Race to develop anti-PCSK9 will boost Repligen's media sales, says analyst

14-Apr-2014 - Last updated on 15-Apr-2014 at 14:52 GMT

Protein A - essential in the purification process of most mAbs

Development of new anti-choloesterol drugs containing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibiting monoclonal antibodies could double Repligen Bioprocessing’s earning power, according to a Jefferies analyst.

Repligen’s revenues were $68m (€49m) for 2013, with 70% coming from sales of consumable bioprocessing products including native and recombinant forms of Protein A, critical reagents used in biomanufacturing to purify monoclonal antibodies.

However, according to Jefferies’ equity analyst Brandon Couillard, industry’s focus on developing monoclonal antibodies to bind to PCSK9 enzymes, inhibiting them for the next generation of anti-cholesterol drugs, is driving the mAb market and presents a huge growth opportunity for Repligen.

“The anti-PCSK9 mAb class holds significant potential to substantially expand global antibody production volumes,” he said in a note, citing the market being worth up to $18bn by 2025.

“Assuming only 6.5% penetration of the market by 2018, we estimate PCSK9 inhibitors could more than double Repligen’s current earnings power.”

Amgen - who is leading Sanofi/Regeneron and Pfizer in the race to commercialise the first anti-PCSK9 mAb - is already validating its PCSK9 manufacturing processes using Repligen’s growth factors for its candidate Dyslipidemia (evolocumab), Couillard added.

Protein A

The comments were made as part of a report on the biologics industry before beginning coverage of the firm, and Couillard believes Repligen “has emerged as a pure-play bioprocessing consumables vendor leveraged to rising biotech drug volumes and a swelling new monoclonal antibody pipeline.”

One major factor cited by the report is Repligen’s position of holding an effective monopoly in the bulk Protein A market, following its acquisition of Novozyme’s Biosciences business in 2011.

Protein A is an essential component used to filter and purify nearly all monoclonal antibodies, and currently Repligen makes seven various forms of Protein A ligands, covalently bonded to proprietary microscopic beads to create the media.

Therefore Couillard said: “With over 350 mAb-based drugs in development (versus approximately 40 commercial mAbs), Repligen should realize amongst the highest organic growth in the life science tools space over the intermediate-term.”