Biotechnology giant MedImmune has appointed Bahija Jallal, its current Executive Vice President for R&D, as its new President.

The former President of the Maryland-based company, Peter Greenleaf, will take over leadership of parent company AstraZeneca’s (AZ) Latin American business.

The transition accompanies the formal designation of MedImmune as the global biologics division of AZ, which acquired it for $15.6bn in 2007.

Bahija Jallal is a former researcher at the Max-Planck Institute of Biochemistry in Germany. While VP of Drug Assessment and Development at Chiron, she was headhunted by MedImmune in 2006, becoming its Head of Translational Science.

Commenting on that appointment, Jallal said: “I was struck by MedImmune’s history of innovation. And I looked at who they had on their board of directors and their executives. There were more women than you would see at other companies.”

The fortune paid by AZ to acquire MedImmune surprised many in the industry. The acquisition was followed by investment in its R&D capability, including the development of a new site in Cambridge, England, and the merger of the UK group with Cambridge Antibody Technology.

According to MedImmune spokesman Mike O’Brien, the biotech company’s commercial operation now formally belongs to AZ’s North American business, while its manufacturing operation is part of AZ’s global operations.

“The driver for these changes is not cost but even faster decision-making in key areas of the business and a need to reduce complexity,” he said.

Through MedImmune, AZ plans to deliver an average of one new biologic drug per year from 2013.

MedImmune’s past successes include two innovative vaccines: the first monoclonal antibody approved by the FDA for use against an infectious disease (Synagis, used to prevent the childhood lung disease RSV); and the first intranasal vaccine against influenza (FluMist).

The arthritis therapeutics market is expected to experience significant growth in the coming years, a new report predicts.

Research found that arthritis therapeutics are becoming a “gigantic attraction” for pharmaceutical companies as the condition continues to be one of the most common causes of disabilities.

Rising incidence rates of osteoarthritis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are expected to see revenues reach $35.8 billion by 2018.

Several major pharmaceutical and biotechnology companies have already shown an interest in obtaining market share and have made investments in the potentially lucrative industry.

Pfizer, Amgen, Merck, Roche and Novartis, the report found, have increased R&D efforts in the field with several promising therapies in late-stage development.

The current pipeline includes many small molecule drugs and biologic therapies, as well as novel oral Disease-Modifying Anti-rheumatic Drugs (DMARDs).

Biologics, the report predicts, will feature heavily as the market expands and drive growth during the coming years.

Existing market leaders are also expected to benefit from the predicted demand.

Amgen’s patent on blockbuster drug Enbrel was recently extended until 2028 by the FDA following a number of court proceedings. Other well-established brands have also had their protection protected.

However, the patents for Rituxan (rituximab), Remicade (infliximab), Celebrex (celecoxib) and Humira (adalimumab) will see a number of generic alternatives enter the market.

Despite cheaper therapeutic products being made available, the report estimates the market will grow at a compound annual growth rate (CAGR) of 7.2% for the next six years.

Partnership is the new black. Lonely-hearted blogger Maxine Vaccine raises the flag for life science collaboration – as long as the goal is truly mutual and not just a one-molecule stand.

Spare a thought for the pharmaceutical industry’s logo designers. A few years ago they were creating new logos like there was no tomorrow, as each merger or acquisition led to a new company name. The redesigning of wall plaques and letterheads rivalled R&D as a running cost for the industry.

Now, all the offices have white patches on the walls where the corporate logo used to be. There’s nothing there, because a biotech company has been invited to come and work with the team – and after Easter, it will be another company sitting in the same chairs and drinking coffee from the same mugs. Another month, another molecule.

We’ve gone from the harem model – one master and many brides all under the same roof – to the rapid turnover of the speed dating model. Why merge when you can partner on a contract basis, share resources for the duration of a single project, and not argue about who does the washing-up?

Is this just commitment phobia on the part of big pharma? Are those CEOs worried that raising investment will be too difficult if there isn’t a bright new partner every time? Well, yes – but it’s not that simple. It’s about the way biologics work – which is, of course, the way life works.

The role of biotechnology in drug discovery is one of the two great principles of healthcare in the 21^st century. As healthcare becomes more personalised, drugs map more closely onto the patient’s genetic and physiological make-up, and the relationship between biological processes and the drugs that protect or modify them becomes more and more that of a lock and key.

