In a deal signed with US-based Proteus Biomedical, Lloydspharmacy will offer drugs containing edible microchips that transmit a signal to a disposable monitoring patch attached to the patient’s skin. The signals transmitted from the microchip will monitor the use of the drug, sleep patterns, heart rate and body posture, allowing the patient and carer to monitor the progress made through a computer or mobile device.

The service, which will cost approximately £50 per month, is due to be launched in September 2012 and will initially consist of a placebo pill containing a soluble microchip, an adhesive patch and data support. Despite the positives of such a method, concerns have been raised regarding patient privacy and the possibility of a two-tiered provision of healthcare being created, as the UK’s National Health Service (NHS) will not pay for the package, leaving the patient to pick up the bill.

The programme is designed to meet a growing need for greater provision of patient medication, with some estimates suggesting that as many as half of patients do not take medications as prescribed, costing the NHS as much as £400m a year.

At the time of approval in August 2011, the regulator had seen one case of progressive multifocal leukoencephalopathy (PML) in a patient who had taken the drug, marketed by Seattle Genetics and Takeda Pharmaceutical. Since then, two more cases have been reported and the FDA is requiring a boxed warning – its strictest warning – to be placed on Adcetris’ label. The regulator has also warned that Adcetris should not be taken with cancer drug bleomycin due to increased risk of lung toxicity. Seattle Genetics must now conduct follow-up studies to confirm the safety of the treatment.

In 2011, Adcetris became the first drug to be approved by the FDA for the treatment of Hodgkins in 30 years. The drug also treats a rare disease known as systemic anaplastic large cell lymphoma.

Chief medical officer Thomas Reynolds said in a statement, “Although PML in lymphoma patients can be caused by factors such as underlying disease and prior therapies that affect the immune system, a contributory role of Adcetris cannot be excluded.”

Costing about £50 a month, medical experts said the new “intelligent medicines” could revolutionise the way patients take drugs, which will allow them to better follow doctors’ orders.

Figures from the World Health Organisation suggest that up to half of patients do not take their medications properly, potentially placing their health at risk.

The annual cost to the NHS of unused medication is estimated to be up £400 million.

According to the pill’s manufacturer, the “sensor” can monitor when drugs are taken, how much dosage should be administered while at the same time monitoring a patient’s heart rate and body temperature.

The partnership with IMS Health will give AstraZeneca access to pre-existing anonymised electronic health records, which include clinical outcome, economic and treatment pattern data. In addition, the companies will jointly develop a customised research and data analysis platform. The information will provide a deeper insight into how medicines that are already on the market are working in real-world settings across Europe, painting a picture of unmet needs in the current standard of care and treatment patterns across a number of therapeutic areas, with an emphasis on chronic illnesses. The data will also be used to inform AstraZeneca’s discovery and clinical development programmes.

Martin Mackay, AstraZeneca’s President of Research and Development, said: “Our collaboration with IMS is a key milestone in our commitment to understand the impact of our medicines in the real world, beyond what we see in controlled clinical trials. This insight will help us and healthcare decision-makers to improve the treatment of disease and ensure effective use of medicines to minimise the burden on individuals and healthcare budgets.”

Jon Resnick, IMS Health’s Vice President of Real-World Evidence Solutions, said: “This joint initiative reflects a shared perspective on the transformative power of real-world evidence on global health systems. Our unique information assets, coupled with our services and technology capabilities, make IMS a leading partner for healthcare organisations in the identification, integration and interpretation of real-world outcomes. We are extremely pleased to be working with AstraZeneca on this collaboration.”

The collaboration reflects the interest among healthcare decision-makers in examining the cost and effectiveness of new and existing medicines and health technologies to help allocate their increasingly limited resources more efficiently. Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information, patient registries and patient surveys. By evaluating the data associated with the delivery of care, ‘real-world’ analyses can demonstrate treatment impact on measurable outcomes such as hospital length of stay, readmissions, overall health status and total cost of care.

Today’s announcement builds on AstraZeneca’s existing ‘real-world’ data and research partnership with HealthCore in the US, the health outcomes research subsidiary of WellPoint.
The financial terms of the collaboration agreement are not disclosed.

The user fee proposal is one of three such agreements that the agency is submitting to Congress for approval by lawmakers. The agreements would each charge drug manufacturers application fees for reviewing traditional drugs, generic drugs and a new class of generic biotech drugs, respectively.

The FDA has used industry fees to hire extra staff to review regular prescription drugs since 1992. One of the proposals unveiled Friday extends that approach to generic drugs, which have long had slower review times.

Whereas most new drugs are reviewed in 10 months, the typical review time for a generic drug is 30 months. The FDA has a backlog of more than 2,000 generic drug applications awaiting review, according to the Generic Pharmaceutical Association.

