April 26, 2013

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SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that data from preclinical studies evaluating Ligand’s HepDirect™ liver-targeting technology platform will be featured in a poster presentation at the 48th Annual International Liver Congress hosted by the European Association for the Study of the Liver (EASL) in Amsterdam. The data show highly targeted liver delivery of a clinically active NS5B polymerase inhibitor utilizing the HepDirect technology platform, and demonstrated that HepDirect liver targeting of active nucleosides may be an effective method to improve efficacy while reducing systemic side effects in HCV treatment.

In preclinical studies, Ligand evaluated the pharmacokinetics and liver targeting of LGD-7501, a HepDirect prodrug designed for increased liver targeting compared to other phosphoramidate prodrugs of the same active nucleoside. The compound using HepDirect technology efficiently targeted the liver with greatly reduced systemic distribution in preclinical models, providing further proof-of-concept of the value and utility of the HepDirect technology platform.

“Our HepDirect technology is an important example of Ligand’s diverse portfolio of internal and un-partnered assets and technologies, and has applicability for liver-targeting for a wide range of therapeutic areas, including HCV,” commented Matthew W. Foehr, Chief Operating Officer of Ligand Pharmaceuticals. “These positive findings represent the first preclinical example of HepDirect’s delivery efficiency when directly compared to other prodrugs of the same active nucleoside that have been previously tested clinically.”

About Ligand’s HepDirect HCV Inhibitor Program

HepDirect is a pro-drug technology that targets delivery of certain drugs to the liver by using a proprietary chemical modification that renders a drug biologically inactive until cleaved by a liver-specific enzyme. Antiviral therapies for the treatment of HCV often have significant undesired side effects related to systemic exposure of the compounds. The HepDirect technology may improve the efficacy and/or safety of certain drugs and can be applied to marketed or new drug products.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances with the world's leading pharmaceutical companies including GlaxoSmithKline, Onyx Pharmaceuticals, Merck, Pfizer, Baxter International, Bristol-Myers Squibb, Celgene, Lundbeck Inc., Eli Lilly & Co., Spectrum Pharmaceuticals and The Medicines Company. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains certain forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These statements include those related to the level of targeting, the utility, importance and value of LGD-7501, the HepDirect technology, Ligand’s assets and the HCV Inhibitor program. Actual events or results may differ from our expectations. For example, there can be no assurance that LGD-7501 or other HepDirect or HCV Inhibitor drug candidates will progress through clinical development or receive required regulatory approvals within the expected timelines or at all, that further clinical trials will confirm any safety or other characteristics or profile described in this press release, that there will be a market of any size for such drug candidates or that such drug candidates will be beneficial to patients or successfully marketed. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases available via www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source: Ligand Pharmaceuticals Incorporated

Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
Jennifer Capuzelo, Investor Relations
858-550-7584
jcapuzelo@ligand.com
or
LHA
Don Markley, 310-691-7100
dmarkley@lhai.com

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J_J

July 22, 2011

-Expanding new treatment class for patients with HCV-

Beerse, Belgium, 22 July, 2011 - Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of INCIVO (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin, the previously accepted standard of care.

The CHMP positive opinion is based on results from three phase III clinical trials, ADVANCE1, REALIZE2 and ILLUMINATE3 which evaluated the efficacy and safety of telaprevir in combination with pegylated-interferon and ribavirin in more than 2,290 treatment-naïve and previously-treated genotype 1 HCV patients.1,2,3 Data from ADVANCE and REALIZE were published in the 23rd June edition of the New England Journal of Medicine. Data from the ILLUMINATE study were presented at the 61st annual meeting of the American Association for the Study of Liver Diseases in 2010.

The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. Telaprevir was approved by the U.S. Food and Drug Administration (FDA) in May 2011 and is marketed by Vertex Pharmaceuticals under the brand name INCIVEK. Following marketing authorization approvals, telaprevir will be marketed in the EU and certain other global territories under the brand name INCIVO by the Janssen Companies.

"We are encouraged by this positive decision from the CHMP and will continue to work closely with other regulatory authorities to make telaprevir available for people with HCV. If approved by the European Commission, the addition of telaprevir will offer patients an improved treatment option compared to the previously accepted standard of care, which only cures 40-50 percent of genotype 1 patients" said Ramon Polo, INCIVO Compound Development Team Leader. "Telaprevir is part of Janssen's expanding infectious disease portfolio, which is comprised of innovative therapies in HIV/AIDS, tuberculosis and now HCV that are helping to redefine and improve treatment outcomes. Janssen remains dedicated to improving the lives of patients and supporting healthcare professionals around the world."

About INCIVO
INCIVO is being developed by Tibotec, one of the Janssen Pharmaceutical Companies, in collaboration with Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma. The Janssen Companies have the right to commercialize telaprevir in Europe, Latin America, the Middle East, Africa, India, Australia and New Zealand under the commercial name INCIVO®; Vertex has the right to commercialize telaprevir in North America under the name INCIVEK; Mitsubishi Tanabe Pharma has the right to commercialize telaprevir in Japan and certain Far Eastern countries.

On May 23rd 2011, US FDA approved telaprevir for the treatment of people with chronic genotype 1 hepatitis C with compensated liver disease.

About HCV
HCV is a blood-borne infectious disease that affects the liver.4 With an estimated 170 million people infected worldwide, and three to four million people newly infected each year,5 HCV puts a significant burden on patients and society. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant in Europe.6 The previously accepted standard of treatment for HCV is pegylated-interferon combined with ribavirin,7 however this only cures 40-50 percent of genotype 1 patients.8

About Tibotec
Tibotec Virco-Virology BVBA, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.

About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology , immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.

Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.

More information can be found at www.janssen-emea.com

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Tibotec Virco-Virology BVBA, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Janssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statements as a result of new information or future events or developments.

References:

  1. John G et al. Telaprevir in Combination with Peginterferon and Ribavirin in Genotype 1 HCV Treatment-Naïve Patients: Final Results of Phase 3 ADVANCE study. Paper presented at: The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD); 2010.
  2. Zeuzem S, Andreone P, Pol S et al. REALIZE trial final results: telaprevir-based regimen for genotype 1 hepatitis C virus infection in patients with prior null response, partial response or relapse to peginterferon/ribavirin. Paper presented at: 46th annual meeting of the European Association for the Study of the Liver (EASL); 2011.
  3. Sherman KE et al. Telaprevir in Combination with Peginterferon Alfa2a and Ribavirin for 24 or 48 weeks in Treatment-Naive Genotype 1 HCV Patients who Achieved an Extended Rapid Viral Response: Final Results of Phase 3 ILLUMINATE Study. Paper presented at: The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD); 2010.
  4. Centres for Disease Control and Prevention. Hepatitis C FAQs. [cited 2009 Dec 17] Available from: http://www.cdc.gov/hepatitis/C/cFAQ.htm#transmission.
  5. World Health Organization. Hepatitis C. Weekly Epidemiological Record. 1997;72:65-69.
  6. The Hepatitis C Trust. Treatments: Potential New Drugs. [cited 2010 Feb 20] Available from: http://www.hepctrust.org.uk/treatment/potential-new-drugs/Drugs+that+target+the+virus.
  7. McHutchison J. et al. Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. N Engl J Med. 2009; 361: 580-93.
  8. Simin M et al. Cochrane systematic review: pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C. Alimentary Pharmacology & Therapeutics. 2007; 25(10):1153-62.

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