Pharmaceutical companies Otsuka and Lundbeck have expanded their collaboration to include the promotion of schizophrenia drug Abilify (aripiprazole) in 14 EU countries from 1 April.

The two companies will co-promote Abilify, which is currently marketed by Otsuka, in the UK and six other European countries.

Lundbeck will promote the antipsychotic drug in Ireland and six other EU countries.

The collaboration covers all forms of Abilify that are available: three oral formulations and the rapid intramuscular injectable version.

Abilify is now the biggest-selling drug in the US, despite the limited incidence of schizophrenia (an estimated 1% of the population).

Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the UK, while Lundbeck will promote it in Austria, Belgium, Ireland, the Netherlands, Poland, Portugal and Romania.

Taro Iwamoto, President of Otsuka, said: “The agreement will further strengthen the Abilify brand in Europe and also position Otsuka and Lundbeck to successfully develop and launch up to five more new products there.”

The partners are about to launch a new monthly injectable version, Abilify Maintena, in the US, and submitted it to for EMA approval in December 2012.

Ulf Wiinberg, CEO of Lundbeck, commented: “Abilify Maintena represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance.”

Aripiprazole is a partial D2 dopamine receptor agonist that has been shown to reduce the risk of relapses in people suffering from schizophrenia.

Otsuka and Lundbeck signed an agreement to collaborate in the development and promotion of drugs to treat central nervous system disorders in November 2011.

Lundbeck’s Executive Vice President of Commercial Operations Marie-Laure Pochon has resigned from her position.

She stated the decision to stand down from the role she began in September 2011 was based on family and private reasons.

The outgoing EVP said she has had a “fantastic journey” and leaves Lundbeck with a “strong commercial platform with many product launches in the near-term future”.

Senior Vice President Ole Chrintz, who is currently responsible for Lundbeck’s international markets, will now add European commercial operations to his duties.

“I respect Marie-Laure’s decision and would like to thank her for her dedication and contribution to Lundbeck during the five years she has been with the company,” said Ulf Wiinberg, President and CEO of Lundbeck.

“We will continue the implementation of our commercial strategy to diversify our product portfolio and expand geographically with our strong and very capable commercial leadership team.”

Revenue fell at Lundbeck by 8% in Q1 2012 after price reductions and generic competition on Lexapro reduced sales to DKK 3.7bn.

Sales in the US were down by nearly a third (30%) and in Europe by 6% after Lexapro lost patent protection and saw profits drop by DKK 320m, compared to Q1 2011.

Ulf Wiinberg, Lundbeck’s President and CEO, said that despite the losses the company is “off to a good start for the year and on track to meet our expectations”.

Lundbeck has maintained its guidance for 2012 and expects revenue to be in the region of DKK 14.5 to 15.2 billion.

Excluding sales of Lexapro in the US, Lundbeck recorded an increase in revenue of 2%. Sales of the anxiety drug dropped from DKK 741 in Q1 2011 to DKK 336 in the first three months of the year.

Sales of Cipralex were heavily impacted by generic competition in Spain as revenue fell by 4% to DKK 1.47bn. However, this was compensated by increased sales of Xenazine (35%), Sabril (14%) and Ebixa (11%).

Growth was recorded in International Markets where revenue was up 15% and in the US – excluding sales of Lexapro – by 18% compared to Q1 2011.

Lexapro was recently launched in Japan and Lundbeck says the drug holds a market share of 3.4%. It hopes to build on this and launch a number of new products in the next 18 months.

“We are on track with the diversification of our product portfolio, with the three recent launches of Lexapro in Japan, Sycrest and Onfi,” said Ulf Wiinberg. “During the next 1½ years we will potentially launch four additional products.”

Lundbeck has appointed Jacob Tolstrup as Vice President of Business Development.

The 39-year-old joins from the company’s US subsidiary and will spearhead the development and strengthening of its existing and future partnerships and explore new growth opportunities.

Ulf Wiinberg, Lundbeck CEO, said the company was pleased to “recruit such a strong person internally to lead the important work of our on-going business development”.

Mr Tolstrup, who will also join Lundbeck’s Corporate Management Group, has held several management positions since joining the company more than a decade ago.

He began working in the pharmaceutical industry in 1998 at Abbott Laboratories and moved to Lundbeck a year later as Financial Analyst and Financial Planner. He then served in a number of different roles and joins after serving as vice president of finance and administration at Lundbeck US.

“Jacob has delivered strong results in a very professional manner for several years in various positions,” added Ulf Wiinberg.

Lundbeck saw revenue increase to record levels last year after seeing growth in its key products Cipralex, Ebixa and Azilect.

Revenue for 2011 reached DKK 16 billion, an increase of 8% on 2010, after sales in international markets improved by 17%, in the US by 12% and in Europe by 2%.

