SEC Company Response from ACORDA THERAPEUTICS INC (CIK 0001008848) — Oct 25, 2005
ACORDA THERAPEUTICS INC (CIK 0001008848)
Date: Oct. 25, 2005 · CIK: 0001008848 · Accession: 0001104659-05-050133
AI Filing Summary & Sentiment
Show Raw Text
CORRESP
1
filename1.htm
Certain portions of this letter have been omitted
pursuant to a request for confidentiality. Such omitted portions, which are
marked with brackets [...] and an asterisk*, have been separately filed with
the Commission.
[ACORDA THERAPEUTICS LETTERHEAD]
Ms.
Mary K. Fraser, Esq.
Division
of Corporation Finance
U.S.
Securities and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549
Fax
(202) 772-9213
October
26, 2005
Dear
Ms. Fraser,
In
connection with our filing on October 5, 2005 of a Form S-1, we have assessed whether
historical financial statements are required pursuant to Regulation S-X
210.3-05, Financial Statements of Businesses Acquired or to
be Acquired (“Rule 3-05”) regarding our acquisition of certain product
assets. The following provides
background on our Company, our evaluation of whether those product assets are
an acquired business pursuant to Rule 11-01(d) of Regulation S-X, and our
conclusions as to why they are not and, accordingly, historical financial
statements are not required.
Background
Company Overview
Acorda Therapeutics, Inc.
(the “Company”) is a commercial-stage biopharmaceutical company dedicated to
the identification, development and commercialization of novel therapies that
improve neurological function in people with multiple sclerosis (“MS”), spinal
cord injury (“SCI”), and other disorders of the central nervous system, or CNS.
Our lead marketed drug, Zanaflex Capsules™, is FDA-approved for the management
of spasticity. Our lead product candidate, Fampridine-SR, is in a Phase 3
clinical trial for the improvement of walking ability in people with MS. Our
preclinical programs also target MS and SCI, as well as other CNS disorders,
including stroke and traumatic brain injury.
Our marketed products,
Zanaflex Capsules and Zanaflex tablets, which we acquired in 2004, are
FDA-approved for the management of spasticity, a symptom of other conditions
such as MS and SCI that can cause stiffness and rigidity, restrict movement and
result in painful muscle spasms. These products contain tizanidine hydrochloride,
or tizanidine, one of the two leading treatments currently used for the
management of spasticity.
Key Terms of the Zanaflex Acquisition
Agreement
The Company acquired the
U.S. sales, marketing and distribution rights to Zanaflex Capsules and Zanaflex
tablets in July 2004 from Elan Pharmaceuticals, Inc (“Seller”). These products
are approved for the management of spasticity. Zanaflex tablets were approved
by the FDA in 1996 and lost compound patent protection in 2002. There are
currently 11 generic versions of Zanaflex tablets on the market. Zanaflex
Capsules were approved by the FDA in 2002, but were never
Confidential
Treatment
Requested
by Acorda
Therapeutics,
Inc.
ACR
00001
1
Certain
portions of this letter have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [...] and
an asterisk*, have been separately filed with the Commission.
marketed by the Seller.
Zanaflex Capsules are protected by a patent that expires in 2021. The Company
began marketing Zanaflex Capsules in April 2005.
We
acquired our Zanaflex assets pursuant to an Asset Purchase Agreement entered
into with the Seller. The assets acquired included the FDA registration and FDA
dossier for each product (the Capsules were approved under a separate NDA (New
Drug Application) from the tablets), a patent protecting the Capsules and two
related patent applications and existing Zanaflex tablet inventory. We also
entered into a trademark license that allows us to buy the Zanaflex trademark
for a nominal sum once specific milestone and royalty payments have been made.
In addition, we assumed the rights and obligations under a license and supply
agreement for Zanaflex tablets with a third party contract manufacturer that
expires in 2007. Additionally, we
entered into a five-year supply arrangement with the Seller to manufacture
Zanaflex Capsules for us.
We
made an upfront payment of $2 million at the time of closing and agreed to pay
milestones potentially totaling [***] We
also agreed to pay total royalties [***] based on total net sales of Zanaflex tablets
and Zanaflex Capsules. The Company has calculated the significance of the
acquisition (as if it were a business) under the tests in Rule 1-02(w) and
determined that the greatest level of significance would approximate 47% under
the investment test. It should be noted
that this calculation includes the contingent consideration described above,
substantially all of which we would expect to be allocated to Zanaflex
Capsules.
