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SEC Company Response from CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294) (CPIX) — Jul 6, 2007

CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294)
Date: July 6, 2007 · CIK: 0001087294 · Accession: 0000950144-07-006411

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

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Reasoning

Referenced dates: July 2, 2007

Date
July 6, 2007
Author
Not clearly detected
Form
CORRESP
Company
CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294)

Letter

SEC Response Letter

Attorneys at Law

Baton Rouge

Birmingham

Houston

Jackson

Memphis

Mobile

Nashville

New Orleans

Washington, DC

July 6, 2007

United States Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

Attention: Mr. Jeffrey Riedler

Re:

Cumberland Pharmaceuticals Inc.

Registration Statement on Form S-1, Amendment 1

Filed June 22, 2007

File No. 333- 142535

Ladies and Gentlemen:

We are responding to comments received in a letter dated July 2, 2007 from Mr. Jeffrey Riedler to A.J. Kazimi of Cumberland Pharmaceuticals Inc. with respect to Amendment No. 1 to the Registration Statement on Form S-1 of Cumberland Pharmaceuticals filed June 22, 2007. For your convenience, we have repeated in bold type the comments and requests for additional information exactly as set forth in Mr. Riedler’s letter. We enclose a copy of Amendment No. 2 to the Registration Statement filed today, which is marked to reflect the changes made to Amendment No. 1.

The following paragraphs set forth the responses of Cumberland Pharmaceuticals to the comments contained in Mr. Riedler’s letter of July 2, 2007. Page references in our responses are to Amendment No. 2.

FORM S-1

General

1.

Please submit on EDGAR the supplemental correspondence and other information dated June 22, 2007 that you submitted with your response letter. These documents respond to comments 8, 28, and 48, and you did not request confidential treatment for them.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 2

Response:

The Company will comply with this request by submitting the supplemental correspondence dated June 22, 2007 on EDGAR next week. The Company will file an Application for Confidential Treatment with the Commission related to this supplemental correspondence.

Prospectus Summary, page 1

2.

We note your response to comment 8. Please cite in the filing the source or sources that support your assertion that “NAC is accepted worldwide as the standard of care for treating acetaminophen overdose.”

Response:

The Company has complied with this comment by adding a reference to an article printed in Current Opinion in Pediatrics to the first sentence of the third paragraph discussing Acetadote on page 2 of the Prospectus Summary.

3.

We note your response to comment 5. Please disclose your accumulated deficit in the “Risks Affecting Us” discussion on page 3.

Response:

The Company has complied with this comment by adding a new sentence to the end of the Prospectus Summary section entitled “Risks Affecting Us” on page 3.

Summary Consolidated Financial Data, page 5

4.

Please revise your table to only present pro forma net income per share amounts for the most recent fiscal year and interim period presented. Please refer to Rule 11-01(a) of Regulation S-X.

Response:

The Company has complied with this comment by revising the table on page 5 of Amendment No. 2 to include only the information required by Rule 11-01(a) of Regulation S-X.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 3

Use of Proceeds, page 24

5.

We note the revisions pursuant to comment 21. You are registering the sale of up to $115 million in common stock, and you state specific uses of $32 million. Please state the planned uses for the remainder of the proceeds.

Response:

The Company has complied with this comment by amending the second paragraph on page 24 with new disclosure that further clarifies that, while no assurances can be given and the Company is not currently involved in discussions regarding a material acquisition, the Company hopes to use the proceeds of this offering to acquire additional products for its sales forces to sell. The Company has also complied with this comment by inserting a new bullet point in the third paragraph on page 24.

6.

We note the revisions pursuant to comment 22. Since Amelior is in phase III trials, please state whether you expect the $4 million you plan to spend on this drug candidate to be sufficient to complete the product’s development and file a new drug application.

Response:

The Company has complied with this comment by changing the second bullet point in the third paragraph of the “Use of proceeds” section on page 24 to clarify that it anticipates that $4.0 million will be sufficient to develop Amelior through the date that the Company submits an NDA on Amelior to the FDA.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Critical Accounting Policies and Significant Judgments and Estimates

Revenue Recognition, page 32

7.

