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                    AMENDMENT NO. 1 TO STOCKHOLDERS AGREEMENT

                                  BY AND AMONG

                                  ASTRALIS LTD.

                                 SKYEPHARMA PLC

                      THE PARTIES LISTED IN ANNEX A HERETO

                                       AND

                        THE PARTIES WHO EXECUTE ADDENDUMS










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      This is an amendment (this "Amendment") dated January 20, 2004 to the
Stockholders Agreement (the "Agreement") dated as of December 10, 2001 by and
among Astralis Ltd., a Delaware corporation (the "Corporation"), SkyePharma PLC,
a company incorporated under the laws of England and Wales ("SkyePharma"), those
parties listed in Annex A hereto (the "Original Stockholders"), and the parties
subject to an Addendum. All parties to this Amendment, the Agreement and any
Addendum, with the exception of the Corporation, are collectively referred to as
the "Stockholders."

                                    RECITALS

      WHEREAS, the Original Stockholders beneficially own shares of the issued
and outstanding voting Common Stock of the Corporation, par value $0.0001 per
share ("Common Stock") or are otherwise Founders (as hereinafter defined) of the
Corporation;

      WHEREAS, the Corporation and SkyePharma entered into a Purchase Agreement,
dated as of December 10, 2001 (the "Purchase Agreement"), pursuant to which
SkyePharma purchased 2,000,000 shares of the Corporation's Series A Convertible
Preferred Stock, par value $0.001 per share (the "Convertible Preferred Stock")
and in connection with the execution of the Purchase Agreement, the Corporation
and certain of the Original Stockholders entered into the Agreement; and

      WHEREAS, the Corporation and the Original Stockholders desire to amend the
Agreement in connection with the conversion of SkyePharma of the Convertible
Preferred Stock on the date hereof pursuant to the terms of the Omnibus
Conversion Agreement, dated as of January 12, 2004, by and between the
Corporation and SkyePharma (the "Omnibus Conversion Agreement").

      NOW THEREFORE, in consideration of the mutual promises and covenants set
forth in this Amendment and other good and valuable consideration, the receipt,
sufficiency and adequacy of which are hereby acknowledged, the parties hereto
agree as follows:

      1.    General.

      The parties acknowledge that all provisions of the Agreement, except as
amended hereby, shall remain in full force and effect.

      2.    Definitions.

      Capitalized terms used herein and not defined shall have the meanings
assigned to them in the Agreement. Whenever appearing in the Agreement, and any
other documents executed in connection with the Purchase Agreement, the term
"Agreement" shall be deemed to mean the Agreement as amended.

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      3.    Section 2.1 of the Agreement.

      Section 2.1 of the Agreement is hereby deleted and replaced in its
entirety as follows:

      2.1   Board of Directors.

            (a) From and after the date of this Amendment, at all times while
the Agreement is in effect, the Board of Directors of the Corporation shall be
comprised of at least seven Directors and shall include at least two Independent
Directors. The Board of Directors of the Corporation shall at all times use its
best efforts to nominate at least two persons for election by the holders of
shares of Common Stock to serve as Independent Directors. Fabien Pictet shall
not, solely as a result of his involvement in the Private Placement (as such
term is defined in the Omnibus Conversion Agreement), be disqualified from being
an Independent Director. The parties agree that other factors, relationships or
involvement in other transactions with, by or on behalf of the Corporation
(whether of a similar nature to the Private Placement or not) could be
considered in the future in determining whether Mr. Pictet may qualify as an
Independent Director. However, as of the date of this Amendment, the parties
agree that Mr. Pictet qualifies as an Independent Director.

            (b) From and after the date of this Amendment, at all times while
this Section 2.1(b) is in effect, SkyePharma shall have the right to nominate
one Director (the "SkyePharma Director"), who shall initially be Michael Ashton.

