Ebola nurse back in hospital

by Amy Schofield 23. February 2016 11:05

Pauline Cafferkey, the nurse who has already battled Ebola twice, is back in hospital for a third time.

The Scottish nurse first contracted the virus in December 2014 while working with Ebola victims in Sierra Leone. She was flown back to the UK and spent almost a month in isolation at the Royal Free hospital in north London. Ms Cafferkey recovered after treatment with a survivor’s plasma and an experimental antiviral drug.

She again fell ill with Ebola in October 2015 and almost died from meningitis caused by the virus, an event described at the time as "unprecedented". She once again recovered and returned home to South Lanarkshire.  

It has now emerged that Ms Cafferkey, 39, has today been admitted to the infectious diseases unit at Glasgow’s Queen Elizabeth University hospital to be treated again.

An NHS Greater Glasgow and Clyde spokesman said: “Under routine monitoring by the infectious diseases unit, Pauline Cafferkey has been admitted to hospital for further investigations.”

There is currently no approved vaccine or treatment for Ebola. However, last month the Gavi alliance for vaccines and immunisation signed a $5m (£3.5m) deal with Merck to buy an Ebola vaccine currently under development. A clinical trial in Guinea, involving 4000 people who had been in close contact with an Ebola case, has shown that the vaccine offered complete protection after 10 days.

 

Image: Sierra Herald

Mylan acquires Sweden’s Meda in $9.9 billion deal

by Kevin 11. February 2016 09:25

Three months after failing in its bid to acquire Perrigo, Mylan has leapt on the merger merry-go-round again to buy Sweden's Meda.

The deal is valued at $9.9 billion, or $7.2 billion excluding debt and the 165 Swedish kroner paid represents a 92% premium. The offer has already been accepted by Meda's two largest shareholders, who own about 30% of its outstanding shares.

For its money, Mylan has now moved into the over-the-counter space and will have a $1 billion OTC business at close. It will also gain entry into new growth markets such as China, Southeast Asia, Russia and the Middle East.

The combined entity will have sales of $11.8 billion for 2015 and adjusted pretax earnings of approximately $3.8 billion. It will also have “a balanced portfolio of more than 2,000 products across the branded/specialty, generics and OTC segments, sold in more than 165 markets around the world”, Mylan added.

The transaction will build on Mylan's recent acquisition of Abbott’s non-US developed markets specialty and branded generics business “to create an unparalleled European platform for growth [and] consolidates the EpiPen Auto-Injector for allergic reactions in Europe, which until now has been partnered with Meda.

The deal also could create about $350 million in annual pretax synergies by the fourth year after closing.

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Pfizer inks research alliance with Breast Cancer Now

by Kevin 10. February 2016 14:21

Pfizer has signed up to an initiative established by Breast Cancer Now, giving researchers access to marketed and investigational drugs in its oncology portfolio that can be used to deliver new therapies more quickly.

The charity has unveiled its Breast Cancer Now Catalyst Programme, which hopes to add other pharmaceutical companies to a scheme aimed at stopping women dying from breast cancer by 2050. As well as being the first firm to sign up, Pfizer has also committed £10 million which Breast Cancer Now will use to award grants to the best proposals from independent researchers over the next three years.

Baroness Delyth Morgan, chief Executive at Breast Cancer Now, said: “In the last 20 years, we’ve made great progress in treating breast cancer, but progress has slowed, and 12,000 deaths a year in the UK from this disease is still too many.” She claimed the Catalyst Programme marks a “new era of collaboration and fresh thinking, focused on excellence and new discoveries”.

George Freeman, minister for life sciences, said the programme “places NHS patients at the heart of 21st century research collaboration and promises to bring innovative new treatments to patients as fast as possible”. He added that “the landscape of drug development and discovery is changing, and this incredibly exciting new initiative demonstrates exactly how the pharmaceutical industry, charities and researchers can work together to achieve life-changing breakthroughs”.