Refer to your response to prior comment 26. We continue to believe that your disclosure related to estimates that reduce gross revenue such as chargebacks, discounts, rebates and product returns could be improved. Please revise your disclosure and include the following:

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 4

a.

A roll forward of the accrual for each estimate for each period presented showing the following:

•

Beginning balance,

•

Current provision related to sales made in current period,

•

Current provision related to sales made in prior periods,

•

Actual returns or credits in current period related to sales made in current period,

•

Actual returns or credits in current period related to sales made in prior periods, and

•

Ending balance.

Response:

The Company has complied with this comment by including a new table on page 33 of Amendment No. 2 which includes the requested information with respect to its accruals related to gross revenue.

Stock-Based Compensation, page 34

8.

Please refer to your response to prior comment 27. Expand your disclosure to provide the following information:

a.

Please clarify, if true, that the various measurement models disclosed were used to determine your enterprise value. Disclose how management selects the amount within the range of values to determine your enterprise value as of each grant date.

Response:

The Company has complied with this comment by clarifying that various measurement models were used to determine enterprise value and by adding a sentence to the second paragraph of the section entitled “Stock-Based Compensation” on page 35 to clarify how management formulates its recommendation to its Board of Directors with respect to the pricing of stock related compensation.

b.

As previously requested, please disclose the method used to allocate enterprise value to the outstanding equity to determine the fair value of the underlying common stock.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 5

Response:

The Company has complied with this comment by amending the second paragraph of the section entitled “Stock-Based Compensation” on page 35 to clarify that, in determining share value and option exercise prices, enterprise value is assigned to all shares equally.

c.

State whether the valuations prepared by independent third parties were performed contemporaneous or retrospective.

Response:

The Company has complied with this comment by adding a sentence to the second paragraph of the section entitled “Stock-Based Compensation” on page 35 of Amendment No. 2 indicating that such valuations were performed contemporaneously with stock issuances and/or option grants.

d.

Disclose the name of the independent third party valuation firm and provide their consent in the registration statement.

Response:

The Company has complied with this comment by amending the second paragraph of the section entitled “Stock-Based Compensation” on page 35 of Amendment No. 2 to identify Morgan Joseph & Co. Inc. as the third party which assisted management in preparing a valuation analysis, and we have included a consent of Morgan Joseph & Co. Inc. as Exhibit 23.3 to Amendment No. 2.

9.

Refer to your response to prior comment 28. Please tell us on a supplemental basis specifically why you determined these public companies to be similar. Please address each company individually. Also explain to us how you determined your expected volatility for 2006 and 2007 based on an analysis of these companies.

Response:

There are several factors the Company considers when identifying other companies that it believes are the most comparable to it for purposes of assigning a likely volatility factor to its common stock. Specifically, the Company has based its stock volatility analysis on the following companies for the reasons indicated:

Myriad Genetics — due to this company’s industry segment (pharmaceutical) and its focus on development of novel healthcare products, as well as its focus in generating revenue from

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 6

existing products. Like Cumberland Pharmaceuticals, Myriad has a pipeline for early stage drug candidates and develops late-stage (Phase III) development products. Additionally, Myriad is similar to the Company in that its existing products are ‘mid-sized’ revenue generators. Like Cumberland Pharmaceuticals, Myriad also has stock-based compensation expense, including stock option grants.

Bradley Pharmaceutical — due to this company’s focus as a specialty pharmaceutical company that provides product in niche specialty markets including gastroenterology, an area in which the Company operates. Bradley is similar to the Company in that it has demonstrated a steady growth in revenues and profitability. Bradley is also similar in that its revenue is generated by small and/or mid-sized products, as compared with companies that generate the majority of their revenue from large, block-buster type products.

Nabi Pharmaceutical — due to this company’s industry segment (pharmaceuticals) and its focus on niche and underserved markets, a similar approach to the Company. Like Cumberland Pharmaceuticals, Nabi has research capabilities to develop drugs as well as having established marketplace products. Nabi’s business strategy is similar to the Company’s in that both companies are focused on optimizing the value of their current operations, building value through strategic partnerships and commercial alliances and providing growth and value through research and development of late-stage product candidates.

