Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%. GSK hopes that the transaction will increase the company’s exposure to India, which it describes as a key emerging market. The tender offer for the shares was undertaken by GSk’s subsidiary in Singapore, GlaxoSmithKline Pte. Ltd.

The offer was first announced in November 2012 and commenced on 17 January 2013. According to a press statement, shareholders of GlaxoSmithKline Consumer Healthcare Ltd tendered shares representing 29.3% (12,319,749) of the total outstanding shares. 

The offer of 3900 Indian Rupees ($73.22) values the transaction at approximately $90 million. The final payment for shares tendered and accepted will be completed on or before February 13 2013. After this point, GlaxoSmithKline Pte. Ltd, will acquire full beneficial ownership of the shares tendered in the offer. 

, David Redfern, chief strategy office at GSK, said, “We are very pleased with the outcome of this transaction, which will further increase our exposure to a key emerging market. It is a significant vote of confidence in the long-term growth prospects of our Consumer Healthcare business in India.”

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GlaxoSmithKline has increased its stake in its Indian subsidiary, GlaxoSmithKline Consumer Healthcare Ltd, from 43.2% to 72.5%.

GSK Increases Stake in Indian Subsidiary

Consultancy firm IDEA Pharma has released what it calls a ‘Productive Innovation Index’, which ranks pharmaceutical companies based on their ability to successfully commercialise new innovations. The company has been published the index for three years and uses publicly available data to reach its conclusions.

		Although the index may not be a complete picture of innovation in the industry, given that there are no doubt many other data not available to the public about the state of innovation within a company, the results are still an interesting read.

		“We wanted to assess the pharmaceutical industry’s ability to add value to, and derive value from, molecules in pre-launch, so we analysed the major players based on a range of observations including speed to market, attrition rate in phase III, sales versus ostensibly similar molecules, and regulatory success,” IDEA Pharma’s CEO, Mike Rea, said in a statement.

		Johnson & Johnson claimed the top spot as the pharmaceutical industry’s most innovative firm. According to IDEA Pharma, there were two main factors contributing to the company’s success. Rea said, “It successfully brought to market Abiraterone (Zytiga) - a lyase and steroid synthesis inhibitor for use in the treatment of prostate cancer - and furthermore it was a major riser in the Access to Medicine Index, which is of increasing global importance.”

		The other nine companies occupying the top ten were Amgen, Roche/Genentech, Merck & Co., Sanofi, Eli Lilly, Novartis, GlaxoSmithKline, Bristol Myers Squibb and Abbott (ranked second to ninth respectively in the index). Do you agree with the results?

		Rea added, “Innovation is not only about what you discover, it’s about what you put on the market, so a carefully-considered strategy is critical. Some companies are so eager to clear the regulatory hurdles that it creates a culture of panic leading to the wrong behaviour.”

		One notable omission from the top ten is Pfizer, which was ranked eleventh. AstraZeneca also failed to make the top ten; coming in at fifteenth.

		“AstraZeneca is the perfect example of a company which has shown all the signs of panic over the past five years,” said Rea. “The stress of an underwhelming pipeline has led it to make bad decisions on top of bad decisions, and although it enjoyed some top line growth by flogging its sales model, the same primary care sales model has led to poor decisions in many areas.”

		You can read the full index, comprising 24 pharmaceutical companies, 

Consultancy firm IDEA Pharma has released what it calls a ‘Productive Innovation Index’, which ranks pharmaceutical companies based on their ability to successfully commercialise new innovations.

Pharma’s Most Productive Innovators

FDA approved 39 new molecular entities and new biologic licenses in 2012, up from 30 in 2011. December is typically an active month for FDA approvals and December 2012 was no exception, with FDA approving seven new drugs. 

The management board of EMA has endorsed the agency's work program for 2013, as well as several activities relating to implementing Europe's new pharmacovigilance legislation. EMA says it expects approximately 100 applications for human medicines in 2013. 

AbbVie, a specialty biopharmaceutical company recently spun off from Abbott, was officially launched in January. The new company will employ approximately 21,000 people in more than 40 countries. 

The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals will be collaborating to advance the development of malaria vaccines using a new vaccine delivery technology that combines genetically engineered DNA with electroporation. 

• A three-year agreement will see Janssen Pharmaceuticals and GlycoVaxyn working together on a multivalent bacterial vaccine. 

• Almac and TTP Labtech's alliance will give customers of either party access to a range of biological applications coupled with microplate-reader technology. 

• Mobile technology will be used to vaccinate children in Africa against common infectious diseases as part of a collaboration between GlaxoSmithKline and Vodafone. 

• OPKO and Bristol-Myers Squibb have expanded their collaboration to identify biomarkers predictive of drug response in several therapeutic areas.  

View more poll results at: PharmTech.com/Polls 

 is seeking reader input on process analytical technology and parenterals. Send your questions and thoughts to the editorial team at 

"From 2013 onwards, we can expect to see more bolt-on acquisitions, more divestitures, and more offshore deals. "  

 "According to a recently conducted global survey, the overall reputation of the pharma industry declined more in 2012."	 

 "With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class. "  

A round up of news from across the web, including trends from social social media platforms.

Pharma Conversation & Community

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules. 

The EC has issued a Statement of Objections, a formal step in the investigation process, with the preliminary view that an agreement concluded between Janssen-Cilag and Sandoz, subsidiaries of J&J and Novartis, respectively, delayed the market entry of generic versions of the painkiller fentanyl in the Netherlands. Fentanyl is a strong painkiller that is used to treat patients with severe pain.

