Content about Pharmaceutical industry

February 1, 2011

NEW YORK — The U.S. healthcare system could get at least $70 billion in savings over the next four years thanks to loss of patent protection for branded drugs, according to published reports.


IMS Health SVP Murray Aitken said at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014, Reuters reported.


February 1, 2011

SUPPLIER NEWS — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related breakthrough pain, Watson said. The drug is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November 2010, according to IMS Health.


February 1, 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 31, 2011

Nearly half a million people participated in AstraZeneca's prescription savings programs.

WILMINGTON, Del. — Nearly half a million people participated in AstraZeneca's prescription savings programs.

The drug maker reported that it provided $947 million in savings last year to the more than 545,000 patients in the United States who participated. Participation in the AZ&Me prescription savings programs has increased steadily over the past three years, up 7% over 2009 and 19% over 2008, AstraZeneca said.

January 31, 2011

Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.

January 28, 2011

Though Schering-Plough’s — now Merck’s — Claritin and Johnson & Johnson’s Zyrtec product lines have dominated the over-the-counter antihistamine market, the big share of the prescription antihistamine market held by Sanofi-Aventis’ Allegra (fexofenadine hydrochloride) could give it a battering ram to bust in as well, thanks to the big break Sanofi got in the form of a Food and Drug Administration approval of an OTC switch for the drug.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Though Schering-Plough’s — now Merck’s — Claritin and Johnson & Johnson’s Zyrtec product lines have dominated the over-the-counter antihistamine market, the big share of the prescription antihistamine market held by Sanofi-Aventis’ Allegra (fexofenadine hydrochloride) could give it a battering ram to bust in as well, thanks to the big break Sanofi got in the form of a Food and Drug Administration approval of an OTC switch for the drug.

January 28, 2011

The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.

January 28, 2011

Pfizer has cleared one of the main legal hurdles in its effort to purchase drug maker King Pharmaceuticals, Pfizer said Friday.

NEW YORK — Pfizer has cleared one of the main legal hurdles in its effort to purchase drug maker King Pharmaceuticals, Pfizer said Friday.

Pfizer, the world’s largest drug company, said the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 had been terminated, one of the conditions necessary for the completion of Pfizer’s tender offer for King.

Pfizer announced plans in October to purchase Bristol, Tenn.-based King for $3.6 billion, or $14.25 per share.

January 27, 2011

Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

SAN DIEGO — Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

January 27, 2011

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

January 27, 2011

Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

BASEL, Switzerland — Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

That compared with sales of $12.9 billion and $44.3 billion during fourth quarter 2009 and 2009 as a whole, respectively. Profits for the year were nearly $10 billion, an 18% increase from $8.4 billion in 2009, though profits for the quarter decreased by 2%, from fourth quarter 2009’s $2.32 billion to $2.27 billion in fourth quarter 2010.

January 26, 2011

Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

January 25, 2011

Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

WOODCLIFF LAKE, N.J. — Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

Eisai said a phase-3 trial of the drug eritoran found the drug did not significantly reduce mortality in patients with the condition compared with placebo.

Severe sepsis causes about 215,000 deaths in the United States every year, with a mortality rate of about 30%.

January 25, 2011

Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).

Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.

January 25, 2011

Sanofi-Aventis and its U.S. consumer healthcare division Chattem on Tuesday afternoon announced the Food and Drug Administration has approved the Allegra (fexofenadine HCl) family of allergy medication products for over-the-counter use in adults and children 2 years of age and older.

PARIS — Sanofi-Aventis and its U.S. consumer healthcare division Chattem on Tuesday afternoon announced the Food and Drug Administration has approved the Allegra (fexofenadine HCl) family of allergy medication products for over-the-counter use in adults and children 2 years of age and older.

Products will be on store shelves in March, the companies announced.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

The FDA approved Matrix Labs’ pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths.

The drug is a version of Protonix DR, made by Wyeth, now part of Pfizer. Various versions of the drug had sales of around $1.7 billion during the 12-month period ended in September, according to IMS Health. The FDA also approved a version made by Dr. Reddy’s Labs on Friday.

January 21, 2011

Pfizer again has extended the expiration date on its tender offer to buy Bristol, Tenn.-based King Pharmaceuticals to Jan. 28, the drug maker said Friday.

NEW YORK — Pfizer again has extended the expiration date on its tender offer to buy Bristol, Tenn.-based King Pharmaceuticals to Jan. 28, the drug maker said Friday.

Pfizer announced in October that it would buy King for $3.6 billion, or $14.25 per share. King manufactures branded prescription drugs, including several painkillers.

January 21, 2011

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

NEW YORK — Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

The company expected the forecasted sales for the year to include between $2.8 billion and $3 billion in global generics sales, compared with around $2.35 billion in 2010. Total sales for 2010 were around $3.5 billion, according to preliminary financial results released last week.

January 20, 2011

Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

January 19, 2011

German drug maker Boehringer Ingelheim will purchase a manufacturing plant from U.S. biotech company Amgen, the two said.

THOUSAND OAKS, Calif. — German drug maker Boehringer Ingelheim will purchase a manufacturing plant from U.S. biotech company Amgen, the two said.

The plant, located in Fremont, Calif., is 100,000 sq. ft. and employs around 360 people. BI has been a contract manufacturer for Amgen for more than 10 years. Financial terms of the deal were not disclosed, though BI said it would purchase “substantially all” of the assets at the plant.

January 19, 2011

Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.

January 19, 2011

In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

HAYWARD, Calif. — In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

The company said several financial websites had reported that Impax had found a way to make a generic version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin calcium).

January 18, 2011

Colin Mackenzie has been appointed the new president of GlaxoSmithKline Consumer Healthcare North America. Mackenzie succeeds Roger Scarlett-Smith, who is relocating to London to become president of GSK Consumer Healthcare Europe.

PITTSBURGH — Colin Mackenzie has been appointed the new president of GlaxoSmithKline Consumer Healthcare North America. Mackenzie succeeds Roger Scarlett-Smith, who is relocating to London to become president of GSK Consumer Healthcare Europe.

Mackenzie has been directing the U.S. oral care business since 2007. Under the leadership of MacKenzie, the business accelerated its net sales growth rate, acquired the leading dry mouth product, Biotene, in 2008, and claimed the No. 1 toothpaste SKU in the United States (Sensodyne Extra Whitening).

January 18, 2011

Healthcare market research firm IMS Health will buy privately held market research firm SDI Health, IMS said.

NEW YORK — Healthcare market research firm IMS Health will buy privately held market research firm SDI Health, IMS said.

Terms of the transaction were not disclosed, but the deal would bring together two of the leading healthcare analytics companies. In terms of drug industry analytics, IMS focuses on drug sales and dispensed prescriptions, while SDI provides data on prescriptions written by physicians and other prescribers.