            (c) From and after the date of this Amendment until the third
anniversary of the date of this Amendment, Jose Antonio O'Daly, Mike Ajnsztajn,
Gaston Liebhaber and Gina Tedesco (each a "Founder" and collectively, the
"Founders") shall each have the right to nominate one Director (each a
"Founder's Director" and collectively, the "Founders' Directors"). Such
Founders' Directors shall initially be Jose Antonio O'Daly, Mike Ajnsztajn,
Gaston Liebhaber and Gina Tedesco. A Stockholder shall cease to be a Founder and
shall be unable to exercise the rights granted to Founders hereunder including
under Sections 2.1(c), 2.1(d), 2.1(e), 2.2(c) and 2.2(d) of this Agreement (but
shall for all other purposes continue to be a Stockholder) if, (i) in the case
of Jose Antonio O'Daly and Mike Ajnsztajn, (x) such Founder shall no longer
beneficially own, in the aggregate, at least 25% of the shares of Common Stock
held by such Founder on the date hereof and (y) such Founder ceases to be an
officer of the Corporation (unless such Founder is terminated other than for
cause) or (ii) in the case of Gina Tedesco, such Founder ceases to be an officer
of the Corporation (unless such Founder is terminated other than for cause) or
(iii) in the case of Gaston Liebhaber, such Founder shall no longer beneficially
own, in the aggregate, at least 25% of the shares of Common Stock held by such
Founder on the date hereof.


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            (d) If, at any time when SkyePharma has the ability to appoint the
SkyePharma Director under Section 2.1(b) above, SkyePharma requests that the
SkyePharma Director be removed (with or without cause) by written notice thereof
to the other Stockholders, then each Stockholder shall vote all shares of Common
Stock owned or held of record by such Stockholder to effect the removal and vote
for the replacement Director designated by SkyePharma. If, at any time when a
Founder has the ability to appoint a Founders Director under Section 2.1(c)
above, such Founder requests that the Founders Director he or she nominated be
removed (with or without cause) by written notice thereof to the other
Stockholders, then each Stockholder shall vote all shares of Common Stock owned
or held of record by such Stockholder to effect the removal and vote for the
replacement Director designated by such Founder.

            (e) If, at any time when SkyePharma has the ability to appoint the
SkyePharma Director under Section 2.1(b) above, a vacancy is created on the
Board of Directors at any time by reason of death, disability, retirement,
resignation, removal or otherwise of the SkyePharma Director, SkyePharma shall
be entitled to nominate a successor Director to fill the vacancy created
thereby. If, at any time when a Founder has the ability to appoint a Founder's
Director under Section 2.1(c) above, a vacancy is created on the Board of
Directors at any time by reason of death, disability, retirement, resignation,
removal or otherwise of a Founder's Director, the Founder who nominated such
Founder's Director shall be entitled to nominate a successor Director to fill
the vacancy created thereby.

            (f) At all times while this Agreement is in effect, a quorum of the
Board of Directors shall consist of a majority of the entire Board of Directors
and must include at least one Independent Director.

            (g) The Corporation agrees to use its best efforts to ensure that
the rights granted hereunder are effective and that the parties hereto enjoy the
benefits hereof. Such actions include, without limitation, the use of the
Corporation's best efforts to cause the nomination and election of the directors
designated as provided above.

      4.    Section 2.2 of the Agreement.

      Section 2.2 of the Agreement is hereby deleted in its entirety and
replaced as follows:

      2.2   Stockholder Votes.

            (a) Each Stockholder shall vote its shares of Common Stock
      (including any shares of Common Stock issued upon exercise of any
      Warrants) at any regular or special meeting of stockholders of the
      Corporation or in any written consent executed in lieu of such a meeting
      of stockholders of the Corporation, and shall take all other actions
      necessary, to elect the Independent Directors nominated by the Board of
      Directors as described in Section 2.1(a) of this Amendment.


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            (b) Each Stockholder shall vote its shares of Common Stock,
      (including any shares of Common Stock issued upon exercise of any
      Warrants) at any regular or special meeting of stockholders of the
      Corporation or in any written consent executed in lieu of such a meeting
      of stockholders of the Corporation, and shall take all other actions
      necessary, to elect the nominee if so nominated to the Board of Directors
      by SkyePharma pursuant to Section 2.1(b) or 2.1(d) or 2.1(e) of this
      Amendment.

            (c) Until the third anniversary of the date of this Amendment,
      SkyePharma shall vote its shares of Common Stock (including any shares of
      Common Stock issued upon exercise of any Warrants) at any regular or
      special meeting of stockholders of the Corporation or in any written
      consent executed in lieu of such a meeting of stockholders of the
      Corporation, and shall take all other actions necessary, to elect the
      nominee if so nominated to the Board of Directors by the Founders pursuant
      to Section 2.1(c), 2.1(d) or 2.1(e) of this Amendment.

