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.

Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.

Healthcare corporation 3M has lost its dispute with representatives of the British Government over the company’s failure to market a diagnostic for MRSA developed within the Ministry of Defence.

The complainants have won $1.3 million in damages, whereas they were seeking $40 million – an outcome claimed by both sides as a success.

The BacLite medical device, which uses photoluminescence to detect MRSA bacteria, was purchased by 3M in 2007 and then abandoned as having failed the necessary clinical trials to support its marketing in the EU and the US.

The MoD, its spin-out company Ploughshare Innovations and private equity firm the Porton Group together claimed that 3M had deliberately mismanaged the BacLite trials in order to protect its rival (and more expensive) Fastman device.

The High Court in London found that 3M was in material breach of its obligation “actively to market” BacLite in the EU, the US, Canada and Australia, including its obligation to seek regulatory approval in the US.

However, it did not find that 3M had “intended” a breach of contract and thereby conducted the clinical trials dishonestly.

3M has announced its intention to pursue charges in the US against the Porton Group for alleged attempts to “extort” an out-of-court settlement by threatening to use political influence.

While the arguments rage on, the question of whether BacLite has the potential to improve worldwide treatment of MRSA remains unresolved.

Bristol-Myers Squibb has entered into a strategic partnership with Singapore-based ASLAN Pharmaceuticals for the licensing and development of one of its investigational oncology compounds.

Under the agreement, ASLAN has the rights to develop and commercialise BMS-777607, a small molecule inhibitor of the MET receptor tyrosine kinase for treatment of solid tumours, in China, Australia, Korea, Taiwan and other selected Asian countries. BMS will retain rights for the rest of the world.

ASLAN will also complete and fund the development of the compound under a pre-agreed programme that will initially target gastric and lung cancers.

Francis Cuss, Senior Vice President, Research, BMS, says the agreement is part of the company’s “Oyster strategy” which aims to produce “high-quality data that may be used to further develop and commercialise the medicine worldwide”.

“As part of our biopharma strategy, Bristol-Myers Squibb seeks to seed companies in key markets with promising investigational medicines of continued interest to Bristol-Myers Squibb,” he said.

GlaxoSmithKline (GSK) has agreed to pay $3 billion to settle US criminal and civil investigations into whether the company illegally marketed drugs and other matters.

The investigations include a Department of Justice review of the UK company’s controversial diabetes drug Avandia, which has been linked to heart risks.

The settlement follows clampdowns since the late 1990s in the US on unfair pharmaceutical industry practices that may have prioritised sales targets over payer and patient interests, such as marketing drugs for unapproved uses.

Andrew Witty, CEO of GSK, said: “This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today.

“In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity.”

Mr Witty said that the company has put in place a new bonus system for US sales, which no longer focuses on individual sales goals, but is now based on selling competency, customer evaluations and overall performance of the sale representative’s business unit.

Federal prosecutors began investigating GSK in 2004, into whether the company promoted drugs for unapproved indications, and into cases where the company may have potentially influenced doctors.

The inquiry involved nine of the company’s best-selling products from 1997 to 2004, including lung therapy Advair.

Gbola Amusa, an analyst at UBS AG in London, said: “This news essentially draws a line under a 10-year legal saga.”

Both civil and criminal settlements are expected to be finalised in 2012.

ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

Pfizer has agreed to pay $14.5 million for illegally marketing overactive bladder drug Detrol, for males with benign prostatic hypertrophy.

The settlement resolves the last of ten whistleblower suits that were filed by the government against Pfizer, under which the company agreed to pay $2.3 billion dollars to resolve multiple civil claims and criminal charges.

Carmen Ortiz, US Attorney for the District of Massachusetts, said: “We hope and expect that this is indicative of a commitment to move forward in compliance with the law, and we will continue to watch vigilantly to ensure that Pfizer complies with the law in its sales and marketing of drugs sold to the public.”

It was filed that the company illegally marketed Detrol for treatments not approved by the FDA, marketing it for use in men suffering from benign prostatic hypertrophy and several allied conditions, including lower urinary tract symptoms and bladder outlet obstruction.

Tony West, Assistant Attorney General of the Justice Department's Civil Division, said: “Whistleblowers play an important role in protecting taxpayer funds from fraud and abuse.”

The $14.5 million fine will be divided between the US and participating state Medicaid programs, with nearly $12 million going to the federal government and $2.5 million going to state Medicaid programmes.

“Settlements like this one help maintain the integrity of FDA's drug approval process and support important federal and state health care programs,” added Mr West.

This settlement is part of the government scheme to combat healthcare fraud through the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was established in May 2009.

Bristol-Myers Squibb and Gilead Sciences have signed a licensing agreement to develop and commercialise a potential fixed-dose combination single pill for the treatment of HIV.

The combination would include BMS’ protease inhibitor Reyataz (atazanavir sulfate) and Gilead’s pharmacoenhancing agent cobicistat.

Elliott Sigal, Executive Vice President, Chief Scientific Officer and President, R&D, BMS, says the pill has the potential “simplify HIV therapy” and address unmet needs for innovative treatment options.

The combination is currently being studied in Phase II and Phase III studies in HIV-1 treatment-naive patients.

Reyataz is a prescription medicine used in combination with other medicines to treat people aged 6 years of age and older who are infected with HIV. Gilead’s cobicistat is a boosting agent that increases blood levels of certain strains of the virus.

Under the terms of the agreement, BMS will be responsible for the worldwide formulation, manufacturing, development, registration, distribution, and commercialisation. It will pay Gilead an undisclosed royalty based on the annual net sales of the product when released.

“This collaboration with Gilead builds on Bristol-Myers Squibb’s longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options,” said Mr Sigal.

Gilead will retain the sole rights for the manufacturing, development and commercialisation of cobicistat as a stand-alone product and for any future combinations with other agents.

SomaLogic has entered into a research agreement with Novartis to use its proprietary proteomics technology to help develop Novartis’ drug discovery.

“We are excited by this opportunity to work with Novartis' world-class researchers to help them define robust biomarkers, validate novel drug targets, and even develop companion clinical diagnostics,” said Larry Gold, CEO of SomaLogic.

“"We believe that our technology is uniquely able to address the significant drug discovery and development challenges currently faced by biopharmaceutical companies.”

Terms of the agreement were not disclosed.

SomaLogic develops biomarker discovery and clinical diagnostics and is based in Boulder, Colorado.