Indevus Pharmaceuticals will launch Supprelin LA (histrelin acetate), a subcutaneous implant, in "early summer" for the treatment of central precocious puberty, the premature onset of puberty in children. The once-yearly gonadotropin-releasing hormone agonist cleared FDA May 3.

"Supprelin LA is the first once-yearly therapy for CPP," Chief Executive Officer Glenn Cooper stated during a conference call announcing the approval May 4. "Currently, these children have one primary treatment option, deep and often painful intramuscular injections of the GnRH agonist leuprolide, given every three to four weeks, often for several years."

Leuprolide is marketed under the brand name Lupron Depot for CPP by TAP Pharmaceuticals.

Lexington, Mass.-based Indevus said it will launch Supprelin LA using a subset of its existing 100-person sales force. Sales reps will target the 700 pediatric endocrinologists in the U.S. who do most of the formal diagnostic work and therapy initiation associated with CPP.

"The relatively small size of this physician audience allows us to optimize our reach in frequency without having to expand the current size of our sales force," Exec VP and Chief Sales and Marketing Officer John Tucker stated. "Although pediatric endocrinologists are clearly the key physician audience, we will also be detailing and educating nurses, physician assistants and other physician specialties that influence how CPP is diagnosed, treated and monitored."

Since Supprelin LA is the first new treatment for CPP in over 13 years, Tucker said the company will spend a considerable amount of time educating healthcare providers on the disease, as well as on treatment options and side effects. CPP is a disorder that affects approximately 20,000 children in the U.S., primarily girls, and is defined as the appearance of physical and hormonal signs of puberty at an early age, generally below the age of eight.

The current market for CPP represented by Lupron Depot is approximately $80 million in the U.S., according to Indevus.

"Supprelin LA, clearly a revolutionary treatment option, can achieve significant market share in this disorder," Cooper predicted.

Indevus plans to price the product "close to" Lupron Depot, which costs about $8,000 to $15,000 a year for the 13-dose regimen, Tucker said.

The Supprelin LA approval was based on data from two clinical studies in children ages four to 11, including a total of 47 children, evaluating treatment over nine to 18 months. A long-term follow up study is ongoing. The most commonly reported adverse event was implant site reaction, which was reported by 51.1 percent of patients, according to labeling.

Supprelin LA is available as a 50 mg subcutaneous implant for the inner upper arm that delivers 65 mcg histrelin acetate per day over 12 months. Labeling for the drug provides details on inserting the implant, a surgical procedure.

Indevus gained the implant through its acquisition of Valera Pharmaceuticals, announced in December, as part of an initiative to build a leading urology and endocrinology-focused specialty pharmaceutical company (¹ Also see "Indevus Gains Supprelin LA With Purchase Of Valera" - Pink Sheet, 12 December, 2006.).

The acquisition also included Valera's prostate cancer implant Vantas (histrelin) and the bladder cancer therapy Valstar (valrubicin), which was approved in 1998 but removed from the market in 2002 due to manufacturing issues around stability of an inactive ingredient. Indevus recently submitted a supplemental NDA to reintroduce Valstar by the end of the year, claiming that the stability issues have been resolved (² Also see "Indevus Plans To Relaunch Valstar By Year-End" - Pink Sheet, 20 April, 2007.).

Indevus is also anticipating approval and launch of a once-daily form of its incontinence therapy Sanctura (trospium) in early fall, the firm said.

-Jessica Merrill (j.merrill@elsevier.com)

Indevus' Supprelin LA Clears FDA As Once-Yearly Treatment For Premature Puberty

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