SEC Company Response from HEMOSOL CORP (CIK 0001285233) — Aug 19, 2005
HEMOSOL CORP (CIK 0001285233)
Date: Aug. 19, 2005 · CIK: 0001285233 · Accession: 0000909518-05-000671
AI Filing Summary & Sentiment
Referenced dates: August 4, 2005
Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Weil, Gotshal & Manges LLP
767 Fifth Avenue
New York, NY 10153
(212) 310-8000
August 18, 2005
Securities and Exchange Commission
Division of Corporation Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
Attn: Gregory S. Belliston
RE: HEMOSOL CORP.
ANNUAL REPORT ON FORM 20-F FOR THE YEAR ENDED
DECEMBER 31, 2004, FILE NO. 0-50778
---------------------------------------------
Ladies and Gentlemen:
On behalf of our clients, Hemosol Corp. (the "Company"), we are
transmitting herewith via the EDGAR system for filing with the Commission the
Company's response to the Staff's letter dated August 4, 2005 pertaining to the
Annual Report on Form 20-F for the Year Ended December 31, 2004 (the "Form
20-F") (File No. 0-50778).
Set forth below in bold are each of the comments in the Staff's letter.
Immediately following each of the Staff's comments is the Company's response to
that comment, including where applicable, a cross-reference to the location of
changes made in response to the Staff's comment. For your convenience, each of
the numbered paragraphs below corresponds to the numbered comment in the Staff's
comment letter and includes the caption used in the comment letter.
STRATEGIC ALLIANCE WITH PROMETIC, PAGE 16
1. BASED ON THE EMPHASIS YOU PLACE ON THE CASCADE TECHNOLOGY THROUGHOUT
THE FILING, IT APPEARS YOU SHOULD FILE AS EXHIBITS THE LICENSE
AGREEMENT AND THE STRATEGIC ALLIANCE AGREEMENT WITH PROMETIC. SEE
INSTRUCTION 4(B)(II) TO EXHIBITS IN FORM 20-F. PLEASE INCLUDE THESE
EXHIBITS IN AN AMENDED FORM 20-F.
The Company intends to comply with the Staff's comment by including
the license and strategic alliance agreements as Exhibits to the Form
20-F. See Exhibits 4.29 and 4.30.
CLINICAL OVERVIEW - HEMOLINK, PAGE 22
2. (I) PLEASE IDENTIFY AND DESCRIBE THE ADVERSE EVENTS THAT CAUSED YOU TO
HALT CLINICAL TRIALS IN MARCH 2003.
<PAGE>
The Company has complied with the Staff's comment. The adverse events
that caused the Company to halt clinical trials in March 2003 were
based on an observation by the Data and Safety Monitoring Board of an
imbalance in the incidence of certain adverse events between the
HEMOLINK and control groups and is described in the Form 20-F as
"observed adverse cardiovascular related events." See page 22. The
Company also disclosed in its Annual Report on Form 20-F for the Year
Ended December 31, 2002, that:
In June 2003, we completed our internal review of
data generated from the cardiac trial (HLK 213/304) for the
use of HEMOLINK in patients undergoing cardiac bypass
grafting surgery. The review confirmed the observation made
by the Data and Safety Monitoring Board of an imbalance of
the incidence of certain adverse events between the
HEMOLINK and control groups with a higher number occurring
in the HEMOLINK group. It is unclear what role HEMOLINK
played in causing the imbalance. As expected, limiting
enrolment decreased the planned statistical power of the
study with respect to efficacy, and the study was unable to
meet its primary objective to demonstrate efficacy in the
total patient population.
We elected to terminate the HLK 213/304 trial early
in order to conduct a full safety analysis and initiate a
comprehensive process aimed at completely understanding the
data in the context of the observations made by the Data
and Safety Monitoring Board. Among the elements of this
process was the creation of an Independent Safety Review
Committee (the "ISRC") to review the safety data from the
HLK 213/304 trial in order to assist us in identifying the
cause of the imbalances found by the Data and Safety
Monitoring Board. The ISRC was comprised of experts in
their respective fields of transfusion medicine,
cardiology, anaesthesiology, cardiac surgery and
biostatics. Concurrently with the ISRC review, our
Scientific Advisory Board, in conjunction with our internal
personnel, undertook its own evaluation of the safety data.
The Company has revised the 2004 Form 20-F to include this
disclosure. See page 24.
(II) ALSO, IN THE "CLINICAL HIGHLIGHTS" DISCUSSION ON PAGE 23,
IDENTIFY AND DISCUSS THE PRINCIPAL ISSUES NOTED BY HEALTH CANADA ON
APRIL 25, 2001, BY THE U.K. MEDICINES CONTROL AGENCY AFTER YOUR
FEBRUARY 2001 SUBMISSION, AND BY THE FDA ON AUGUST 13, 2001.
