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.

In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk.

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.

Draft NICE guidance does not recommend the routine use of AstraZeneca’s anti-oestrogen drug Faslodex (fulvestrant) in the NHS to treat certain types of breast cancer.

Faslodex was authorised in 2010 for marketing as an alternative to aromatase inhibitors to delay the growth of oestrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women who have already received anti-oestrogen therapy (such as tamoxifen).

NICE’s Independent Advisory Committee has concluded that the drug is not significantly more effective than existing treatments, and so its routine use would not be a good use of resources.

The Committee judged AstraZeneca’s claim that Faslodex could extend life relative to the aromatase inhibitors anastrozole and letrozole to be uncertain as network meta-analyses showed no statistically significant differences.

In addition, they found that Faslodex delayed cancer growth more effectively than anastrozole but not more so than letrozole. An incremental cost effectiveness ratio of £35,000 per QALY gained for Faslodex 500mg compared with anastrozole was estimated, but with “considerable uncertainty”.

The draft guidance thus recommends that NHS doctors should not prescribe Faslodex as an alternative to aromatase inhibitors in relevant cases – but that women who are currently receiving Faslodex should be able to continue to do so until they and their doctors decide to stop.

Sir Andrew Dillon, Chief Executive of NICE, commented: “While there is evidence that fulvestrant can delay the growth of breast cancer, our independent committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS.

“As fulvestrant has not been proven to be cost-effective, we cannot justify diverting NHS funds from other areas of healthcare in order to fund its use.”

The draft guidance is open to appeal until 24 November. NICE hopes to publish final guidance in January 2012.

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.

The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.

Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.

Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.

The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.

Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.

The products are expected to be launched for sale in early 2012.

Between 1,000 and 1,500 jobs are expected to be lost at Teva Pharmaceutical Industries as part of the company’s cost-cutting measures.

Reports from Israel claim the majority of the layoffs will be made in the US and Europe and mainly focused in Teva’s recently acquired Cephalon’s generic business.

The reports say that Teva is hoping to raise $500 million in synergies from its takeover with job losses expected to raise the majority of its target.

Teva has already said it is planning to cut sales, marketing and administrative expenses by $300 million, R&D by between $120 million and $150 million, and production costs by $50 million to $80 million. R&D savings would be achieved by cutting duplicate operations, the company said.

Teva has a history of job losses following takeovers of generic companies. In 2008 it bought US generic specialist Barr and reduced its workforce by 10%, reports say.

A reduction of 1,000 jobs at Cephalon would represent a loss of 27% roles before the takeover. But one company where job losses will be made, the reports say, is at Mepha, the Swiss generics manufacturer Cephalon bought last year. The company had 620 jobs prior to the acquisition.

Novartis has appointed Dr Timothy Wright as its new Global Head of Development.

Dr Wright joined the pharmaceutical company in 2004 and most recently served as Senior Vice President and Global Head of Translational Sciences at Novartis Institutes for BioMedical Research (NIBR).

His previous positions include exploratory therapy area leader for Inflammation at Pfizer and chief of the Division of Rheumatology and Clinical Immunology at the University of Pittsburgh.

 

The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.