Mallinckrodt wins exclusive worldwide licenseIn a move that marks a major milestone for the company, startup biopharmaceutical firm Palatin Technologies this month signed a letter of intent with Mallinckrodt for a marketing alliance covering
Mallinckrodt wins exclusive worldwide license
In a move that marks a major milestone for the company, startup biopharmaceutical firm Palatin Technologies this month signed a letter of intent with Mallinckrodt for a marketing alliance covering Palatins radiolabeled infection imaging agent, LeuTech. When finalized, the deal will give Palatin access to Mallinckrodts extensive distribution network, while Mallinckrodt will gain exclusive rights to a product it believes will become the standard for diagnosing infections like appendicitis. The two firms expect to complete a formal agreement within 60 days.
The May 17 letter of intent states that Princeton, NJ-based Palatin will complete the development of LeuTech and Mallinckrodt will market, sell, and distribute LeuTech products exclusively worldwide, except in Europe. In addition to milestone payments, Mallinckrodt will fund 50% of the development and clinical testing expenses of LeuTech, and will pay Palatin for rights to the product, as well as a royalty on net sales. For an estimated $13 million, the St. Louis-based company will purchase 700,000 shares of convertible preferred stock from Palatin, with the option to convert to common stock after five years.
LeuTech is being developed for imaging such infections as appendicitis and osteomyelitis using a monoclonal antibody and the necessary reagents labeled with technetium. The agent binds to white blood cells in vivo, which means that LeuTech can be injected and white cells labeled without technologists having to draw blood from the patient.
Todays products require (technologists) to draw blood, spin it down, separate out the white cells, perform some chemistry, label the cells with technetium, and then reinject the solution, said Charles Putnam, Palatin COO. All that blood handling creates risk for healthcare providers and patients, and it takes time and money. So a directly injectable white cell labeling technology is an attractive product.
Palatin has its roots in RhoMed, a company established in the early 1990s by Buck Rhodes, formerly at the College of Pharmacy at the University of New Mexico, to develop novel radiopharmaceuticals. RhoMed went public in 1996 and changed its name to Palatin. The company employs 29 people.
Although there are other firms developing direct injection infection imaging products, Palatin believes LeuTech boasts some distinct advantages, according to Putnam. Other direct injection kits take four to six hours to produce an image, according to the company. LeuTech can produce a negative diagnosis in approximately 60 to 90 minutes and a positive diagnosis in 30 to 45 minutes.
Palatin has completed multisite phase III trials that it began last fall (SCAN 8/19/98), and plans to submit a biologic license application (BLA) for LeuTech to the Food and Drug Administration in July. LeuTech should receive clearance six to 12 months after Palatin submits the BLA, Putnam said. After the FDA approves LeuTechs initial BLA, which covers appendicitis, the company plans to seek regulatory approval for other infection indications such as osteomyelitis, infected prosthesis, fever of unknown origin, and localization of abscess.
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