DID - May 12, 2009 Issue

Vol. 8 No. 92

AstraZeneca’s Brilinta Beats BMS’ Plavix in Clinical Trial

AstraZeneca’s investigational oral antiplatelet drug Brilinta was more effective than Bristol-Myers Squibb’s blood-thinner Plavix in preventing cardiovascular events in patients with acute coronary syndromes (ACS) in a Phase III clinical trial. 

Brilinta (ticagrelor) achieved statistical significance in delaying the time to first occurrence of heart attack, stroke or death from cardiovascular causes, the primary efficacy endpoint, compared with Plavix (clopidogrel bisulfate), AstraZeneca says in a statement Monday. 

The drug is the first reversibly binding oral adenosine diphosphate receptor antagonist and is chemically distinct from thienopyridines like Plavix, according to the company.

The trial, known as PLATO (Study of Platelet Inhibition and Patient Outcomes), enrolled 18,624 ACS patients at 742 sites in 43 countries. The overall safety profile for Brilinta was similar to that observed in the Phase II studies. The company is still analyzing the study database, secondary variables and subgroups, and it plans to submit the data to a peer-reviewed medical journal and present it at the annual meeting of the European Society of Cardiology in August.

AstraZeneca says it is planning to submit Brilinta applications to the FDA, the European Medicines Agency and other regulatory authorities in the fourth quarter. Brilinta is a proposed trade name that requires regulatory approval. — Martin Berman-Gorvine


Vermont Bill Requires Full Disclosure of Gifts from Drug Manufacturers

The Vermont Legislature voted to require full disclosure of gifts from manufacturers of prescription drugs, medical devices and biologics to doctors, nonprofits, healthcare organizations and state-funded schools.

The bill, S. 48, now heads to Gov. Jim Douglas for his signature. The legislation closes a loophole that allowed most gift data to be submitted in aggregate form. Vermont already required the disclosure of many gifts and payments to prescribers.

“The bill allows consumers going to their physician to know whether their doctor is taking money from the pharmaceutical companies,” state Sen. Peter Shumlin, president pro tempore and sponsor of the bill, says in a statement. The bill “is a good step toward addressing our rising health care costs.” 

Shumlin is a founding member of the National Legislative Association on Prescription Drug Prices (NLARx), an organization of state legislators working to lower prescription drug costs and improve access to medicines.

Vermont’s lawmakers join those in Minnesota and Massachusetts in passing a ban on many gifts, Sharon Treat, executive director of the NLARx, says in a statement. — Elizabeth Jones   


Drugmakers Cite Innovation in Healthcare Reform Summit on Cost-Cutting

PhRMA cited disease prevention and innovation as two critical steps in helping President Barack Obama reduce spending after a White House summit with stakeholders on healthcare reform.

The group, which also included insurers, hospitals, physicians, medical device companies and labor representatives, pledged to cut the growth rate of national healthcare spending by 1.5 percentage points a year — to a total of more than $2 trillion — over the next 10 years, Obama said after the meeting Monday.

“The coalition also recognizes the importance of encouraging medical innovation as a key element in both improving patient health and reducing the growth of overall health costs,” Billy Tauzin, CEO of PhRMA, says in a statement. “For example, recent research has estimated that delaying the onset or slowing the progression of Alzheimer’s disease by five years could save $126 billion by 2025 in Medicare and Medicaid costs.”

Obama highlighted the need for drugmakers to focus on prevention as well as medical advances to cut spending, a point that was supported by PhRMA.

Tauzin says significant work is being done on cancer research, with 861 medicines and vaccines being researched and developed by PhRMA member companies.

“Our commitment to innovation is unfaltering, as reflected in the record $65.2 billion invested in R&D by pharmaceutical research and biotechnology companies last year,” Tauzin says. — David Belian


FDA Approves New Formulation of GSK’s Epilepsy Treatment

GlaxoSmithKline (GSK) has received FDA approval for Lamictal orally disintegrating tablets (ODT), a treatment for epilepsy and bipolar disorder. 

Lamictal ODT (lamotrigine) was approved based on the demonstration of bioequivalence to the tablet formulation of the drug. The anticonvulsant was developed in collaboration with Eurand.

Eurand will receive an undisclosed milestone payment upon the product’s launch, as well as royalties on net sales and milestone payments, as part of an agreement between the two companies. Lamictal ODT will be available in 25-, 50-, 100- and 200-mg strengths and is expected to be available in pharmacies in early July.

Lamictal ODT is indicated for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in adults who have been treated for the episodes with other medicine.

Net sales of Lamictal were $1.3 billion in the U.S. last year, according to a Eurand statement. — Elizabeth Jones


Exelixis, Boehringer Ingelheim Reach Autoimmune Therapy Agreement

Boehringer Ingelheim and Exelixis have agreed to collaborate on developing and commercializing treatments for autoimmune diseases.

The collaboration will focus on the discovery of sphingosine-1-phosphate type 1 receptor agonists — a central mediator of multiple pathways implicated in a variety of autoimmune diseases, the companies say in a statement.

Exelixis will receive a $15 million upfront payment and as much as $339 million in potential milestone payments based on development goals, regulatory approvals and royalties from sales. The companies will share discovery responsibilities, and Boehringer will take sole responsibility for all subsequent preclinical, clinical, regulatory, commercial and manufacturing activities.

Boehringer will bring its expertise in immunology research and global drug development resources to the collaboration, Andreas Barner, the company’s chairman of the board of managing directors and head of the corporate division pharmaceutical research, says in the statement. — David Belian

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