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Transition Therapeutics Announces Development Update

April 7, 2014

TORONTO, April 7, 2014 /PRNewswire/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI) (TSX: TTH) provided an
update on the development of its drug candidates and plans for future
growth. The addition of the neuropsychiatric drug candidate ELND005
has broadened the Company’s development pipeline with an un-partnered
late-stage clinical asset, coupled with Transition’s core strategy of
advancing assets acquired from pharmaceutical partners. From a
corporate standpoint, the Company will seek to leverage the economic
benefits of ELND005 and future in-licensed assets through its recently
acquired Irish domiciled subsidiary, Transition Therapeutics Ireland
Limited. The Company has completed a rigorous evaluation of each of
its development programs with the intent to implement a balanced
strategy for growth in three key areas: late stage development of
ELND005 in neuropsychiatric indications, Phase 2 development of
diabetes drug candidate TT401, and capacity for the addition of one or
two new in-licensed programs. A conference call will be held on
Monday, April 7, 2014 at 8:30am Eastern time to discuss the development
update with investors.

ELND005 – Neuropsychiatric Drug Candidate

On February 28, 2014, Transition acquired all the development and
commercialization rights to neuropsychiatric drug candidate, ELND005.
With completion of this transaction, the Company took control of three
ongoing Phase 2 trials investigating ELND005 in Agitation and
Aggression in Alzheimer’s disease (“AD”), Bipolar Disorder Maintenance
and Down Syndrome Cognition at various stages of enrollment. The
Company’s highest priority was to first evaluate all of the data
available from previously completed and ongoing clinical trials, assess
the likelihood of success for each indication, analyze the costs to
complete each trial, and lastly ensure that integrity of the trials and
data generated will be maintained to completion.

Agitation and Aggression in AD: Transition has reviewed all the
Agitation and Aggression data from the previously completed phase 2
trials in mild to moderate Alzheimer’s Disease (AD201 and AD251), as
well as all of the blinded data from the large ongoing ELND005 clinical
trials of Agitation and Aggression (AG201 and AG251). Based on this
in-depth review and analysis, Transition is fully committed to
allocating all the financial and human resources necessary to support
the Phase 2 study evaluating ELND005 in mild to severe Alzheimer’s
disease patients who are experiencing agitation and aggression. This
ongoing clinical study (AG201) is called the “Harmony AD” study (www.harmonyadstudy.com) and has a projected enrollment of up to 400 subjects. Transition
expects enrollment to be completed by the first quarter of 2015 with
results from the study expected in mid-2015. A safety extension study
(Study “AG251″) is ongoing and is enrolling subjects who have completed
the placebo-controlled “HarmonyAD” study. To date, the large majority
of subjects completing the “HarmonyAD” study are participating in the
AG251 extension study. This Agitation and Aggression in AD program has
received fast track status from the United States Food and Drug
Administration.

The Phase 2a study of ELND005 in young adult subjects with Down Syndrome
is near completion of enrollment. This study evaluates the safety,
pharmacokinetics of ELND005 and includes selected cognitive and
behavioral measures over a one-month treatment period. The data from
this study are expected to be available in the third quarter of
calendar 2014. Following the completion of this study, depending on
the data and the advice from regulatory agencies and experts in the
field, the next step in development would be a larger Phase 2b study in
Down syndrome subjects.

With the focus of ELND005 development on Alzheimer’s disease and Down
Syndrome, Transition has decided to discontinue the Bipolar Disorder
Maintenance study (BPD201). The decision followed a commercial
assessment of the size and length of study, costs and timelines for
completion. This decision was not based on any analysis of efficacy
data (blinded or unblinded), since the number of subjects who completed
the randomized phase of the trial was too small. There were no
adverse safety findings that contributed to this decision. Regular
evaluations by the study’s independent safety monitoring committee have
supported the continuation of the study with no changes. This study
will provide valuable safety data from approximately 300 subjects and
imaging data in a subset of patients that will support the ELND005
program.

Overall, there is a very comprehensive package of clinical and
non-clinical data that continues to support the ELND005 programs in AD
and Down Syndrome. In the coming months, Transition will be presenting
data from three additional ELND005 Phase 1 studies demonstrating the
metabolism, renal clearance and cardiovascular characteristics (QT
study) of ELND005.

TT-401 – Type 2 Diabetes Drug Candidate

Transition’s partner, Eli Lilly, has been very committed to the
advancement of TT401 across all areas of development. A Phase 2 study
of TT401 is in the final preparation stage with dosing expected to
commence in calendar Q2 2014. Transition will be supporting this
study with an expected contribution of US$14 million in three
installments during the study.

Growth Through In-Licensed Programs

With multiple Phase 2 programs in development, Transition continues its
strategy of mitigating risk through the parallel development of
additional programs. Allocation of development resources to these drug
candidates follows a strict discipline of evaluating costs, timelines
and selecting candidates with a strong likelihood of success.
Following this approach, Transition has decided to end development of
osteoarthritis preclinical candidate, TT601. This decision was made
after expanded toxicology study data and regulatory interactions
revealed the development plan would be restricted and timelines
delayed. Transition has ongoing diligence processes to in-license
additional drug candidates and expand the Company’s overall development
pipeline.

Conference Call

Investors are invited to participate in a conference call to discuss
Transition’s development update on April 7(th), 2014 at 8:30am Eastern time. In order to participate in the
conference call, please call (800) 617-7643 (North America), (303)
223-2688 (International). A replay of the conference call will be
available on Transition’s website www.transitiontherapeutics.com for seven days following the call.

About Transition

Transition is a biopharmaceutical company, developing novel therapeutics
for disease indications with large markets. The Company’s lead CNS drug
candidate is ELND005 for the treatment of Alzheimer’s disease and Down
syndrome. Transition’s lead metabolic drug candidate is TT-401 for the
treatment of type 2 diabetes and accompanying obesity. The Company’s
shares are listed on the NASDAQ under the symbol “TTHI” and the Toronto
Stock Exchange under the symbol “TTH”. For additional information about
the Company, please visit www.transitiontherapeutics.com.

Notice to Readers: Information contained in our press releases should be
considered accurate only as of the date of the release and may be
superseded by more recent information we have disclosed in later press
releases, filings with the OSC, SEC or otherwise. Except for historical
information, this press release may contain forward-looking statements,
relating to expectations, plans or prospects for Transition, including
conducting clinical trials and potential efficacy of its products.
These statements are based upon the current expectations and beliefs of
Transition’s management and are subject to certain risks and
uncertainties that could cause actual results to differ materially from
those described in the forward-looking statements. These risks and
uncertainties include factors beyond Transition’s control and the risk
factors and other cautionary statements discussed in Transition’s
quarterly and annual filings with the Canadian commissions.

SOURCE Transition Therapeutics Inc.


Source: PR Newswire



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