Apr. 10, 2014, 9:32 AM
- 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)
Apr. 10, 2014, 8:05 AM
- Pfizer (PFE) ends its licensing agreement with Acura Pharmaceuticals (ACUR) for its AVERSION anti-abuse technology.
- PFE returns all rights to OXECTA (oxycodone hydrochloride) tablets CII to Acura but will retain the OXECTA trademark. All studies, data, regulatory filings and other information will be returned to Acura.
- ACUR pays a $2M termination fee to PFE.
- Neither party has royalty obligations except PFE for OXECTA sales before the April 9 termination date.
Apr. 9, 2014, 4:18 AM
- Profits that major U.S. corporations have parked overseas in order to avoid taxes at home jumped 93% to $2.1T in 2008-2013, research firm Audit Analytics has calculated.
- GE (GE) held the most amount of money abroad with $110B and Microsoft (MSFT) was second with $76.4B, after which comes Pfizer (PFE) with $69B, Merck (MRK) with $57.1B and Apple (AAPL) with $54.4B.
- The numbers have prompted fresh calls for an overhaul of the tax code, including from Senate Finance Committee Chairman Ron Wyden.
Apr. 7, 2014, 3:56 AM
- Pfizer's (PFE) Palbociclib treatment doubled progression-free survival to 20.2 months in a Phase 2 trial of 165 patients with advanced breast cancer.
- Palbociclib also helped patients live four months longer, although the result isn't statistically significant.
- Palbociclib is part of a new class of drug called CDK 4/6 inhibitors, which limit the activity of two enzymes involved in cell division — cyclin-dependent kinases 4 and 6.
- Palbociclib is considered a potential blockbuster that could be used with other cancers, and it is forecast to sell $3.11B by 2020. Amgen (AMGN) would receive an 8% royalty on any sales. (PR)
Apr. 2, 2014, 11:30 AM
- 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)
Mar. 31, 2014, 7:36 AM
- The Anti-Infective Drugs Advisory Committee reviews Durata Therapeutics' (DRTX) dalbavancin and Cubist Pharmaceuticals' (CBST) tedizolid today.
- The FDA granted both products priority review status under the less-rigorous "non-inferiority" method.
- Dalbavancin is comparable to vancomycin, but it is administered via two IV infusions a week apart and enables the patient to avoid two weeks of hospitalization.
- Tedizolid is also comparable to an existing drug but it will be evaluated for hospital-acquired MRSA infections.
- Two other antibiotics given the accelerated review have a heightened risk of serious adverse events and/or death.
- (JNJ) (PFE)
Mar. 28, 2014, 1:54 PM
- 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)
Mar. 27, 2014, 9:32 AM
- Pfizer's (PFE) Bococizumab (RN316) met the primary goal of a Phase IIb trial, significantly lowering LDL-C cholesterol across several dosing regimens in patients with a high risk of cardiovascular events.
- Bococizumab is part of a set of treatments known as PCSK9 inhibitors, which several major pharmaceuticals companies are working on. (PR)
Mar. 27, 2014, 4:26 AM
- 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)
Mar. 26, 2014, 8:33 AM
- Pfizer's (PFE) Genotropin growth hormone achieved the primary endpoint in a Phase IIIb study of children aged 24-30 months who are small for their age.
- After 24 months, children who took Genotropin grew more than those in the untreated control group.
- Eight participants suffered a combined 14 serious adverse events, of which two were related to treatment with Genotropin. The side effects were consistent with the drug's known safety profile. (PR)
Mar. 26, 2014, 8:33 AM
- 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)
Mar. 25, 2014, 8:48 AM
- Pfizer's (PFE) Xalkori (Crizotinib) treatment met the main goal of a Phase III trial of untreated patients with a certain form of lung cancer by "significantly prolonging progression-free survival (PFS)" when compared with standard chemotherapy.
- The study, called Profile 1014, is the second positive global Phase III test that evaluated Xalkori against chemotherapy.
- Xalkori has already been authorized to treat previously treated patients. (PR)
Mar. 20, 2014, 8:56 AM
- Pfizer's (PFE) Bivalent rLP2086 treatment has received a breakthrough designation from the FDA for preventing Meningococcal B Disease in sufferers aged 10-25.
- Pfizer is conducting Phase II and III trials for rLP2086 in studies that involve over 20,000 participants, of which 14,000 will receive the vaccine.
- Meningococcal disease is caused by a bacterium called Neisseria meningitidis and can lead to meningitis and widespread blood infection (sepsis), as well as death or long-term disabilities such as brain damage and hearing loss.
- Of the five main meningococcal serogroups, serogroup B is the only one for which there is no FDA approved broadly-protective vaccine. (PR)
Mar. 18, 2014, 4:59 AM
- Pfizer (PFE) has sued to prevent India's Torrent Pharmaceuticals from selling a generic version of Viagra until the drug's patent expires in October 2019.
- Pfizer's action comes after Torrent filed to market a copycat form of the product before the patent ends.
- The stakes are high, as Viagra generated $1.88B in sales last year, or 3.6% of Pfizer's total revenue
- Pfizer has sued other firms over the same issue and has reached an agreement with Teva (TEVA) that would allow the Israeli company to start selling generic Viagra in December 2017 or earlier under certain circumstances.
Mar. 14, 2014, 1:52 PM
- The FDA approves Bristol-Myers Squibb (BMY) and Pfizer's (PFE) sNDA for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis for patients who have undergone knee or hip replacement surgery.
- In the U.S., 719,000 knee replacement and 332,000 hip replacement surgeries are performed each year.
- The product is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Mar. 13, 2014, 7:27 AM| 6 Comments
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Pfizer Inc is a research-based biopharmaceutical company. The Company has five operating segments: Primary Care; Specialty Care and Oncology; Established Products and Emerging Markets; Animal Health; and Consumer Healthcare.
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