o |
Rule
13d-1(b)
|
x |
Rule
13d-1(c)
|
o |
Rule
13d-1(d)
|
1.
|
Names
of Reporting Persons.
I.R.S.
Identification Nos. of above persons (entities only).
Paolo
Cavazza
|
||
2.
|
Check
the Appropriate Box if a Member of a Group
|
||
3.
|
SEC
Use Only
|
||
4.
|
Citizenship
or Place of Organization
Italy
|
||
5.
|
Sole
Voting Power
1,190,770
|
||
Number
of
Shares
Beneficially
|
6.
|
Shared
Voting Power
17,022,767
|
|
Owned
by Each
Reporting
Person
With:
|
7.
|
Sole
Dispositive Power
1,190,770
|
|
8.
|
Shared
Dispositive Power
17,022,767
|
||
9.
|
Aggregate
Amount Beneficially Owned by Each Reporting Person
18,213,537
|
||
10.
|
Check
box if the Aggregate Amount in Row (9) Excludes
|
||
11.
|
Percent
of Class Represented by Amount in Row (9)
15.4%
(based on 118,472,164 shares of common stock, equal to 101,805,497 shares
of common stock outstanding as of November 4, 2008, as reported in
the Issuer’s quarterly report on Form 10-Q for the quarterly period
ended September 30, 2008 filed with the Securities and Exchange
Commission on November 14, 2008 plus the 16,666,667 shares of common
stock issued by the Issuer pursuant to the transaction with Sigma-Tau
Pharmaceuticals, Inc. reported in the Issuer’s report on 8-K filed with
the Securities and Exchange Commission on December 1,
2008)
|
||
12.
|
Type
of Reporting Person (See Instructions)
IN
|
1.
|
Names
of Reporting Persons.
I.R.S.
Identification Nos. of above persons (entities only).
Claudio
Cavazza
|
||
2.
|
Check
the Appropriate Box if a Member of a Group
(See
Instructions) (a)
o
(b) o
|
||
3.
|
SEC
Use Only
|
||
4.
|
Citizenship
or Place of Organization
Italy
|
||
5.
|
Sole
Voting Power
0
|
||
Number
of
Shares
Beneficially
|
6.
|
Shared
Voting Power
16,666,667
|
|
Owned
by Each
Reporting
Person
With:
|
7.
|
Sole
Dispositive Power
0
|
|
8.
|
Shared
Dispositive Power
16,666,667
|
||
9.
|
Aggregate
Amount Beneficially Owned by Each Reporting Person
16,666,667
|
||
10.
|
Check
box if the Aggregate Amount in Row (9) Excludes
Certain
Shares (See
Instructions)
o
|
||
11.
|
Percent
of Class Represented by Amount in Row (9)
14.1%
(based on 118,472,164 shares of common stock, equal to 101,805,497 shares
of common stock outstanding as of November 4, 2008, as reported in
the Issuer’s quarterly report on Form 10-Q for the quarterly period
ended September 30, 2008 filed with the Securities and Exchange
Commission on November 14, 2008 plus the 16,666,667 shares of common
stock issued by the Issuer pursuant to the transaction with Sigma-Tau
Pharmaceuticals, Inc. reported in the Issuer’s report on 8-K filed with
the Securities and Exchange Commission on December 1,
2008)
|
||
12.
|
Type
of Reporting Person (See Instructions)
IN
|
1.
|
Names
of Reporting Persons.
I.R.S.
Identification Nos. of above persons (entities only).