Forest Laboratories — due to this company’s industry segment, its marketing strategy and its development strategy and capabilities. Although significantly larger than the Company, Forest demonstrates a similar business approach. Specifically, both Forest and Cumberland Pharmaceuticals conduct clinical studies, manage the regulatory approval process, and market products to physicians. Both companies also co-promote products as well as owning products outright. Additionally, like Cumberland Pharmaceuticals, Forest incurs stock-based compensation expense including stock option grants.

Salix Pharmaceuticals — due to this company’s industry segment, and its focus on specialty pharmaceuticals in the gastroenterology market. Like Cumberland Pharmaceuticals, Salix focuses primarily on the U.S. market. Salix’ approach to research and development aims to identify late-stage proprietary products, an approach also used by the Company. Both companies outsource manufacturing and have focused specialty sales forces. Both Salix and Cumberland Pharmaceuticals have demonstrated top line growth in revenue while forging ahead with development activities. Both companies use stock-based compensation as a method of compensating their employees. Salix and Cumberland Pharmaceuticals are both focused on growing their business by adding new products to their portfolios via expanding the indications

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 7

for their current products, acquiring new products and/or co-promoting selected third-party products.

With respect to determining its stock volatility in 2006 and 2007, the Company calculated the volatility for each of these companies based on the term of the option granted. The Company then took an average of the volatility calculated for these peer companies and used that average as its volatility rate.

Liquidity and Capital Resources, page 41

10.

We note the revisions pursuant to comment 32. Please disclose separately the minimum purchase amounts applying to Kristalose and Acetadote.

Response:

The Company has complied with this comment by amending the sixth paragraph on page 43 of Amendment No. 2 to disclose minimum purchase requirements for each product.

Business, page 47

11.

We note your response to comment 37.

•

Please clarify what type of “data on the use of intravenous ibuprofen” the license from Vanderbilt University covers, as discussed at the top of page 54. Also, describe the consideration you are required to pay to Vanderbilt. This information would appear to be material to investors.

Response:

The Company has complied with this comment by amending the paragraph beginning at the bottom of page 53 and continuing at the top of page 54 in order to describe the data in more detail and to set forth the consideration it is required to pay to Vanderbilt.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 8

•

We note from the bullet point at the bottom of page 59 that Mayne Pharma Pty. Ltd. is your exclusive manufacturer for Amelior and will continue to be the exclusive manufacturer after FDA approval. Please disclose the aggregate development, regulatory, and inspection and audit costs you have paid to date. Also, please file this agreement as an exhibit.

Response:

The Company has complied with this comment by amending the first bullet point on page 60 to address the development, regulatory, inspection and audit costs that it has paid to date to Mayne pursuant to this agreement. Cumberland Pharmaceuticals will also file documentation to verify that Mayne assumed all of the rights and obligations of F.H. Faulding & Co. Limited under the Strategic Alliance Agreement dated July 21, 2000, between the Company and F. H. Faulding & Co. Limited (previously filed as Exhibit 10.8 to the Registration Statement).

•

Please revise to disclose the terms of the release between you and Bertek Pharmaceuticals.

Response:

The Company has complied with this comment by amending the second full paragraph in the “Kristalose” section on page 56 to describe the release entered into by Bertek and the Company.

•

Regarding the agreement with Inventiv Commercial Services, we understand from a June 27, 2007 conversation with your counsel that the agreement is currently filed as exhibits 10.4 and 10.5, and it was assigned to Inventiv by way of exhibit 10.6. Exhibit 10.6 is not yet filed, but the description of exhibit 10.6 in the exhibit index does not mention Inventiv. Please ensure that you have filed all agreements, amendments, and assignments related to this relationship.

Response:

The Company has complied with this comment by amending its description of Exhibit 10.6 in both Part II and the Exhibit Index to describe the contractual relationship with Inventiv Commercial Services.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 9

•

Please disclose the monthly fee you pay to Inventiv, as mentioned at the bottom of page 58. Also disclose the aggregate amount you have reimbur

Show Raw Text
CORRESP
1
filename1.htm

SEC Response Letter

Attorneys at Law

Baton Rouge

Birmingham

Houston

Jackson

Memphis

Mobile

Nashville

New Orleans

Washington, DC

July 6, 2007

United States Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

Attention: Mr. Jeffrey Riedler

    Re:

    Cumberland Pharmaceuticals Inc.

