Posts tagged ‘Roche’

November 21, 2013

Roche says Kadcyla wins European approval

ZURICH (Reuters) – Roche said on Wednesday its drug Kadcyla, a treatment for an aggressive form of breast cancer, had been approved in Europe following U.S.

(Reuters) – Roche said on Wednesday its drug Kadcyla, a treatment for an aggressive form of breast cancer, had been approved in Europe following U.S. approval in February.

Kadcyla treats patients with late-stage disease whose cancer cells contain increased amounts of a protein known as HER2.

It works by attaching Herceptin to a drug called DM1, developed by ImmunoGen, which interferes with cancer cell growth. ImmunoGen will receive a $5 million milestone payment from Roche following the approval.

(This story corrects to remove reference to Japan approval from the third paragraph)

(Reporting By Katharina Bart; Editing by Andrew Heavens and Louise Heavens)

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November 18, 2013

New Roche leukemia drug helps patients live longer

Gazyva, previously known as GA101, was approved in the United States last week as an initial treatment for patients with chronic lymphocytic leukemia.

(Reuters) – Roche’s newly approved leukemia drug Gazyva helped patients live nearly a year longer without the disease worsening than the drugmaker’s top-selling Rituxan in a head-to-head trial that should help fend off competition from cheaper versions of the older medicine.

Gazyva, previously known as GA101, was approved in the United States last week as an initial treatment for patients with chronic lymphocytic leukemia, or CLL, one of the most common forms of blood cancer. It is awaiting approval decisions in Europe and other markets.

Roche, in the trial, aimed to demonstrate the clear superiority of the new drug over Rituxan in order to protect and build on its $7 billion a year blood cancer franchise before Rituxan begins to face competition from cheaper versions known as biosimilars.

Rituxan’s European patent protection expires late this year. It is not clear when the first biosimilar will arrive on the market.

Rituxan’s U.S. patent does not expire until 2018, giving Roche additional time to switch patients over to Gazyva in the most lucrative market. As with Rituxan, Roche will share a portion of Gazyva profits with Biogen Idec after Biogen exercised its option on the new drug.

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November 4, 2013

Roche in $550 million deal for superbug-fighting antibiotic

ZURICH (Reuters) – Swiss drugmaker Roche will pay up to 500 million Swiss francs ($548 million) for an experimental antibiotic, marking a rare foray by a major pharmaceutical firm into the battle against…

The World Health Organisation has warned of the growing public health threat from drug-resistant superbugs. There are 25,000 deaths each year in the European Union alone due to antimicrobial resistance, Roche said on Monday.

However, the problem is not yet widespread enough to attract major investment by most top pharmaceutical companies, with many of them in fact cutting back research into antibiotics.

Pfizer, once the leader in the field, closed its antibiotic R&D centre in Connecticut in 2011, while Bristol-Myers Squibb and Eli Lilly have also cut back, leaving few big firms in the game.

Roche said it had signed an exclusive global licensing deal to develop and commercialize privately held Polyphor’s investigational antibiotic POL7080 against certain superbug infections found in hospitals.

Under the deal, Roche will make an upfront payment of 35 million Swiss francs and milestone payments of up to 465 million.

In addition, Polyphor will be entitled to tiered, double-digit percentage royalties on any product sales and will retain the option to co-promote an inhaled formulation of POL7080 in Europe, Roche said.

POL7080 belongs to a new class of antibiotics that kills Pseudomonas aeruginosa, a bacterium found in hospitals and resistant to many antibiotic treatments, by a novel mode of action, the Swiss group added.

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November 3, 2013

Is there a Roche antibiotics strategy? Does it involve Polyphor?

Roche hasn’t developed antibiotics in some time. But read a new report that says the Roche antibiotics strategy means buying a drug from Polyphor.

GENEVA (Reuters) – Swiss drugmaker Roche is poised to get back into antibiotics by taking over a candidate drug being developed by privately-owned Polyphor, the NZZ am Sonntag paper said on Sunday, without citing a source for the information.