Sigma-Tau
Finanziaria S.p.A.
|
||
2.
|
Check
the Appropriate Box if a Member of a Group
(See
Instructions)
(a) o
(b) o
|
||
3.
|
SEC
Use Only
|
||
4.
|
Citizenship
or Place of Organization
Italy
|
||
5.
|
Sole
Voting Power
0
|
||
Number
of
Shares
Beneficially
|
6.
|
Shared
Voting Power
16,666,667
|
|
Owned
by Each
Reporting
Person
With:
|
7.
|
Sole
Dispositive Power
0
|
|
8.
|
Shared
Dispositive Power
16,666,667
|
||
9.
|
Aggregate
Amount Beneficially Owned by Each Reporting Person
16,666,667
|
||
10.
|
Check
box if the Aggregate Amount in Row (9) Excludes
Certain
Shares (See
Instructions)
o
|
||
11.
|
Percent
of Class Represented by Amount in Row (9)
14.1%
(based on 118,472,164 shares of common stock, equal to 101,805,497 shares
of common stock outstanding as of November 4, 2008, as reported in
the Issuer’s quarterly report on Form 10-Q for the quarterly period
ended September 30, 2008 filed with the Securities and Exchange
Commission on November 14, 2008 plus the 16,666,667 shares of common
stock issued by the Issuer pursuant to the transaction with Sigma-Tau
Pharmaceuticals, Inc. reported in the Issuer’s report on 8-K filed with
the Securities and Exchange Commission on December 1,
2008)
|
||
12.
|
Type
of Reporting Person (See Instructions)
CO
|
1.
|
Names
of Reporting Persons.
I.R.S.
Identification Nos. of above persons (entities only).
Sigma-Tau
International S.A.
|
||
2.
|
Check
the Appropriate Box if a Member of a Group
(See
Instructions)
(a) o
(b) o
|
||
3.
|
SEC
Use Only
|
||
4.
|
Citizenship
or Place of Organization
Luxembourg
|
||
5.
|
Sole
Voting Power
0
|
||
Number
of
Shares
Beneficially
|
6.
|
Shared
Voting Power
16,666,667
|
|
Owned
by Each
Reporting
Person
With:
|
7.
|
Sole
Dispositive Power
0
|
|
8.
|
Shared
Dispositive Power
16,666,667
|
||
9.
|
Aggregate
Amount Beneficially Owned by Each Reporting Person
16,666,667
|
||
10.
|
Check
box if the Aggregate Amount in Row (9) Excludes
Certain
Shares (See
Instructions)
o
|
||
11.
|
Percent
of Class Represented by Amount in Row (9)
14.1%
(based on 118,472,164 shares of common stock, equal to 101,805,497 shares
of common stock outstanding as of November 4, 2008, as reported in
the Issuer’s quarterly report on Form 10-Q for the quarterly period
ended September 30, 2008 filed with the Securities and Exchange
Commission on November 14, 2008 plus the 16,666,667 shares of common
stock issued by the Issuer pursuant to the transaction with Sigma-Tau
Pharmaceuticals, Inc. reported in the Issuer’s report on 8-K filed with
the Securities and Exchange Commission on December 1,
2008)
|
||
12.
|
Type
of Reporting Person (See Instructions)
CO
|
1.
|
Names
of Reporting Persons.
I.R.S.
Identification Nos. of above persons (entities only).
Sigma-Tau
America S.A.
|
||
2.
|
Check
the Appropriate Box if a Member of a Group
(See
Instructions)
(a) o
(b) o
|
||
3.
|
SEC
Use Only
|
||
4.
|
Citizenship
or Place of Organization
Luxembourg
|
||
5.
|
Sole
Voting Power
0
|
||
Number
of
Shares
Beneficially
|
6.
|
Shared
Voting Power
16,666,667
|
|
Owned
by Each
Reporting
Person
With:
|
7.
|
Sole
Dispositive Power
0
|
|
8.
|
Shared
Dispositive Power
16,666,667
|
||
9.
|
Aggregate
Amount Beneficially Owned by Each Reporting Person
16,666,667
|
||
10.
|
Check
box if the Aggregate Amount in Row (9) Excludes
Certain
Shares (See
Instructions)
o
|
||
11.
|
Percent
of Class Represented by Amount in Row (9)
14.1%
(based on 118,472,164 shares of common stock, equal to 101,805,497 shares
of common stock outstanding as of November 4, 2008, as reported in
the Issuer’s quarterly report on Form 10-Q for the quarterly period
ended September 30, 2008 filed with the Securities and Exchange
Commission on November 14, 2008 plus the 16,666,667 shares of common
stock issued by the Issuer pursuant to the transaction with Sigma-Tau
Pharmaceuticals, Inc. reported in the Issuer’s report on 8-K filed with
the Securities and Exchange Commission on December 1,
2008)
|
||
12.
|
Type
of Reporting Person (See Instructions)
CO
|
1.
|
Names
of Reporting Persons.