    Registration Statement on Form S-1, Amendment 1

    Filed June 22, 2007

    File No. 333- 142535

Ladies and Gentlemen:

     We are responding to comments received in a letter dated July 2, 2007 from Mr. Jeffrey
Riedler to A.J. Kazimi of Cumberland Pharmaceuticals Inc. with respect to Amendment No. 1 to
the Registration Statement on Form S-1 of Cumberland Pharmaceuticals filed June 22, 2007.
For your convenience, we have repeated in bold type the comments and requests for additional
information exactly as set forth in Mr. Riedler’s letter. We enclose a copy of Amendment
No. 2 to the Registration Statement filed today, which is marked to reflect the changes made
to Amendment No. 1.

     The following paragraphs set forth the responses of Cumberland Pharmaceuticals to the
comments contained in Mr. Riedler’s letter of July 2, 2007. Page references in our
responses are to Amendment No. 2.

FORM S-1

General

    1.

    Please submit on EDGAR the supplemental correspondence and
other information dated June 22, 2007 that you submitted with your response
letter. These documents respond to comments 8, 28, and 48, and you did not
request confidential treatment for them.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 2

     Response:

     The
Company will comply with this request by submitting the supplemental
correspondence dated June 22, 2007 on EDGAR next week. The Company will file an Application for Confidential Treatment with the Commission
related to this supplemental correspondence.

     Prospectus Summary, page 1

    2.

    We note your response to comment 8. Please cite in the filing
the source or sources that support your assertion that “NAC is accepted
worldwide as the standard of care for treating acetaminophen overdose.”

     Response:

     The
Company has complied with this comment by adding a reference to an article
printed in Current Opinion in Pediatrics to the first sentence of the third paragraph discussing
Acetadote on page 2 of the Prospectus Summary.

    3.

    We note your response to comment 5. Please disclose your
accumulated deficit in the “Risks Affecting Us” discussion on page 3.

     Response:

     The Company has complied with this comment by adding a new sentence to the end of the
Prospectus Summary section entitled “Risks Affecting Us” on page 3.

     Summary Consolidated Financial Data, page 5

    4.

    Please revise your table to only present pro forma net income
per share amounts for the most recent fiscal year and interim period presented.
Please refer to Rule 11-01(a) of Regulation S-X.

     Response:

     The Company has complied with this comment by revising the table on page 5 of Amendment No. 2
to include only the information required by Rule 11-01(a) of Regulation S-X.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 3

     Use of Proceeds, page 24

    5.

    We note the revisions pursuant to comment 21. You are registering the
sale of up to $115 million in common stock, and you state specific uses of $32
million. Please state the planned uses for the remainder of the proceeds.

     Response:

     The Company has complied with this comment by amending the second paragraph on page 24 with
new disclosure that further clarifies that, while no assurances can be given and the Company is not
currently involved in discussions regarding a material acquisition, the Company hopes to use the
proceeds of this offering to acquire additional products for its sales forces to sell. The Company
has also complied with this comment by inserting a new bullet point in the third paragraph on page
24.

    6.

    We note the revisions pursuant to comment 22. Since Amelior
is in phase III trials, please state whether you expect the $4 million you
plan to spend on this drug candidate to be sufficient to complete the
product’s development and file a new drug application.

     Response:

     The Company has complied with this comment by changing the second bullet point in the third
paragraph of the “Use of proceeds” section on page 24 to clarify that it anticipates that $4.0
million will be sufficient to develop Amelior through the date that the Company submits an NDA on
Amelior to the FDA.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Critical Accounting Policies and Significant Judgments and Estimates

Revenue Recognition, page 32

    7.

    Refer to your response to prior comment 26. We continue to
believe that your disclosure related to estimates that reduce gross revenue
such as chargebacks, discounts, rebates and product returns could be
improved. Please revise your disclosure and include the following:

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 4

    a.

