Surge in profits at Merck

by diana 28. April 2011 16:55

Dr Karl-Ludwig Kley Profits were up 77% in the first quarter of 2011 at the Merck Group and total revenues increased a fifth to €2.5 billion in Q1, mainly due to the acquisition of the Millipore Corporation in the US.

Sales of Erbitux (€209 million), Gonal-f (€113 million), Concor (€95 million), Glucophage (€81 million) and Euthyrox (€46 million) were all up as free cash flow totalled €645 million.

Dr Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, says the Group “generated a solid performance” in Q1 and it was “off to a very good start” to the year.

Acquisitions and divestments accounted for 16% percent of the increase of revenue while positive currency effects and increased sales also boosted results.

The gross margin in the first quarter improved by 19% to €1.9 billion, compared to €1.6 million a year ago, after the cost of sales increased by almost a third (31%).

Driven by the strength of the Group’s Performance Materials and Merck Millipore divisions, investment in R&D increased by 9.3% to €380 million. A further €4.2 million was also spent on repairs to a Merck facility in Japan damaged during the March 11th earthquake.

“We continue to expect the increase in the Group’s 2011 operating result will remain as stated on February 21st, namely 35% to 45%,” said Dr Kley.

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News

US-approved pain drug reduces ulcer risk

by diana 28. April 2011 16:47

The FDA has approved Horizon Pharma’s Duexis, a new treatment for osteoarthritis and rheumatoid arthritis patients who are at risk for upper gastrointestinal ulcers.

The treatment contains a fixed-dose combination of ibuprofen and famotidine and has been proven to cause fewer upper gastrointestinal ulcers compared to ibuprofen alone.

Timothy P. Walbert, Chairman, President and CEO of Horizon Pharma, commented: “The approval of Duexis is a transformative event for Horizon Pharma, representing our first US approval. We would like to thank the patients and clinical investigators who participated in the pivotal REDUCE-1 and REDUCE-2 trials.”

The REDUCE-1 and REDUCE-2 trials studied more than 1,500 patients with mild-to-moderate pain or arthritis. In REDUCE-1, just 8.7% of patients treated with Duexis developed a gastric ulcer, compared to 17.6% of those who received ibuprofen alone. The comparison was 10.5% versus 20.0% in REDUCE-2, also in Duexis’ favour.

Michael Schiff, MD, Clinical Professor of Medicine at the University of Colorado School of Medicine, Rheumatology Division, said: “In my view, Duexis will allow more people access to the benefits of ibuprofen, while reducing the significant GI risk associated with its use.”

Horizon Pharma is a biopharmaceutical company focused on developing medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases.

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News

Tax breaks help AZ

by diana 28. April 2011 15:56

david brennan Tax gains from the British and US tax authorities helped boost AstraZeneca’s profits in the first quarter of 2011.

Sales fell slightly below expectation by 3% to $8.29 billion but the Anglo-Swedish company paid less tax that budgeted after agreeing a £500 million deal last month for Q1.

The deal was made to help the company offset mounting pressure from generic competition on some of its best selling products.

David Brennan, CEO, AZ, says that Q1 revenue performance “reflects the anticipated generic competition in the US and Western Europe”.

AstraZeneca faces generic erosion of Arimidex for breast cancer, Pulmicort for asthma and heart drug Toprol XL. Patents are also set to expire on Nexium and Seroquel.

The company hopes that new heart drug Brilinta and strong sales of Crestor will combat lost sales, although Brilinta has yet to win approval in the US and sales of Crestor are expect to suffer when the US patent on Pfizer’s Lipitor expires in November.

“We remain focused on driving operating performance in order to invest in the development of innovative new products while providing attractive cash returns to shareholders,” said David Brennan.

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News

Growth expected by GSK after sales drop in Q1

by diana 28. April 2011 15:44

Andrew Witty Sales fell by 10% at GSK in Q1 of 2011, largely due to a £1 billion reduction in sales of its pandemic products Avandia and Valtrex.

Turnover for the quarter also declined 10% to £6,585 million after pharmaceutical turnover dropped 14% to £5,264 million.

Andrew Witty, Chief Executive, says the results are “in line” with expectations but backed GSK to make “significant progress during 2011”.

The company has focused its business around the delivery of three strategic priorities: to grow a diversified global business; deliver more products of value; and to simplify its operating model with the aim to increase growth, reduce risk and improve long-term financial performance.

The expected decline in sales of Avandia and Valtrex decreased from £1.1 billion in Q1 of last year to just £140 million compared to the same period in 2011. The decline has had a significant negative impact on pharmaceutical sales growth in all regions, the company says. But GSK expects the negative quarter-on-quarter negative impact to be lower in the future.

Excluding the sales performance of Avandia and Valtrex, underlying sales growth for the Group was up 4%. This was achieved despite the impact of the US Healthcare reform and European austerity, which GSK estimates cost the company a further £85 million in lost sales.

