 3mg (Yaz) administered in a 24/4 regimen, based on historical data from two identically-designed studies. Bayer-Schering's objective was to convince physicians to switch patients from Yasmin (which has lost patent protection in the US) to Yaz.
The results showed that patients receiving Yaz had similar cycle control to the patients receiving Yasmin. In both studies, all women recorded bleeding daily prospectively over 13 treatment cycles. The proportion of women who experienced intracyclic bleeding was highest in cycle 1, with 24.8% in the Yasmin group and 24.7% in the Yaz group reporting this event. The proportion of women with intracyclic bleeding fell by approximately 50% with both contraceptives from cycles 1 to 4, and remained fairly stable thereafter. During cycles 4-13, the proportion of women who experienced intracyclic bleeding ranged between 7.9% and 13.1% in the Yasmin group and 8.9% and 13.8% in the Yaz group.
'Natural estrogen is better'
In the symposium on October 7, Bayer-Schering presented its new hormonal contraceptive Qlaira (dienogest). Qlaira is the first oral triphasic contraceptive to deliver estradiol valerate, which is metabolized directly to 17 beta-estradiol, the estrogen identical to the one produced by the female body. The drug was recently approved in the EU and is currently undergoing FDA review.
Although it is thought that the use of natural estrogen will reduce the incidence of venous thromboembolism, this has not been confirmed in trials. The three speakers at the symposium presented clinical data from pivotal studies conducted in the US and EU. They emphasized the notion that Qlaira will be the first hormonal contraceptive in a new class. Interestingly, Bayer-Schering warned opinion leaders of the possible safety scares which are hyped by the media. Dr Monsur from the UK cited the 'Weber effect': a phenomenon whereby the number of reported adverse reactions for a drug increases until the middle to end of the second year of marketing. This suggests that Bayer-Schering is already preparing to face possible litigations in this high-risk market.
Bayer-Schering presented data regarding the efficacy and tolerability of Qlaira's three large-scale trials. A combined analysis of trial data showed that in 2,226 women aged 18-50 years, 19 pregnancies occurred, yielding an unadjusted Pearl Index of 0.79. Qlaira was well-tolerated, with the majority of users being satisfied or very satisfied with treatment. Overall, 10.1% of women prematurely discontinued treatment due to adverse events. The proportion of women who prematurely discontinued treatment because of bleeding disorders ranged from 0.0% to 5.5%, indicating an acceptable bleeding profile.
More importantly, Bayer-Schering presented new data showing that Qlaira could be used to treat heavy and/or prolonged menstrual bleeding without organic pathology. The study showed that Qlaira greatly reduced menstrual blood loss and improved iron metabolism parameters in women with heavy/prolonged menstrual bleeding without organic pathology. Women were then randomized to receive Qlaira or placebo for 196 days (seven cycles), and data from the last 90 days of treatment and the 90-day run-in period were subsequently compared. The adjusted mean difference in menstrual blood loss over 90 days with Qlaira vs. placebo was -373mL (95%CI -490, -255; p<0.0001). A significant improvement in iron metabolism parameters was observed with Qlaira only.
The study suggests that Bayer-Schering will try and expand Qlaira's indications to include the treatment of menorrhagia, which will be an important differentiating factor for the brand. Interestingly, Dr Monsur also mentioned the fact that Qlaira may reduce menstrual related migraine due to the reduced 'pill free' time. Should this be confirmed, it would be another opportunity for Bayer-Schering to increase Qlaira's differentiation compared to rival brands.
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