            (d) Until the third anniversary of the date of this Amendment, when
      and as instructed by the Founders in accordance with Section 2.2(e),
      SkyePharma shall vote all of its shares of Common Stock in favor of any
      resolution approved by the Board of Directors (provided, however, that the
      resolution shall have been approved by all directors who qualify as
      Independent Directors currently serving as Directors) pursuant to which
      there is proposed the following:

                  (i) an amendment to the Certificate of Incorporation providing
            solely for an increase in authorized capital stock of the
            Corporation or a change in capital stock by means of a stock split,
            reverse stock split or stock dividend;

                  (ii) an adoption of, or any amendment to, any employee benefit
            plan generally applicable to all employees of the Corporation,
            including without limitation, a stock option plan, stock issuance
            plan or rights plan;

                  (iii) the issuance of additional securities for cash (if
            required to be solicited in accordance with the rules of the Nasdaq
            or other market or stock exchange upon which the Corporation's
            Common Stock is listed or traded); or

                  (iv) the sale of all outstanding capital stock of the
            Corporation, the sale of all or substantially all of the
            Corporation's assets or the merger of the Corporation with another
            entity, as a result of which the stockholders of the Corporation
            immediately prior to such transaction hold less than 50% of the
            combined entity, provided, however, that SkyePharma will only be
            required to vote in favor of a transaction in which (x) SkyePharma
            will receive the same consideration for its shares of Common Stock
            as all other holders of Common Stock and will be able to participate
            in such transaction upon the same terms as the most favorable terms
            available to the Founders or any other stockholders of the
            Corporation and (y) the total consideration for such transaction is
            greater than $135 million.


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            (e) Notwithstanding any other provisions of this Agreement, (i) for
      purposes of nominations, appointments or instructions to vote for
      Founders' Directors pursuant to Section 2.1 of this Agreement, no such
      nomination, appointment or instruction to vote shall be binding with
      respect to any Stockholder unless such Stockholder shall have received a
      notice signed by the Founder nominating such Founder's Director containing
      clear instructions with respect to the voting of the shares held by such
      Stockholder and (ii) for purposes of nominations, appointments and
      instructions to vote required or permitted to be given by the Founders,
      other than the election of Founders' Directors pursuant to Section 2.1 of
      this Agreement, no such nomination, appointment or instruction to vote
      shall be binding with respect to any Stockholder unless such Stockholder
      shall have received a notice, signed by more than a simple majority of the
      Founders, containing clear instructions with respect to the voting of the
      shares held by such Stockholder.

            (f) Each Stockholder agrees that such Stockholder shall not deposit
      any shares of Common Stock in a voting trust or subject the shares of
      Common Stock to any agreement, arrangement or understanding with respect
      to the voting of the shares of Common Stock, to the extent such
      arrangement or trust is inconsistent with the Agreement.

      5.    Ownership of Shares.

            Annex A hereto correctly sets forth, as of the date of this
Amendment, the number of shares of Common Stock and Warrants owned beneficially
and of record by each Original Stockholder.

      6.    Section 3.1 of the Agreement

            (a) The first sentence of Section 3.1 of the Agreement is hereby
amended to read as follows:

            Other than Transfers to the public pursuant to (i) an effective
Registration Statement or (ii) on a recognized national securities exchange, the
Nasdaq Stock Market, the Nasdaq SmallCap Market, the OTC Bulletin Board or any
similar quotation and reporting service, each Stockholder (other than
SkyePharma) will cause any proposed transferee of any share of Common Stock or
of any Warrant held by him or it to agree to take and hold such share of Common
Stock or Warrant, as the case may be, subject to the provisions and upon the
conditions specified in this Agreement and to become a party to this Agreement
as set forth in the Addendum to this Agreement.


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            (b) The following subparagraph is added to Section 3.1 of the
Agreement:

            In the event SkyePharma transfers any share of Common Stock or any
Warrant to any Affiliate, SkyePharma will cause any such proposed Affiliate
transferee of any share of Common Stock or of any Warrant held by it to agree to
take and hold such share of Common Stock or Warrant, as the case may be, subject
to the provisions and upon the conditions specified in this Agreement and to
become a party to this Agreement as set forth in the Addendum to this Agreement.
No such Transfer shall be binding upon the Corporation unless:

                  (i) such transferee shall have executed and delivered to the
            Corporation, as a condition precedent to any Transfer of shares of
            Common Stock or of any Warrant, a written agreement confirming that
            such transferee agrees to be bound by the terms of this Agreement;
            and

                  (ii) the certificates issued to such transferee which
            represent the shares of Common Stock or Warrants so Transferred
            shall bear the legends provided in Section 4.2.

