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.

Global revenue from cancer treatments is set to reach $75 billion this year, a new report predicts.

Leading Anti-Cancer Drugs and Associated Market 2012-2022 estimates that overall revenues will increase strongly in the next decade due to emerging technologies and increasing demand.

An industry analyst at visiongain – who published the report – says there is an unmet need for “well targeted therapies with better safety and efficacy”.

The report predicts that Roche will continue to lead the oncology market throughout the study’s forecast period with its selection of brands.

Demand in both western and emerging markets also holds great promise as a global increase in cancer incidence and prevalence takes place.

New opportunities for treatments exist, the report says, with an increase in sales of small-molecule products and biological agents expected. Individual, personalised medicines will also benefit from unmet need.

Global sales in the submarkets of traditional antineoplastic agents, novel antineoplastic agents, hormone therapies, immunotherapies and other agents are also predicted in the study.

“Although oncology is one of the most researched areas of medicine, there remain un-met and under-met treatment needs,” the analyst said.

“There is a need for well targeted therapies with better safety and efficacy. It is crucial that anti-cancer drugs have minimal side effects, so that the quality of patients’ lives can be enhanced. Pharma companies will further explore this field, making therapeutic progress this decade. In particular, companion diagnostic tests with drugs will help in cancer treatment, giving more-personalised, better-targeted medicine.”

Napp Pharmaceuticals has appointed Dietmar Leitner as its new Managing Director.

Mr Leitner has more than 16 years experience within the pharmaceutical industry having worked at Abbott Laboratories before joining Mundipharma Gesellschaft m.b.H. in Austria.

The new Managing Director says he is “delighted” to be joining the Cambridge-based company and hopes to continue and build on its success.

He succeeds Antony Mattessich who left Napp in May 2011 to become Regional Director Europe at Mundipharma International Limited.

Napp specialises in the field of pain control. It has been committed to furthering the understanding and treatment of pain relief for the last three decades. It also has a growing expertise in oncology and respiratory medicines.

“Napp has significant expertise in analgesics, an expanding oncology portfolio and a very promising respiratory franchise,” commented Mr Leitner. This, alongside our very collaborative approach to business, will, I believe, be a significant strength in the emerging healthcare environment.”

Deal-making activity fell by nearly a fifth last year as pharmaceutical companies reduced R&D expenditure and streamlined their activities, research has shown.

PharmaVentures found that overall deals were down by 18% in 2011 and licensing arrangements fell by 16%. However, M&A activity increased by 30% as companies sought to secure their futures.

Fintan Walton, Chief Executive of PharmaVentures, said the industry is “undergoing a rapid and major transformation” but there was still “significant opportunity for great deals to be done”.

Research focused on PharmaVentures’ database, records and working relationships from within the pharmaceutical industry. It revealed that although merger deals were on the rise, so too were the contingency payments included in recent deals.

Oncology was the most popular therapeutic area to dominate the landscape with Roche being the most prolific deal-maker.

Unsurprisingly, pharmaceutical companies turned to Emerging Markets – particularly China and India – to conduct the majority of their deals. AstraZeneca recently completed a deal to acquire Guangdong BeiKang Pharmaceutical, a manufacturer of generic injectable antibiotics, to strengthen its position in the region. Bayer HealthCare also increased its presence in India last year when it partnered with Zydus Cadila after Merck had created a similar venture with Sun Pharmaceutical Industries.

PharmaVentures is an international healthcare advisory group.

Astellas Pharma Europe Ltd (APEL) has appointed Mike Crooks as General Manager of its UK operation, Astellas Pharma Ltd (APL).

Mike Crooks will seek to expand Astellas’ UK business, focusing on the therapy areas where the company aims for global leadership: transplantation, urology, dermatology, anti-infectives, pain management and oncology.

Mr Crooks has 30 years’ experience in the pharmaceutical industry, holding positions at Ciba, Novartis and Zeneca before becoming Marketing and Sales Director: Diabetes, Northern Europe at Novo Nordisk. He joined APL in 2007 as Marketing Director, and became Sales & Marketing Director for Specialist Brands in 2010.

In his new role Mr Crooks replaces Amit Makwana, who sadly passed away last year.

Ken Jones, President and CEO of APEL, said: “When Mike joined Astellas he brought with him a high level of expertise. With a proven track record in delivering sales, and a wealth of experience, Mike provides the right leadership to deliver on our commercial objectives and will support our commitment to patients and healthcare professionals in the UK.”

“With a strong team, product portfolio and a rich pipeline in Phase III development, this marks an important period for the business,” commented Mr Crooks. “Having already established category leadership in urology and transplantation, we are looking to do the same in oncology, reinforcing our commitment to bringing new and effective therapies to market in areas where unmet needs still exist.”

Based in Staines, UK, APEL is the European subsidiary of Tokyo-based Astellas Pharma Inc.

The European Medicines Agency (EMA) has published draft guidelines on the assessment of stratified medicine for cancer, including the use of biomarkers and companion diagnostics.

