1999年第２四半期Prosorba column売上は$585,000（前年同期$493,000）。 1999年第１四半期は$588,000。 Prosorba columnのＲＡ適応追加は1999.3月、DMARDs無効例に有効だが知名度は低い（Cypress社）
SAN DIEGO--(BW HealthWire)--July 19, 1999--Cypress Bioscience
Inc. (Nasdaq:CYPB) announced today its financial results for the
second quarter of 1999.
For the quarter, the company reported a net loss of $1.7 million,
or $0.04 per share, compared to a net loss of $2.7 million or $0.07
per share in 1998. Net loss for the six months ended June 30, 1999 was
$4.8 million, or $0.11 per share, compared to a net loss of $4.7
million or $0.12 per share for the same period in 1998.
In March 1999, Cypress entered into an agreement with Fresenius
Hemotechnology Inc. (FHI), a U.S. subsidiary of Fresenius AG
(Fresenius) of Bad Homburg, Germany. FHI is a leading provider of
apheresis equipment and disposables. The agreement provides Fresenius
with an exclusive license to manufacture and distribute the Prosorba
column in the U.S., Europe, Latin America, and subject to certain
conditions, Japan and certain other countries. Operating revenues in
the second quarter of 1999 were made up of expense reimbursement from
the sale of Prosorba(R) columns by FHI. As such, it is not directly
comparable to revenues recorded in the prior period.
Prosorba column sales for the second quarter of 1999 totaled
$585,000 compared to $493,000 in 1998. This increase in Prosorba
column sales was attributed to initial sales of the product for use in
rheumatoid arthritis (RA). Sales of the Prosorba column during the
second quarter of 1999 were down slightly from first quarter 1999
sales of $588,000. This resulted from increases in sales of the
Prosorba column for RA that did not entirely offset decreased sales
for the idiopathic thrombocytopenic purpura (ITP) indication.
"At the time of launch into the rheumatoid arthritis market three
months ago, Prosorba column awareness was low. We are building
awareness and generating interest in the RA community and educating
the rheumatologists about how to incorporate this novel approach to
managing RA into their practice. As we anticipated, this process takes
time," said Carl Bobkoski, president and chief operating officer of
Cypress. "While it requires multiple sales calls to go from first
contact to patient treatment, the unique characteristics of the
non-drug Prosorba column have been well received by rheumatologists,
many of whom have identified Prosorba column candidates within their
practice."
In April 1999, Fresenius exercised its option to acquire the
Prosorba column manufacturing facility and related assets, located in
Redmond, Wash., for $5.2 million. The purchase price paid to Cypress
consisted of cash of $1.2 million and an offset of $4.0 million from
the previous draw down of an interest-free line of credit provided by
Fresenius.
In connection with this transaction, Fresenius purchased from the
company inventory for $2.0 million that resulted in a gain to Cypress
of $693,000. The purchase price of the manufacturing facility and
related assets may result in a gain to Cypress. The potential gain was
deferred since the company is responsible for reimbursing Fresenius
for certain operating costs associated with this facility during 1999.
The net book value of the property and equipment sold to
Fresenius totaling $1.4 million was recorded on the balance sheet as
"Assets of Business Transferred." The purchase price of the property
and equipment sold totaling $3.2 million was recorded as "Liabilities
of Business Transferred." When the obligation to Fresenius lapses at
year end, the assets sold will be removed from the company's balance
sheet and the excess of the purchase price over the net book value of
the assets sold plus reimbursement of certain operating costs will be
recorded as a gain from sale of assets, if any.
In April 1999, the company launched sale of the Prosorba column
for the treatment of moderate to severe RA in adult patients with long
standing disease who have failed or are intolerant of
disease-modifying anti-rheumatic drugs (DMARDs). Operating revenues
for six months ending June 30, 1999 were $1.0 million, compared to
operating revenues of $1.2 million for the same period in 1998.
Operating revenues for the six months ended June 30, 1998 included
$204,000 of grant income.
Operating expenses for the six month period ended June 30, 1999
and 1998 were $6.7 million and $6.0 million, respectively. As a result
of Fresenius' purchase of the Redmond manufacturing plant, the company
will not incur production costs for the Prosorba column after April
1999. Accordingly, operating expenses for the six months ended June
30, 1999 were not comparable to the prior period. The increase to
operating expense of $0.7 million during the six months period in 1999
compared to 1998 resulted from higher sales and marketing expenses
offset by lower production and research and development expenses. The
decrease in research and development expenses was due to completion of
Phase III clinical studies of the Prosorba column for RA. The increase
in sales and marketing expense resulted from the hiring of a sales
force and other activities associated with the launch of the Prosorba
column for RA in April 1999.