Biologics have a great history. Vaccination gained proof of concept in 1796, when Edward Jenner showed that fluid from cowpox sores could be used to inoculate people against smallpox. The first artificial vaccine (against rabies) was developed by Louis Pasteur in 1885. The first injection of an extracted human hormone, insulin, was achieved by Frederick Banting and Charles Best in 1923 – we are told that its effect on a ward of children dying from type 1 diabetes was greeted as a miracle. The first antibiotic, penicillin, was discovered by Alexander Fleming in 1928 – another medical miracle, until...

Until the overuse of broad-spectrum antibiotics in modern medicine led to the growing problem of antibiotic-resistant strains of bacteria, and a need for new and more closely targeted antibiotics. Recently, GSK’s Andrew Witty drew attention to the need for better industry collaboration to address this crucial danger. At the moment, he said, new antibiotics cannot command a huge market. But by the time there is a major unmet need, it may be too late. The solution lies in collaboration, so that the costs, risks and rewards are shared across a spectrum of life science industry stakeholders.

“We are trying to get ahead of the disaster,” said Witty. “Everybody has a concern that, one day, there might be a bug for which we don't have a drug. We don’t want that day to happen, and we need to re-double our energies, and the way to do that is to acknowledge that the market has failed.”

And there’s the second great principle of healthcare in the 21^st century.

Maxine’s views are not necessarily those of Pharmaceutical Field.

AstraZeneca will collaborate with Amgen to develop and commercialise five products from the US biotech company’s portfolio of antibodies to fight inflammation.

The five monoclonal antibodies offer potential treatments for psoriasis, psoriatic arthritis, asthma, Crohn’s disease, ulcerative colitis and lupus.

Under the terms of the agreement, the UK pharma company will make a one-off $50m upfront payment and then the companies will share costs and profits.

The collaboration will increase Amgen’s resources for drug development, drawing on the expertise of AZ’s biologics business MedImmune as well as its global commercial reach.

The companies will jointly develop and commercialise the following five assets from Amgen’s clinical-stage portfolio:

• Brodalumab (AMG 827), currently being investigated for psoriasis (planned phase III), psoriatic arthritis (phase II) and asthma (phase II).

• AMG 139, being investigated for Crohn’s disease (phase Ib).

• AMG 181, being investigated for ulcerative colitis (phase Ia) and Crohn’s disease ((phase Ib).

• AMG 557, being investigated for autoimmune diseases such as lupus (phase Ib).

• AMG 157, being investigated for asthma (phase Ib).

The agreement does not include certain territories covered by Amgen’s existing agreements with Kyowa Hakko Kirin for brodalumab and Takeda for AMG 557.

AZ will fund approximately 65% of costs for these products to the end of 2014, and then the companies will split costs equally. Amgen will book global sales and retain a single-digit royalty for the portfolio, after which they will share profits equally.

Amgen will lead the development and commercial strategy for brodalumab and AMG 557, while AZ will do the same for AMG 139, AMG 157 and AMG 181.

David Brennan, CEO of AstraZeneca, said: “This creative collaboration will make the most of both companies’ respective capabilities, including AstraZeneca’s extensive global reach, to help bring these potentially innovative treatment options for a variety of respiratory and inflammatory diseases to patients around the world.”

“We believe this collaboration has the potential to bring more therapies to patients sooner, across more geographic areas,” commented Kevin Sharer, CEO of Amgen. “We are impressed with AstraZeneca’s extensive experience in developing and launching products in the respiratory and gastroenterology areas, and believe this collaboration is an opportunity to work with a partner that has leading regulatory and commercial expertise in inflammation indications.”

Sanofi has lost a legal appeal against the decision that Roche and Biogen Idec did not infringe its patent for biologic drug development.

Roche’s Genentech business and biotech specialist Biogen Idec did not steal Sanofi’s IP for genetic medicine to develop the cancer drugs Avastin and Rituxan, a US appeals court determined.

The decision reflects the growing commercial potential of biologics and the tense relationship between big pharma and the biotech sector.

The dispute began in 2008, when Genentech cancelled its long-standing licensing agreement with Sanofi. The genetic medicine specialist was acquired by Roche in 2009.

