Trine Agreement Termination

RNS Number:6872N
Napo Pharmaceuticals Inc
11 February 2008


For immediate release                                 11 February 2008

                          Napo Pharmaceuticals, Inc
                          ("Napo" or "the Company")


                       Termination of Trine Agreement
     Napo now in active discussions for commercial partner for crofelemer



South San Francisco, California, 11 February 2008 - Napo Pharmaceuticals, Inc
(LSE: NAPL) announces that Trine Pharmaceuticals, Inc ("Trine") and Napo have
mutually agreed to terminate their license agreement for Napo's
gastro-intestinal product, crofelemer.  The termination follows Trine's
disclosure to Napo of Trine's review of preliminary data of the Phase 2b study
conducted by Trine for the treatment of diarrhoea-predominant irritable bowel
syndrome ("D-IBS") with crofelemer ("CRO-IBS"). Napo has been informed by Trine
that, based on the data currently available to it (full patient data sets not
yet available, at least 25% of patients with incomplete data sets), they have
determined that the primary clinical endpoint of pain was not achieved; that
there were no drug related adverse events; and that Trine will wind down to less
than two full time equivalent employees by the end of Feb. 2008.  Napo expects
Trine to receive the full data from the trial and then forward it to Napo within
the next several weeks. Napo will then fully analyse this data and make a
complete announcement with respect to the findings in due course.


Trine conducted a single-dose evaluation of crofelemer in a Phase 2b
confirmatory study of the previous successful Phase 2a result, the results of
which were presented at Digestive Disease Week in May 2007.   In the
confirmatory Phase 2b study, Trine evaluated a single active dose against
placebo and dramatically modified the formulation of the drug used in the
original Phase 2a study.


As part of the mutual termination, full commercial rights of crofelemer
previously licensed to Trine have reverted to Napo, and Napo will receive 100%
of the profits from each of these indications.  These include worldwide rights
to CRO-IBS (previously a 65:35 Trine:Napo profit share); co-commercial rights to
CRO-HIV in the US (previously a 50:50 profit share); acute infectious diarrhoea
("CRO-ID") rights in western territories; as well as any future potential
clinical indications, such as cancer or transplant patient related diarrhoeas,
among others (which were also all subject to the 65:35 Trine:Napo profit share).


As part of the termination, Napo has agreed to pay US$500,000 and US$750,000
CRO-HIV success milestone payments to Trine based on future NDA filing,
approval, and/or commercial alliances. There are no other future obligations to
Trine.


Napo is now in an unencumbered position to continue its ongoing discussions with
potential commercial licensees in western territories for all indications of
crofelemer, with near-term focus on securing a commercial partner with specialty
pharma capability in the HIV marketplace in the US, and gastro-intestinal
development and commercial capability, including for the paediatric indication.


Crofelemer is the subject of three on-going clinical trials for various
diarrhoea indications:


-   CRO-HIV for chronic diarrhoea in people living with HIV/AIDS. This final
Phase 3 study is being conducted in the US, sponsored by Napo. Napo anticipates
an NDA filing in late 2008.  CRO-HIV is fast-tracked by the FDA.

-   CRO-ID for adult acute infectious diarrhoea in India, for which Glenmark is
the trial sponsor and for which results are expected in Q2, 2008.

-   CRO-ID for cholera in Bangladesh for which Napo is the trial sponsor (with
support from NIH) and for which results are expected in Q2, 2008.


Napo's Chief Executive Officer, Lisa Conte, commented: "At this point, Napo
finds the results of the Phase 2b trial inconclusive as to the value of
crofelemer for D-IBS. We believe the primary clinical endpoint will not achieve
significance, yet the dramatic change in the formulation of the product and the
use of a single dose may have confounded the results and powering of this trial.
As Trine had substantially downsized and had limited resources, we understand
their need to make a rapid commercial decision as to whether to proceed with
CRO-IBS. Napo will make a complete announcement as to our findings once we
obtain the full data set from this trial.   We believe the proof of concept for
D-IBS from the Phase 2a plus the safety database from the Phase 2b will serve as
the basis of evaluation for a potential commercial partner with the appropriate
resources and endpoint/indication expertise to pursue IBS.   Napo's focus is on
the completion of our final Phase 3 study for CRO-HIV, which is expected to be
the company's first NDA filing in 2008.  The endpoint of the CRO-HIV trial, as
well as the diarrhoea endpoints of our current cholera and acute infectious
diarrhoea trials with CRO-ID, are matched to the clinical implications of the
anti-secretory mechanism of action of crofelemer.  With the reversion of our
commercial rights, we are actively in discussions with potential commercial
partners for crofelemer."


Dr. Pravin Chaturvedi, Napo's Chief Scientific Officer, commented: "We continue
to be optimistic about our other clinical programmes and the addition of
approximately 120 crofelemer treated patients with no adverse events to our
safety database. The diarrhoea endpoint in the ongoing clinical trials is
distinct from the primary endpoint of pain targeted in the D-IBS Phase 2b study.
As regards the CRO-HIV trial, Napo spent over 6 months designing an appropriate
adaptive clinical trial and ran approximately 800,000 simulations to determine
the sample size in the crofelemer ADVENT trial, and these simulations and sample
size calculations were shared with the FDA in designing the final Phase 3
CRO-HIV study to support the clinical trial design.  Napo's diarrhoea trials
mentioned above are testing multiple doses and all are using similar
formulations to ensure continuity of crofelemer release in the intestine."

For more information please contact:

Napo Pharmaceuticals, Inc.
Lisa Conte, Chief Executive Officer
(001) + 650 616 1902

Charles Thompson, Chief Financial Officer
(001) + 650 616 1903

Buchanan Communications
020 7466 5000
Mary-Jane Johnson, Tim Anderson, Catherine Breen

Nomura Code Securities Limited
020 7776 1205
Clare Terlouw



Notes for Editors:

About Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. focuses on the development and commercialisation of
proprietary pharmaceuticals for the global marketplace in collaboration with
local partners. Napo was founded in November 2001, and is based in California,
USA with a subsidiary in Mumbai, India.

Napo's late-stage proprietary gastro-intestinal compound, crofelemer, is in
various stages of clinical development for four distinct product indications,
including a late-stage Phase 3 program:

  * CRO-HIV for AIDS diarrhea, Phase 3
  * CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2
  * CRO-ID for acute infectious diarrhea (including cholera), Phase 2
  * CRO-PED for paediatric diarrhea, Phase 1

The FDA has granted fast-track status to CRO-IBS and CRO-HIV.

Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a
medicinal plant which can be sustainably harvested from several countries in
South America. Napo also plans to develop an early clinical stage product,
NP-500, for the treatment of insulin resistant diseases of Type II diabetes and
metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo also has a plant
library of approximately 2,300 medicinal plants from tropical regions, and Napo
has entered two screening relationship associated with this collection.
Currently, products are based on the chemical and biological diversity derived
from plants with medicinal properties, but future products may be in-licensed
from other sources.

Napo has partnerships with Glenmark Pharmaceuticals Limited of India; and
AsiaPharm Group Ltd. of China. For more information please visit
www.napopharma.com.




                      This information is provided by RNS
            The company news service from the London Stock Exchange
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