Belgian biopharma company UCB has predicted that patent expiry will strongly affect its European growth in 2012.

While UCB’s blockbuster epilepsy drug Keppra faced little generic competition in Europe following its patent expiry in 2011, the company predicts a 50% sales fall for the product in 2012.

However, the company’s CEO said its focus on severe diseases of the immune system and CNS has helped to insulate it against economic austerity.

UCB saw its revenues rise by 1% to €3.25bn in 2011, but predicts a fall of nearly 5% to €3.1bn in 2012.

According to a UCB spokesman, Keppra faces competition from more than 100 generic substitutes in 2012, and its European sales can be expected to fall by 50%.

Delays in the launch of generic alternatives protected Keppra in 2011, when its global sales increased by 3% despite its patent expiry.

UCB’s CEO, Roch Doliveux, said that its commitment to therapy areas such as epilepsy and immunology had shielded the company from the impact of European austerity: “We still have the means in Europe for many years to come to pay for severe healthcare issues, and that’s what we’re addressing.”

Last year, UCB benefited from increased sales of three products: Vimpat for epilepsy, Neupro for Parkinson’s disease and restless legs syndrome, and Cimzia for Crohn’s disease and rheumatoid arthritis (RA).

Doliveux also argued that value-based pricing – due to be adopted by the NHS in 2014 – is not a good model to support innovation. He argued that the current PPRS system is “a very robust system that a lot of countries have tried to copy, and PPRS works well.”

Among non-UK companies, UCB is the leading non-British investor in UK pharmaceutical R&D.

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

Nycomed, a Takeda company, has appointed Jostein Davidsen as its new Head of Emerging Markets.

Mr Davidsen will take on the post in addition to his current role as Area Head of Russia/CIS, reporting to Frank Morich, EVP, International Operations at Takeda Pharmaceuticals International, and CEO of Nycomed.

“Jostein's strong track record of leading Russia/CIS over the past 17 years makes him an ideal candidate for this position,” said Mr Morich.

“His extensive knowledge of the industry, combined with vision and tenacity, has propelled Russia/CIS to become one of Nycomed's top revenue contributors.”

Takeda’s acquisition of Nycomed in September 2011 was driven by Nycomed’s presence in Emerging Markets in Russia/CIS, Latin America, Middle East-Turkey-Africa and South Asia.

Takeda is a research-based global company with a main focus on pharmaceuticals. The combined company has an active commercial presence in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

Takeda Pharmaceutical Company has acquired Nycomed in a deal worth €9.6 million on a cash-free, debt-free basis.

The combined company will be commercially active in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

Current Takeda Executive Vice President of International Operations, Dr Frank Morich, has been appointed as CEO of Nycomed.

Yasuchika Hasegawa, President and CEO of Takeda, said: “Partnering the two organisations will have complementary effects and further increase our potential to become a truly global pharmaceutical company.”

Dr Morich said that the combined company’s pharmaceutical market will cover more than 70 countries, with a presence in Japan, North America, Europe and Asia.

“I look forward to bringing Takeda and Nycomed together to ensure we can achieve enhanced revenue, growth and diversification, while maintaining the strong momentum of both companies,” he said.

Roche’s RoActemra has been approved in Europe for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA).

The medicine is intended to treat patients two years of age and older who have responded inadequately to previous therapy with NSAIDS and systemic corticosteroids.

RoActemra is known as Actemra outside of Europe can be prescribed alone or in combination with methotrexate.

Hal Barron, Chief Medical Officer and Head of Global Product Development at Roche, stated: “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”

sJIA is the rarest form of Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis (JRA). The disease affects about 10-20% of children with JIA, with the peak age of developing sJIA being between 18 months and two years of age, although the disease can persist into adulthood. 

Roche is a biotechnology company with focus on pharmaceuticals and diagnostics. The organisation manufactures medicines to be used in areas of oncology, virology, inflammation, metabolism and CNS.