Archimedes Breakthrough Pain Drug Gets Pain-Free REMS
BioWorld Today Washington Editor and BioWorld Today Contributing Writer
Archimedes Pharma Ltd.'s Lazanda isn't the first fentanyl product to get the FDA's nod for breakthrough cancer pain, but its pain-free risk evaluation and mitigation strategy (REMS) and intranasal delivery could give it an edge in the U.S. market once it launches in the fall.
The FDA's approval last week of Lazanda – the first U.S. approval for the privately owned Reading, UK-based biotech – included a REMS that requires prescribers, pharmacies and patients to enroll in a database before prescribing, dispensing or taking the Schedule II narcotic.
In comparison, the REMS for BioDelivery Sciences International Inc.'s Onsolis, a fentanyl buccal-soluble film approved for the same indication last year, requires a courier to deliver the drug to patients, Rodman & Renshaw analyst Michael Higgins said.
Onsolis, which reached the market in April 2010, missed market expectations, due largely to the required courier delivery, Higgins said, creating a "burden that physicians didn't have to deal with in prescribing Fentora and Actiq."
Meanwhile, Lazanda's intranasal delivery will set it apart from oral fentanyl tablets like Cephalon Inc.'s Fentora and former blockbuster Actiq, now available in generic versions.
Lazanda uses Archimedes' pectin-based drug delivery system PecSys, which allows for a rapid, controlled absorption of the pain killer. Delivering relief quickly is important in treating the intense breakthrough cancer pain that comes on suddenly and can last for up to an hour, Archimedes CEO Jeffrey Buchalter told BioWorld Today.
While Lazanda may be the only intranasal fentanyl product approved for breakthrough pain, it could face new competition from other formulations in the next few years. For instance, Orexo AB is developing OX27 – an opioid successor to its biggest-selling product Abstral, a sublingual formulation of fentanyl – for breakthrough cancer pain. (See BioWorld Today, May 11, 2011.)
Breakthrough pain affects more than half of cancer patients and is currently a $500 million market in the U.S., Higgins said.
Now that Lazanda has FDA approval, Archimedes is building its U.S. sales team, packaging the product and setting up distribution for a fall launch. "It takes a little bit of time to load a product," Buchalter said.
The U.S. approval complements the September 2010 approval for the product in Europe, where it is marketed as PecFent. It is currently available in five countries and will be launched in France in the next few months, Buchalter said.
As for future plans, Archimedes is looking for a partner to take the fentanyl product to market in Asia. There's been interest, Buchalter said, adding that "people see the benefit of this as an intranasal" product.
Archimedes also will study new indications for Lazanda, particularly pediatric use. The product is currently approved for patients 18 and older who are already receiving opioids for underlying cancer pain.
More than 500 patients were involved in Archimedes' clinical trial program for U.S. registration. Lazanda showed a statistically significant improvement compared with placebo on the primary endpoint of pain intensity at 30 minutes post-administration. Onset of pain relief began as early as five minutes after administration, with meaningful relief in 10 minutes.
The Phase III studies covered 42,227 episodes in which Lazanda was self-administered. A single dose was effective in 94 percent of the episodes.
Aside from developing Lazanda for other uses, Archimedes is exploring other drugs that could be enhanced with the biotech's PecSys delivery system, Buchalter said.
In March 2010, Archimedes raised $96.9 million, the biggest fund-raising round by a European company in 15 years, to set up its U.S. operations and begin commercialization of PecFent in Europe. (See BioWorld Today, March 3, 2010.)
The round was led by Novo Growth Equity, the equity fund of Novo A/S, with further backing from Warburg Pincus, which financed the founding of the company by three former executives of Shire Pharmaceuticals Group plc in 2004. At the same time, Buchalter, formerly the president and CEO of Enzon, was appointed to head Archimedes.
Archimedes announced plans in August to set up U.S. operations in Bedminster, N.J., after winning a grant from the New Jersey Economic Development Authority.
Published: July 6, 2011
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