Rhythm and Camurus Announce License Agreement for Extended Release FluidCrystal Setmelanotide


Boston and Lund, Sweden — 5 January 2016 — Rhythm and Camurus announced today a
license agreement for the use of Camurus’ drug delivery technology,
FluidCrystal®, to formulate setmelanotide (RM-493), Rhythm’s novel melanocortin
-4 receptor (MC4R) agonist. Under the terms of the agreement, Camurus has
granted Rhythm a worldwide license to the FluidCrystal technology to formulate
setmelanotide and to develop, manufacture, and commercialize this new
formulation that has the potential for once-weekly dosing, administered as a
subcutaneous injection. Rhythm plans to initiate a Phase I clinical trial with
the setmelanotide FluidCrystal formulation after completing GMP manufacturing.

“We have developed a setmelanotide formulation with Camurus with an impressive
sustained-duration profile,” said Bart Henderson, President of Rhythm. “We
believe this new formulation will provide a significant benefit to patients,
improving compliance and ease of use with once-weekly dosing.”

“The partnership with Rhythm follows the formulation development and preclinical
assessment of this compelling drug candidate based on our FluidCrystal Injection
depot technology,” said Fredrik Tiberg, President and CEO of Camurus. “Rhythm’s
setmelanotide represents a novel approach to treating patients suffering from
life-threatening obesity due to these rare and serious genetic disorders.”

The license granted to Rhythm is specific to the FluidCrystal technology
incorporating setmelanotide. The formulation has been developed in a
collaboration between the companies. Under the terms of the license agreement,
Rhythm is responsible for manufacturing, development, and commercialization of
the setmelanotide FluidCrystal formulation worldwide. Camurus is eligible to
receive an upfront payment and progressive payments of approximately $65
million, of which the majority are sales milestones. In addition, Camurus is
eligible to receive tiered, mid to mid-high, single digit royalties on future
sales of the product.

About Setmelanotide (RM-493)
Setmelanotide is a potent, first-in-class MC4R agonist in development for the
treatment of obesity caused by genetic deficiencies in the MC4 pathway, a key
pathway in humans that regulates energy expenditure, homeostasis, and appetite.
The critical role of the MC4 pathway in weight regulation was validated with the
discovery that single genetic defects along this pathway result in early-onset
and severe obesity. A Phase 2 setmelanotide trial is ongoing for the treatment
of Prader-Willi syndrome (PWS), a rare genetic disorder that causes life
-threatening obesity. Recent scientific evidence implicates defects in the MC4
pathway as the likely cause of the weight and appetite abnormalities in PWS. A
second Phase 2 trial is ongoing for the treatment of pro-opiomelanocortin (POMC)
deficiency obesity, a very rare, life-threatening genetic disorder of the MC4
pathway associated with unrelenting appetite and obesity.

About FluidCrystal Injection Depot
The FluidCrystal Injection depot delivers therapeutic levels of drug substance
over extended periods — tunable from days to months — from a single injection.
While traditional depot therapeutics comprise complicated microsphere
technology, Camurus' depot offers a liquid solution that transforms into a
controlled release liquid crystal gel matrix in situ on contact with minute
quantities of aqueous fluid at site of injection. The FluidCrystal delivery
system overcomes traditional side effects associated with high initial drug
release on injection (drug burst) and poor drug stability by effectively
encapsulating the drug compound in the nanopores of the depot matrix throughout
the entire process from injection until final degradation. This, together with
the ready-to-use product design, makes the system highly suitable for sustained
parenteral delivery of peptides and proteins. FluidCrystal is a registered
trademark of Camurus AB.

About Rhythm (www.rhythmtx.com)
Rhythm is a biopharmaceutical company focused on developing peptide therapeutics
for the treatment of rare genetic deficiencies that result in life-threatening
metabolic disorders. Rhythm’s lead peptide product candidate is setmelanotide, a
first-in-class melanocortin 4 receptor (MC4R) agonist for the treatment of rare
genetic disorders of obesity. The company is based in Boston, Massachusetts.

About Camurus
Camurus is a Swedish research-based pharmaceutical company committed to
developing and commercialising innovative and differentiated medicines for the
treatment of severe and chronic conditions. New drug products with best-in-class
potential are conceived based on the proprietary FluidCrystal® drug delivery
technologies and an extensive R&D expertise. Camurus’ clinical pipeline includes
products for treatment of cancer, endocrine diseases, pain and addiction,
developed in-house and in collaboration with international pharmaceutical
companies. The company’s shares are listed on Nasdaq Stockholm under the ticker
“CAMX”. For more information, visit www.camurus.com.

Media Contacts

Camurus
Fredrik Tiberg, President & CEO
Tel: +46 (0)46 286 46 92

Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
ir@camurus.com

Rhythm
Bart Henderson, President
Tel.: +1-857-264-4281
bhenderson@rhythmtx.com

The information in this press release is disclosed by Camurus AB in accordance
with the Swedish Securities Markets Act and/or the Swedish Financial Instruments
Trading Act. The information was submitted for publication at 08.00 a.m. CET on
5 January 2016.

Attachments

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