The paper did not give any details of the transaction, but said the contract would be signed this weekend.

Roche’s Chief Executive Severin Schwan said last month that the company was interested in “bolt-on acquisitions”.

But a company spokesman declined to confirm the report on Sunday, saying the firm did not comment on rumors.

“We have an open and pragmatic approach to R&D and have mentioned in the past that antibiotics is an area where a lot of interesting science is going on,” Roche spokesman Daniel Grotzky said in an emailed reply to a Reuters enquiry.

Polyphor, based in Allschwil in Switzerland, said in March it had successfully completed a phase 1 clinical trial for its POL7080 drug, a Pseudomonas specific antibiotic, which it said had shown outstanding efficacy against septicaemia, peritonitis and lung and thigh infection.

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October 24, 2013

Roche CEO does not rule out move into rare diseases

PARIS (Reuters) – The chief executive of Roche did not rule out a move into treatments for rare diseases on Wednesday, saying the Swiss drugmaker would go where it could address unmet medical needs, even for very small numbers of patients.

There has been speculation that Roche might branch out into the lucrative area of rare or so-called orphan diseases, which affect only a small number of people, after reports it was considering bids for two U.S.-based companies, Alexion Pharmaceuticals and BioMarin Pharmaceuticals.

Chief Executive Severin Schwan told a news conference in Paris that Roche’s main criteria when looking at which diseases to go after was not the size of the patient population but how much additional value and medical benefit could be generated for the individual patient.

Asked if that meant he did not exclude a move into rare diseases, he said: “We go where the science takes us, wherever it is, independent from the size of the patient population.”

Schwan said that Roche’s portfolio already included treatments for rare diseases such as cystic fibrosis and chronic lymphocytic leukaemia (CLL).

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October 24, 2013

Roche plaide pour un prix reflétant l’impact du médicament – Octobre 2013 – Pharmaceutiques

Le laboratoire Roche propose un système de “fixation des prix personnalisé”, dépendant de la valeur apportée par un produit en fonction de l’indication, du type de patient et du parcours de soins.

Lors d’une conférence de presse organisée à Paris par le groupe suisse Roche le 23 octobre, son directeur général Severin Schwan (en photo) a plaidé pour un nouveau système de fixation des prix des médicaments, qui prendrait en compte le bénéfice réel apporté au patient.
Alors que dans la situation actuelle, le prix d’un produit est fixé, de façon indifférenciée, en fonction du volume (par flacon ou par milligramme de molécule), ce dernier juge qu’il est temps de s’orienter vers « des modèles de fixation de prix plus sophistiqués », pour créer un environnement tarifaire à la fois durable pour la société et incitatif pour les industriels engagés dans l’innovation.

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October 15, 2013

Roche plans $880M investment in manufacturing for biologic medicines – MedCity News

ZURICH, Oct 14 (Reuters) – Swiss drugmaker Roche is to invest 800 million Swiss francs ($880 million) in its global manufacturing facilities over the next five years, creating 500 jobs, as it prepares for growing demand for its biologic medicines.

The world’s largest maker of cancer drugs said on Monday the investment would increase its production capacity in Penzberg in Germany, Basel in Switzerland and Vacaville and Oceanside in the United States.

The expansion indicates Roche’s confidence in its development pipeline of new cancer drugs and bucks a trend of cost-cutting by some big drugmakers in response to slowing sales growth.

Last week Israel-based Teva, the world’s largest maker of generic drugs by sales, said it would cut 5,000 jobs, while Merck & Co plans to slash annual operating costs by $2.5 billion and eliminate more than 10 percent of its workforce.

Many of Roche’s most promising medicines, such as rheumatoid arthritis treatment RoActemra and new breast cancer drugs Kadcyla and Perjeta are biologics, which unlike chemical drugs are proteins or cells derived from living organisms that are hard to replicate.

The Basel-based firm also has 39 investigational biologic medicines in its pipeline.

