Karo Bio AB is a biopharmaceutical company that specializes in utilizing nuclear receptors for the development of pharmaceuticals targeting metabolic diseases, such as dyslipidemia, diabetes, inflammation and various diseases affecting women’s health. The Company’s product development portfolio includes Eprotirome, a drug against dyslipidemia; ER-beta selective compounds, against depression, inflammation, cancer, pain and women’s diseases and KB3305, a drug against type 2 diabetes. The Company also runs partner projects together with such companies as Merck & Co., Wyeth Pharmaceutical and Zydus Cadila. The Company reports one segment, Research and Development of Drugs. Karo Bio AB reports one wholly owned, dormant subsidiary, Karo Bio Research AB and is active in Europe and the United States.


Karo Bio entered into a collaboration agreement with the Wyeth-Ayerst division of American Home Products focusing on the Liver X receptor (LXR) with the goal of developing an entirely new drug for the prevention and treatment of atherosclerosis.
Bristol-Myers Squibb filed an IND and initiated Phase I clinical studies for an obesity treatment candidate jointly discovered with Karo Bio in their ongoing collaboration.
U.S. Patent granted to Karo Bio for desirable effects of thyroid hormone and thyroid analogs upon the composition of treated skin.
U.S. Patent granted on estrogen receptor beta crystal structures.
In collaboration with Abbott Laboratories, Karo Bio solved the glucocorticoid receptor 3D structure.
A new technology for lead compound characterization and selection was in-licensed from Duke University, Durham, North Carolina.

A clinical development candidate was selected in July in the project with Merck & Co., Inc. for development of compounds targeting estrogen receptors and Karo Bio received a significant milestone payment.
Promising compounds were generated in the collaboration with Bristol-Myers Squibb for treatment of obesity. The first compound in clinical development was abandoned due to potential toxic effects. The collaboration was extended for an additional six months until March 31, 2003.
Project goals in the Aventis Biokeyr collaboration were achieved. Milestone payments received.
41 new patents were granted during the year. Most significant were US patents for compounds targeting glucocorticoid and thyroid hormone receptors for treatment of metabolic disorders.

A preclinical milestone for a second compound was reached and a milestone payment was received in May in the Merck&Co., Inc. collaboration.
Karo Bio obtained all rights to compounds and technologies, including the A-348441 lead compound, in the collaboration with Abbott Laboratories in November. Karo Bio has selected the A-348441 compound from the Abbott collaboration as a candidate drug for type 2 diabetes.
A reorganiziation and consolidation of research operations to Sweden was carried out in January and November, resulting in lower cost-base and increased efficiency.
In August, Merck&Co., Inc. decided to discontinue the development of the first drug candidate selected in 2002.
A fully subscribed new share issue was successfully completed in May, generating MSEK 18.6

The collaboration project with Wyeth Pharmaceuticals on atherosclerosis advanced to predevelopment status in June 2004, yielding a milestone payment to Karo Bio. Research terms extended with one year through August 2005.
Bristol-Myers Squibb decided to return project rights, including lead compound KB2115, to Karo Bio in April 2004.
Cost savings initiatives, including a staff reduction, was implemented to re-allocate resources to drug development activities.
Successful new share issue completed in October 2004, generating in total MSEK 119.6 before transaction cost

Per Olof Wallström was appointed President of Karo Bio in March.
Karo Bio decided in September to modify its strategy. In addition to the current partnership based model, Karo Bio will bring selected compounds to late stage clinical development.
Phase I clinical study with KB2115 successfully completed. The goal is to initiate phase II clinical studies in the second half of 2006.
Clinical and preclinical development organization strengthened with specific competences to increase the chances of being successful in clinical development projects.
The collaboration with Wyeth Pharmaceuticals was extended in August for an additional year until August31, 2006.
Significant milestone from Merck & Co. was trigged in January for initiation of phase I clinical trials. In April, the development was discontinued due to adverse findings in animals. Additional compounds continue to be evaluated in preclinical studies for their potential to advance to clinical study.
Successful new share issue completed in December, generating MSEK 263.4 after transaction costs.

