BioWorld International Correspondent
BioPartners GmbH, as expected, became the second company to receive regulatory approval from the European Commission for a generic biologic drug.
Valtropin, its "biosimilar" version of the recombinant human growth hormone somatropin, gained formal approval from the commission last week, following a positive opinion from the London-based European Medicine Agency's (EMEA) Committee of Medicinal and Human Products (CHMP), which was handed down Feb. 23.
The hormone is approved for three pediatric indications - children with growth failure due to inadequate secretion of growth hormone; short stature in children with Turner syndrome, confirmed by chromosome analysis; and growth retardation in pre-pubertal children with chronic renal insufficiency. It also is approved as replacement therapy in adults.
Valtropin's approval follows that of Omnitrope (somatropin), developed by Holzkirchen, Germany-based Sandoz GmbH, a subsidiary of Basel, Switzerland-based Novartis AG. The Valtropin dossier was based on the use of Humatrope, marketed by Eli Lilly and Co., of Indianapolis, as the reference drug. The EMEA review commenced on July 19, 2004, and had an active review time of 179 days.
BioPartners, of Baar, Switzerland, plans to market Valtropin via distributors, said Marie-Joëlle Gaufrès, head of commercial operations. It has appointed two so far - Cambridge Laboratories Ltd., of Wallsend, UK, and Nycomed ApS, of Roskilde, Denmark, which will sell the drug in the UK and Scandinavia, respectively.
"We are still negotiating with other ones," Gaufrès said. BioPartners has a 10-year agreement with The Medical House plc, of Sheffield, UK, which is supplying its needle-free device for delivery of the peptide.
BioPartners licensed European and Asian rights to Valtropin from LG Life Sciences, of Seoul, South Korea. The two companies co-developed the molecule together. LG Life Sciences, which owns the American rights, will receive a royalty on product sales in other territories, Gaufrès said. LG now intends to seek FDA approval for the product.
BioPartners also has submitted for approval a sustained-release version of Valtropin. "We are waiting for the [CHMP's] opinion before the end of May," Gaufrès said. It is also developing a version of interferon alpha for treatment of hepatitis C infection.