This biopharma has a new distribution agreement for its obesity drug, and is expected to grow by 47% this year, then 16.1% annually over the next five years.
Rhythm Pharmaceuticals, Inc. (RYTM)
From Canaccord Genuity Research
Rhythm Pharmaceuticals announced an exclusive distribution agreement with Medison Pharma to commercialize Imcivree in Israel. With the exclusive distribution agreement with Medison Pharma, positive Committee for Medicinal Products for Human Use (CHMP) opinion for Imcivree, and dataflow paving the way for potential setmelanotide utility in additional MC4R-driven obesity indications, we reiterate our BUY.
Medison is a global pharmaceutical company and one of the top three in Israel by sales. Medison Pharma provides a full spectrum of services, including registration, reimbursement, distribution, marketing for biotech companies looking to enter markets in Israel. We view the expansion of RYTM’s commercial footprint into Israel as a positive.
CHMP issued positive opinion for Imcivree for proopiomelanocortin (POMC)/ leptin receptor (LEPR)/ proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency; on track for mid-21 European Medicines Agency (EMA) approval. In May, RYTM announced CHMP adopted a positive opinion for Imcivree for the treatment of obesity due to LEPR, POMC, PCSK1 deficiencies in adults and children of >6yo. We continue to expect EMA approval mid-21. Imcivree has EU PRIority MEdicines (PRIME) designation.
At ENDO21 in March, 52-week data from the Ph3 was presented: of 32 Ph3 Bardet-Biedl Syndrome (BBS) + 6 Alstrom Syndrome (AS) patients, 34.5% of those ≥12yo (n=31) achieved the primary endpoint of ≥10% WL (all had BBS) and 60.2% achieved ≥25% reduction in maximal hunger score weekly after 52wks setmelanotide. For 16 BBS patients ≥18yo, setmelanotide significantly decreased (-24.5%, p=0.0006) BMI Z score, which Management indicates is more meaningful for adolescents normally gaining height and weight. In 2H21,
RYTM plans to present full Ph3 data and file with FDA and EMA for BBS. We note relevant fall/winter medical meetings include European Society for Paediatric Endocrinology (ESPE) September 22-26, Obesity Medicine Association’s (OMA)'s Overcoming Obesity meeting September 23-26, the Obesity Society’s Obesity Week November 1-5.
In 2H21, we expect full Imcivree Ph3 BBS/Alstrom data presentation (including the previously excluded placebo period data) at a fall medical meeting (potentially ESPE Sept 22-26, OMA Sept 23-26, Obesity Week Nov 1-5) and Ph2 exploratory basket topline as well as clinical trial starts for setmelanotide Ph3 SRC1/SH2B1/HETs, Ph2 hypothalamic obesity, , Ph2 exploratory MC4R pathway (31 gene) basket, pediatric studies, and registrational weekly formulation studies.
Arlinda Lee, Ph.D., and Benedict Shim, Canaccord Genuity Research, canaccordgenuity.com, July 23, 2021