Weekly News Roundup For Pharma CROs, CMOs—August 12, 2014

Generic Production Returning To U.S., Report Shows

A new CPhI Pharma Insights and InformEx U.S. market report was recently released, which reveals that the U.S. should expect to see generics production return, especially as safety concerns about overseas generic production continue to grow. According to the report, 70 percent of domestic respondents are forecasting that domestic production of generics (off-patent prescriptions and branded over-the-counter drugs) is poised for growth in the wake of overseas safety concerns. This is not to say however, that domestic companies believe drugs manufactured on U.S. soil are any safer than those produced in the EU. Indeed, 75 percent of domestic companies do not see U.S. made drugs as safer. In contrast, 50 percent of international firms view production in the U.S. in a more positive light. The report also highlights the strength of the U.S. regulatory system and IP guidelines.

Finding Practical RBM Approach Stumps Industry

A new survey released by CluePoints found that, for 42 percent of respondents, finding the best and most practical approach to RBM is the biggest challenge standing in their way of an effective RMB strategy. Central Statistical Monitoring was found to be the most widely used technique among the 520 survey respondents. According to 59 percent of respondents, Central Statistical Monitoring has significant advantages, as it can detect data accuracy and issues earlier and, in turn, requires less work from study teams. Overall however, the study has illuminated the fact that the decision makers in the industry still do not have a clear understanding of how to practically implement RBM approaches.

Mexico’s Pharma Industry To Hit $28 Billion By 2020

According to Global Data, Mexico’s pharmaceutical and medical devices industries are expected to be worth $22.5 billion and $5.4 billion respectively by 2020. Aiding this market in its growth are several factors, including the prevalence of non-communicable diseases, regulatory guideline improvements, government support for the healthcare sector, and the North American Free Trade Agreement. There are over 350 domestic and multinational companies manufacturing pharma products in Mexico, and this industry is only poised to keep growing as the branded drugs lose market exclusivity.

Collaborations On The Rise To Reduce Development Risk

Pharma and biotech companies have begun to increase the number and types of collaborations they form with other developers and service providers, the Tufts Center for the Study of Drug Development (CSDD) has revealed. According to Tufts CSDD, nearly half of all new drugs approved in the U.S. between 2000 and 2011 were developed in a collaboration of some kind. The study found that sharing risks and rewards through a collaborative agreement can help increase the possibility that a new medicine could win regulatory approval and see the market. 

Pharma Talking Points

The European Commission announced that it would be providing additional funding to the Airport Communication project (AIRCOP) in order to cut down on the transportation and distribution of illegal and counterfeit drugs in Africa, Latin America, and the Caribbean. To date, this project has been successful in attaining roughly 1400 kg of counterfeit drugs.

Forbes features a column by John LaMattina, who discusses the pricing of Gilead’s HCV drug Sovaldi. The drug is under contention in the U.S. because of its high price, however it is expected to be sold for less in poorer countries.  In India, for example, the cost will be $900/patient, and Gilead has agreed to work with Indian generic manufacturers in order to produce the drug locally and keep costs low.  While this pricing is lower, Indian officials are still hesitant to consider this affordable because of the fact 80 percent of the population does not have insurance.

Another article from Forbes argues that the DISARM Act will play a key role in bolstering drug development and reinvigorating the pipeline of new antibiotic drugs as drug-resistant bacteria becomes an increasingly large concern.