US pharmaceuticals (4%) and Europe pharmaceuticals (5%) sales were both down but the news was more positive as GSK saw Asia Pacific pharmaceuticals increase by 12% and in Emerging Markets by nearly a quarter (23%). Impressive sales were also recorded in Japan where an increase of 53% was led by Cervarix, the only HPV vaccine currently approved by regulators.

Other strong pharmaceutical performances in the quarter included Augmentin, up by 19%, Avodart, up by a fifth, and Lovaza, which recorded an increase of 21%.

Commenting on the results, Andrew Witty said: “I believe this first quarter performance is positive on many fronts, with good progress made in delivery of our strategy to improve long-term financial performance.”

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News

Single-pill Rasilamlo approved in Europe

by diana 28. April 2011 12:40

David Epstein Patients with high blood pressure in Europe are set to benefit after a new convenient single-pill treatment was approved by the European Commission.

Rasilamlo, a combination of aliskiren and amlodipine, has been given the green light for patients with high blood pressure not controlled by either aliskiren or amlodipine alone.

Professor Gordon McInnes, Professor of Clinical Pharmacology, Institute of Cardiovascular and Medical Sciences, University of Glasgow, says that research has shown an “innovative new single-pill” is needed.

It is estimated that around a billion people globally have high blood pressure with only an average of 8% of patients in the EU thought to have their condition under control.

The Novartis pills combines the only approved direct renin inhibitor in the world Rasilez with the widely used calcium channel blocker amlodipine.

It has been evaluated in clinical studies involving more than 5,000 patients with mild-to-severe high blood pressure. Data showed that Rasilamlo provides greater blood pressure reductions than Rasilez and amlodipine alone.

The single-pill combination works to lower blood pressure in two ways. The Rasilez component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. The calcium channel blocker amlodipine also lowers blood pressure by relaxing the blood vessel walls through the inhibition of calcium.

“We are pleased to announce that following today's EC approval Rasilamlo will now be available to high blood pressure patients in the EU who are not controlled by either aliskiren or amlodipine alone,” said David Epstein, Division Head of Novartis Pharmaceuticals (pictured). “This approval reinforces the Novartis commitment to developing new treatment options for patients with uncontrolled high blood pressure.”

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Customers come, customers go

by diana 28. April 2011 11:12

Industry insider Pf’s Industry Insider offers bereavement counselling on how to say goodbye to a valued customer, and nurture a new one.

Our customers can be very inconsiderate at times can’t they? We invest a huge amount of time visiting them, listening to them moan about their surgery partners and patients alike. We establish good relationships with them and if we’re lucky, manage to persuade them to prescribe a few scripts along the way. Then all of a sudden they’re gone, either through moving elsewhere, retirement, removal from the medical register for some form of misdemeanour or, heaven forbid, death. If they are good customers, and by Sod’s Law, they so often are, their disappearance from your territory can leave a gaping hole which needs filling with a like for like replacement ASAP.

Recently I have lost quite a few very good customers to retirement, doctors I have known for many years and customers I will genuinely miss visiting. Our job would be so easy if we were simply expected to manage the status quo in our respective accounts across our territories. But no, sales targets go up every quarter and the need to find new target customers is constantly with us.

The loss of any valued customers can be quite a poignant moment, but this sadness can be ameliorated when you hear, as I recently did, of a new Consultant appointment in one of my hospitals, especially as the person is someone I have known and nurtured since I first met him as a house officer around eight years ago. Whilst this person has moved around my territory and also further afield, I have always kept in touch and followed their career progression somewhat like a surrogate parent. I’ve shared the highs and lows of their good and bad interviews, exam passes/retakes, weeks of on-call and much more besides! Patience is a virtue and low and behold, 7-8 years on, said customer is now a Consultant and has reached the top of the medical greasy pole! I’ve shown my loyalty and I expect reciprocity, and in my experience, this generally happens.

What am I saying here? See the bigger, long-term picture. Today’s medical student, house officer or GP registrar is tomorrow’s Consultant or full blown GP partner in that surgery or hospital department you’ve never managed to get in to. Next time you are in a surgery or hospital out-patients department and there is a young fresh faced medic sitting in on the consultation, show an interest, ask who they are and where their medical interests lie. You never know when you may see them again and how they may be of use to you. Failure to nurture new medical talent in your accounts will make your job very difficult in years to come and I’ve always striven to widen my prescribing net regularly. I’m also motivated by more pressing, personal issues. This medical representative isn’t getting any younger and neither is my family and I want the best preferential medical treatment in years to come when I need it. That’s the return on my investment which really counts!

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Blogs

Call for GP blood tests to detect ovarian cancer

by Joel 27. April 2011 18:35

GPs should offer a blood test for earlier detection of ovarian cancer, according to new NICE guidelines for England and Wales.

The test, which measures a key tumour marker but is only about 50% reliable, is being recommended to improve the low survival rate of women with ovarian cancer in the UK.

About 7,000 women are diagnosed with the disease in the UK each year, but two-thirds die within five years.

