Roche Reaffirms Full Year Outlook But Suffers From Currency MovementsTrefis • Yesterday, 6:02 PM
Roche Hikes Dividend By 6%, Remains A Safe Yield Play
Roche: Impact Of Rituxan Patent Expiration In EuropePharma Reports • Oct. 21, 2013
Will Lost Patents Force Roche Into Acquisition Mode?
Roche Holdings: New Drugs Drive Oncology Unit's GrowthTrefis • Mar. 15, 2013
Roche Holding: Revised $58 Price Estimate On Strong PipelineTrefis • Feb. 14, 2013
Roche: A Leader In Biotech And Diagnostics, Part 2
Roche: A Leader In Biotech And Diagnostics, Part I
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
Wednesday, Apr 1612:41 PM
Wednesday, Apr 1612:41 PM| Comment!
- Vials from nine batches of Roche's (RHHBY) top-selling drug allegedly stolen in Italy have been tampered with and reintroduced into the European market. Adulterated vials have turned up in Germany, Finland and the U.K. Some do not contain any trastuzumab at all while others have been diluted.
- There are no reports of harm to patients from the fakes. The company is recalling the suspect vials as a precaution.
- Herceptin sales last year were $6.9B.
Monday, Apr 142:29 PM
Monday, Apr 142:29 PM| Comment!
- The European Medicines Agency concludes its inquiry into Roche's (RHHBY +2%) drug safety reporting. The firm allegedly under-reported adverse events for 19 of its drugs.
- It sends its findings to the European Commission for follow through.
- The EC will decide if the matter should be pursued and if financial penalties should be imposed.
- Under "pharmacovigilance" obligations per EU rules, the company could be liable for fines up to 5% of its annual turnover or $14.6B although a penalty this severe is unlikely.
Thursday, Apr 103:17 PM
Thursday, Apr 103:17 PM| Comment!
- London's High Court rules Roche's (RHHBY -0.7%) 115 and 455 Herceptin patents are invalid paving the way for Hospira (HSP -3.5%) to market a biosimilar version in Britain.
- Hospira wants to sell its offering of trastuzumab after Herceptin's core patent expires on July 28.
- Although Britain comprises a small part of Herceptin's $6.9B sales, Roche is carefully assessing its options in light of a possible domino effect in other European countries.
Thursday, Apr 109:32 AM
Thursday, Apr 109:32 AM| 12 Comments
- In its recent healthcare budget, French lawmakers introduced a measure that will allow pharmacists to substitute generics for prescribed brand-name biotech drugs. This has rattled the industry since France is Europe's #2 pharmaceutical market behind Germany.
- A decree must be passed before it becomes effective.
- France is the first European country to pursue biologic substitution. Big Pharma fears a domino effect if it is successful despite the heretofore slow uptake of biosimilars.
- The initiative applies only to patients starting a new course of treatment. Doctors will still retain the ability to demand the branded product.
- Unsurprisingly, Big Pharma is upset at not being consulted prior to the law's passage.
- Some analysts believe France could save up to $1.4B by 2020 by using generics.
- Substitutions only apply to retail pharmacies. 40% of biotech prescriptions are filled in hospitals.
- (RHHBY) (AMGN) (NVS) (SNY) (LLY) (PFE) (BMY) (MRK) (GSK) (JNJ) (HSP) (ABBV) (AZN) (BAYRY)
Thursday, Apr 107:17 AM
Thursday, Apr 107:17 AM| Comment!
- Scientists from the research network the Cochrane Review doubt the wisdom of governments spending billions stockpiling Roche's (RHHBY) flu drug Tamiflu. Based on their review of the data, they conclude the only benefit is a half day reduction in flu symptoms.
- There is no good evidence that the drug reduces hospital admissions or lessens complications from the disease or can prevent a pandemic.
- Predictably, Roche disputes the claims saying the quality and integrity of its data speaks for itself. Complicating matters is the company's refusal to allow the group unlimited access to its Tamiflu data.
- The U.S. government has spent more than $1.3B stockpiling antivirals including Tamiflu. The British government has spent $703M on 40M Tamiflu doses.
- The European Medicines Agency states that it reviewed all 20 studies in its approval process and Cochran's work did not raise any new concerns over the drug's effectiveness.
- It appears that the only to resolve the dispute is for a global flu pandemic to occur to see if Tamiflu works as claimed.
Wednesday, Apr 97:34 AM
Wednesday, Apr 97:34 AM| Comment!
- Roche (RHHBY) and Hitachi High-Technologies Corporation renew their partnership with a 10-year contract to jointly develop and manufacture next generation instruments and workflow automation solutions for medical laboratories. The firms have been working together for 36 years.
- One of the primary strategic thrusts will be modular lab solutions.
Monday, Apr 711:31 AM
Monday, Apr 711:31 AM| Comment!
- Phase 2 clinical trial results show Puma Biotech's (PBYI +1.9%) cancer drug is more effective than Roche's (RHHBY -0.7%) in HER2 breast cancer patients when given before surgery.
- In the 193-patient trial, 39% of HER2 patients given the combination of neratinib and chemotherapy achieved a pathologic complete response compared to 23% who received Herceptin and chemo.
- Puma's drug is a pill whereas Roche's is given by infusion.
- ~25% of breast cancer cases are HER2 positive.