Ulf Wiinberg, Lundbeck President and CEO, says 2011 was an “excellent year” for the company with “revenue and earnings higher than ever”.

But despite the record-breaking year, the Danish-based pharmaceutical company now expects revenue to drop to between DKK 14.5 to 15.5 billion in 2012 when Lexapro loses patent protection in the US in March.

Antidepressant Cipralex was the company’s best-selling brand last year as it saw a 3% growth to DKK 5.9bn. Alzheimer’s treatment Ebixa saw sales increase by 14% to DKK 2.7bn with Azilect enjoying similar growth (15%) totalling revenue of DKK 1.1bn.

Xenazine (+40%) and Sabril (+73%) both saw a big increase in sales but were unable to prevent the company’s profit dropping from DKK2.4bn in 2010 to DKK 2.2bn last year.

Lundbeck currently has a number of products being considered for approval by health authorities around the world. It is also conducting Phase III and Phase II trials on different treatments and hopes these, along with the partnerships it entered in 2011, will assist with continued growth.

“We improved our long term outlook with solid progress in our late-stage pipeline and several important partnerships, including the deal with Otsuka, which has transformational potential,” said Mr Wiinberg.

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.

Revenue was up 10% in Q3 at Lundbeck to DKK 4.9 billion but profit from operations fell nearly a quarter (22%) after restructuring its R&D department.

Growth was driven by an increase in revenue from a number of its key products and milestone payments following the launch of escitalopram in Japan.

Ulf Wiinberg, Lundbeck’s President and CEO, says the company is “very pleased with yet another strong quarter” after its branded products delivered “solid results”.

Sales of Sabril increased by nearly half (47%) to DKK 77 million, compared to the third quarter in 2010, with revenue also up for Xenazine in the US by a fifth, compared with the same period, to DKK 191 million.

Lundbeck’s key products, Cipralex, Ebixa and Azilect, which grew 5%, 18% and 20% respectively, compared to the period last year, helped boost revenue from International Markets up 20% to DKK 901 million.

“We are now entering a new era with many new product launches,” said Ulf Wiinberg. “With the launch of Lexapro in Japan, the continued roll out of Sycrest and the forthcoming launch of OnfiTM in the US, we have expanded on our product diversification and strengthened our long term growth prospects substantially.”

Lundbeck has appointed Marie-Laure Pochon as its new Executive Vice President of Commercial Operations and slim lined its Executive Management Group in the process.

The new EVP has joined the Group after “realising high growth” as the Chief Executive of Lundbeck France and the Regional Vice President for France, Belgium, UK, Spain, Italy, Turkey & Germany.

Ulf Wiinberg, President and CEO, says he is “very pleased that Marie-Laure Pochon is joining Lundbeck’s Executive Management Group, where she can contribute with her strong commercial experience from a long career in the pharmaceutical industry”.

The company says it will “execute on many new opportunities” to implement its strategy and secure long-term growth and will reduce its Executive Management from six to four members in order to do so.

Peter Høngaard Andersen will now exit the Executive Management, but continue as part of Lundbeck’s corporate management team as Senior Vice President, External Scientific Relations & Patents.

Lars Bang will also leave the Group, but continue his role as Senior Vice President, Supply Operations & Engineering, leading Lundbeck’s global supply chain.

As a result, Anders Götzsche, Executive Vice President, CFO, Anders Gersel Pedersen, Executive Vice President, R&D, plus Ulf Wiinberg and Marie-Laure Pochon, now complete the Group.

Growth increased by almost a tenth (9%) at Lundbeck in Q2 of 2011 after revenue in several products and in key markets improved.

Sales of Cipralex, Ebixa and Azilect all continued to rise with revenue for Xenazine up 42% to DKK 209 million and Sabril increased 113% to DKK 80 million.

But despite the solid sales figures, Lundbeck still plans to cut between 125-175 R&D jobs in Denmark and the US.

Ulf Wiinberg, President and CEO at Lundbeck, says the job losses are regretful but necessary “in order to strengthen our long term growth prospects”.

As part of the company’s ‘optimisation process’ it also plans to write off between DKK 300-400 million on buildings and IP.

Operating profit increased 4% before depreciation and amortisation (EBITDA) to reach DKK 1,250 million and corresponding to an EBITDA margin of 30.5%.

Lundbeck now anticipates sales to reach between DKK 15.3-15.8 million and EBITDA to reach the upper end of guidance ranges of DKK 4.3-4.6 billion.

“Again our key products deliver solid growth and during the quarter we received positive and encouraging data from the phase III trials with nalmefene,” said the President. “We continue to invest in product and geographical diversification in order to deliver on our growth opportunities.”