    A roll forward of the accrual for each estimate for each
period presented showing the following:

    •

    Beginning balance,

    •

    Current provision related to sales made in current period,

    •

    Current provision related to sales made in prior periods,

    •

    Actual returns or credits in current period related to sales made
in current period,

    •

    Actual returns or credits in current period related to sales made
in prior periods, and

    •

    Ending balance.

     Response:

     The Company has complied with this comment by including a new table on page 33 of Amendment
No. 2 which includes the requested information with respect to its accruals related to gross
revenue.

     Stock-Based Compensation, page 34

    8.

    Please refer to your response to prior comment 27. Expand
your disclosure to provide the following information:

    a.

    Please clarify, if true, that the various
measurement models disclosed were used to determine your enterprise
value. Disclose how management selects the amount within the range of
values to determine your enterprise value as of each grant date.

     Response:

     The Company has complied with this comment by clarifying that various measurement models were
used to determine enterprise value and by adding a sentence to the second paragraph of the section
entitled “Stock-Based Compensation” on page 35 to clarify how management formulates its
recommendation to its Board of Directors with respect to the pricing of stock related compensation.

    b.

    As previously requested, please disclose the
method used to allocate enterprise value to the outstanding equity to
determine the fair value of the underlying common stock.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 5

     Response:

     The Company has complied with this comment by amending the second paragraph of the section
entitled “Stock-Based Compensation” on page 35 to clarify that, in determining share value and
option exercise prices, enterprise value is assigned to all shares equally.

    c.

    State whether the valuations prepared by
independent third parties were performed contemporaneous or
retrospective.

     Response:

     The Company has complied with this comment by adding a sentence to the second paragraph of
the section entitled “Stock-Based Compensation” on page 35 of Amendment No. 2 indicating that
such valuations were performed contemporaneously with stock issuances and/or option grants.

    d.

    Disclose the name of the independent third
party valuation firm and provide their consent in the registration
statement.

     Response:

     The
Company has complied with this comment by amending the second paragraph of the section
entitled “Stock-Based Compensation” on page 35 of Amendment
No. 2 to identify Morgan Joseph & Co. Inc. as the third party which
assisted management in preparing a valuation analysis, and we have
included a consent of Morgan Joseph & Co. Inc. as Exhibit 23.3 to
Amendment No. 2.

    9.

    Refer to your response to prior comment 28. Please tell us on
a supplemental basis specifically why you determined these public companies
to be similar. Please address each company individually. Also explain to us
how you determined your expected volatility for 2006 and 2007 based on an
analysis of these companies.

     Response:

     There are several factors the Company considers when identifying other companies that it
believes are the most comparable to it for purposes of assigning a likely volatility factor to its
common stock. Specifically, the Company has based its stock volatility analysis on the following
companies for the reasons indicated:

     Myriad Genetics — due to this company’s industry segment (pharmaceutical) and its focus on
development of novel healthcare products, as well as its focus in generating revenue from

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 6

existing
products. Like Cumberland Pharmaceuticals, Myriad has a pipeline for early stage drug candidates
and develops late-stage (Phase III) development products. Additionally, Myriad is similar to the
Company in that its existing products are ‘mid-sized’ revenue generators. Like Cumberland
Pharmaceuticals, Myriad also has stock-based compensation expense, including stock option grants.

     Bradley Pharmaceutical — due to this company’s focus as a specialty pharmaceutical company
that provides product in niche specialty markets including gastroenterology, an area in which the
Company operates. Bradley is similar to the Company in that it has demonstrated a steady growth in
revenues and profitability. Bradley is also similar in that its revenue is generated by small
and/or mid-sized products, as compared with companies that generate the majority of their revenue
from large, block-buster type products.

     Nabi Pharmaceutical — due to this company’s industry segment (pharmaceuticals) and its focus
on niche and underserved markets, a similar approach to the Company. Like Cumberland
Pharmaceuticals, Nabi has research capabilities to develop drugs as well as having established
marketplace products. Nabi’s business strategy is similar to the Company’s in that both companies
are focused on optimizing the value of their current operations, building value through strategic
partnerships and commercial alliances and providing growth and value through research and
development of late-stage product candidates.

