Status: approved; marketed

Organizations involved:

Allergan, Inc. – Manuf.; R&D; Tech.; World mark

Inamed Corp. – R&D; Tech.; Former

Cross ref.: Note, only this particular collagen derived from cultured human tissue is included in Biopharmaceutical Products in the U.S. and European Markets. Other collagen products derived from bovine (cow) or porcine (pig) tissue are considered natural products (drugs; chemical substances), not biopharmaceuticals (and not included in in this book/database), with their manufacture not dependent on living organism(s), e.g., bovine and porcine collagen are extracted, usually from bones, using severe acid/base, heat/boiling, and/or other harsh conditions.

Description: CosmoDerm and CosmoPlast are sterile aqueous formulations containing collagen derived from cultured human fibroblast cells used for cosmetic indications:, e.g., filling facial lines, wrinkles, scars, and restoration of the lip border. CosmoDerm and CosmoPlast are the only FDA-approved and marketed dermal fillers containing human collagen.

CosmoDerm contains collagen, 35 mg/mL, in phosphate-buffered physiological saline containing 0.3% lidocaine (local anesthetic). CosmoPlast contains collagen, 35 mg/mL, cross-linked with glutaraldehyde, and dispersed in phosphate-buffered saline containing 0.3% lidocaine. The products are packaged in 1 mL prefilled syringes, are stored at 2-10˚C (refrigerated), and have a shelf life of 15 months.

Companies.: CosmoDerm was originally developed, marketed and manufactured by Inamed Corp. Allergan acquired Inamed in early 2006.

Manufacture: The fibroblast cell line used for collagen production is qualified by extensive testing for viruses, retroviruses, cell morphology, karyology, isoenzymes, and tumorigenicity. As the collagen is isolated from the tissue, it is subjected to additional viral inactivation (unspecified). Prior to release, each lot is tested for protein concentration, purity, pH, lidocaine content, residue on ignition, differential scanning calorimetry, extrusion, appearance, sterility, and pyrogenicity.

Nomenclature: Collagen, human [BIO]; CosmoDerm [TR]; CosmoPlast [TR]

FDA class: Medical device PMA

Approvals: Date= 20030311; PMA

Indications: [unofficial] CosmoDerm is indicated to treat fine lines, wrinkles and shallow scars, and for use in thin skin area. CosmoPlast is indicated to treat deep lines furrows and scars, and for use in thick skin areas.

Status: CosmoDerm has receive CE Mark (medical device) approval in the European Union.

Medical: Unlike other collagen dermal filler products, all containing bovine-derived collagen, no skin test is required prior to injection. This allows same-day treatment. Current collagens for dermal injection require a pretreatment skin test, followed by a 28-day period to test for allergic responses. CosmoDerm and CosmoPlast are used for the correction of facial and other wrinkles, glabellar lines ( (between the eyebrows), nasolabial folds (from the root of the nose to the angle of the mouth), vermilion borders, distensible scars and other soft tissue deficiencies. Results generally last 3-6 months, with the collagen absorbed into surrounding tissue and the wrinkles/folds/scars returning to their original shape.

CosmoDerm is injected into the superficial, papillary dermis. Enough material is injected so that the defect is overcorrected 1.5-2.0 times the initial depth of the wrinkle. Cosmo-Plast is used to treat deeper furrow lines or scars. CosmoPlast is injected into the mid-to-deep reticular dermis, with enough material injected so the defect is optimally corrected, but not over-corrected. Careful layering of CosmoDerm over Cosmo-Plast can be performed to eliminate a wrinkle or scar with no overcorrection.

Market: Average Wholesale Prices (AWP) are not available (not in 2007, 2005 or 2004 Red Book).

Same-day use, i.e., no need for 28-day allergy testing, is a major marketing point. The products are promoted as an, “Excellent complement to Botulinum Toxin treatments,” referring to Botox Cosmetic (entry #601).

Competition: Many other collagen products, primarily bovine derived, are on the market. These are not considered to be biopharmaceuticals, since they are derived from death tissue, i.e., their is no dependence on a living source and, particularly no bioprocessing, with the collagen extracted, e.g., from bones, and further processed using high heat (boiling), extreme acid/base conditions, and/or other methods not suited for biological molecules.

In Dec. 2006, FDA approved Radiesse, a calcium particle-based cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds such as nasolabial folds; and for the long-lasting correction of facial fat loss (lipoatrophy) in people with HIV-infection. Radiesse is composed of calcium hydroxylapatite microspheres in a water- based gel carrier.