Upon signing of the Fresenius agreement, Cypress received a total
of $1.5 million from Fresenius consisting of the purchase of 297,530
shares of Cypress common stock for $1.0 million, and $500,000 for the
purchase of a three-year warrant to buy 342,466 shares of common stock
at $7.50 per share. In March and April 1999, Cypress received proceeds
of $5.2 million from the exercise of warrants to purchase 2.6 million
shares of common stock. At June 30, 1999, the company had cash, cash
equivalents, and short-term investments of $13.0 million.
Cypress Bioscience Inc. will hold a conference call on Tuesday,
July 20, 1999 at 10:00 a.m. EST. To join the call dial 888/221-6607
toll free, or 703/834-7676 for international calls.
Cypress Bioscience Inc. develops and markets medical devices and
therapeutics for the treatment of certain types of immune disorders
and is engaged in the development of novel therapeutic agents for the
treatment of blood platelet disorders. The Prosorba column, a
therapeutic medical device, was approved by the U.S. Food and Drug
Administration in March 1999 for use in the therapeutic reduction of
the signs and symptoms of moderate to severe rheumatoid arthritis in
adult patients with long standing disease who have failed or are
intolerant to DMARDS.
It was previously approved in 1987 for use in Idiopathic
Thrombocytopenic Purpura (ITP), an immune bleeding disorder. In
addition to Cypress's lead product, the Prosorba column, the company
is developing Cyplex(TM) (Infusible Platelet Membranes), which is
positioned to become an alternative for traditional platelet
infusions. For more information about the Prosorba column and Cypress,
please visit the company's Web site at www.cypressbio.com.
Except for historical information contained herein, this news
release contains forward-looking statements regarding Cypress
Bioscience Inc.'s operating results or financial condition that
involve risks and uncertainties, including, but not limited to, the
company's and Fresenius' ability to market successfully the Prosorba
column for use as a treatment for RA; whether the company will be
successful in collaborating with Fresenius; and the Company's ability
to develop and receive regulatory approval for Cyplex on a timely
basis, if at all, as well as other risks detailed from time to time in
the company's SEC reports, including its Annual Report on Form 10-K
for the year ended Dec. 31, 1998 and its most recent Quarterly Report
on Form 10-Q.
CYPRESS BIOSCIENCE INC. Condensed Financial Data (In thousands, except per share data) Statements of Operations Data Quarter ended Six months ended June 30, June 30, 1999 1998 1999 1998 (unaudited) (unaudited) Operating revenues $ 379 $ 645 $ 977 $ 1,194 Operating expenses 2,932 3,457 6,673 6,039 Gain from sale of inventory 693 -- 693 -- Other income, net 129 72 170 172 Net loss $(1,731) $(2,740) $(4,833) $(4,673) Net loss per share - basic and diluted $ (0.04) $ (0.07) $ (0.11) $ (0.12) Shares used in computing net loss per share - basic and diluted 43,013 38,923 42,691 38,806 Balance Sheet Data June 30, Dec. 31, 1998 1999 1998 (unaudited) Assets Cash, cash equivalents and short-term investments $ 12,959 $ 5,620 Assets of business transferred 1,359 -- Other current assets 575 1,853 Non-current assets 296 1,843 Total assets $ 15,189 $ 9,316 Liabilities and Stockholders' Equity Current liabilities $ 1,460 $ 1,905 Liabilities of business transferred 3,217 -- Long term liabilities 541 566 Stockholders' equity 9,971 6,845 Total liabilities and stockholders' equity $ 15,189 $ 9,316
CONTACT: Cypress Bioscience Inc.
Jay D. Kranzler, Carl Bobkoski, Manda Hall
858/452-2323
=======================================================
| ●Nasdaq - News :Cypress Announces Fresenius AG To Purchase Prosorba Column Manufacturing Facility; Approximately $5.2 Million in Proceeds to Cypress |
SAN DIEGO--(BW HealthWire)--April 27, 1999--Cypress Bioscience
Inc. (Nasdaq:CYPB) announced today that Fresenius AG of Bad Homburg,
Germany has exercised the option and acquired the Prosorba(R) column
manufacturing function and related assets, located in Redmond,
Washington.
