Mallinckrodt buys US drug licensing rights from Neuromed

[Tchort]

6/19/2009

St.Louis Business Journal

Covidien’s pharmaceutical products subsidiary Mallinckrodt Inc. has acquired the licensing rights to a drug candidate from Neuromed Pharmaceuticals Ltd in Canada.

Mallinckrodt bought the licensing rights for ExalgoTM, a formulation of an opioid analgesic, for an undisclosed sum.

This formulation of hydromorphone was developed by Mountain View, Calif.-based ALZA Corp. In 2007, Neuromed acquired the U.S. marketing rights to Exalgo from ALZA.

Mallinckrodt will be responsible for all commercialization activities for Exalgo in the United States, including marketing and sales.

Neuromed will work to complete the clinical development and the regulatory approval process.

Mallinckrodt Inc. will be responsible for all regulatory filings post-FDA approval. For a specified period, ALZA will remain responsible for the manufacturing, packaging and supply of Exalgo. The intellectual property covering the hydromorphone formulation under review will be owned by ALZA.

Neuromed has received a one-time upfront payment and could receive additional development and, if Exalgo is approved, regulatory approval milestone payments as well. ALZA will also receive regulatory milestone payments. In addition, Covidien will pay royalties to Neuromed and ALZA based on commercial sales of Exalgo.

Covidien expects that the upfront payment noted above, in combination with the payment to Nuvo Research announced Tuesday, will result in its fiscal third quarter research and development expense being higher than previously anticipated.

Covidien plc, formerly known as Tyco Healthcare, operates Covidien Imaging Solutions and Pharmaceutical Products, also known as Mallinckrodt Inc., which is located in St. Louis and provides medical imaging technology and pharmaceuticals. Covidien was spun off from Tyco International Ltd. in 2007.

With 2008 revenue of nearly $10 billion, Covidien has 3,000 employees in the St. Louis area and more than 41,000 employees worldwide.

http://www.bizjournals.com/stlouis/stories/2009/06/15/daily38.html

3 notes for readers:

1) Exalgo is Hydromorphone in extended-release tablet form.

2) ALZA is responsible for the extended-release matrix found in Concerta.

3) This means we will have Hydromorphone extended-release tablets in the US again soon!.

Rach posted about Jurnista elsewhere on the forum. Jurnista is a new high dose extended release Hydromorphone tablet found in European/Asian countries which contains the ALZA ER matrix. This is going to be the North American equivalent of Jurnista.

 

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About Exalgo


Neuromed acquired from ALZA Corporation the U.S. marketing rights to Exalgo, an extended release formulation of hydromorphone. Hydromorphone is a Schedule II opioid that has been used for many years. Oral hydromorphone products currently available in the U.S. are immediate release formulations, requiring dosing several times per day. Exalgo, if approved, will employ the OROS(R) PUSH-PULL(TM) osmotic delivery system designed to release hydromorphone at a controlled rate over an extended period of time. An identical formulation, under the trade name JURNISTA(R), has been launched in several countries by Janssen-Cilag. JURNISTA(R) was first launched in Germany in August 2006.

Exalgo is an investigational drug and has not been approved by the FDA. To date, Exalgo has been studied in more than 2,000 patients in clinical trials. The most common adverse events seen in those clinical trials to date are opioid-related events such as constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including Exalgo.

The OROS(R) Push-Pull matrix is what is present in Concerta and Jurnista, and is the creation of ALZA. I wonder if this means if you break the shell you'll have a white side (HM) and a green side (time release)? Wouldn't that be humorous. Given the history of Palladone in the US.