Sanofi claimed that Genentech and Biogen Idec had used its proprietary techniques to enhance gene expression, improving the efficiency of drug production.

However, the US court upheld the previous decision that in both cases, the drug production methods were different from those covered by Sanofi’s patent.

Avastin and Rituxan, both cancer drugs, are among Roche’s best-selling products: Rituxan achieved sales of $6.6bn, and Avastin $5.81bn, in 2011. Avastin is marketed by Roche, while Rituxan is co-marketed with Biogen in the US.

According to Sanofi spokesperson Carrie Brown, the company is “currently evaluating its options and next steps.”

Patent applications for biologics by leading pharmaceutical companies are surging further ahead of applications for small-molecule drugs, according to a new report.

Another report notes that the next few years will offer major opportunities for pharma companies to develop biosimilars.

Both of these findings reflect the increasing importance of biotechnology in drug development.

Research by patent law specialist Withers & Rogers shows that while the number of patent applications for biologics has exceeded that for small-molecule drugs for 15 years, the gap has widened rapidly since 2007.

The legal firm’s analysis of the top 10 global pharma companies reveals that the gap between the numbers of patents filed for biologics and for small molecules grew by 14.5% between 2007 and 2009.

By 2009, 60% of the drug patents filed by these companies were for biologics.

Novartis made the greatest number of patent applications for biologics in 2009, followed by Johnson & Johnson and Merck & Co.

Nicholas Jones, patent attorney at Withers & Rogers, said that despite the impact of “economic uncertainty and cost pressures facing big pharma as blockbuster drugs hit the patent cliff, R&D interest in biologics has remained strong.”

He noted although “it is considerably easier to develop and manufacture small-molecule drugs”, major drug companies may be “increasingly willing to compete with major generics producers for a share of the follow-on biologics market”.

Growth partnership company Frost & Sullivan (F&S) reached the same conclusion in a report on the growing opportunity for biosimilars in the European drug market, where numerous blockbuster biologics are nearing the patent cliff.

However, the report noted, the cost of developing and manufacturing biosimilars makes them financially a more high-risk option than conventional generics.

Srinivas Sashidhar, Research Analyst at F&S, said: “$100 billion worth biologics are expected to go off patent by 2020, as a result of which the market is likely to hold significant potential.”

Before this potential can be exploited, he commented, “Improvements concerning the manufacturing and the clinical development processes of biosimilars have to take place.”

The report predicted the European biosimilars market will grow from $172m in 2010 to $3,987 in 2017, at a CAGR of 56.7%.

To overcome the challenges in the way of access to the growing biosimilars market, Sashidhar said, “Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected. The strong integration of marketing and research and development skills is the key to success in the biosimilars market.”

F&S expects the growing biosimilars market to drive growth in such therapy areas as diabetes and oncology, where biologics are having the greatest impact.

Healthcare giant Abbott plans to split into two companies: one in diversified medical products and the other in research-based pharmaceuticals.

The diversified medical products company will include medical devices, diagnostics, nutrition and generic drugs, and will retain the Abbott name.

The research-based drug company will cover Abbott’s existing portfolio of proprietary pharmaceuticals and biologics.

Abbott’s cardiac stents and other vascular devices have made the company a global leader in interventional cardiology.

Miles D. White, Chairman and CEO of Abbott, will remain Chairman and CEO of the diversified medical products company, which aims to be one of the largest and fastest-growing investment opportunities in this area.

The Abbott medical products company, whose current annual revenue is estimated at $22 billion, will continue to aim for double-digit growth and geographic expansion, particularly in emerging high-growth markets.

Its existing portfolio includes laboratory, point of care and molecular diagnostics and medical devices for cardiovascular, diabetes and vision care. It will develop an extensive and broad-based pipeline of medtech.

“Today’s news reflects another dynamic change in our company’s 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns,” said Miles D. White.

“Abbott will be one of the largest and fastest-growing global diversified medical products companies, with a compelling portfolio of durable growth businesses in medical technology, branded generic pharmaceuticals and nutritionals. We will continue to grow our product lines, market share and global presence, especially in emerging markets.”

The transaction will take the form of a tax-free distribution to Abbott shareholders of a new publicly traded stock for the new drug company.

