By Brady Huggett
Alkermes Inc., providing the delivery method for the anti-psychotic drug Risperdal, and partner Janssen Pharmaceutica NV completed two Phase III trials and are preparing for a new drug application filing.
Data analysis from the two multicenter trials of an intramuscular injectable sustained-release formulation of Risperdal is under way. The formulation is based on Alkermes' Medisorb injectable drug-delivery system.
"[Trial completion] is a significant milestone for the company and is another validation of our technology platform," said Rebecca Peterson, director, investor relations at Alkermes. "With this formulation there is a potential to offer a better quality of life for a broader range of patients as a result of superior efficacy and safety profiles."
The sustained-release formulation allows two weeks between injections and is especially important when considering the patient base, Peterson said.
"The reason why it is being developed is to enhance compliance," Peterson said. Peterson added that patients suffering from symptoms of their affliction often have difficulty taking medication on their own.
Alkermes, of Cambridge, Mass., has not released a time frame for the NDA filing. Alkermes and Janssen, a Beerse, Belgium, Johnson & Johnson unit, began working on the formulation in 1996, under a $20 million collaboration. At the time, the drug itself was not disclosed, but at the outset of Phase III trials, the companies released that Risperdal was being tested with the Medisorb technology. (See BioWorld Today, Oct. 28, 1996, and April 23, 1999.)
Alkermes focuses on controlled, sustained release of injectable drugs using its ProLease, Medisorb and AIR pulmonary technologies. It managed to put five products into the clinic last year.
"We also have in the Alkermes' pipeline Medisorb Naltrexone," Peterson said. "It's an intramuscular injection given every four weeks to potentially treat alcoholism and opiate addiction. It's already on the market in pill form, but this is another instance where compliance could be enhanced."
Peterson said Alkermes has ProLease technology applied to several products, including Nutropin Depot, partnered with Genentech Inc., of South San Francisco. The drug is for growth hormone deficiency in children and was approved in December 1999. Peterson said the companies will do a pivotal trial in adults that is expected to begin sometime in the first half of 2001. (See BioWorld Today, Dec. 27, 1999.)
Its AIR product line focuses on drug delivery to the lungs. Alkermes is working on a long-acting formulation of Albuterol, for the treatment of asthma, and a pulmonary insulin product. Both are proprietary, but Alkermes is partnered with GlaxoSmithKline plc, of Brentford, UK, in a pulmonary relationship that covers four therapeutic categories.
In separate news, Alkermes said it is calling the remaining approximately 1.7 million shares of its $3.25 convertible exchangeable preferred stock for redemption on March 8. Upon redemption, Alkermes will pay the holders $52.275 per share, plus all accrued and unpaid dividends. Holders are entitled to convert their shares of preferred stock into 3.375 shares of common stock, and, based on the current market price, Alkermes anticipates holders will choose that option. If all shares are converted, Alkermes will issue approximately 6 million common shares, increasing its total shares outstanding to 63.1 million shares. If none of the shares of preferred stock is converted, Alkermes will make an aggregate redemption payment of about $92.4 million, plus accrued and unpaid dividends.
Alkermes' stock (NASDAQ:ALKS) closed unchanged Tuesday at $31.937. n