The FDA proposes collecting $299 million in fees annually to hire additional generic drug reviewers starting in fiscal year 2013. That figure would come from an estimated 750 generic drug applications per year as well as other fees, including the inspection of foreign drug manufacturing sites. In return for these fees, the FDA will aim to review 90 percent of generic drug applications within 10 months.

“These agreements are important because they are a substantial resource that lets the agency carry out its mission of protecting patients and ensuring important products come to market in a timely way,” said Allan Coukell, director of the Pew Charitable Trusts’ health advocacy group. “For the first time we will also have funding directed at increasing FDA’s inspection of foreign manufacturing facilities.”

Another first-of-a-kind agreement would charge companies for the review of generic versions of biotech drugs, which are complex medicines that often contain proteins and living microorganisms.

Up until 2010, the FDA did not have authority to approve knock-off versions of biotech drugs, or biosimilars, which are produced using far more complicated manufacturing processes than traditional chemical drugs. But the Obama administration’s health reform law signed into law in March 2010 instructed the FDA to begin reviewing and approving biosimilars. The FDA is still drafting instructions on how companies should submit applications for biosimilars.

The FDA also sent Congress its proposal for the traditional prescription drug user fee program, which is expected to raise more than $712.8 million in fees annually over five years. Like the other agreements, the deal must be approved and drafted into law by Congress before Oct 1, 2012, to be in place for the government’s next fiscal year.

Lawmakers already have granted three 5-year extensions to the Prescription Drug User Fee Act, which has allowed the FDA to hire hundreds of additional scientists in return for meeting certain performance goals. Under the latest version of the agreement, the FDA would be tasked with providing more meetings and updates to companies that have submitted first-of-a-kind drugs for review.

Separate but similar talks between the FDA and medical device makers are dragging out over a number of disagreements. Those companies have made shorter review times a priority, though the FDA says that goal will require significantly more funding, according to minutes from closed-door meetings between regulators and company executives.

Xiaoming Yang, President of CNBG, said of the agreement: “CNBG has a great deal of expertise and energy to invest in this partnership. Not only is TB a public health crisis of the developing world, it is also a priority health issue here in China. We look forward to working with our counterparts at Aeras to develop new TB vaccines that will help stop tuberculosis in all corners of the world.”

Multiple research institutes operating under the umbrella of CNBG will engage with Aeras on a strategy focused on the joint development, manufacturing and distribution of affordable new TB vaccines for use globally. The agreement spans all aspects of TB vaccine development – from vaccine discovery to pre-clinical research to clinical research to manufacturing – and positions CNBG as a major emerging player in the TB vaccine field.

Bacille Calmette-Guerin (BCG), the only currently-licensed TB vaccine, does not prevent pulmonary TB, the most common form of the disease. As part of this collaboration, Aeras will license its recombinant BCG (rBCG) platform – which aims to improve upon the current TB vaccine – and other technologies to CNBG. The groups will jointly develop novel TB vaccines using the rBCG platform and other technologies provided by Aeras or CNBG’s research institutes. A variety of candidate booster vaccines will be engineered to match the new constructs with a goal to create more efficacious and longer-lasting protection against TB disease.

A keystone of this broad collaboration is the implementation of joint product development teams to develop and execute comprehensive plans for both the research and clinical development of TB vaccines and the design, construction and validation of a vaccine process development and manufacturing facility in China, which will receive financial support and technical expertise provided by Aeras.

“The synergy created by bringing together our scientific and manufacturing expertise could have a substantial impact on efforts to advance innovative candidates in TB vaccine development,” said Jim Connolly, President and CEO of Aeras. “We look forward to working with the largest biotech corporation in a country with the skills, resources and TB disease burden to play a major role in overcoming the complex challenges of TB vaccine R&D.”

TB is a major public health priority in China, where there are more than one million new TB cases every year. Globally, the TB epidemic is responsible for the deaths of 1.4 million people annually.

About AerasAeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective TB vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. Aeras utilizes its broad capabilities and technologies in collaboration with numerous partners and stakeholders to support the development of vaccines and other biopharmaceuticals to address TB and other significant public health needs of underserved populations. Aeras has invented or supported the development of six TB vaccine candidates to date, five of which are currently undergoing Phase I and Phase II clinical testing in Africa, Asia and North America. Aeras receives funding from the Bill & Melinda Gates Foundation, other private foundations and various governments. Aeras is based in Rockville, Maryland, USA – where it operates a state-of-the-art manufacturing and laboratory facility – and Cape Town, South Africa.