Accounting
Treatment
We have accounted for this
acquisition as an asset acquisition for accounting purposes. We have considered the guidance in EITF 98-3,
Determining Whether
a Nonmonetary Transaction Involves Receipt of Productive Assets or of a
Business, and concluded that the assets, functions and operations that we did not acquire (e.g.
warehousing and distribution, accounting, sales and marketing, manufacturing,
strategic management, employees and human resources) cannot generally be
replaced with relative ease and without significant cost. Accordingly, management concluded that it would
not have been able to conduct normal operations and sustain a revenue stream
based solely upon the acquired assets.
In
connection with our filing of a Form S-1, we have considered the application of
Rule 3-05 to the acquisition of Zanaflex Capsules and Zanaflex tablets and,
more specifically, whether this acquisition meets the definition of a business
pursuant to Regulation S-X 210.11-01(d) (“Rule 11(d)”).
Acorda’s
Zanaflex Operations
We
launched Zanaflex Capsules in April 2005 and are working to convert all of the
existing tablet business to Zanaflex Capsules. We also have invested in a sales
force and a marketing campaign aimed only at the Zanaflex Capsules business. We
hired a 14-person sales force, deployed a 162-person contract sales force, and
have invested in marketing plans, a sample program, a patient assistance
program, continuing medical education, promotional materials and a
telemarketing campaign, all aimed solely at building the Zanaflex Capsules
business. Although we cannot accurately predict exactly how long it will take
to convert our customer base to Zanaflex Capsules, it is our intention to
complete this process as soon as possible [***]
Confidential
Treatment
Requested
by Acorda
Therapeutics,
Inc.
ACR
00002
2
Certain
portions of this letter have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [...] and
an asterisk*, have been separately filed with the Commission.
A
key motivation for the Zanaflex acquisition was that it could enable us to
establish commercial capabilities and to extend our networks among physicians
treating nervous system conditions in advance of the approval and launch of
Fampridine-SR, our lead product candidate.
The potential market opportunity, should Fampridine-SR be approved by
the FDA, is estimated to be much greater than that for Zanaflex.
Zanaflex
Tablets
Until
mid-2002 the Seller’s historical Zanaflex business consisted of the active
marketing and sale of Zanaflex tablets, which the Seller had developed into a [***]
million product. The Seller had used the typical array of resources used to
market pharmaceutical products, including a sales force, advertising and
promotional materials, and educational seminars. Anticipating the product’s 2002
patent expiration, the Seller developed and received FDA approval for a new
product, Zanaflex® Capsules, to which the Seller hoped to shift its tablet
business and thus preserve its Zanaflex franchise. However, the Seller never launched
the capsule product. The Seller ceased actively marketing Zanaflex tablets in
2002, two years prior to Acorda’s acquisition of Zanaflex. As a result of the
tablets losing compound patent protection and the launch of generic
competition, Zanaflex tablets had shrunk to annual sales of approximately [***]
million by 2003.
At
the time that we acquired the drug in July 2004, Zanaflex tablet revenues
consisted primarily of filling repeat orders placed through wholesalers. Tablet
sales averaged approximately [***] million dollars per month in 2004. [***]
Zanaflex
Capsules
Although
never launched by the Seller, Zanaflex Capsules is a new patent-protected drug
with product attributes that differentiate it from the tablets. The key attribute is its different pharmacokinetic
profile. Studies have demonstrated that Zanaflex Capsules, when taken with
food, reduce and prolong peak levels of tizanadine in the patient’s blood. Zanaflex tablets, in contrast, actually
increase peak levels when taken with food.
The FDA recognizes the importance of these differences in
pharmacokinetic profile, and has determined that Zanaflex Capsules are not
therapeutically equivalent to Zanaflex tablets and therefore, under state
pharmacy laws, pharmacists may not properly substitute the tablets when filing
a prescription for Zanaflex Capsules. Thus,
the products are not AB-rated in FDA’s Orange Book.
The
drug labeling also states that pharmacokinetic differences between Zanaflex
Capsules and tablets may result in clinically significant differences when
switching between the two drugs. A portion of our new physician, patient and
pharmacist education programs is devoted to educating physicians about
switching patients from one formulation to the other and the precautions
required.
Other
important differences between Zanaflex Capsules and Zanaflex tablets include:
• Zanaflex Capsules can be opened and sprinkled
on food, which can be easier to take for patients who have difficulty taking
tablets or swallowing whole capsules. It also allows for dosing through an NG
tube.
• Zanaflex Capsules provide new dosing
flexibility. They are available in 2mg, 4mg and new 6mg strengths. The 6mg is
only available in the Capsule, which gives patients and prescribers an additional
choice in dosing and an opportunity to reduce the number of pills a person must
take daily (the drug is labeled for up to 36mg per day.)