     Forest Laboratories — due to this company’s industry segment, its marketing strategy and its
development strategy and capabilities. Although significantly larger than the Company, Forest
demonstrates a similar business approach. Specifically, both Forest and Cumberland Pharmaceuticals
conduct clinical studies, manage the regulatory approval process, and market products to
physicians. Both companies also co-promote products as well as owning products outright.
Additionally, like Cumberland Pharmaceuticals, Forest incurs stock-based compensation expense
including stock option grants.

     Salix Pharmaceuticals — due to this company’s industry segment, and its focus on specialty
pharmaceuticals in the gastroenterology market. Like Cumberland Pharmaceuticals, Salix focuses
primarily on the U.S. market. Salix’ approach to research and development aims to identify
late-stage proprietary products, an approach also used by the Company. Both companies outsource
manufacturing and have focused specialty sales forces. Both Salix and Cumberland Pharmaceuticals
have demonstrated top line growth in revenue while forging ahead with development activities. Both
companies use stock-based compensation as a method of compensating their employees. Salix and
Cumberland Pharmaceuticals are both focused on growing their business by adding new products to
their portfolios via expanding the indications

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 7

for their current products, acquiring new products
and/or co-promoting selected third-party products.

     With respect to determining its stock volatility in 2006 and 2007, the Company calculated the
volatility for each of these companies based on the term of the option granted. The Company then
took an average of the volatility calculated for these peer companies and used that average as its
volatility rate.

     Liquidity and Capital Resources, page 41

    10.

    We note the revisions pursuant to comment 32. Please
disclose separately the minimum purchase amounts applying to
Kristalose and Acetadote.

     Response:

     The
Company has complied with this comment by amending the sixth paragraph on page 43 of
Amendment No. 2 to disclose minimum purchase requirements for each product.

     Business, page 47

    11.

    We note your response to comment 37.

    •

    Please clarify what type of “data on the use of intravenous
ibuprofen” the license from Vanderbilt University covers, as discussed
at the top of page 54. Also, describe the consideration you are
required to pay to Vanderbilt. This information would appear to be
material to investors.

     Response:

     The Company has complied with this comment by amending the paragraph beginning at the bottom
of page 53 and continuing at the top of page 54 in order to describe the data in more detail and
to set forth the consideration it is required to pay to Vanderbilt.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 8

    •

    We note from the bullet point at the bottom of page 59 that Mayne
Pharma Pty. Ltd. is your exclusive manufacturer for Amelior and will
continue to be the exclusive manufacturer after FDA approval. Please
disclose the aggregate development, regulatory, and inspection and
audit costs you have paid to date. Also, please file this agreement as
an exhibit.

     Response:

     The Company has complied with this comment by amending the first bullet point on page 60 to
address the development, regulatory, inspection and audit costs that it has paid to date to Mayne
pursuant to this agreement. Cumberland Pharmaceuticals will also file documentation to verify that
Mayne assumed all of the rights and obligations of F.H. Faulding & Co. Limited under the Strategic
Alliance Agreement dated July 21, 2000, between the Company and F. H. Faulding & Co. Limited
(previously filed as Exhibit 10.8 to the Registration Statement).

    •

    Please revise to disclose the terms of the release between
you and Bertek Pharmaceuticals.

     Response:

     The Company has complied with this comment by amending the second full paragraph in the
“Kristalose” section on page 56 to describe the release entered into by Bertek and the
Company.

    •

    Regarding the agreement with Inventiv Commercial Services, we
understand from a June 27, 2007 conversation with your counsel that the
agreement is currently filed as exhibits 10.4 and 10.5, and it was
assigned to Inventiv by way of exhibit 10.6. Exhibit 10.6 is not yet
filed, but the description of exhibit 10.6 in the exhibit index does
not mention Inventiv. Please ensure that you have filed all agreements,
amendments, and assignments related to this relationship.

     Response:

     The Company has complied with this comment by amending its description of Exhibit 10.6 in both
Part II and the Exhibit Index to describe the contractual relationship with Inventiv Commercial
Services.

Adams And Reese llp

United States Securities and Exchange Commission

July 6, 2007

Page 9

    •

    Please disclose the monthly fee you pay to Inventiv, as mentioned
at the bottom of page 58. Also disclose the aggregate amount you have
reimbur