Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, announced the initiation of a Phase 1 clinical study to assess the safety, dosimetry and tolerability of LMI1195, a novel F-18 small molecule tracer for imaging cardiac neuronal function, in healthy subjects, undergoing positron emission tomography (PET) imaging.

Heart failure is a serious medical condition, in which the heart muscle progressively loses its ability to pump blood, that affects more than five million people in the United States and results in about 1.1 million hospitalizations and 300,000 deaths each year.1,2 Patients with heart failure are six to nine times more likely than the general population3 to suffer sudden cardiac death as a result of abnormal cardiac neuronal function resulting in a fatal arrhythmia. According to the American Heart Association, the total cost of heart failure is estimated to be $37.2 billion in 2009, putting very significant health and financial burdens on patients, their families and society as a whole.

“Given the high incidence of heart failure and associated deaths, there is a significant need to develop new diagnostic tools to help clinicians improve risk stratification and better identify heart failure patients at risk of arrhythmia and sudden cardiac death who might benefit from direct interventional therapy,” said D. Scott Edwards, vice president, global research & development, Lantheus Medical Imaging, Inc. “We look forward to the Phase 1 trial results and advancing the LMI1195 clinical development program.”

The Phase 1 open-label, non-randomized, single-dose study will be conducted in the United States. The study is designed to estimate the radiation dosimetry of LMI1195 in healthy subjects undergoing a PET scan. The study will also evaluate the safety and tolerability of the tracer, gather pharmacokinetic and metabolic data, and assess PET imaging parameters and image quality.

“The initiation of this study represents an important milestone in our strategy to develop a rich pipeline of diagnostic products to advance patient care,” said Don Kiepert, president and chief executive officer of Lantheus Medical Imaging, Inc. “LMI1195 is our second pipeline product to enter clinical development that uses molecular imaging and PET technology to improve cardiovascular imaging. We’re excited about the promise of this imaging agent to change how heart failure patients are evaluated.”

References

1. National Heart Lung and Blood Institute, Heart Failure Fact Sheet 2007.
2. American Heart Association, http://www.americanheart.mediaroom.com
3. American Heart Association. Heart Disease and Stoke Statistics, 2009 Update.

Source
Lantheus Medical Imaging, Inc.

The importance of pharmacy assistants to the pharmacy profession is being recognized
in special weekend presentations for assistants at the Pharmacy Australia Congress in
Sydney this year.

Pharmacy assistants outnumber pharmacists by a ratio of more than five-to-one and it is
estimated there are currently more than 27,000 pharmacy assistants working across the
nation.

The President of the Pharmaceutical Society of Australia, Warwick Plunkett, said the
value and importance that pharmacy assistants played could not be over-stated.

“These assistants are often the first person that a consumer meets when they come into
a pharmacy to ask for advice,” Mr Plunkett said.
“Their role is a critical part of the profession of pharmacy and their knowledge and skills
are essential to the health and wellbeing of Australians.

“In recognition of this, PAC is running two mornings of presentations developed
specifically for pharmacy assistants.”

The PAC09 Pharmacy Assistants Program runs from 9.30am on both Saturday 17
October and Sunday 18 October.

Topics to be covered include:

- coping with the complexities of quit smoking strategies
- selling sun protection for the fashion conscious customer
- increasing confidence in the baby care business
- effective over the counter treatments for urinary tract infections
- winning the battle against brittle bones
- hayfever - how to help with the very latest treatments.

As an added incentive for pharmacy assistants, the presentations are free of charge if
the pharmacy assistant is a staff member of full delegates to PAC.

The presentations are among the highlights of PAC09, the pre-eminent pharmacy event
of the year being held at the Sydney Hilton from 15-18 October under the primary theme
of Securing Your Practice Advantage.

Full details of PAC and the Pharmacy Assistants Program can be found at
http://www.pac2009.com.au.

Source
Pharmaceutical Society of Australia

A survey of attitudes among leaders of UK-based pharmaceutical companies shows how important it is that plans to improve Britain’s environment for medicines research are turned into reality.

Research conducted by the Association of the British Pharmaceutical Industry (ABPI) and the CBI shows that three-quarters of UK-based companies do not see the UK as an attractive place to do business when viewed in a global context, and policy and regulations are seen as inappropriate for the modern pharmaceutical industry.

But the blueprint of the Office of Life Sciences (OLS) is a sign of change of attitude towards the industry - although the plans that have been announced must be turned into delivery.

Some 43 per cent of companies expect the OLS plans to have an impact even over the comparatively short timespan of a year, according to the survey, which included more than half of the ABPI’s membership - nearly 50 companies.

ABPI President Chris Brinsmead said: “Companies’ attitudes reflect today’s realities, with a significant proportion of the industry believing the OLS will make an impact on the environment in the future. The survey shows a marked increase in confidence over last year’s survey but highlights that there are still major concerns over the UK environment for medicines development, needing plans to improve the situation.

Other key points that emerged from the survey, conducted by research company ComRes, include:
- The two most important steps the government could take to improve the business and marketing environment are reducing the time it takes for patients to gain access to modern medicines (83 per cent believe it is “very important”) and rewarding innovation (80 per cent).
- Some 37 per cent of companies are planning to change their business model for discovering and developing medicines - indeed, many have already done this.

- Almost 40 per cent of companies believe the UK-based industry is well placed to weather the recession.

- More than three-quarters (78 per cent) of those surveyed are planning to change how they work with the NHS.

Richard Lambert, Director-General of the CBI, said: “The pharmaceutical industry is a real UK success story and will be critical to our recovery from this recession. The industry underpins over 250,000 jobs and drives a quarter of all R&D investment.

“Unfortunately this survey reveals some real concerns about the UK’s regulatory climate, and it is worrying that so many pharma companies do not rate the UK against its international competitors. The industry must get better support in the UK to help it continue to invest and innovate.”

ABPI Director General Dr Richard Barker added: The OLS blueprint, on which many of us have worked hard, is still just that - a blueprint. Construction of the new environment on the basis of that document must now be the priority.”

Note

ComRes surveyed 47 general managers or managing directors of ABPI member companies through an online questionnaire between August 1 and September 9, 2009. Full tables can be found at http://www.comres.co.uk

Source
British Pharmaceutical Industry