The blood test measures a protein called cancer antigen 125 or CA 125, which is found in greater concentration in ovarian cancer cells than in other cells of the body. CA 125 can also be elevated by other conditions such as pregnancy and endometriosis.

The CA 125 test detects cancer only about half of the time. NICE argues that using it more frequently with women who present with relevant symptoms, alongside ultrasound scans (where necessary) and increased awareness of the symptoms, will improve the “disappointing” survival rate for ovarian cancer in the UK.

“This strategy won’t be the perfect answer, but we think it will make a measurable difference,” said Mr Charles Redman, a consultant gynaecological oncologist. “Trying to encourage women who might have ovarian cancer to present earlier will undoubtedly give the NHS challenges. But the current situation is very poor. Other countries do better than us.”

Frances Reid, Public Affairs Director for Target Ovarian Cancer, commented: “This guidance could save hundreds of lives. It is now imperative to include ovarian cancer in the Department of Health’s cancer awareness campaigns, so that women know to go and ask for these tests.”

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Medtech News

J&J to merge DePuy and Synthes

by Joel 27. April 2011 17:45

Johnson & Johnson (J&J) is to acquire Swiss orthopaedic device company Synthes and will merge it with DePuy to create a new global orthopaedics business.

Together, Synthes and the DePuy companies will comprise the largest business within the Medical Devices and Diagnostics segment of J&J.

J&J will acquire Synthes for $21.3 billion.

The acquisition follows a year in which DePuy Orthopaedics has been rocked by a major product recall, threats of litigation and a high-profile corruption scandal.

DePuy – including DePuy Orthopaedics and DePuy Spine – offers one of the industry’s most diverse portfolios of orthopaedic products. Synthes specialises in implants, biomaterials and instruments for the surgical fixation, correction and regeneration of the skeleton and associated soft tissues.

The combined company aims to provide a comprehensive portfolio of orthopaedic products and services that can address such market trends as the ageing population, increasing rates of obesity, and the movement towards early intervention.

DePuy and Synthes will combine their product pipelines and product development capabilities, as well as the potential for technology convergence across J&J. It will bring a broader portfolio of orthopaedic solutions to developed and emerging markets worldwide.

“DePuy and Synthes together will create the most innovative and comprehensive orthopaedics business in the world,” said Bill Weldon, Chairman and CEO of J&J. “Orthopaedics is a large and growing $37 billion global market and represents an important growth driver for Johnson & Johnson.”

Michel Orsinger, President and CEO of Synthes, commented: “Synthes and Johnson & Johnson are both respected as global leaders, and also have very similar company cultures. The combination presents a significant opportunity to jointly bring our products, services and educational offerings to the next level. Together, we will be a more attractive and exciting company for our employees, and a more resourceful partner for our customers.”

The transaction is expected to close in the first half of 2012, subject to regulatory and anti-trust clearance.

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Medtech News

WHO launches action plan for tackling killer diseases

by diana 27. April 2011 15:19

Dr Margaret Chan Noncommunicable diseases are the leading killer today and are on the increase, especially in lower income countries, a WHO report has shown.

The first WHO Global status report on noncommunicable diseases (NCDs) shows that 36.1 million people died from conditions such as heart disease, strokes, chronic lung diseases, cancers and diabetes in 2008. Nearly 80% of these deaths occurred in low- and middle-income countries.

Without action, the report predicts, the NCD epidemic will kill 52 million people annually by 2030.

WHO Director-General Dr Margaret Chan (pictured) said that the rise presents an “enormous challenge” and, for some countries, “an impending disaster”.

She added: “Chronic noncommunicable diseases deliver a two-punch blow to development. They cause billions of dollars in losses of national income, and they push millions of people below the poverty line, each and every year.”

The report was launched during the WHO Global Forum on addressing the challenge of noncommunicable diseases in Moscow.

The report includes advice for all countries and argues that deaths from these diseases can be prevented by improving access to healthcare and by implementing anti-tobacco controls, reducing alcohol use and promoting healthy lifestyles.

It represents a key component of the 2008-2013 Action Plan for the implementation of the WHO Global Strategy on the Prevention and Control of Noncommunicable Diseases, which provides guidelines for countries on taking action against NCDs.

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News

Photocure expands management team

by diana 27. April 2011 15:10

Photocure has expanded its management team with the appointment of Kathleen Deardorff as Chief Operating Officer.

In her new role, Kathleen will provide leadership for the company’s business development and alliance management/strategic partner relationship functions, as well as having involvement in strategy development and execution and corporate communications.

Kathleen has 25 years’ experience of the pharmaceutical industry and has held various senior leadership roles, including Head of Global Marketing at GE Healthcare and Vice President for Bristol-Myers Squibb’s US Oncology Franchise.

Kjetil Hestdal, President and CEO of Photocure, said: “We are delighted that Kathleen Deardorff has joined the Photocure team. Her knowledge of the business and industry across multiple geographies and high level of business acumen will further strengthen our team as we continue to execute our strategy of evolution into a specialty pharmaceutical company.”

Photocure is a Norwegian pharmaceutical company specialising in dermatology and cancer.

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