The Company has complied with the Staff's comment. The Staff's
comment in question 2(ii) are based on the disclosure of the
Company's experience guiding HEMOLINK through the regulatory process.
The process for submission of any new compound to a drug regulatory
authority for marketing approval is described in the Form 20-F in the
section titled "Path to Commercialization" at pages 21 and the
cross-references contained therein. At each stage of the regulatory
2
<PAGE>
review process, the regulator (regardless of jurisdiction) has the
right to request additional data (i.e. additional demonstration of a
product's efficacy and safety profile) prior to approving progression
of that product into the next phase of the approval process. In some
cases that data requested can be ascertained from the existing
submission, in others, additional clinical trial activity is required
to satisfy the regulator. It is within this process that "issues"
were raised by each of the regulators identified by the Staff in its
comment.
As part of the regulatory framework, Health Canada reserves the right
to seek clarification on any point made in a new drug submission.
Following the review of the Company's new drug submission for
HEMOLINK, Health Canada exercised this right to seek additional
clarification on the data and conclusions submitted by the Company.
The Company responded within the time allotted by referencing
available data derived from the completed clinical trials. Health
Canada accepted the Company's responses and proceeded to evaluate the
Company's application to market HEMOLINK in Canada. As noted in the
Form 20-F on page 24, on March 20, 2002, Health Canada advised the
Company that the new drug submission for HEMOLINK had not been
approved for marketing in Canada on the basis that it would require
additional data in a re-filed new drug submission. The Company
elected to move forward with its U.S. trials (described in the Form
20-F) and sought to use the additional data generated from those
trials to support its applications in both Canada and the U.S.
As noted on page 23 of the Form 20-F, "Following an initial review of
[the submission to market HEMOLINK in the U.K.], the U.K. regulatory
authorities requested additional information primarily related to
supplementing the clinical experience sections with additional
studies. This submission remains open and further regulatory agency
reviews are awaiting the filing of supplemental clinical trial data."
Thus, the U.K. regulatory agency requested that additional clinical
trials be conducted to provide additional data to support the
application for marketing. As in Canada, the Company intended to use
the data provided by the additional U.S. trials of HEMOLINK to
support this application, however when the U.S. trials were halted,
it stalled all regulatory activity.
As also noted on page 24 of the Form 20-F, "[the Company] received
notification from the FDA of changes that it wanted made to [the
Company's] Phase III clinical trial protocol for HEMOLINK to
strengthen the efficacy analysis for inclusion in a Biologic License
Application. As a result of these discussions with the FDA, [the
Company] suspended this trial in order to develop and undertake a
more comprehensive Phase II trial that would, in turn, more
effectively ground the resumption of a Phase III clinical trial
protocol for HEMOLINK."
Thus, as noted above, upon review of the Company's application for
HEMOLINK, the FDA requested changes to the scope of the previously
approved Phase III trial in order to generate additional data. In
response, the Company proposed (and the FDA accepted) a two tiered
approach: rather than revising the protocol for the existing Phase III
trial, the Company would undertake a more comprehensive Phase II trial
3
<PAGE>
and based, on a positive review of the data it generated, the Company
would then undertake a final Phase III study, that, if successful
would support the Company's application for marketing approval. As
noted above, in the course of this Phase II study, certain adverse
cardiac events were noted and the entire HEMOLINK clinical trial
program was halted.
3. PLEASE EXPLAIN WHAT YOU WILL NEED TO DO TO RE-INITIATE CLINICAL
TRIALS ON HEMOLINK IN THE U.S., CANADA, AND THE U.K. FOR EXAMPLE, WILL
YOU NEED TO RE-SUBMIT ANY APPLICATIONS, OR WILL YOU SIMPLY BE ABLE TO
RESUME TRIALS AT WILL?
As already disclosed on page 24 of the Form 20-F, in order to
re-initiate clinical trials on Hemolink, the FDA has indicated that
the Company will be first required to conduct additional pre-clinical
activity with a modified formulation of Hemolink and then, based on
that pre-clinical activity, a new investigational new drug application
("IND") would need to be approved prior to re-starting active human
clinical trials. However, as disclosed previously, the Company does
not intend to resume clinical trials of HEMOLINK. The Company has
instead elected to participate in the market for oxygen therapeutic
products by shifting resources to the development of its
second-generation product, HRC-101. HEMOLINK was a first-generation
product. Instead of working to re-initiate a development and clinical
path for a modified form of HEMOLINK, the Company made the decision to
direct its limited resources to (i) seizing the considerable
commercial opportunities presented by the Cascade; and (ii) developing
HRC-101. As a result of this decision, the Company officially
closed-out all open IND files in all jurisdictions (the U.S., the U.K.
and Canada) involving Hemolink.