The proposed changes reflect the growing relationship, both clinical and commercial, between genetic analysis and the development of drugs (such as Herceptin) that target patients with a specific genotype.

The revised EMA guidelines on Evaluation of Human Anticancer Medicines guidelines include new disease-specific guidance on lung cancer and prostate cancer and revised guidelines on blood cancers.

They also emphasise the value of exploratory studies to establish the “technical/quantitative reliability” of biomarkers, and to maximise the application of companion diagnostics.

In addition, the methodology of phase III trials using progression-free survival or disease-free survival as a key outcome is reviewed.

The Evaluation of Human Anticancer Medicines guidelines were first adopted in 1996. They cover all stages of clinical drug development for the treatment of cancers. Disease-specific guidance was introduced in 2010.

The consultation on the revisions will run until May 31, 2012.

Takeda America Holdings, the US subsidiary of Japanese pharma giant Takeda, is to acquire biotechnology company Intellikine for $190m upfront and up to $120m in clinical development milestone payments.

US company Intellikine specialises in developing small-molecule kinase inhibitors for the treatment of cancer, and the deal will add two new compounds to Takeda’s oncology pipeline.

Since its formation in 2007, Intellikine has raised $41m from investors including Novartis Venture Funds and Biogen Idec.

Intellikine’s drug candidate INK128, an mTORC1/2 inhibitor, is expected to enter Phase II studies in 2012; while its INK1117, a PI3Ka inhibitor, entered clinical testing in September 2011.

Both drugs will be developed by Millennium, Takeda's business unit for global oncology strategy and development.

“INK128 and INK1117 are potential best-in-class inhibitors of critical pathways driving cancer cell growth,” said Deborah Dunsire, CEO of Millennium. “As single agents or in different combinations with novel molecules within our robust pipeline, we anticipate that these assets will be able to deliver transforming therapies to cancer patients.”

Troy Wilson, CEO of Intellikine, commented: “Intellikine has advanced three programs against the PI3K/mTOR pathway into human clinical testing in just four years. We are pleased that Takeda recognises the potential of our clinical-stage programs as well as our strong pipeline and discovery engine.”

The transaction is expected to be finalised in January 2012.

Biotech company Amgen and pharma company Watson Pharmaceuticals are collaborating to develop and commercialise a number of biosimilar antibody-based products in the oncology field.

Amgen will develop the products with funding and expert support from Watson, who will also manage their commercialisation.

The products developed through the collaboration will be sold under a joint Amgen/Watson label.

Founded in 1980, Amgen was one of the first biotech companies to take new therapies all the way from the laboratory to the patient. Watson is an integrated global specialty pharmaceutical company focused on urology and women’s health.

According to the two US companies, the collaboration demonstrates that biosimilars are distinct from generics, requiring more infrastructure and expertise for their development.

Under the terms of the agreement, Amgen will take primary responsibility for developing, manufacturing and launching the biosimilars. Watson will contribute up to $400 million in co-development costs, providing development support and sharing risks.

Watson will also manage the commercial life cycle of the biosimilars, and will receive royalties from product revenues and sales milestones.

“The pairing of Amgen's 30 years of experience in biologics together with Watson’s substantial generics and specialty pharmaceutical experience and complementary commercial and distribution capabilities provides great potential for worldwide patient access to high-quality oncology biosimilar medicines," said Amgen President Robert A. Bradway.

Paul Bisaro, Watson’s President, commented: “This collaboration places Amgen and Watson in an unparalleled position in the global biosimilars market by capitalising on best-in-class capabilities in both innovative biologics and specialty pharmaceuticals and generics.

“We believe that biosimilars are the next frontier in the evolution of the healthcare market, and we are prepared to bring all of our resources to bear in this collaboration to ensure this partnership can most effectively compete in the biosimilar space.”

Roche has appointed Pamela Carroll as its new Global Head of Pathways Biology within in Pharmaceutical Research and Early Development unit.

She will also act as oncology discovery site head at the company’s research facility in Nutley, New Jersey.

Mike Burgess, Global Head Oncology, Discovery and Translational Area, and head, large molecule research at Roche, says Pam “has built a reputation for scientific excellence and leadership in the field”.

She first entered the pharmaceutical industry in 1999 with Bristol-Myers Squibb before joining Merck. Two years ago, she moved to the Belfer Institute of Applied Cancer Sciences at Dana Farber Cancer Institute, Harvard Medical School.

“Her broad knowledge and successful history in leading oncology drug discovery efforts make her is an ideal fit for this position,” Mr Burgess added.

The FDA has again extended the indication for Erbitux (cetuximab) and approved the treatment for patients with advanced head and neck cancers in combination with chemotherapy.

The extension is based on the EXTREME study of 442 patients previously untreated with chemotherapy that demonstrated those treated with Erbitux lived 10.1 months on average, compared with 7.4 months on those treated with chemotherapy alone.

Richard Pazdur, Head of Oncology, FDA, says the medication is an “important tool” for doctors and patients.

Erbitux is now approved for five separate indications across two tumour types and becomes the first regimen in 30 years with extended overall survival in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck to be approved.