Confidential
Treatment
Requested
by Acorda
Therapeutics,
Inc.
ACR
00003
3
Certain
portions of this letter have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [...] and
an asterisk*, have been separately filed with the Commission.
Rule S-X 3-05 Assessment
The
first step in applying Rule 3-05 is to determine whether the registrant has
acquired a business or assets. Acquisitions of assets that do not constitute a
business are not subject to Rule 3-05. A key consideration in whether a business
has been acquired is whether there is continuity of the acquired operations
prior to and after the transaction so that disclosure of prior financial
information is material to an understanding of future operations. As indicated
above, there is little continuity from the Seller’s tablet sales to Acorda’s
marketing, promotion and selling of Zanaflex Capsules.
The
following discusses the criteria set forth in Rule 11-01(d) for evaluating
whether an asset acquisition constitutes a business:
• Whether the nature of the revenue-producing
activity remains generally the same.
As
noted above, we launched Zanaflex Capsules in April 2005, and are working to
convert all of the existing tablet business to Zanaflex Capsules. Although we
can not accurately predict exactly how long it will take to convert our
customer base to Zanaflex Capsules, it is our intention to complete this
process as soon as possible and ultimately eliminate our tablet business
completely. From the date of acquisition
through current, we have not actively promoted Zanaflex tablets nor do we
anticipate promoting them in future periods.
Substantially all of our marketing and promotion efforts are focused on
Zanaflex Capsules, which compete directly with Zanaflex tablets for market
share. We anticipate that we will have phased out most of the Zanaflex tablet
product line by December 2006.
We
believe the launch of Zanaflex Capsules in April 2005 has had a negative effect
on Zanaflex tablets market share. Through April 2005, we were selling approximately
$1.0 million of Zanaflex tablets per month and subsequent to April 2005 have
observed a declining trend in Zanaflex tablet distribution to approximately [***]
in September 2005. Conversely, we have
sold over [***] million in Zanaflex Capsules over the six month period April —
September 2005.
• Whether certain specified attributes remain with
the acquired assets after the transaction.
Here,
six of the eight factors identified in Rule 11-01(d) — physical facilities,
employee base, market distribution system, sales force, customer base, and
production techniques — have materially changed or substantially expanded from
the tablet business run by the Seller to the Capsule business run by Acorda.
Essentially, only the Zanaflex trademark remains the same, and we have applied
to register a new “Zanaflex Capsules” trademark. In fact, Zanaflex Capsules
compete with Zanaflex tablets; a patient will take either one or the other, but
not both.
1. Physical facilities — The
manufacture, supply and distribution chain for the Capsules is different from
that for the tablets. As no commercial
stock of Capsules had been manufactured by the Seller prior to the acquisition,
the entire Capsules chain is new and has been established since the acquisition. The Capsules are manufactured by the Seller,
shipped to the Seller’s facility in Georgia for packaging, and then shipped to
our distribution center in Tennessee for warehousing and distribution. The tablets continue to be manufactured through
a third party contracted supply chain, although
Confidential
Treatment
Requested
by Acorda
Therapeutics,
Inc.
ACR
00004
4
Certain
portions of this letter have been omitted pursuant to a request for
confidentiality. Such omitted portions, which are marked with brackets [...] and
an asterisk*, have been separately filed with the Commission.
the contractual obligations and
oversight have now shifted from the Seller to Acorda. We have also changed the warehousing and distribution
facility for the tablet business from the Seller to our distributor.
We
did not acquire any physical facilities from the Seller in connection with the
transaction. All other physical
facilities now in use by Acorda for both products, including those for marketing
and commercial operations, headquarters and support functions, have changed
from the Seller’s to our (or our vendors’) facilities.
2. Employee base — There was no
transfer of employees from the Seller to Acorda as part of the acquisition. Acorda’s
Zanaflex operation is managed entirely by Acorda employees, almost all of whom
were hired since the acquisition (and none from the Seller), thus providing a completely
new base of employees.
3. Market distribution system — Most U.S. pharmaceutical
drug sales are sold through the same limited group of wholesalers throughout
the United States. The Seller sold Zanaflex tablets through wholesalers, but
not Capsules.
Acorda
markets the Capsules through [***] large national wholesalers and approximately
[***] wholesalers, under its own contractual relationships; the Seller has
indicated to us that it did not have contractual relationships with these
wholesalers. Tablets are also sold to these wholesalers. Shortly after the product acquisition, we completely
changed the distribution chain for the products, moving the warehousing and
logistics process from the Seller to our own distributor.
4. Sales force — P