, the EC explains that a “co-promotion” agreement may have been made between Janssen-Cilag and its generic competitor Sandoz in July 2005. 

“At the time there were no regulatory barriers to develop and market generic versions of the fentanyl patches and therefore for Sandoz to enter the Dutch market,” said the EC. “The agreement foresaw monthly payments from Janssen-Cilag to Sandoz for as long as no generic product was launched in the Dutch market.”

Sandoz did not enter the generic market with fentanyl patches for the duration of the agreement, which lasted until December 2006.

"If our preliminary conclusions are confirmed, the Dutch subsidiaries of Johnson & Johnson and Novartis entered into a so-called 'co-promotion' agreement to avoid competing against each other, depriving users of fentanyl in the Netherlands from access to a cheaper pain killer,” Joaquín Almunia, Commission Vice President in charge of competition policy, said in the statement. 

The EC first began investigating the companies in October 2011. 

J&J and Novartis have been informed in writing about the EC’s objections. The companies can now examine the documents in the investigation file, reply in writing and request an oral hearing to present their comments. If there is sufficient evidence of a breach of a antitrust rules, the EC can issue a decision prohibiting the conduct and impose a fine of up to 10% of a company's annual worldwide turnover.

The EC has been keeping a close eye on potential breaches of antitrust rules through the European pharmaceutical industry ever since an inquiry in 2009  indicated “a number of structural issues and problems in companies' practices that potentially led to distortions of competition and delays to the entry of new, innovative and cheaper generic medicines into the EU market”. In particular, the inquiry found that originator drug companies may be paying to delay the market entry of generic medicines. 

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

European Commission Investigates J&J and Novartis

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination paediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.

If the vaccine is approved, it will combine GSK’s injectable polio vaccine and Biological E’s pentavalent vaccine for diphtheria, tetanus, whooping cough, hepatitis B and hemophilus influenza type B, and could be the first vaccine of its type, according to a GSK 

The vaccine is intended to reduce the number of injections for children and to improve compliance with immunisation schedules. Space at local storage facilities would also be freed up because the vaccine is intended to be a fully liquid, ready-to-use formulation with no need for additional ingredients or materials. Phase I development is expected to start in the next two years. 

Each company will have a 50% stake in the joint venture and will bear the development costs. A small cash investment will be made by both companies to cover the start-up costs and further development costs will be split equally. 

Completion of the transaction is expected later this year.

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.

GSK in Joint Venture for Pediatric Vaccine

Biosimilars. They bring cheap prices to patients and healthcare payers, but for biopharmaceutical companies, such products impact the sales of innovative biopharmaceuticals. The pros and cons of biosimilars have been under discussion for some time in the bio/pharma industry, but the debate is now gaining increased momentum as the US moves closer to solid guidance concerning the development of biosimilars.

		In Europe, the EMA has had approval procedures in place for biosimilars for years and many products are already available in the EU marketplace. In the US, however, the subject is a little newer and there are still many concerns.

		Last week, BioWorld published a new report on biosimilars. “The emergence of this new drug development sub-industry translates into opportunities for patient access to very expensive but effective biotech-based therapeutics,” BioWorld’s executive editor, Lynn Yoffee, said in a 

. “But the development of biosimilars brings myriad questions related to drug efficacy - since they are not exactly duplicates, just similar - as well as quality, safety and interchangeability with originator products.”

		Indeed, the above concerns of safety and efficacy have long been iterated by innovator biopharmaceutical companies

		In February 2012, FDA invited comments on three draft guidance documents concerning biosimilar product development in the US. In response, biopharmaceutical company Amgen explained that clinical studies “will be necessary to demonstrate biosimilarity for the forseeable future.”  The company also firmly pointed out that biosimilars are not generic drugs and that the scientific understanding of the reference product is often incomplete, although the analytics of protein biologics are improving.

		Many other companies had similar concerns to Amgen, but the era of biosimilars is inevitable in the US. Fortunately, many companies are beginning to accept this. On Friday, Amgen released a 

 expressing its support for biosimilars initiatives that focus on sound science and patient safety. Once again, however, Amgen emphasised that biosimilars are not identical to their reference product.

		“Biologics are so complex that they can usually only be made by a living cell.  In fact, when made by different manufacturers, they differ from each other.  They are also very large compared to chemical drugs and can be more sensitive to storage and handling. As a result biologic medicines have the potential to cause an unwanted immune response, which can show up months after taking the medicine,” said the Amgen statement.

		BioWorld believes that biosimilars will have a bright future ahead of them, but the products still have to prove themselves. In the BioWorld release, biosimilars expert and Washington editor, Mari Serebrov, said, ”As the US continues to wait for its first biosimilar to step up to the plate, global players are already betting on follow-on biologics to be one of the biggest hits in town. To earn that status though, biosimilars will have to show payers the money pretty quickly by delivering the power of biologics at a price economically strapped countries can afford.”

		And, as Amgen emphases, by delivering therapies that are as safe and effective as their reference products. Amgen has made several suggestions to make sure that the biosimilars era delivers safe therapies. Amgen suggests that patient medical records must accurately reflect the biologic medicine that is being taken, and that physicians be informed when an interchangeable biologic substitution has occurred.

Biosimilars. They bring cheap prices to patients and healthcare payers, but for biopharmaceutical companies, such products impact the sales of innovative biopharmaceuticals.