About CNBG CNBG (www.cnbg.com.cn) is a company limited by shares, the controlling shareholder of which is China’s National Pharmaceutical Corporation (Sinopharm). CNBG has 10 subsidiaries and is the largest biotech corporation in China engaged in the research and development, manufacturing and marketing of biological products. CNBG manufactures more than 200 kinds of biological products (with approximately 100 GMP product lines) for prophylactic, therapeutic and diagnostic use, including all the vaccines in China’s EPI programme, and maintains an 80% share of the public sector in China. In 2010, the annual output of CNBG reached 730 million doses, and it maintains one of the broadest portfolios of vaccine products in the world.

The case was filed by a whistleblower, however the state of Texas joined and now more US states are launching federal cases, accusing Johnson & Johnson of illegal marketing practices.

Johnson & Johnson are alleged to have exaggerated the safety of the drug and made kickbacks in order to boost the drug’s reputation over its competitors, influencing the nation’s Medicaid program to select it for use to treat schizophrenia and bipolar disorder.

The company has vehemently denied the claims and has said it will defend itself against the lawsuit.

A jury was selected on Monday 9 January, and opening statements are due to be made to the courtroom in Austin, Texas today, with the case expected to last at least two weeks.

Whistleblower Allen Jones, formerly of the Office of Inspector General in Pennsylvania, US, originally filed the lawsuit in 2004. He alleges to have uncovered Johnson & Johnson’s actions in Texas while investigating similar claims in Pennsylvania.

Previous cases have been ruled against the pharmaceutical major, with a jury finding Johnson & Johnson guilty of violating Louisiana’s Medicaid Fraud Act in 2010, followed by a South Carolina judge ruling that the company must pay a $327m civil penalty in 2011.

US-based Bristol-Myers Squibb will pay $26 per share, representing a 163% premium over its closing price on 6 January, and the Inhibitex board of directors has approved of the deal.

Other shareholders, holding 17% of the company’s common stock, have also entered into agreements with Bristol-Myers Squibb in order to support the merger.

Inhibitex’s lead compound, INX-189, is an oral nucleotide polymerase inhibitor currently in Phase II development, having demonstrated high levels of antiviral activity.

The company also has its FV-100 nucleoside inhibitor, used to reduce pain associated with shingles, in a Phase II trial, and humanised monoclonal antibody Aurexis, which is used to treat Staphylococcus aureus bloodstream infections.

The market for hepatitis C treatments is considered a large growth area, with Gilead Sciences in particular making a strong movement into the area with its $11bn acquisition of Pharmasset in November 2011.

Bristol-Myers Squibb chief executive Lamberto Andreotti said: “There is significant unmet medical need in hepatitis C. This acquisition represents an important investment in the long-term growth of the company.”

Last week, Bristol-Myers Squibb was named as the ‘Best Big Drug Company of 2011′ by business magazine Forbes following a year that saw the company’s share price rise 32%.

The Phase 1 study showed that CVT-301 achieved sufficient plasma levels of L-dopa through inhaled delivery to the lung, resulting in a pharmacokinetic profile that supports its therapeutic potential. Immediate absorption and dose proportional pharmacokinetics were seen across all doses tested. In addition, all doses tested of CVT-301 were safe and well tolerated. Civitas plans to present comprehensive data from the Phase 1 study at a future scientific meeting.

“Due to the unpredictability of oral L-dopa, the therapeutic rationale for using inhaled L-dopa to manage motor fluctuations in Parkinson’s disease was intuitive but until now was technically impractical,” said Dr. Martin Freed, Chief Medical Officer and co-founder of Civitas. “The Phase 1 data demonstrate the transformative potential of CVT-301 to enable patients to better manage their motor symptoms in light of the extensive clinical experience correlating L-dopa plasma levels to symptomatic relief documented over the past 40 years.”

This Phase 1 study in healthy volunteers evaluated the safety, tolerability and L-dopa pharmacokinetic profile across a range of doses of CVT-301 delivered using Civitas’ proprietary, simple handheld breath-actuated inhaler. By delivering L-dopa through the pulmonary route, CVT-301 is being evaluated as an intermittent adjunct therapy with the potential to produce rapid, consistent and durable relief from debilitating motor fluctuations associated with Parkinson’s disease.

“As expected, the tolerability of CVT-301 and L-dopa pharmacokinetic profile behaved consistently with the other molecules we have taken into the clinic over the last decade with the ARCUS(TM) platform,” said Dr. Richard Batycky, Chief Scientific Officer and co-founder of Civitas. “Our technology’s proven unique ability to deliver a large precise dose with an immediate onset should enable Parkinson’s patients to abort ‘off’ episodes and thereby helping to avoid debilitating disruptions in their lives.”