      7.    Section 4.3 of the Agreement.

            Section 4.3 of the Agreement is hereby deleted and replaced in its
entirety as follows:

      4.3   Notices.

            All notices, requests, demands and other communications which are
required or may be given under the Agreement shall be in writing and shall be
deemed to have been duly given when received if personally delivered; when
transmitted, if transmitted by telecopy, electronic or digital transmission
method; the day after it is sent, if sent for next day delivery to a U.S.
address by recognized overnight delivery service (e.g., Federal Express); and
upon receipt, if sent by registered or certified mail (or any substantially
similar form of mail), postage prepaid and return receipt requested. In each
case notice shall be sent to:

                  If to the Corporation addressed to:

                           Astralis Ltd.
                           75 Passaic Avenue
                           Fairfield, NJ 07004
                           Attention:  Mr. Mike Ajnsztajn
                           Telecopier: +1-973-227-7169

                  With a copy to:

                           McCarter & English, LLP
                           4 Gateway Center
                           100 Mulberry Street
                           Newark, NJ 07102
                           Attn:  Jeffrey A. Baumel, Esq.
                           Telecopier: +1-973-624-7070



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                  If to SkyePharma addressed to:

                           SkyePharma PLC
                           105 Piccadilly
                           London, England W1J 7NJ

                           Attention:  Company Secretary
                           Telecopier: +44-20-7491-3338

                  With a copy to:

                           Sullivan & Cromwell LLP
                           1 New Fetter Lane
                           London, England EC4A 1AN
                           Attention:  Kathryn A. Campbell, Esq.
                           Telecopier: +44-20-7710-6565

            If to any Stockholder (other than SkyePharma), to such Stockholder
at the address indicated in Annex A hereto or in the Addendum. Changes in notice
addresses may be made by a notice delivered to the Corporation pursuant to this
Section 4.3.

      8.    Section 4.5(a) of the Agreement.

            Section 4.5(a) of the Agreement is hereby deleted and replaced in
its entirety as follows:


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      4.5   Agreement; Amendments and Waivers; Addendums.

            (a) This Agreement constitutes the entire agreement among the
parties pertaining to the subject matter hereof and supersedes all prior
agreements, understandings, negotiations and discussions, whether oral or
written, of the parties. This Agreement shall terminate upon the later to occur
of (i) the SkyePharma Termination Date or (ii) the third anniversary of this
Amendment. Further, this Agreement may be terminated by the mutual written
consent of the parties hereto. For purposes hereof, the "SkyePharma Termination
Date" shall mean the date on which SkyePharma shall no longer beneficially own,
in the aggregate, at least 20% of the shares of the outstanding Common Stock of
the Corporation, calculated by (i) including in the numerator any shares of
Common Stock into which securities held by SkyePharma are exercisable or
convertible and (ii) including in the denominator only those shares actually
issued and outstanding, and not including stock held in the treasury or
repurchased by the Corporation. No waiver of any of the provisions of this
Agreement shall be deemed or shall constitute a waiver of any other provision
hereof (whether or not similar), nor shall such waiver constitute a continuing
waiver unless otherwise expressly provided for herein or therein.

      9.    Section 4.6 of the Agreement.

            Section 4.6 of the Agreement is hereby deleted and replaced in its
entirety as follows:

      4.6   Successors and Assigns.

            This Agreement shall inure to the benefit of, and be binding upon,
the Corporation, each Stockholder and their respective successors, assigns,
heirs, executors and administration. Notwithstanding the above, the rights that
are specific to the Founders hereunder (and the corresponding obligations of
SkyePharma), including the right to nominate a Founders Director pursuant to
Section 2.1(c), the right to require SkyePharma to vote in favor of such
Founders Director under Section 2.2(c) and the right to require SkyePharma to
vote its shares in favor of certain transactions approved by the Board of
Directors under Section 2.2(d) shall not be transferable or assignable by such
Founder without the prior written consent of SkyePharma, such consent not to be
unreasonably withheld.

