Teva Launches Generic Version of Mylan's EpiPen for KIds


2019-08-22 16:08:00 Zacks


Shares of Teva Pharmaceutical Industries Limited TEVA rose 4.5% on Tuesday after it announced the launch of a generic version of Mylan’s MYL popular EpiPen Jr auto-injector for severe allergy treatment. Generic versions of EpiPen Jr for young children along with EpiPen for adults in 0.3 mg and 0.15 mg strengths were approved by the FDA in August to treat life-threatening allergic reactions like anaphylaxis. Teva had launched the generic version of EpiPen auto-injector 0.3 mg for adults in November last year. Teva has priced generic EpiPen Jr at $300 for a pack of two, same as the adult version as well as Mylan’s authorized generic version of its own branded product. Teva’s shares have declined 54.6% this year so far compared with the industry’s decrease of 9.5%. Teva has a license, development and supply agreement with Antares Pharma per which the latter is responsible for the supply of EpiPen, which Teva will commercialize and distribute.. The approval of this drug-device combination product is part of FDA’s efforts to improve access to cheaper copycat versions of complex yet critically important medicines/products like EpiPen. Mylan ran into massive trouble in 2016 for raising the price of EpiPen by more than 400% since its acquisition in 2007, drawing immense flak from lawmakers, consumers and common people alike. As a result of the increased prices of EpiPen, Mylan launched the first authorized generic for EpiPen in December 2016, which cost almost half of the branded version. Mylan is facing some supply shortages for EpiPen. Its manufacturing partner, Pfizer PFE continues to experience interruptions in the production of EpiPen. Hence, Pfizer’s supplies to Mylan are inconsistent and inadequate in meeting global demand, including the United States. This leaves a significant market opportunity for Teva to capture. Meanwhile, cheaper FDA approved branded alternatives to EpiPen, Auvi-Q and Adrenaclick, are also available in the market. Also, Adamis Pharmaceuticals and partner Sandoz, Novartis’ NVS generic arm, gained FDA approval for a competing low cost pre-filled epinephrine syringe called Symjepi in June 2017. Sandoz launched it in 0.3 mg and 0.15 mg doses for both adult and pediatric patients in January this year. However, Teva’s product is the first true generic rival of EpiPen to be approved by the FDA. Though Teva initially faced some supply issues for generic EpiPen, it is confident about a pickup in sales.
梯瓦(Teva) Pharmaceutical Industries Limited TEVA 股价周二上涨4.5%,此前该公司宣布推出一款仿制版本迈兰(Mylan)的 MYL 广受欢迎的 EpiPen Jr 自动注射器,用于治疗严重过敏。 8月, FDA 批准了用于儿童的 EpiPen Jr 和用于成人0.3毫克和0.15毫克强度的 EpiPen 的通用版本,用于治疗像过敏性反应这样的威胁生命的过敏反应。去年11月,梯瓦(Teva)公司为成年人推出了 EpiPen 自动注射器0.3mg 的仿制药。 梯瓦(Teva)将仿制药 EpiPen Jr 的售价定为300美元,一包两款,与成人版以及迈兰(Mylan)授权的仿制药版自有品牌产品相同。 今年迄今为止,梯瓦(Teva)的股价已下跌54.6%,而该行业的股价则下跌了9.5%。 Teva 与 Antares Pharma 签订了许可、开发和供应协议, Antares Pharma 负责 EpiPen 的供应,梯瓦(Teva)将对 EpiPen 进行商业化和分销。。 该药物-器械组合产品的批准是 FDA 努力改善获得更便宜的仿制版本的复杂但至关重要的药物/产品,如 EpiPen 的一部分。 自从2007年收购 EpiPen 以来,迈兰(Mylan)在2016年因将价格提高了400%以上而陷入了巨大的麻烦,这引起了立法者、消费者和普通人的极大不满。由于 EpiPen 价格上涨,迈兰(Mylan)于2016年12月推出了 EpiPen 的首个授权仿制药,售价几乎为品牌版本的一半。迈兰(Mylan)面临 Epippen 的一些供应短缺。其制造合作伙伴辉瑞(Pfizer) PFE 继续经历 EpiPen 生产中断。因此,辉瑞(Pfizer)对迈兰(Mylan)的供应不一致,不足以满足包括美国在内的全球需求。这给梯瓦(Teva)留下了一个重要的市场机遇。 同时,更便宜的 FDA 批准的 EpiPen 、 Auvi-Q 和 Adenaclick 品牌替代品也可在市场上买到。此外, Adamis Pharmaceuticals 和诺华(Novartis) NVS 仿制药子公司 Sandoz 于2017年6月获得 FDA 批准,生产一种名为 Symjepi 的低成本预填充肾上腺素注射器。今年1月, Sandoz 以0.3毫克和0.15毫克的剂量向成人和儿童患者推出了该产品。 然而,梯瓦(Teva)的产品是第一个真正的仿制药竞争对手 EpiPen 将批准 FDA 。虽然梯瓦(Teva)最初面临一些仿制药 EpiPen 的供应问题,但它对销量的回升充满信心。