Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis

Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI
                Results, in Patients with Rheumatoid Arthritis

- Baricitinib advancing into Phase III trials for rheumatoid arthritis -

Lilly and Incyte to host a webcast for investors featuring these results
today, Nov. 13 at 7 p.m. ET

PR Newswire

WASHINGTON, Nov. 13, 2012

WASHINGTON, Nov. 13, 2012 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY)
and Incyte Corporation (Nasdaq: INCY) today announced 24-week results from the
continuation of an ongoing Phase IIb study of baricitinib, an orally available
janus kinase (JAK) inhibitor, in patients with moderate-to-severe rheumatoid
arthritis (RA) who had an inadequate response to treatment with methotrexate.
Additionally, Magnetic Resonance Imaging (MRI) technology was used in a
sub-study to examine the effect of baricitinib on joint erosion and other
markers of structural changes in and around the joint. The findings were
presented at the annual meeting of the American College of Rheumatology (ACR)
in Washington, D.C.

Positive results of the placebo-controlled 12-week portion of the study were
presented at the European League Against Rheumatism's (EULAR) Annual European
Congress of Rheumatology in June 2012.[1] Patients taking baricitinib 4 mg or
8 mg once daily reported significant differences in ACR20, ACR50 and ACR70
responses compared with patients taking placebo. Data from the 12- to 24-week
portion of the study, which did not include a placebo control, showed that
patients who continued to receive 2 mg, 4 mg or 8 mg baricitinib once daily
doses maintained or improved ACR20, ACR50 and ACR70 responses. The following
chart defines the percentage of patients that achieved ACR20, ACR50 and ACR70
at 24 weeks of treatment with baricitinib.

                     2 mg    4 mg   8 mg
Response at 24 weeks         (n=52) (n=50)
                     (n=52)
ACR20                63      78     73
ACR50                20      48     55
ACR70                10      28     24

"These data are important because collectively they show patients experienced
improvement with baricitinib as early as week two that was sustained through
week 24," said Mark Genovese, M.D., the James Raitt professor of medicine and
co-chief, division of immunology and rheumatology at Stanford University
School of Medicine in Palo Alto, Calif., and steering committee member for the
study. "Also of note is that the percentage of patients achieving ACR50 and
ACR70 increased over time and no unexpected safety findings emerged with
continued dosing."

Also Presented: MRI Findings
The study also included a large sub-study of 154 patients using Magnetic
Resonance Imaging to examine the effect of different doses of baricitinib on
joint changes in a subgroup of patients with erosive RA and inadequate
response to treatment with methotrexate. There was statistically significant
improvement in both the Total Inflammation Score and the Total Joint Damage
Score for both 4 mg and 8 mg baricitinib doses compared with placebo at 12
weeks. The effects persisted through 24 weeks.

"This sub-study illustrates not only the efficacy of oral baricitinib in
suppressing joint damage in RA, but also the power of MRI to demonstrate
therapeutic effects in RA on synovitis, osteitis, bone erosion and even
articular cartilage loss far more quickly (within only 12 weeks) and with far
fewer patients than would be needed with conventional radiography," said
Charles Peterfy, M.D., Ph.D., president and CEO of Spire Sciences LLC, who
performed the image analyses.

"We believe the janus kinase inhibitors are an innovative class of molecules
which we hope have the potential to improve outcomes for patients with
diseases such as rheumatoid arthritis. We are very encouraged about the
results for baricitinib, which represent the first 24-week clinical data for a
selective JAK1 and JAK2 inhibitor in RA," said Eiry Roberts, M.D., vice
president of autoimmune product development at Lilly. "Based on the
benefit/risk data from the Phase II program for baricitinib, we recently moved
ahead with Phase III clinical trials in RA."

Safety Results
In the 12-week portion of the study, the most common treatment-emergent
adverse event (TEAE) class was infections, with a similar rate observed among
patients in the placebo group (12 percent) and patients receiving baricitinib
(14 percent).

Over 24 weeks in the combined 2 mg, 4 mg and 8 mg groups, the rate of TEAEs
was 64 percent (36 percent mild, 23 percent moderate, 5 percent severe) and
the rate of serious adverse events was 5 percent.

There were no opportunistic infections and no deaths reported through week 24.
Dose-dependent changes in laboratory tests (hemoglobin, lymphocyte and
neutrophil count, low-density lipoprotein and high-density lipoprotein) were
observed, with greater changes being observed in the 8 mg baricitinib group
than in the 2 mg and 4 mg groups.