THE CASCADE PROCESS, PAGE 24
4. IN THIS SECTION, YOU STATE THE CASCADE TECHNOLOGY EXTRACTS CERTAIN
PROTEINS FROM PLASMA. WE PRESUME THIS MEANS THE PLASMA HAS LESS OF THE
PROTEINS AFTER UNDERGOING THE CASCADE TECHNOLOGY. HOWEVER, BASED ON
THE DESCRIPTIONS OF THE THREE TARGET PRODUCTS ON PAGES 26-27, IT
APPEARS THE CASCADE TECHNOLOGY WILL BENEFIT PEOPLE WITH DEFICIENCIES
OF THOSE THREE PRODUCTS. PLEASE CLARIFY HOW REDUCING THE PROTEINS IN
THE PLASMA WILL CURE A DEFICIENCY. FOR EXAMPLE IS THE PLASMA THAT GOES
THROUGH THE CASCADE FROM PEOPLE OTHER THAN THE PATIENT, AS OPPOSED TO
A PATIENT'S OWN PLASMA?
The Company has complied with the Staff's comment. Just to clarify for
the Staff's benefit, the Company will not be processing plasma drawn
from patients, rather it will be purchasing bulk plasma, isolating the
key proteins using the Cascade and then selling the target proteins
extracted from the bulk plasma for administration to patients with the
applicable deficiencies.
The plasma that serves as the raw material for the Cascade process is
separated from whole blood that is collected from blood donors by
blood collection organizations. This plasma is sold commercially in
large quantities and can be purchased from numerous suppliers as a
commodity product. The Company will purchase bulk plasma in this
manner and then use the Cascade to isolate the target proteins. After
receiving all requisite regulatory approvals, the Company will then
4
<PAGE>
sell these proteins for use by patients that have deficiencies of
these proteins or for whom the administration of these proteins may
offer therapeutic value.
SHARE OWNERSHIP, PAGE 56
5. PLEASE DISCLOSE THE PERCENTAGE OF TOTAL OUTSTANDING SHARES OWNED BY
EACH PERSON IN THE TABLE. SEE ITEM 6.E OF FORM 20-F.
The Company has complied with the Staff's comment by adding the
percentages requested and amending the table to include the following
statement: "individually and in aggregate the officers and directors
of the Company beneficially owned directly or indirectly, controlled
or directed less than 0.5% of the total outstanding shares." See pages
57 to 58.
ITEM 15. CONTROLS AND PROCEDURES, PAGE 73
6. WE NOTE THE CEO AND CFO'S EVALUATION TOOK PLACE WITHIN 90 DAYS OF THE
DATE OF FILING, AND THE CONCLUSION OF EFFECTIVENESS IS "AS OF THE DATE
OF HIS EVALUATION." ITEM 15(A) OF FORM 20-F REQUIRES THAT THE
CONCLUSION BE AS OF THE END OF THE PERIOD COVERED BY THE REPORT, NOT
AS OF A TIME WITHIN 90 DAYS OF FILING. PLEASE REVISE THIS SECTION
ACCORDINGLY.
The Company has complied with the Staff's comment by revising the
section accordingly. See page 74.
CONSOLIDATED FINANCIAL STATEMENTS
AUDITOR'S REPORT, PAGE F-2
7. PLEASE TELL US THE NAME OF THE AUDITORS. PLEASE NOTE THAT THE
AUDITORS' OPINION SHOULD INCLUDE THE NAME OF THE AUDITING FIRM AS
REQUIRED BY RULE 2.02(A) OF REGULATION S-X.
The Company has complied with the Staff's comment by adding the name
of its accounting firm, Ernst and Young LLP to the opinion. See page
F-2.
CONSOLIDATED STATEMENTS OF LOSS, PAGE F-4
8. IT APPEARS THE FUTURE TAX BENEFIT RECORDED IN CONSOLIDATED STATEMENT
OF LOSS FOR 2004 IS RELATED TO THE NET GAIN RECORDED ON THE SALE OF
YOUR FUTURE TAX ASSETS AS DISCLOSED IN FOOTNOTE 9. PLEASE TELL US WHY
YOU HAVE RECORDED A BENEFIT INSTEAD OF A CHARGE RELATED TO THE FUTURE
TAX LIABILITY. TO ASS