Biodel's VIAject gets name change

   

DANBURY, Conn. (Sept. 1) A specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes has changed the name of its lead product candidate.

Biodel said that the name Linjeta will replace the name of the company's rapid-acting insulin formulation VIAject, which currently is under review by the Food and Drug Administration.

Errol De Souza, Biodel 's president and CEO, stated, "Today's news reflects the continued progress of the Linjeta new drug application through FDA review and is an important milestone in our effort to commercialize this new drug candidate."

Pfizer to acquire FoldRx

   

NEW YORK (Sept. 1) Pfizer announced Wednesday that it will acquire a privately held drug discovery and clinical development company.

FoldRx's portfolio includes clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding, which increasingly is recognized as an underlying cause in many chronic degenerative diseases. FoldRx's lead product candidate, tafamidis meglumine, is an oral, disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option that currently is available, the companies said.

Financial terms of the agreement were not disclosed.

"By combining FoldRx's proprietary expertise in identifying and developing treatments for protein misfolding diseases with Pfizer's commercial, medical and regulatory expertise, and global strengths in patient services and reimbursement, we are taking a significant step toward potentially bringing, for the first time, a nonsurgical treatment option for underserved patients affected by the deadly disease ATTR-PN," said Geno Germano, president and general manager of Pfizer's specialty care business unit. "This transaction will add another important component to the growing portfolio of innovative in-line and investigational medicines for orphan and rare diseases within Pfizer's specialty care business, and will complement the current and planned future research and clinical development taking place in Pfizer's specialty care neuroscience disease area."

Added FoldRx president and CEO Richard Labaudiniere, "Pfizer's strong clinical and regulatory resources, global marketing reach and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease."

IMS Health exec to NACDS conference attendees: Expect opportunities, uncertainties for drug market

   

IMS Health VP industry relations Doug Long addresses attendees at the NACDS 2010 Pharmacy and Technology Conference.

SAN DIEGO (Aug. 31) The U.S. drug market will present opportunities as well as uncertainties over the next decade, according to remarks made by IMS Health VP industry relations Doug Long at the National Association of Chain Drug Stores’ 2010 Pharmacy and Technology Conference held here on Monday.

A slideshow listed 20 drugs that will lose patent protection between 2010 and 2014, with a total market value of $107 billion, including Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin calcium) and Purdue Pharma’s painkiller Oxycontin (oxycodone hydrochloride).

“So you have this patent cliff, which means there are going to be plenty of generic opportunities between now and 2014,” Long said.

With eight of the drugs listed ranking on IMS’ list of the top 10 in terms of sales, the patent expiries will produce huge rewards for the first companies to market generic versions of these drugs, but after 2015, the number of top-selling drugs losing patent protection will drop. That, Long said, could affect not just generic drug companies, but also retailers and other businesses that benefit from generics.

Of course, use of generics has increased markedly, growing from 57.7% of total prescriptions dispensed to nearly 75% between 2005 and July 2010, even as their market share in terms of percentage of dollars fell from 85.4% to 80.7% during the same period. Sales for the top 10 generic drug companies have grown by 15.1% in the 12-month period ended in June, with Teva Pharmaceutical Industries and Mylan accounting for 34.4% of generic prescriptions, and Teva ranking as the eighth-largest drug maker overall in terms of sales.

Coinciding with the economic crisis, Long said, there was a growing trend of patients starting or continuing therapies with generic rather than branded drugs. Still, the market share of generic drugs, as measured by percentage of dollars, increased from 14.6% in 2005 to 19.3% as of July 2010, while market share as measured by prescriptions grew from 57.7% to 74.8%.

On the branded side, Long noted such trends affecting drug innovation as fewer products going to market, development skewed toward specialty drugs –– meaning those prescribed by specialist physicians –– and orphan drugs and away from primary care drugs, and greater control exerted by payers. Indeed, according to the Food and Drug Administration and IMS, the FDA has approved more specialty drugs than primary care drugs every year between 1998 and 2009, except in 2002.

Many top-selling branded drugs continue to have strong sales growth. Aside from Lipitor, which had sales decline by 4.3%, all of the drugs that IMS listed as the top 20 in terms of sales grew during the 12-month period ended in June, and sometimes quite strongly. AstraZeneca’s cholesterol-lowering drug Crestor (rosuvastatin calcium) had $3.5 billion in sales, growing 34.7%, while Otsuka American Pharmaceutical’s and Bristol-Myers Squibb's antipsychotic and antidepressant Abilify (aripiprazole) had sales of $4.3 billion, growing 22.3%. Purdue’s Oxycontin had sales of $3.1 billion, growing by 18.6%.