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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GSK may consider spin-offs but not for a while

by Admin 14. January 2016 09:53

Following repeated calls from a high-profile UK investor that GlaxoSmithKline should be broken up, chief executive Sir Andrew Witty says he is willing to consider the possibility but not for a while.

In an interview with Bloomberg at the JP Morgan Healthcare Conference in San Francisco, Sir Andrew noted that the firm’s huge asset swap with Novartis which only closed in March last year, has created market-leading businesses in consumer health and vaccines. This gives the UK major new options once the integration is complete, he said.

Sir Andrew told the news agency that “by bringing these businesses all to real global scale, it for the first time creates the optionality for potentially different structures down the road”. However, “we certainly have a year or two more of work to finish” the integration, he added.

His comments followed statements last week by influential investor Neil Woodford who repeated his call that GSK requires radical restructuring and should be divided into separate companies. The founder of Woodford Investment Management told the BBC that GSK is so complicated, it is "like four FTSE 100 companies bolted together" and claimed that the pharmaceuticals giant does not "do a particularly good job of managing all of the constituent parts".

Some observers have suggested that GSK’s consumer health division would be ripe for a spin-off and Sir Andrew said the latter “is so big in scale, it could one day have a life of its own”. However, he added that a spinoff would not happen this year or next.

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One-hour diagnosis of heart attack with Roche test

by Admin 14. January 2016 09:48

Roche’s high-speed heart attack test, which “drastically shortens” time to diagnosis and enables quicker treatment, has successfully come through a three-year trial involving more than 1,200 patients.

The test, which measures troponin (a heart muscle protein released into the blood stream during a heart attack) reduces the observation time needed to rule-in or rule-out a heart attack from three to six hours to just one hour. Prompt treatment is essential because every 30 minutes of delay from the onset of symptoms to treatment increases the mortality risk by 7.5%, Roche notes.

Thanks to this new approach, “we can now shorten the time to heart attack diagnosis for millions of patients presenting in emergency rooms with acute chest pain all over the world,” said Christian Mueller at the University of Basel. “Patients no longer have to wait for three or more hours in the emergency department, not knowing whether they have an acute, life-threatening disease or if their chest pain is caused by other reasons”.

Results of the study “once again demonstrate how diagnostics can influence clinical practice to contribute to better patient outcomes", said Roland Diggelmann, Roche Diagnostics’ chief operating officer.

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Merck & Co acquires Scotland’s IOmet Pharma in £280 million deal

by Admin 14. January 2016 09:43

Merck & Co has acquired IOmet, a privately-held Scotland-based drug discovery company specialising in immunotherapy and cancer metabolism.

The US giant is getting hold of IOmet’s pre-clinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase) and dual-acting IDO/TDO inhibitors. Eric Rubin, head of oncology early-stage development at Merck Research Laboratories, said the acquisition is an example of the firm’s commitment to fully realising the potential of this rapidly evolving field”. It is already leading the pack with its checkpoint inhibitor Keytruda (pembrolizumab), which is already marketed for advanced melanoma and non-small cell lung cancer.

Financial terms of the acquisition were not broken down but the BBC reported that Edinburgh-headquartered IOmet could bank £280 million if all milestones are met. The deal went down well with the Scottish government, with the Deputy First Minister John Swinney saying that “it is testament to the intellectual vibrancy and strong commercial attractiveness of Scotland's life science businesses”.

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