US-based generics manufacturer, Mylan, has divested the rights to two generic drugs. This is in accordance with the Federal Trade Commission‘s (FTC) demands and will allow Mylan to acquire the Swedish pharmaceutical company Meda.
Mylan gives up two generic drugs to allow for acquisition of Meda
Home/Policies & Legislation | Posted 26/08/2016 0 Post your comment
Mylan’s acquisition of Meda is a deal worth US$7.2 billion dollars [1]. Yet, it is not one that has progressed smoothly. Two initial takeover offers were rejected by Meda’s board of directors and shareholders, prior to the final price being settled [2]. Once the deal was made, Meda faced objections by trade authorities.
The FTC in the US and the European Commission (EC) in Europe, have been concerned over the acquisition of Meda, as it is thought that this could reduce competition for several pharmaceutical products. Both of these commissions have a duty to assess mergers and acquisitions involving high turnover companies, and to prevent deals with the potential to impede competition.
In order to allow the acquisition to go through, the FTC demanded that Mylan sell certain generic drugs. As such, Mylan will now sell its US marketing rights for 250 mg generic carisoprodol tablets and 400 mg and 600 mg generic felbamate tablets. The respective use of these drugs is in the treatment of muscle spasms and stiffness, and refractory epilepsy.
Without this forced relinquishment, the Mylan–Meda merger would mean that there are only two companies (where there were once three, Meda being the third) manufacturing and marketing 400 mg and 600 mg generic felbamate tablets worldwide. This would eliminate future competition and lead to higher prices payable by consumers. Under the FTC settlement, the rights to these therapeutics will be sold to Alvogen Pharma.
At present, only Meda and one other company have the rights to market 250 mg generic carisoprodol tablets in the US. However, Mylan now has the US marketing rights for a recently approved carisoprodol product. This would increase competition if Mylan were not about to acquire Meda. Thus, Indicus Pharma LLC (the product owner), will obtain the US marketing rights to allow for beneficial competition and facilitate the lowering of prices.
The situation in Europe is not dissimilar. The acquisition was approved in July 2016 under certain conditions related to the promotion of competition. This includes the divestment of a number of Mylan and Meda’s businesses across Europe (1).
References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan receives EU go-ahead to purchase Meda, with conditions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 August 26]. Available from: www.gabionline.net/Pharma-News/Mylan-receives-EU-go-ahead-to-purchase-Meda-with-conditions
2. GaBI Online - Generics and Biosimilars Initiative. Mylan to acquire Swedish drugmaker Meda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 August 26]. Available from: www.gabionline.net/Pharma-News/Mylan-to-acquire-Swedish-drugmaker-Meda
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.
Source: EMA, US FTC
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Reports
Top nine biological drugs by sales in 2023
New findings of semaglutide in managing hidradenitis suppurativa
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Comments (0)
Post your comment