      10.   Integration.

            This Amendment together with the Agreement constitute the entire
agreement and understanding among the parties relating to the subject matter
hereof and thereof and supersede all prior proposals, negotiations, agreements
and understandings relating to such subject matter.


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      11.   Amendments; Waivers.

            No term, covenant, agreement or condition of this Amendment may be
amended, or compliance therewith waived (either generally or in a particular
instance and either retroactively or prospectively), unless agreed to in writing
by the party to be bound thereby.

      12.   Severability.

            In the event that any one or more of the provisions contained in
this Amendment shall, for any reason, be held to be invalid, illegal or
unenforceable in any respect, then to the maximum extent permitted by law, such
invalidity, illegibility or unenforceability shall not affect any other
provision of this Amendment.

      13.   Incorporation by Reference.

            This Amendment is incorporated by reference to the Agreement. Except
as otherwise provided herein, all of the provisions of the Agreement are hereby
confirmed and ratified and shall remain in full force and effect as of the date
of this Amendment.

      14.   Governing Law; Successors and Assigns.

            This Amendment shall be construed in accordance with the laws of the
State of New York, without regard to conflict of law provisions thereof. Each
party hereto agrees that it shall bring up any action or proceeding in respect
of any claim arising out of or related to this agreement or the transactions
contained in and contemplated by this Amendment, whether in tort or contract or
at law or in equity, exclusively in the United States District Court for the
Southern District of New York or, if such court is not available, the Supreme
Court of the State of New York for the county of New York (the "Chosen Courts")
and solely in connection with claims arising under the Agreement or the
transactions contained in or contemplated by this Amendment (i) irrevocably
submits to the exclusive jurisdiction of the Chosen Courts, (ii) waives any
objection to laying venue in any such action or proceeding in the Chosen Courts
and agrees not to commence any action in respect of any such claim in any other
court or forum, (iii) waives any objection that the Chosen Courts are an
inconvenient forum or do not have jurisdiction over any party hereto, (iv)
waives any right to a trial by jury and (v) agrees that service of process upon
such party in any such action or proceeding shall be effective if notice is
given in accordance with Section 4.3 of the Agreement.


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      15.   Counterparts.

            This Amendment may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.

      16.   Further Assurances.

            Each of the parties shall execute and deliver such further
instruments and documents and take such further actions as may be reasonably
required or desirable to carry out the provisions hereof and the transactions
contemplated hereby.

      17.   Cumulative Remedies.

            All rights and remedies of each party hereto are cumulative of each
other and of every other right or remedy such party may otherwise have at law or
in equity, and the exercise of one or more rights or remedies shall not
prejudice or impair the concurrent or subsequent exercise of other rights or
remedies.



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            IN WITNESS WHEREOF, the parties hereto have executed this Amendment
as of the date first written above.


                                        Astralis Ltd.

                                        By: /s/ Mike Ajnsztajn
                                            ----------------------------
                                            Name:  Mike Ajnsztajn
                                            Title: Chief Executive Officer


                                        SkyePharma PLC

                                        By: /s/ Donald Nicholson
                                            ----------------------------
                                            Name:  Donald Nicholson
                                            Title: Finance Director

                                        /s/ Jose Antonio O'Daly
                                        --------------------------------
                                        Jose Antonio O'Daly


                                        /s/ Mike Ajnsztajn
                                        --------------------------------
                                        Mike Ajnsztajn


                                        /s/ Gaston Liebhaber
                                        --------------------------------
                                        Gaston Liebhaber


                                        /s/ Gina Tedesco
                                        --------------------------------
                                        Gina Tedesco


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                         LIST OF ORIGINAL STOCKHOLDERS,
                             ADDRESSES AND HOLDINGS


NAME AND ADDRESS           SHARES
----------------           ------

Jose Antonio O'Daly        13,640,000

Mike Ajnsztajn              8,680,000

Gaston Liebhaber            2,480,000

Gina Tedesco                *



Each Original Stockholder's business address is c/o Astralis Ltd., 75 Passaic
Avenue, Fairfield, NJ 07004, U.S.A.

* Gina Tedesco may be deemed to be the beneficial owner of the shares of common
stock owned by her husband, Mike Ajnsztajn.