Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

Bayer Healthcare has pledged its support to a Tuberculosis (TB) partnership by providing 620,000 tablets of the antibiotic moxifloxacin to the World Health Organization (WHO), which will make the tablets available to China’s national TB program. In particular, the medicine will be used to fight multidrug-resistant TB.

"We have decided to make moxifloxacin available to provide quick support to those patients in need," Jörg Reinhardt, chairman of the board of management of Bayer HealthCare, said in a 

. "We were happy to follow the request from WHO because we believe that this is the right step to address an increasing medical need in patients affected with this serious disease and for whom there are only very limited oral treatment options available."

According to Bayer, multidrug-resistant TB does not respond to standard TB drugs and can take two years or longer to cure. “Some countries, especially the former Soviet Union, China and India, have a high incidence of multidrug-resistant TB,” explained Bayer. “According to WHO, an estimated 440,000 multidrug-resistant TB cases and 150,000 deaths occurred in 2008. Multidrug-resistant TB occurs almost everywhere in the world, the main focus being in Asia. Nearly half of multidrug-resistant TB cases are estimated to occur in China and India.”

The medicine provided by Bayer, moxifloxacin, is a broad-spectrum antibiotic, but is not approved for the treatment of TB or multidrug-resistant TB. However, WHO has included the medicine in treatment group III of its guidelines as part of a second-line TB regimen in patients with confirmed multidrug-resistant TB. Moxifloxacin will be administered in China in a highly controlled manner, with close monitoring.

“Together with the Global Alliance for TB Drug Development, Bayer’s pharmaceutical division is working on the development of moxifloxacin as a treatment for drug-susceptible pulmonary TB. It is the aim of ongoing studies to show that use of moxifloxacin could reduce the length of treatment for drug-susceptible TB from six to four months. Bayer HealthCare intends to apply for the approval of moxifloxacin for the treatment of pulmonary TB as soon as clinical trials have been completed,” said Bayer.

The TB partnership, Stop TB, was formed by WHO in 2001, and comprises a network of international organizations, countries, donors from the public and private sectors, and governmental and nongovernmental organizations.

This is the second boost that China has had in recent weeks with regards to TB treatments. 

, the Stop TB Partnership also announced that Aeras, a US-based product development organization and a member of the program’s Working Group on New TB Vaccines, had signed a memorandum of understanding with the China National Biotech Group, with the aim of pursuing opportunities to jointly develop TB vaccines in China. Potential activities will cover the full spectrum of product development, including preclinical development, process development and manufacturing, and clinical development in TB.

, TB is a major public health priority in China where there are more than one million new TB cases every year. Globally, TB is reported to be responsible for 1.7 million deaths every year. 

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Bayer HealthCare has agreed to support the Stop TB Partnership in the fight against multidrug-resistant tuberculosis by making 620,000 tablets of the antibiotic moxifloxacin available to WHO.

Bayer Joins TB Battle

Pfizer has partnered with the University of California’s San Diego Health Sciences (UCSD) in a drug-discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies. The partnership will leverage UCSD’s expertise in neurosciences, cancer, inflammation, metabolism, clinical pharmacology, HIV, and pain.

The collaboration was formed through Pfizer’s Centers for Therapeutic Innovation (CTI). Pfizer established the CTI initiative last year, with the aim of creating a network of collaborative partnerships with research institutions to help bring new breakthroughs into the company’s pipeline. Pfizer currently has CTIs in California, Massachusetts, and New York.

“The collaborative partnerships formed through the CTI between Pfizer and academic medical centers, such as UCSD, allow leading medical and clinical experts to join with Pfizer’s highly skilled scientists—using Pfizer’s resources and expertise and each institution’s advanced drug development capabilities to speed the translation of innovative science into medicine for patients,” Jose Carlos Gutierrez-Ramos, senior vice-president and head of BioTherapeutics Research and Development for Pfizer, said in a 

The $50-million figure represents an estimate of the total support for research programs and potential milestone payments to UCSD for successful projects. The collaboration will include laboratory space at Pfizer’s R&D campus in La Jolla, California, to enable scientists from both Pfizer and UCSD to work closely together. Pfizer has also said that it will provide access to some of its antibody libraries and technologies.

“Public-private partnerships are increasingly important in scientific research, especially in an era of decreasing federal grant support when resources are needed to commercialize innovations related to healthcare,” Gary Firestein, dean and associate vice-chancellor of Translational Medicine and director of the Clinical and Translational Research Institute at the UCSD School of Medicine, explained in the statement.

Firestein added that the main aim of the collaboration was better testing of clinical hypotheses and an increase in the speed at which medicines can be developed.

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Pfizer has partnered with the University of California's San Diego Health Sciences in a drug discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies.

Pfizer's $50-Million Drug-Discovery Partnership

Companies in the life sciences industry are struggling to accurately predict their spending for clinical development, according to a survey conducted by US-based software provider ClearTrial. According to a 

, only 21% of survey respondents are highly confident in the accuracy of their study budgets. 

The study surveyed 187 managers and executives involved in forecasting and budgeting clinical studies in 75 biopharma and medical device companies from the US, Europe and Japan. More than 85% of survey respondents reported typical variance from forecast to the actual costs of clinical studies of at least 6%, while one in five reported a cost variance of 16% or more. For 25% of respondents, variance is 11–15 %.

