Teva has announced the EU approval of NOMAC/E2, the first monophasic contraceptive with natural estrogen. The perceived increased safety of natural estrogen and a global launch will drive sales of the product, making it a leading hormonal contraceptive brand. To maximize its potential, however, Teva needs to show improved safety over synthetic estrogen contraceptives in post-marketing studies.
Nomegestrol acetate/17 beta estradiol (NOMAC/E2), to be marketed as Zoely, is the first oral monophasic contraceptive drug containing an estrogen that is structurally identical to that produced by women to be approved for the prevention of pregnancies in the EU. Zoely is described by Teva as containing a "natural" estrogen, as seen in its press release in March 2011 announcing a positive opinion from the Committee for Medicinal Products for Human Use. Teva intends to launch the product globally, and submitted it for approval in the US in May 2011.
Oral hormonal contraceptives, traditionally known as "the pill," have been used since the 1960s to prevent pregnancies. One of the major concerns with using these drugs is the possible increased risk of blood clots, which are thought to be caused by the synthetic estrogen component, ethinylestradiol. For this reason, companies are developing new drugs containing natural estrogens, which are perceived to be safer, although this has yet to be determined in clinical trials.
In 2008, Bayer-Schering launched oral Qlaira/Natazia (estradiol valerate/dienogest), which was the first triphasic contraceptive containing natural estrogens. Qlaira sales were lower than expected due to its complicated dosing regimen, which has four sequential phases of estrogen step-down and progestogen step-up. In contrast, Zoely has the benefit of being monophasic, which means there are no changes in dose throughout the monthly cycle. The monophasic class of contraceptives are often preferred by women due to there being less cause for concern if they miss a pill. In 2010, the monophasic class accounted for over 60% of global hormonal contraceptive sales.
Teva became a key player in the contraceptive market after acquiring Barr Pharmaceuticals in 2008. The company's contraceptive franchise achieved sales of $751m in 2010 and includes several key branded generics, such as Ocella (drospirenone and ethinylestradiol), a generic version of Bayer-Schering's market-leading Yasmin. Teva's position was further consolidated in 2010 with the acquisition of the European women's health drug company Theramex from Merck KGaA, which had been developing Zoely.
Teva's greatest opportunity is to position Zoely as a safer drug than other contraceptives because of the natural estrogen component and as an easier drug to use than Qlaira. However, in a market where brand loyalty is high, Teva's main challenge will be to convince women and prescribers of the advantages of its product. Moreover, Teva will need to ensure that its marketing messages adhere to tighter regulations. While in the past contraceptive companies such as Bayer-Schering used aggressive marketing campaigns to drive sales, the FDA is becoming stricter on direct-to-consumer advertising campaigns. For example, the term "natural" is not used to describe Natazia on its US website. Importantly, any safety superiority claims that Teva may make will need to be backed up with robust data from post-marketing studies showing benefits over contraceptives using synthetic estrogen.
Assuming that the drug achieves a US launch, Zoely's sales are forecast to exceed $350m in 2020 across the seven major markets (the US, Japan, France, Germany, Italy, Spain, and the UK), making this one of the leading brands in the market.