“I am encouraged to see that CVT-301 appeared to be so well tolerated and safe in this initial study. By essentially eliminating the significant absorption lag time associated with oral L-dopa, and by predictably delivering clinically relevant plasma levels, this data provides a very favorable and unprecedented profile for a self-administered L-dopa therapy,” said Dr. Karl Kieburtz, the Robert J. Joynt Professor of Neurology, University of Rochester, and a member of the Civitas Scientific Advisory Board.

This Phase 1 study of CVT-301 was funded in part by a grant from The Michael J. Fox Foundation for Parkinson’s Research.

About CVT-301

Civitas’ lead program, CVT-301, is an inhaled formulation of L-dopa for the immediate relief from debilitating motor fluctuations associated with Parkinson’s disease. For symptomatic relief, oral L-dopa is administered to maintain dopamine levels in the brain above the therapeutic threshold; yet the efficacy of oral L-dopa is significantly compromised by delayed absorption and excessive variability in the circulating plasma drug concentrations inherent to the oral delivery route. CVT-301 is an ARCUS(TM) therapeutic that incorporates L-dopa and is optimized to deliver a precise dose to the deep lung for rapid and predictable L-dopa absorption. The ARCUS(TM) platform is uniquely able to deliver the necessary L-dopa dose with the required precision. CVT-301 is being developed as an adjunct to standard oral L-dopa therapy to enable patients to manage motor fluctuations caused in part by the inter-dose variability of oral L-dopa. In preclinical models, CVT-301 has demonstrated immediate and consistent increases in L-dopa peak plasma concentration providing rapid, durable symptomatic relief, even when compared to larger doses of oral L-dopa.

About Parkinson’s Disease

Over one million people in the US suffer from Parkinson’s disease, a neurodegenerative disorder caused by the diminished production of dopamine, a key neurotransmitter, resulting in progressive impairment of motor function including tremors, rigidity and difficulty in moving. Even when treated with the current standard of care, the majority of Parkinson’s patients continue to experience motor fluctuations. These motor fluctuations reduce patients’ ability to lead productive, independent lives and are recognized by patients, care givers and healthcare professionals as one of the most troubling and debilitating issues associated with the disease.

About ARCUS(TM) Platform

The ARCUS(TM) inhalation technology delivers a reliable and consistent drug dose with a compact, breath actuated inhaler. The ARCUS(TM) platform uses a proprietary dry powder and inhaler combination that is unique in its ability to deliver a large, precise dose independent of inspiratory flow rate from a simple, easy-to-use device suitable for convenient self-administration. The platform has successfully delivered more than one million doses to patients incorporating active agents ranging from small molecules to large proteins, and has been scaled up to accommodate a commercial product launch.

About Civitas Therapeutics

Civitas is a privately-held pharmaceutical company focused on developing a robust pipeline of inhaled therapeutics with the clinically proven ARCUS(TM) dry powder pulmonary delivery platform. The company’s lead program is for Parkinson’s disease with clinical proof of concept anticipated to be complete in 2012. Additional programs encompass respiratory disease, central nervous system disorders, and infectious disease. Civitas exclusively licensed and purchased the technology and assets underlying the ARCUS(TM) platform from Alkermes plc, including a large intellectual property estate, a set of development stage pipeline assets, specialized equipment for respiratory products and the commercial scale GMP manufacturing facility. Civitas was launched at the beginning of 2011 with Canaan Partners, Fountain Healthcare Partners, Longitude Capital, and Alkermes as investors.

Although the fine detail of the agreement is yet to be written, and depends entirely on the US Food and Drug Administration approving MoxDuo for the market in late June, QRxPharma has received a non-refundable $6 million upfront fee as downpayment by Actavis.
The shares were recently trading 13 cents higher at $1.32, having hit a high of $1.375.

Actavis’ North American chief, Doug Boothe, said that if the FDA approval comes through as expected on June 25, his group aims to have MoxDuo on the market by the third quarter of 2012.

Once Actavis has recovered initial marketing and launch costs, expected to be in early 2013, QRxPharma will be entitled to a 50 per cent royalty on the first $US150 million of the drug’s sales.

Once that $US75 million has been received, QRxPharma’s share of sales slides back to a scale of between 10 per cent and 30 per cent, depending on MoxDuo achieving certain milestones.

The Australian group also has the right to establish its own sales force to work with Actavis in promoting the drug among US doctors who right more than 200 million prescriptions a year for acute pain drugs.

QRxPharma chief John Holaday told a briefing this morning that the company had fewer hurdles to jump with the FDA because MoxDuo is constructed from a 3 to 2 ratio of morphine and oxycodone — two pain management drugs with long histories of safety and performance.

The selling point for MoxDuo is hoped to be that the company’s patented combination drug reduces unwanted effects from the separate uses of morphine and oxycodone.