Monday, Apr 77:08 AM
Monday, Apr 77:08 AM| Comment!
- Roche (RHHBF) has acquired privately held IQuum for up to $450M in a deal that will boost the Swiss company's molecular diagnostics business.
- Roche will pay $275M up front and $175M in product-related milestones.
- IQuum says its "lab-in-a-tube technology" enables "non-specialized personnel to perform more sophisticated biological sample testing in any setting." (PR)
Wednesday, Apr 211:30 AM
Wednesday, Apr 211:30 AM| 3 Comments
- Last summer's dust up between GlaxoSmithKline (GSK) and Chinese regulators over accusations of corruption has quietly subsided. Drug firms perceive the China market has returned to its "business as unusual."
- Glaxo responded to the matter by replacing its sales targets for individual reps with broader performance-rating criteria such as improved patient care.
- Although far from assured, other members of Big Pharma don't expect the authorities to rattle their sabers again any time soon.
- Analysts expect the nation's drug market to continue its annual 15% growth rate and emerge as the globe's second largest pharmaceutical market behind the U.S. by 2016 on the basis of $165B in sales.
- (SNY) (LLY) (NVS) (AZN) (PFE) (BMY) (JNJ) (BAYRY) (RHHBY) (NVO) (ABBV)
Friday, Mar 281:54 PM
Friday, Mar 281:54 PM| 14 Comments
- The Federal Trade Commission wants to extract least $1B from pharmaceutical companies for their alleged efforts to thwart the entry of cheaper generic drugs by paying generic makers to delay introducing their offerings.
- Last June, the U.S. Supreme Court ruled that the FTC may legally challenge the deals.
- (NVO) (PFE) (SNY) (ABBV) (JNJ) (RHHBY) (GSK) (AZN) (BMY)
Friday, Mar 288:17 AM
Friday, Mar 288:17 AM| Comment!
- The European Commission clears Roche's (RHHBY) subcutaneous formulation of its lymphoma drug MabThera (rituximab). The product uses Haloyzme's (HALO) Enhanze (recombinant human hyaluronidase) technology.
- This is the second Roche offering that uses the technology. The EU approved a subcutaneous version of Herceptin in September 2013.
Thursday, Mar 274:26 AM
Thursday, Mar 274:26 AM| Comment!
- Novartis' (NVS) Ceritinib (LDK378) reduced the size of tumors in 58% of patients in a Phase I study of those suffering from a form of lung cancer that strikes 10,000 people a year in the U.S.
- Ceritinib is the leader of a class of drugs that targets a gene known as ALK and is 20 times as effective as a drug from Pfizer (PFE) called Xalkori.
- However, patients developed resistance to Ceritinib and the median time for progression-free survival was seven months.
- The study involved 114 subjects, and while it was only Phase I, Novartis is using the results to file for FDA approval based on the drug's "breakthrough therapy designation."
- Other companies developing ALK inhibitors include Ariad Pharmaceuticals (ARIA), and Roche (RHHBF) and Japan's Chugai (CHGCY) together, while Pfizer is working on a follow-on to Xalkori. (PR)
Wednesday, Mar 268:33 AM
Wednesday, Mar 268:33 AM| 2 Comments
- Large cap pharma and biotech firms have regenerative therapy R&D programs underway according to a recent survey.
- 69% of respondents are focused on developing cellular-based therapies.
- Wound healing and burns have the greatest near-term potential.
- Long term areas of interest are cardiovascular disease, oncology, neurodegenerative disease, monogenic disorders and ocular disease.
- (AGN) (AMGN) (BAX) (BIIB) (CELG) (LLY) (GSK) (JNJ) (NVS) (NVO) (PFE) (RHHBY) (SNY) (MRK) (SHPG)
Monday, Mar 249:05 AM
Monday, Mar 249:05 AM| Comment!
- The FDA has approved Novartis' (NVS) and Roche's (RHHBY) Xolair treatment for Chronic Idiopathic Urticaria (CIU), a form of hives.
- Xolair is the first biologic medicine to be approved for CIU, a skin condition that can cause severe itching and can last for many years. Around 1.5M people in the U.S. develop CIU at some point in their lives.
- "Nearly 50% of patients have inadequate response to H1-antihistamines, previously the only approved therapy for CIU," Roche says.
- The FDA's authorization covers people 12 years old and older who still suffer symptoms of CIU despite treatment with H1-antihistamines.
- Xolair is also approved for moderate-to-severe persistent allergic asthma. (PR)
Tuesday, Mar 189:42 AM
Tuesday, Mar 189:42 AM| 1 Comment
- Most of the major players in pharmaceuticals are working feverishly to develop injectable drugs for asthma, a disease that remains difficult to control despite treatment advances.
- GlaxoSmithKline (GSK) is the current leader considering the long-term success of Ventolin, but Roche (RHHBY), AstraZeneca (AZN), Sanofi (SNY) and Teva (TEVA) all plan to compete in the space.
- Novel antibody-based drugs target key inflammatory chemicals in the body that trigger asthma. The medical community believes these drugs are major therapeutic breakthroughs.
- Clinical data suggest serious asthma attacks can be reduced by as much as 40% - 60%.
Friday, Mar 1412:27 PM|Friday, Mar 1412:27 PM| Comment!