Trial Design and Status
This Phase IIb randomized double-blind, placebo-controlled, dose-ranging
study, known as JADA, included 301 patients with moderate-to-severe RA with
inadequate response to treatment with methotrexate.

In the initial 12-week treatment duration, patients received one of four doses
of baricitinib or placebo. In the 12- to 24-week portion of the study,
patients initially randomized to placebo or the 1 mg baricitinib dose were
re-randomized to receive either 4 mg once daily or 2 mg twice daily for an
additional 12 weeks; patients initially randomized to the 2 mg, 4 mg and 8 mg
doses continued therapy with those doses. Patients are continuing to
participate in the open-label long-term extension phase of the trial.

About JAK Inhibition
There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. These enzymes are
critical components of signaling mechanisms used by a number of cytokines and
growth factors, including those that are elevated in RA patients. Cytokines
such as interleukin-6, -12 and -23 and both type 1 and type 2 interferons
signal through the JAK/STAT pathways. Additional JAK-dependent cytokines also
have been implicated in a number of inflammatory and autoimmune diseases,
suggesting that JAK inhibitors may be useful for the treatment of a broad
range of inflammatory conditions.

About Baricitinib
Baricitinib is an orally administered selective JAK1 and JAK2 inhibitor that
spares JAK3. Baricitinib is advancing into Phase III development as a
potential treatment for rheumatoid arthritis and it is in Phase II development
as a potential treatment for psoriasis and diabetic nephropathy.

Four Phase III RA studies are planned, which will investigate the safety and
efficacy of baricitinib 2 mg and 4 mg once daily in patients with active RA
who are methotrexate-naive, biologic-naive or biologic-experienced.Patients
completing any of the four studies will be eligible for enrollment in a fifth
study, a long-term extension.

In December 2009, Lilly and Incyte announced an exclusive worldwide license
and collaboration agreement for the development and commercialization of
baricitinib and certain follow-on compounds for inflammatory and autoimmune
diseases.

About Rheumatoid Arthritis
Rheumatoid arthritis is characterized by abnormal immune mechanisms that lead
to joint inflammation and swelling with progressive destruction of joints. In
addition to affecting the joints, RA also can affect connective tissue in the
skin and organs of the body.[2]

Current treatment of RA includes the use of non-steroidal anti-inflammatory
drugs, oral disease-modifying antirheumatic drugs such as methotrexate, and
injectable biological response modifiers that target tumor necrosis factor, a
pro-inflammatory cytokine implicated in the pathogenesis of RA.

About the Webcast
Lilly and Incyte are hosting an investor meeting to discuss the baricitinib
Phase II RA data presented at ACR. The presentation will be webcast live at 7
p.m. ET on Nov. 13, 2012 and will be available as a replay on both Lilly's
website at http://investor.lilly.com/events.cfm and Incyte's website at
http://www.incyte.com/ under Investor Relations, Events and Webcasts.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers –
through medicines and information – for some of the world's most urgent
medical needs. Additional information about Lilly is available at
http://www.lilly.com/.

About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company
focused on the discovery, development and commercialization of proprietary
small molecule drugs for oncology and inflammation. For additional information
on Incyte, please visit the Company's website at http://www.incyte.com/.

This press release contains certain forward-looking statements about
baricitinib as a potential treatment for patients with rheumatoid arthritis
and reflects Lilly and Incyte's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and uncertainties in the
process of development and commercialization. There is no guarantee that
future study results and patient experience will be consistent with study
findings to date or that the product will be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's and
Incyte's filings with the United States Securities and Exchange Commission.
Lilly and Incyte undertake no duty to update forward-looking statements.

P-LLY

[1] Edward Keystone, "Safety and Efficacy of LY3009104 (JAK1/JAK2 inhibitor)
in RA Patients with Inadequate Response to MTX" (presented at the Annual
European Congress of Rheumatology, presented by the European League Against
Rheumatism, Berlin, Germany, June 2012).

[2] Arthritis Foundation, What is Rheumatoid Arthritis,
http://www.arthritis.org/types-what-is-rheumatoid-arthritis.php (Accessed: May
1, 2012).

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SOURCE Eli Lilly and Company; Incyte Corporation

Website: http://www.lilly.com
Website: http://www.incyte.com
Contact: Lilly: Media: Sonja Popp-Stahly, +1-317-655-2993,
spopp-stahly@lilly.com; Investors: Phil Johnson, +1-317-655-6874,
johnson_philip_l@lilly.com; Incyte: Media and Investors: Pam Murphy,
+1-302-498-6944, pmurphy@incyte.com
 
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