I.R.S.
Identification Nos. of above persons (entities only).
Sigma-Tau
Pharmaceuticals, Inc.
|
||
2.
|
Check
the Appropriate Box if a Member of a Group
(See
Instructions)
(a) o
(b) o
|
||
3.
|
SEC
Use Only
|
||
4.
|
Citizenship
or Place of Organization
Nevada
|
||
5.
|
Sole
Voting Power
0
|
||
Number
of
Shares
Beneficially
|
6.
|
Shared
Voting Power
16,666,667
|
|
Owned
by Each
Reporting
Person
With:
|
7.
|
Sole
Dispositive Power
0
|
|
8.
|
Shared
Dispositive Power
16,666,667
|
||
9.
|
Aggregate
Amount Beneficially Owned by Each Reporting Person
16,666,667
|
||
10.
|
Check
box if the Aggregate Amount in Row (9) Excludes
Certain
Shares (See
Instructions)
o
|
||
11.
|
Percent
of Class Represented by Amount in Row (9)
14.1%
(based on 118,472,164 shares of common stock, equal to 101,805,497 shares
of common stock outstanding as of November 4, 2008, as reported in
the Issuer’s quarterly report on Form 10-Q for the quarterly period
ended September 30, 2008 filed with the Securities and Exchange
Commission on November 14, 2008 plus the 16,666,667 shares of common
stock issued by the Issuer pursuant to the transaction with Sigma-Tau
Pharmaceuticals, Inc. reported in the Issuer’s report on 8-K filed with
the Securities and Exchange Commission on December 1,
2008)
|
||
12.
|
Type
of Reporting Person (See Instructions)
CO
|
Item
1(a).
|
Name
of Issuer:
|
Item
1(b).
|
Address
of Issuer's Principal Executive
Offices:
|
Item
2(a).
|
Name
of Person Filing:
|
(i)
|
Paolo
Cavazza
|
(ii)
|
Claudio
Cavazza
|
(iii)
|
Sigma-Tau
Finanziaria S.p.A. (“Sigma-Tau”)
|
(iv)
|
Sigma-Tau
International S.A.
|
(v)
|
Sigma-Tau
America S.A.
|
(vi)
|
Sigma-Tau
Pharmaceuticals, Inc.
|
Item
2(b).
|
Address
of Principal Business Office:
|
(i)
|
Paolo
Cavazza
|
Via
Tesserete 10
|
Lugano,
Switzerland
|
(ii)
|
Claudio
Cavazza
|
Via
Sudafrica, 20
|
Rome,
Italy 00144
|
(iii)
|
Sigma-Tau
|
Via
Sudafrica, 20
|
Rome,
Italy 00144
|
(iv)
|
Sigma-Tau
International S.A.
|
19-21
Boulevard du Prince Henri
|
L-1724
Luxembourg
|
(v)
|
Sigma-Tau
America S.A.
|
19-21
Boulevard du Prince Henri
|
L-1724
Luxembourg
|
(vi)
|
Sigma-Tau
Pharmaceuticals, Inc.
|
800
South Frederick Avenue, Suite 300
|
Gaithersburg,
Maryland 20877
|
USA
|
Item
2(c).
|
Citizenship:
|
(i)
|
Paolo
Cavazza is an Italian citizen.
|
(ii)
|
Claudio
Cavazza is an Italian citizen.