Another key finding of the report related to planning efficiency. Eighty-three percent of respondents said they required at least one to two weeks to create a ballpark budget for clinical studies, while 50% said they required three weeks or more.

According to ClearTrial, one possible reason for the difficulties experienced by companies when it comes to forecasting and budgeting studies could be attributed to the level of technology being used. More than 55% of respondents said they used Microsoft Excel as their primary budgeting tool. Other industries, such as manufacturing or construction, however, use industry-specific planning software.

“The use of planning spreadsheets uncovered by the survey is at a level you would have seen in other industries 10 or 15 years ago,” Andrew Grygiel, Chief Marketing Officer at ClearTrial, said in a statement. “The life sciences industry still lags behind other industries in the use of purpose-built forecasting and budgeting software.”

Companies in the life sciences industry are struggling to accurately predict their spending for clinical development, according to a survey conducted by US-based software provider ClearTrial.

Companies fail to accurately predict clinical spending

Bristol-Myers Squibb (BMS) has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases for $325 million. The amount will be paid upfront, but there is potential for additional milestone payments up to $150 million. The acquisition represents BMS’s entrance into the fibrotic diseases area, which the company says is an area of high unmet need.

“As part of the continued execution of our focused BioPharma strategy, Bristol-Myers Squibb has identified fibrotic diseases as an area of high unmet medical need that complements our research efforts in several of our therapeutic areas,” Elliott Sigal, vice president, chief scientific officer and president, research and development, at BMS, said in a 

According to the statement, BMS will secure Amira Pharmaceuticals’ fibrosis program. This includes the lead asset AM152, an orally available lysophosphatidic acid 1 (LPA1) receptor antagonist that has completed Phase I clinical studies and is now poised for Phase IIa for the treatment of idiopathic pulmonary fibrosis and systemic sclerosis or scleroderma. BMS will also obtain Amira Pharmaceuticals’ preclinical autotaxin program, which the company believes may have potential in the treatment of neuropathic pain and cancer metastases. BMS also added that it plans to retain Amira Pharmaceuticals’ scientists who work on both of these programs and that they will remain located in San Diego.

According to Sigal, the acquisition is an example of the company’s “String of Pearls” strategy, whereby the company aims to conduct a series of “highly targeted” transactions designed to bolster BMS’s pipeline.

Bristol-Myers Squibb has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases, for $325 million.

BMS to Acquire Amira for $325 Million

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Leaflets will now include less rigid language and new sections that provide greater information about a drug’s benefits. There will also be more information about the medicine’s use in children to comply with the requirements of 

The update addresses feedback received during a five-year period of user testing. Stakeholders, including patients, pharmaceutical companies, and national regulatory agencies also contributed their opinions. In addition, the update takes into account the EMA’s 2009 report on the expectations of patients, consumers, and healthcare professionals regarding benefit–risk information, which explains how patients are becoming increasingly involved in choosing their own treatments. In particular, the report called for clear information that is easy to read and understand.

The readability of packaging leaflets and labels is an issue that 

 with Professor DK Theo Rynor. He explained that a number of commonly-used phrases, such as “Avoid alcoholic drink”, are often misunderstood by patients.

 from EMA, the update also includes changes to the templates for the summary of product characteristics, labeling and 'Annex II', the section of the product information covering the conditions imposed on marketing authorizations. The updated templates are available in all official EU languages, together with an implementation plan. 

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand.

EMA Improves the Readability of Packaging Leaflets

A public consultation has opened in Europe for the revised guideline on the good distribution practice of medicinal products for human use. The consultation was launched by the EC’s Directorate General for Health and Consumer Policy and, according to a 

 from the EMA, will be of particular interest to wholesale distributors and brokers of medicinal products for human use, as well as for manufacturers that distribute their own products. The original guideline was introduced in 1994.

“The content of the Guidelines on Good Distribution Practice published in 1994 is no longer adequate,” stated the draft guideline. “It needs to be reviewed to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the EU.”

In particular, the guideline takes into account the new requirements for wholesale distributors and brokers established in Directive 2011/62/EU, which concerns falsified medicines—and was discussed in a previous 

. A number of points in the revised guidance relate to falsified medicines; for example, the guideline states that training programmes should include aspects on identifying and preventing falsified medicines from entering the supply chain, and procedure should be in place for segregating and reporting suspected falsified medicines. 

“Today’s distribution network for medicinal products is increasingly complex and involves many players,” stated the introduction to the draft guideline. “The quality and integrity of medicinal products can be affected by a lack of adequate control over the numerous activities, which occur during distribution and it is also necessary to address the threat that falsified medicinal products pose to the distribution channel.”

The guideline aims to exercise greater control over the entire distribution chain, which includes all activities consisting of procuring, holding, supplying or exporting medicinal products (with the exception of supplying them to the public). It will ensure that products manufactured in or exported into the EU are of a satisfactory quality level. 

The deadline for comments is 31 December 2011.  The guidance is expected to come into operation approximately 6 months after publication.

A public consultation has opened in Europe for the revised guideline on the good distribution practice of medicinal products for human use.