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FDA panel backs Celltrion biosimilar of Remicade

by Kevin 10. February 2016 10:19

Advisors to the US Food and Drug Administration have given their blessing to Celltrion and partner Pfizer's biosimilar of Johnson & Johnson’s blockbuster Remicade.

The agency’s Arthritis Advisory Committee recommended approval of all indications of Celltrion’s version of Remicade (infliximab) by a vote of 21-3. The drug, which will be marketed as Inflectra by Pfizer, is the first biosimilar monoclonal antibody (mAb) to be considered by the FDA (approval is expected in April) and will be available for a variety of serious autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis.

The Committee concluded that the Celltrion version is “highly similar” to Remicade, “notwithstanding minor differences in clinically inactive components”. It also noted that there were “no clinically meaningful differences…in terms of the safety, purity, and potency of the product” in the studied indications of RA and ankylosing spondylitis.

HyoungKi Kim, Celltrion’s chief executive, said “we have experienced the benefits of biosimilars outside of the USA, including Europe, and are looking forward to advancing our development programme with the FDA”. He added that we are in “an age where biosimilar mAbs are globally recognised as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable”.

Sumant Ramachandra, head of R&D at Pfizer’s Global Established Pharma unit, said “biosimilars represent an exciting opportunity to expand patient access to important treatments, and we are proud to be at the forefront of helping shape and prepare the US market for these therapies”.

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AstraZeneca’s Tagrisso gets EU okay for lung cancer

by Kevin 3. February 2016 14:23

AstraZeneca’s lung cancer therapy Tagrisso has got the thumbs-up in Europe, making it the first new medicine to be approved under the European Commission’s expedited process.

Tagrisso (osimertinib), an oral treatment, has been granted conditional marketing authorisation for the treatment of adults with locally advanced epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer. The approval is based on combined data from two Phase II trials where the objective response rate (a measurement of tumour shrinkage) was 66%, and progression-free survival was 9.7 months.

Sean Bohen, chief medical officer at AstraZeneca, said Tagrisso, which was approved in the USA in November, “defines a new generation of targeted EGFR-TKI treatments” and the European Commission’s expedited approval reflects the importance of this innovative medicine”. The company has previously predicted peak annual sales of $3 billion.

Matthew Peters, chair of the Global Lung Cancer Coalition, added that “it is an exciting time in the care of patients with lung cancer”. He said the ability to precisely characterise patients who have different types of the disease based on genetic mutations “and predict their response to targeted treatments offers a more accurate and efficient approach to lung cancer care”.

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Pfizer posts strong revenue rise helped by Hospira

by Kevin 3. February 2016 11:57

Pfizer has posted better-than-expected financials, helped by the contribution of injectables acquired through its $15 billion of Hospira last year.

Revenue rose 7% to $14.05 billion, boosted by $1.51 billion of injectables sold, though net income fell 50% to $613 million, due to production, administration and restructuring costs. Sales of the pneumonia jab Prevnar soared 43% to $1.87 billion, while the epilepsy and pain drug Lyrica (pregabalin) climbed 6% at $955 million.

The rheumatoid arthritis pill Xeljanz (tofacitinib) shot up 66% to $172 million, while sales of the erectile dysfunction therapy Viagra (sildenafil) remain firm, up 2% at $342 million. Pfizer’s new breast cancer drug Ibrance (palbociclib) generated $315 million, while Xalkori (crizotinib) for lung cancer rose 4% to $135 million.

"I believe that we are well positioned to deliver another strong year in 2016," Pfizer CEO Ian Read said. He added that ”the integration of Hospira is well under way and we now look forward to completing the [$160 billion] combination with Allergan, which we still expect to occur during the second half of this year”.

The company forecast $49 -$51 billion in revenues for 2016, below analyst estimates. However, Pfizer noted that it expects generic competition and the strong US dollar to shave $4.6 billion off sales.

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Zika declared global health emergency by WHO

by Kevin 2. February 2016 16:15

The World Health Organisation has declared the spread of microcephaly potentially caused by Zika a global public health emergency, putting the virus in the same category as Ebola.