Karo Bio completed phase I clinical trials with KB2115 and the first phase II study is ongoing
Karo Bio received a milstone payment from Wyeth for selection of a candidate drug and an additional milestone payment for initiation of phase I clinical studies. The collaboration was extended for an additional year until August 31, 2007
KB5359 was selected as a candidate drug for treatment of dyslipidemia and preclinical development was initiated
The clinical development of KB3305 was delayed due to technical issues with the pharmaceutical formulation
Merck initiated phase I clinical studies in the field of estrogen receptors and women’s health with a collaboration compound
Karo Bio outlicensed a class of selective androgen receptor modulators (SARMs) for treatment of osteoporosis to Radius

A new share issue brings just over MSEK400 to the company before transaction costs.
The frst phase II study with KB2115 was finalized with positive results
KB5359, an alternative thyroid receptor stimulating compound for hyperlipidemia, was stopped due to toxicological findings
Merck stopped the development of an estrogen receptor compound after clinical phase I
Wyeth stopped the development of an LXR-receptor stimulating compound after clinical phase I
Dr Leon Rosenberg was elected Chairman of the Board succeeding Per-Olof Mårtensson
Clinical phase I was initiated for Karo Bio’s compound KB3305, indicated for type 2 diabetes
Clinical phase IIb studies started with KB2115 as add on to statins
Eprotirome approved as INN-name for KB2115.

Merck & Co., Inc. enters phase I clinical development with Karo Bio collaboration compound
Karo Bio and Wyeth extend research collaboration and target inflammation
Successful phase II study expands the potential for eprotirome in dyslipidemia treatment
Karo Bio announces successful phase II study with eprotirome in combination with statin
Positive results in first clinical study with anti diabetes compound KB3305
Karo Bio strengthens eprotirome phase II program with additional clinical study
Karo Bio and Zydus Cadila sign research agreement for development of novel drugs to treat inflammatory diseases
Karo Bio reacquires rights to SARM compounds from Radius

Financial platform for the coming 18 months secured through a rights issue of MSEK 166
Two smaller human pharmacological studies of eprotirome, for the treatment of dyslipidemia, were performed to supplement the clinical documentation
Within the estrogen receptor (ER-beta) program, the compound KB9520 was nominated as candidate drug and preclinical development was initiated
Merck initiated clinical phase II studies with MK-6913, the lead investigational drug candidate within the joint collaboration around estrogen receptors (ER) and women’s heath
From September, Wyeth has taken on all research and development activities under the drug discovery collaboration regarding the Liver-X receptor (LXR) and inflammation
Positive proof of principle data for KB3305 in diabetic patients
Decision taken not to do further in-house development of KB3305
Karo Bio AB is a Swedish pharmaceutical company, specializing in nuclear receptors for the development of novel pharmaceuticals with focus on metabolic diseases. The company has expanded from being a drug discovery company by adding in-house preclinical development resources and competence for development of drugs to treat metabolic diseases. The company has a project portfolio that primarily targets a number of diseases such as diabetes, obesity, atherosclerosis and dyslipidemia.
In addition, Karo Bio has two strategic collaborations with international pharmaceutical concerns and one biotech collaboration for development of innovative therapies for the treatment of common diseases. Some of the company’s business partners include Merck & Co., Inc. (estrogen receptors), Radius Health, Inc. (osteoporosis), as well as Wyeth Pharmaceuticals (for atherosclerosis).
The mission of Karo Bio is to develop novel pharmaceuticals for treatment of metabolic diseases. The company was founded in the late 1980s, with a focus on drug discovery targeting nuclear receptors and a project pipeline with innovative and competitive projects was established. Several of these projects were partnered with global pharmaceutical companies at an early stage of development. Karo Bio is listed on the Stockholm stock exchange since 1998. In August 2006, Karo Bio’s partners Merck and Wyeth entered Phase I clinical development with collaboration compounds in the fields of women’s health care and atherosclerosis respectively. An active firm, Karo Bio AB is headquartered in Hudinge, Sweden.

Group or Branch:

Hälsovägen 7 141 57, HUDDINGE, SWEDEN
+46 8 608 6000
+46 8 774 8261
[email protected]

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