|
(iii)
|
Sigma-Tau
is an Italian corporation.
|
(iv)
|
Sigma-Tau
International S.A. is a Luxembourg corporation.
|
(v)
|
Sigma-Tau
America S.A. is a Luxembourg corporation.
|
(vi)
|
Sigma-Tau
Pharmaceuticals, Inc. is a Nevada corporation
..
|
Item
2(d).
|
Title
of Class of Securities:
|
Item
2(e).
|
CUSIP
Number:
|
Item
3.
|
If
this statement is filed pursuant to §§240.13d-1(b) or 240.13d-2(b) or (c),
check whether the person is a:
|
Item
4.
|
Ownership:
|
(a)
|
Amount
beneficially owned:
|
18,213,537
|
(b)
|
Percent
of class:
|
15.4%
|
(c)
|
Number
of shares as to which such person has:
|
(i)
|
sole
power to vote or to direct the vote:
|
1,190,770
|
(ii)
|
shared
power to vote or to direct the vote:
|
17,022,767
|
(iii)
|
sole
power to dispose or to direct the disposition of:
|
1,190,770
|
(iv)
|
shared
power to dispose or to direct the disposition of:
|
17,022,767
|
(a)
|
Amount
beneficially owned:
|
16,666,667
|
(b)
|
Percent
of class:
|
14.1%
|
(c)
|
Number
of shares as to which such person has:
|
(i)
|
sole
power to vote or to direct the vote:
|
0
|
(ii)
|
shared
power to vote or to directthe vote:
|
16,666,667
|
(iii)
|
sole
power to dispose or to directthe disposition of:
|
0
|
(iv)
|
shared
power to dispose or to directthe disposition of:
|
16,666,667
|
(a)
|
Amount
beneficially owned:
|
16,666,667
|
(b)
|
Percent
of class:
|
14.1%
|
(c)
|
Number
of shares as to which such person has:
|
(i)
|
sole
power to vote or to direct the vote:
|
0
|
(ii)
|
shared
power to vote or to directthe vote:
|
16,666,667
|
(iii)
|
sole
power to dispose or to directthe disposition of:
|
0
|
(iv)
|
shared
power to dispose or to directthe disposition of:
|
16,666,667
|
(a)
|
Amount
beneficially owned:
|
16,666,667
|
(b)
|
Percent
of class:
|
14.1%
|
(c)
|
Number
of shares as to which such person has:
|
(i)
|
sole
power to vote or to direct the vote:
|
0
|
(ii)
|
shared
power to vote or to directthe vote:
|
16,666,667
|
(iii)
|
sole
power to dispose or to directthe disposition of:
|
0
|
(iv)
|
shared
power to dispose or to directthe disposition of:
|
16,666,667
|
(a)
|
Amount
beneficially owned:
|
16,666,667
|
(b)
|
Percent
of class:
|
14.1%
|
(c)
|
Number
of shares as to which such person has:
|
(i)
|
sole
power to vote or to direct the vote:
|
0
|
(ii)
|
shared
power to vote or to directthe vote:
|
16,666,667
|
(iii)
|
sole
power to dispose or to directthe disposition of:
|
0
|
(iv)
|
shared
power to dispose or to directthe disposition of:
|
16,666,667
|
(a)
|
Amount
beneficially owned:
|
16,666,667
|
(b)
|
Percent
of class:
|
14.1%
|
(c)
|
Number
of shares as to which such person has:
|
(i)
|
sole
power to vote or to direct the vote:
|
0
|
(ii)
|
shared
power to vote or to directthe vote:
|
16,666,667
|
(iii)
|
sole
power to dispose or to directthe disposition of:
|
0
|
(iv)
|
shared
power to dispose or to directthe disposition of:
|
16,666,667
|
Item
5.
|
Ownership
of Five Percent or Less of a Class:
|
Item
6.
|
Ownership
of More than Five Percent on Behalf of Another
Person:
|
Item
7.
