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and global footprint we will be able to bring additional services and thought leadership to our customers. We are also excited about the potential the combination has to further innovate drug development in the area of Vaccines and Infectious diseases, important areas of focus for both government and commercial customers.”
Mayne Pharma Acquires U.S. Generic
Product Portfolio from Teva and Allergan Mayne Pharma has entered into a binding agreement to acquire a portfolio of U.S. generic products from Teva and Allergan for cash consideration of $652 million. The portfolio consists of 37 approved products and 5 FDA filed products in attractive markets with limited competition, across a range of therapeutic areas.
The Portfolio aligns strongly with Mayne Pharma’s core competency in complex pharmaceutical formulations and includes difficult- to-manufacture, modified-release tablets and capsules, soft-gel capsules and transdermal patches.
The divestiture by Teva was mandated by the Federal Trade Commission (“FTC”) in connection with Teva’s proposed acquisition of Allergan’s generic drug business. Completion of Mayne Pharma’s acquisition is expected to be concurrent with the closing of Teva’s acquisition and is subject to the FTC approving that transaction and Mayne Pharma’s acquisition of the Portfolio.
Rationale for the acquisition
Mayne Pharma’s CEO, Scott Richards, said: “The acquisition transforms Mayne Pharma’s Generic Products Division into a top 25 player in the U.S. retail generics market, diversifying Mayne Pharma’s earnings across a broad range of products, therapeutic areas and technologies. This attractive Portfolio spans multiple dosage forms and complements our expertise in higher-value niche, differentiated products. The on-market products have strong shares in stable, mature markets, while the pipeline products are expected to deliver additional growth in attractive markets as they are launched over the next couple of years.”
The transaction is expected to create multiple opportunities for further growth through leveraging existing relationships with customers and suppliers. Stronger and deeper relationships with customers will drive incremental portfolio selling opportunities for existing marketed products. The expanded supply chain network of active pharmaceutical ingredient providers and contract manufacturing organizations (“CMOs”) also is expected to unlock new portfolio and pipeline opportunities.
This portfolio will strongly complement Mayne Pharma’s existing generic portfolio and lead to greater operational efficiencies due to economies of scale. Up to eleven of the acquired products will be transferred into Mayne Pharma’s commercial manufacturing facilities in Greenville, N.C., and Salisbury, South Australia. This will accelerate the use of existing and previously announced expansions to manufacturing capacity, and enable additional margin to be captured over time, improving overhead recovery and the return on recent capital invested to expand these facilities.
The acquired portfolio is expected to add more than $237 million to Mayne Pharma’s FY17 net sales with gross margins greater than 50 percent. The transaction is expected to be very significantly accretive to earnings per share (on both a cash and reported basis, excluding synergies) in FY17.
Mayne Pharma has been working closely with Teva and the FTC since December 2015 and has established supply agreements with Teva for the manufacture of certain products not currently outsourced to CMOs for up to five years. Following completion, execution risk will be mitigated by the FTC’s ongoing monitoring of compliance with a public Consent Order issued by the FTC, which aims to ensure market competitiveness. Typical obligations in a Consent Order include the seller to prioritize the supply of products to Mayne Pharma over products for its own use, provide certain transitional services and take all necessary actions to maintain economic viability and marketability of the divested products until they are transferred.
Pharm-Olam International Strengthens Country Leadership with Strategic Hire in Mexico
Pharm-Olam International Ltd., a multinational, full-service Clinical Research Organization (CRO), serving the biopharmaceutical and medical device industries, announces the appointment of Fabiola Encinas as the Country Operations Manager for Mexico. Ms. Encinas has over 11 years of experience in the management of development programs throughout Latin America specializing in local team leadership, ensuring efficient and effective trial management.
Pharm-Olam’s Country Operations Managers (COM) play a vital role in study management, acting as experts for their respective countries, optimizing local operations, advising on Regulatory requirements and procedures, and overseeing local site management, feasibility and recruitment.
Quintiles Introduces Continuous Glucose Monitoring Services to Improve Diabetes Outcomes
Quintiles has announced the launch of its new Continuous Glucose Monitoring (CGM) service offering. This new solution combines innovative, wearable technology with Quintiles’ deep therapeutic and analytical expertise to help enhance the efficiency and quality of diabetes-focused clinical trials.
When used in clinical research, the new CGM offering will provide investigators with access to a myriad of customized data analytics and performance reports through its award-winning Quintiles Infosario® technology platform. These optimized glycemic data sets can be analyzed more efficiently to uncover trends such as non-compliance and potential safety triggers faster than traditional diabetes monitoring models. In addition, Quintiles experts from the company’s Diabetes Center of Excellence will provide dedicated support for the offering – combining data
pharmoutsourcing.com | 43 | July/August 2016
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