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.

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.

Takeda Pharmaceutical Company has created several new positions as part of its “Transformation into a New Takeda”, restructuring the company’s business operations.

The new roles include Chief Medical and Scientific Officer (CMSO) and Chief Commercial Officer (CCO).

The CMSO is set to replace the existing post of Chief Scientific Officer, to be filled by board member Dr Tadataka Yamada, a medical doctor and scientist with strong experience in pharmaceutical R&D.

The CCO will be responsible for the company’s global sales structure, replacing existing positions in International Operations in the US, Europe and North Asia.

Takeda’s Chief Executive Dr Frank Morich will claim this position, who will lead sales strategies in the US, EU and key emerging markets.

The restructuring of the company is said to relect Takeda’s recent acquisition of Nycomed, which the firm described as “another significant step towards globalisation”.

Takeda fully acquired Nycomed in October in a cash deal worth €9.6 million.

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.

Sanofi is expected to overthrow Pfizer’s nine-year reign as the world’s biggest drug maker, according to new research.

The French pharmaceutical company is expected to retain the top spot until at least 2016, with Pfizer falling to third place behind Novartis due to the loss of Lipitor’s US patent protection, according to EvaluatePharma (see figure one).

The report says that Sanofi’s numerous acquisitions over the last decade have contributed largely to the company’s success, gaining $20 billion after it bought out Genzyme.

Sanofi’s mergers over the last decade have contributed a great deal to its current position, starting with its $30 billion deal with Synthélabo in 1999.

It is expected that the company will retain its top position until at least 2016, mainly thanks to sales of enzyme replacement therapies through its acquisition of Genzyme.

Also, the company’s addition of Cerezyme and Myozyme blockbuster drugs will help fill the gap left by Lovenox, Taxotere, and Plavix, which loses US patent protection in 2012.

Pfizer’s $68 billion buyout of Wyeth in 2009 helped fill the gap left by Lipitor, but it will be difficult to replace the drug’s global sales figure of $13.4 billion seen in 2008, which set the record as the biggest selling medicine.

Following its loss of US patent protection in November 2011, Lipitor sales are estimated to shrink to $2 billion by 2016.

However, pipeline products such as rheumatoid arthritis (RA) pills tofacitinib and Eliquis are expected to boost Pfizer’s drug sales after 2016, which will help retain the company’s position in the top-five pharmaceutical companies.

Merck’s four-year outlook is seen as bleak despite its takeover of Schering-Plough for $41 billion in 2009, with only 1% annual sales growth predicted, conceding to European companies GlaxoSmithKline and Roche to overtake the company.

EvaluatePharma predicts that Johnson & Johnson’s recent pipeline successes will benefit the company in the coming years, despite its drugs arm being substantially smaller than the five biggest pharma companies.

It is thought that Novartis will be Sanofi’s closest competition over the next few years, with strong sales growth from Gilenya and Tasigna due to Diovan’s loss of patent protection next year.

Figure 1:

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.

GSK has been fined three billion South Korean won ($2.6 million) for conspiring with Dong-A Pharmaceutical over drugs sales, a Fair Trade Commission (FTC) official has said.

The FTC claims that GSK offered Dong-A the exclusive rights to sell the products Zofran (pictured)and Valtrex in 2000.

But in return, the FTC says, if the Seoul-based pharmaceutical company pulled a generic version of Zofran it introduced in 1998 or ever produce or sell medication that could compete against Zofran and Valtrex.

Kim Jun-Ha, a FTC official involved in the case, says the two “shared benefits” which should have gone to consumers after GSK made wrongful gains of around 16 billion won.

“With the cheaper generics made by Dong-A taken off the market, the financial burden on patients and on the government's health insurance budget has increased,” Kim said.

GSK's South Korean unit says the decision is “very regrettable” and “inappropriate” and will appeal against the decision.

“We simply exercised our legitimate patent rights,” a statement said.

The anti-trust agency also fined Dong-A Pharmaceutical $2.1 billion won for its part in the collusion, it added.

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.

Scottish medtech company Aircraft Medical has signed an exclusive INTERNATIONAL distribution agreement with global healthcare supplier Covidien.

Covidien will market and distribute Aircraft’s McGRATH MAC video laryngoscope (pictured) in the UK, the US, Japan, Latin America, Australia and New Zealand.

The new agreement complements Aircraft Medical’s existing distribution agreements in 35 countries, and will see the number of specialist sales and marketing professionals selling the McGRATH laryngoscope worldwide rise above 500.

Launched in October 2010, the portable McGRATH MAC – a development of the award-winning McGRATH design – is the first low-cost video laryngoscope designed to assist both routine and difficult airway intubation in hospitals.

In the US, the majority of the estimated 17 million intubations carried out each year are performed with Covidien products – opening a major market opportunity for the McGRATH MAC.

About 50 million intubation procedures take place globally each year, and that figure is predicted to rise by 5% per year.

“This agreement with Covidien is a significant step forward in the global rollout of the McGRATH MAC video laryngoscope,” said Matt McGrath, CEO of Aircraft Medical. “We expect to now further strengthen our position in the growing video laryngoscope market.”

James E. Willett, General Manager, Respiratory and Monitoring Solutions at Covidien, commented: “Our partnership with Aircraft Medical demonstrates our commitment to deliver clinical value and improve patient outcomes in fast-growing critical-care markets throughout the world.

“By integrating the McGRATH MAC video laryngoscope into our respiratory product portfolio, Covidien can provide critical-care practitioners with a complete intubation solution to meet the needs of the continuum of patients.”

Aircraft Medical, based in Edinburgh, specialises in video laryngoscopes.

Covidien, based in Dublin, is a leading global provider of healthcare products whose 2010 revenue was $10.4 billion.