“As the world’s largest supplier of biologics, Roche is committed to making the necessary investments to ensure ongoing supply of these medicines at the highest quality standards,”? said Daniel O’Day, chief operating officer of Roche’s Pharmaceuticals Division.

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October 14, 2013

Roche to spend $880 million on manufacturing, create 500 jobs

 

ZURICH (Reuters) – Swiss drugmaker Roche is to invest 800 million Swiss francs ($880 million) in its global manufacturing facilities over the next five years, creating 500 jobs, as it prepares for growing demand for its biologic medicines.

The world’s largest maker of cancer drugs, which employs around 80,000 people in over 100 countries, said on Monday the investment would increase its production capacity in Penzberg in Germany, Basel in Switzerland and Vacaville and Oceanside in the United States.

The expansion shows Roche’s confidence in its development pipeline of new cancer drugs and bucks a trend of cost-cutting by some big drugmakers in recent weeks in response to slowing sales growth.

Last week Israel-based Teva, the world’s largest maker of generic drugs by sales, said it would cut 5,000 jobs, while Merck & Co plans to slash annual operating costs by $2.5 billion and eliminate more than 10 percent of its workforce.

Shares in Roche were down 0.2 percent at 238 francs by 0437 EDT, when the Stoxx Europe 600 healthcare sector index was down 0.1 pct.

Vontobel analyst Andrew Weiss said he was not surprised by the investment as manufacturing is a core competency of Roche and the company is at present the leanest drug company with only 15 manufacturing sites worldwide.

Many of Roche’s most promising medicines, such as rheumatoid arthritis treatment RoActemra and new breast cancer drugs Kadcyla and Perjeta are biologics, which unlike chemical drugs are proteins or cells derived from living organisms that are hard to replicate.

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October 14, 2013

Areva et Roche dévoilent un labo de R&D pour de nouveaux traitements contre le cancer

Quotidien des Usines :
Il s’appelle ARCoLab, pour laboratoire commun à Areva Med et Roche, et serait l’un des laboratoires de médecine nucléaire les…

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September 25, 2013

A Novartis — Roche Merger? Say It Isn’t So!

Pharmaceutical industry consolidation has had, at best, mixed results. On the one hand, companies can cite all sorts of potential benefits: blending of existing product lines, elimination of duplication, reducing costs and business synergies.

McCabe cites Pierre Landolt, a Novartis board member since 1996, who said that combining Roche and Novartis would create a European “pharmaceutical champion”. Usually, such a mega-merger is stifled by senior leadership, since there can be only one CEO and each company head would envision himself in the big chair. However, Landolt pointed out that: “Soon both companies will have new chairmen. That might make the dialogue easier.” For the sake of the employees of both companies, I hope that won’t be the case.

Pharmaceutical industry consolidation has had, at best, mixed results. On the one hand, companies can cite all sorts of potential benefits: blending of existing product lines, elimination of duplication, reducing costs and business synergies. That all sounds great. But, in reality, there are also downsides due to the turmoil of uncertainty. Leaders will  lobby for key positions in the new organization; key talent will seek outside opportunities where specific, desirable positions exist; rumors will run rampant about what divisions will be eliminated and what sites will be closed; when the organizational structure is settled upon, there will be “’winners’ and ‘losers’” identified, labels that will be difficult to shake after the merger. As a result, a period of decreased productivity occurs that can last for anywhere from 12 – 24 months.

Nowhere is this more acutely felt than in the R&D organizations – the engines – of both companies. These divisions seem to be especially vulnerable to the negative impact of mergers.  The progress of drugs in each company’s pipeline will be slowed. This occurs because the merger of both pipelines requires extensive reviews. Each program needs to be discussed in terms of the safety and efficacy of each drug candidate, as well as the commercial hurdles and challenges each would face. In cases where each compound may have a similar drug, the discussions as to which should be the lead compound can be rancorous with each side lobbying as to why its is superior. While these portfolio discussions are being held, no new investments are made until the ultimate composition of the pipeline is decided. As these discussions can take weeks, if not months, any pipeline momentum will be derailed.

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