|
Identification
and Classification of the Subsidiary Which Acquired the Security Being
Reported on by the Parent Holding
Company:
|
Item
8.
|
Identification
and Classification of Members of the
Group:
|
Item
9.
|
Notice
of Dissolution of Group:
|
Item
10.
|
Certification:
|
PAOLO
CAVAZZA
|
By: /s/ Maurizio Terenzi
|
Name: Maurizio
Terenzi
|
Title: Proxy-holder
authorized
|
CLAUDIO
CAVAZZA
|
By: /s/ Maurizio Terenzi
|
Name: Maurizio
Terenzi
|
Title: Proxy-holder
authorized
|
SIGMA-TAU
FINANZIARIA SPA
|
By: /s/ Maurizio Terenzi
|
Name: Maurizio
Terenzi
|
Title: Proxy-holder
authorized
|
SIGMA-TAU
INTERNATIONAL S.A.
|
By: /s/ Gregg Lapointe
|
Name: Gregg
Lapointe
|
Title: Attorney-in-fact
|
SIGMA-TAU
AMERICA S.A.
|
By: /s/ Gregg Lapointe
|
Name: Gregg
Lapointe
|
Title: Attorney-in-fact
|
SIGMA-TAU
PHARMACEUTICALS, INC.
|
By: /s/ Gregg Lapointe
|
Name: Gregg
Lapointe
|
Title: Chief
Executive Officer
|
A.
|
Joint
Filing Agreement dated December 3, 2008 by and among Paolo Cavazza,
Claudio Cavazza, Sigma Tau Finanziaria S.p.A., Sigma-Tau Pharmaceuticals,
Inc., Sigma Tau America S.A. and Sigma Tau International
S.A.
|
16
|
B.
|
Power
of Attorney, dated January 9, 2007, granted by Messrs. Dominique
Audia and Luca Checchinato, directors of Sigma-Tau International S.A., in
favor of Messrs. Gregg Lapointe and Don DeLillo1
|
|
C.
|
Power
of Attorney, dated January 9, 2007, granted by Messrs. Dominique
Audia and Luca Checchinato, directors of Sigma-Tau America S.A., in favor
of Messrs. Gregg Lapointe and Don DeLillo2
|
|
D.
|
Power
of Attorney, dated January 10, 2007, granted by Mr. Paolo Cavazza in
favor of Messrs. Antonio Nicolai and Maurizio Terenzi3
|
|
E.
|
Power
of Attorney, dated January 10, 2007, granted by Mr. Claudio Cavazza,
President of Sigma-Tau Finanziaria S.p.A., in favour of Messrs. Antonio
Nicolai and Maurizio Terenzi4
|
|
F.
|
Power
of Attorney, dated January 10, 2007, granted by Mr. Claudio Cavazza
in favor of Messrs. Antonio Nicolai and Maurizio Terenzi5
|
PAOLO
CAVAZZA
|
By: /s/ Maurizio
Terenzi
|
Name: Maurizio
Terenzi
|
Title: Proxy-holder
authorized
|
CLAUDIO
CAVAZZA
|
By: /s/ Maurizio Terenzi
|
Name: Maurizio
Terenzi
|
Title: Proxy-holder
authorized
|
SIGMA-TAU
FINANZIARIA SPA
|
By: /s/ Maurizio
Terenzi
|
Name: Maurizio
Terenzi
|
Title: Proxy-holder
authorized
|
SIGMA-TAU
INTERNATIONAL S.A.
|
By: /s/ Gregg Lapointe
|
Name: Gregg
Lapointe
|
Title: Attorney-in-fact
|
SIGMA-TAU
AMERICA S.A.
|
By: /s/ Gregg Lapointe
|
Name: Gregg
Lapointe
|
Title: Attorney-in-fact
|
SIGMA-TAU
PHARMACEUTICALS, INC.
|
By: /s/ Gregg Lapointe
|
Name: Gregg
Lapointe
|
Title: Chief
Executive Officer
|