The virus, which is transmitted by the Aedes mosquito, has been linked to an upsurge in cases of microcephaly, where babies are abnormally small brains. There have been around 4,000 reported cases of microcephaly in Brazil and WHO director-general Margaret Chan said these cases, “and other neurological disorders reported in Brazil, following a similar cluster in French Polynesia in 2014, constitutes an ‘extraordinary event’ and a public health threat to other parts of the world."

She added that “a coordinated international response is needed to minimise the threat in affected countries and reduce the risk of further international spread”. More than 20 countries have reported cases.

The WHO added that “appropriate R&D efforts should be intensified for Zika virus vaccines, therapeutics and diagnostics”.

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FDA approves Merck & Co’s Zepatier for hepatitis C

by Kevin 2. February 2016 09:33

The US Food and Drug Administration has given the green light to Merck & Co’s hepatitis C combination Zepatier for patients with genotype 1 and 4 infections.

The approval of Zepatier (elbasvir/grazoprevir) is based on data showing that the overall sustained virologic response (SVR) ranged from 94-97% in genotype 1-infected subjects and 97-100% for those with genotype 4. Merck says that the price will be $54,600 for a 12-week treatment regimen.

Zepatier joins a market currently dominated by Gilead’s Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) and featuring AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir) and Bristol-Myers Squibb’s Daklinza (daclatasvir). Some observers believe the increased competition will lead to insurers and other payers getting bigger discounts on these high-priced treatments.

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Six drugs recommended for European approval

by Admin 2. February 2016 09:28

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended six medicines - three new ones and three generics from Mylan - for marketing authorisation.

The CHMP has recommended Bristol-Myers Squibb’s Empliciti (elotuzumab) for the treatment of multiple myeloma. Empliciti, co-developed with AbbVie, is to be used in combination with lenalidomide and dexamethasone for the treatment of patients who have received at least one prior therapy.

The Committee also granted a positive opinion to Coagadex for the treatment of factor X deficiency. The therapy, developed by the UK’s Bio Products Laboratory, is for a rare inherited bleeding disorder.

The CHMP also backed Actelion’s Uptravi (selexipag) for the treatment of pulmonary arterial hypertension. The drug, which was approved in the USA in December, is expected to be a blockbuster.

There was also support for Mylan’s copies of Novartis’ Exforge (amlodipine/valsartan) for hypertension, Teva/Lundbeck’s Azilect (rasagiline) for Parkinson’s disease and Eisai’s seizure drug Zonegran (zonisamide).

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Pharma companies unite to demand action on superbugs

by Admin 27. January 2016 15:11

More than 80 of the world’s leading pharmaceuticals groups have come together to call on governments and industry to collaborate on tackling drug-resistant superbugs.

The Declaration on Combating Antimicrobial Resistance, unveiled at the World Economic Forum in Davos, sees companies commit to increasing investment in new antibiotics. In addition, they called on governments to support new commercial models that would increase incentives for R&D while discouraging overuse of antibiotics.

Paul Stoffels, chief scientific officer at Johnson & Johnson, said that “for the world to continue to have new antibiotics, we need investments in basic science and novel incentive models for industry R&D and to preserve existing treatments, we need new frameworks for appropriate use”.

Jim O’Neill, chairman of the UK government’s Review on Antimicrobial Resistance, said the declaration is “a major step forward in establishing a properly global response” to the problem. He added that “this is a level of consensus that we have not previously seen from the industry”.

Neil Murray, chief executive at the UK’s Redx Pharma, said: "There is a doomsday clock ticking, with the effectiveness of antibiotics diminishing at an alarming rate. New ways must be found to support innovation and drug discovery in this critical area."

World Health Organisation director-general Margaret Chan added that antimicrobial resistance “is beyond the capacity of any organisation or country to manage or mitigate alone”, saying the declaration affirms that the challenges of the problem “can be addressed only through collaboration and global collective action."

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