Abbott currently employs nearly 90,000 people and sells a wide range of products in more than 130 countries.

Read more on this story on Pharmaceutical Field.

A quarter of the NHS drugs spending of £4.1 billion last year went on just ten medicines, according to a new report.

IMS Health found that total prescribing costs in England, including primary care and community prescriptions, reached a record £12.86 billion in 2010, an increase of 4.8% from the previous year.

This total in English hospitals has increased by 7.7%.

The report, commissioned by the NHS, says that this growth is likely to be related to the introduction of new, more expensive treatments.

The top 10 drugs (Figure 1) were mainly biologics used to treat either autoimmune diseases or cancers.

The most expensive were two arthritis drugs, Abbott’s Humira (adalimumab), with an increase of 19% to £180.5 million, and Pfizer and Amgen’s Enbrel (etanercept), costing £179.6 million.

Novartis’ Lucentis (ranibizumab) treatment for eye disease cost £128.9 million, overtaking Roche’s breast cancer medicine Herceptin.

The report noted the difficulty in biologics, as they are unlikely to be copied and manufactured into generics, consequently costing for the NHS more for branded medication. Manufacturers are likely to make more innovative forms of existing drugs, which would also push prices up.

However, the primary care drugs bill, which takes up 66% of the £12.9 billion spending of medicines in the English NHS, is expected to decrease by £1 billion over the next four years due to a series of patent expiry dates.

Abbott Laboratories has revealed plans to separate into two companies, one focusing on diversified medical products and the other in research-based pharmaceuticals.

The new medical products company will contain the company’s current portfolio and retain the Abbott name with the unnamed research-based business including its current portfolio of proprietary pharmaceuticals and biologics.

Miles D. White, Chairman and CEO, Abbott, says the split is a “significant event” in the history of the company whilst “strengthening our outlook for strong and sustainable growth”.

Abbott says the research-based company, which raised almost $18bn in annual revenue, and the diversified medical products firm, with approximately $22bn in annual revenue, will become global leaders in their respective industries.

The research-based arm will include all branded generic pharmaceutical, devices, diagnostic and nutritional businesses. Abbott says it will have a sustainable portfolio of brands, including Humira, Lupron, Synagis, Kaletra, Creon and Synthroid, as well as a pipeline of innovative R&D assets.

Developed markets are expected to generate the majority of the company’s revenue with a sustained portfolio and advancing pipeline having the potential to deliver “accelerating revenue” in the future, Abbott says.

Its new diversified business will include established brands from its four main divisions: pharmaceuticals, nutritionals, diagnostics and vascular devices, where it says it is now the global leader in interventional cardiology.

Abbott believes it will be one of the “largest and fastest” investment opportunities with nearly 40% of sales coming from high-growth emerging markets.

Miles D White will continue as Chairman and CEO of Abbott with Richard A Gonzalez, currently the Executive Vice President, Global Pharmaceuticals, taking on the positions of Chairman and CEO of the unnamed company.

“The research-based pharmaceutical company will be a leader in its industry with a strong and sustainable portfolio of specialty medicines and a promising pipeline of future products,” said Mr. Gonzalez. “This business has been delivering market-leading performance and is well positioned for future success.”

Roche has appointed Dr Harsukh Parmar as Head of Translational and Experimental Medicine (TM) of its Inflammation Discovery and Translational Area (DTA).

Dr Parmar will be responsible for the strategy and implementation of early clinical progress in Inflammation as well as collaborating with Discovery and Clinical Development to ensure high quality of compounds used throughout drug production.

Dr Jacques Banchereau, Head of the Inflammation and Virology Discovery and Translational Areas, said that Harsukh is recognised as “an expert in respiratory, inflammation, immunology and oncology, and possesses the right combination of experience for this pivotal position”.

Dr Parmar joins Roche from AstraZeneca in the UK, where he worked as Early Development Director, Vice President and Global Head of Early Clinical Development in the Respiratory and Inflammation Therapeutic Area. He also previously served at Roche as Global Clinical Science Leader and Director in Oncology, Immunology, Virology and Transplantation.

“Having previously worked for Roche and recognising the rich heritage of innovation that has come from the pharma business in small molecules and biologics, I was excited to rejoin a company that has been a leader in many of its respective fields,” said Dr Parmar.