The acquisition was made by Fresenius's US subsidiary, Fresenius
Hemotechnology Inc. of Concord, Calif. (FHI).
As part of their partnering arrangements, which closed earlier
this year, Cypress granted Fresenius the option to purchase the
Prosorba(R) column manufacturing assets, located in Redmond,
Washington, until the end of 2000.
Associated with this purchase option, Fresenius made available to
Cypress an interest-free line of credit to provide the company with
the working capital required to fund its share of the market launch
and to initiate the scale-up process. Cypress has drawn down to date
approximately $4 million, which will be offset against the purchase
price of the facility. Fresenius has paid an additional amount of
approximately $1.2 million to exercise the purchase option.
"Fresenius's ownership of the manufacturing function will
accelerate the commitment of their proven expertise toward the
scale-up of the Prosorba(R) column to meet anticipated market demand,"
said Jay D. Kranzler, M.D., Ph.D., chairman of the board and chief
executive officer of Cypress Bioscience Inc. "This transaction also
shortens the timeframe for Cypress to reach profitability by reducing
our ongoing operating expenses and capital expenditures."
"Our further investment reflects Fresenius's view of the
promising prospects for the Prosorba(R) column within the rheumatoid
arthritis market place," commented Rainer Baule, president and chief
operating officer, Fresenius Intensive Care and Hemotechnology. The
companies jointly launched the product for the rheumatoid arthritis
application on April 5, 1999.
The agreement between Cypress and Fresenius AG of Bad Homburg,
Germany and FHI provides Fresenius with an exclusive license to
distribute the Prosorba(R) column, a treatment for rheumatoid
arthritis, in the US, Europe and Latin America and, subject to certain
conditions, Japan and select Asian countries.
The terms of the agreement with Fresenius specify joint efforts
to introduce and market the Prosorba(R) column in the U.S., with
Fresenius having exclusive distribution rights and responsibility for
clinical trials and registration overseas. The agreement includes a
50/50 profit split in countries other than the United States.
The profit sharing is 50/50 in the U.S. until Prosorba(R) column
revenue reaches a pre-determined sales threshold, after which time
Cypress will receive 60% of the profits and Fresenius will receive
. In connection with the closing earlier this year, Fresenius made
an up front payment to Cypress of $1.5 million for the purchase by
Fresenius of Cypress common stock and warrants.
Financial terms also include license payments of up to $54
million based on sales.
Cypress Bioscience Inc. develops, manufactures and markets
medical devices and therapeutics for the treatment of certain types of
immune disorders and is engaged in the development of novel
therapeutic agents for the treatment of blood platelet disorders.
The Prosorba(R) column, a therapeutic medical device, was
approved by the FDA in March 1999 for use in the therapeutic reduction
of the signs and symptoms of moderate to severe rheumatoid arthritis
in adult patients with long standing disease who have failed or are
intolerant to disease-modifying anti-rheumatic drugs (DMARDS).
It was previously approved in 1987 for use in Idiopathic
Thrombocytopenic Purpura (ITP), an immune bleeding disorder. In
addition to Cypress's lead product, the Prosorba(R) column, the
company acquired Cyplex(TM) (Infusible Platelet Membranes), which is
positioned to become an alternative for traditional platelet
infusions.
For more information about the Prosorba(R) column and Cypress,
please access the company's Web site at: www.cypressbio.com.
Fresenius AG is one of the leading health care companies
worldwide with products and services for dialysis, the hospital and
the outpatient medical care of patients. In 1998 Fresenius generated
sales of DM 8.444 billion (US $4.593 billion) and a net income of DM
285 million (US $155 million). On Dec. 31, 1998, the Fresenius Group
had more than 39,000 employees.
Fresenius Hemotechnology Inc. is a US subsidiary of Fresenius AG
that focuses on cell separators, autotransfusion devices, blood
filters and products for blood banks and hospitals including
progenitor cell enrichment devices.
Except for historical information contained herein, this news
release contains forward-looking statements that involve risks and
uncertainties, including, but not limited to, the company's and its
partner's ability to market successfully the Prosorba(R) column for
use as a treatment for RA; whether the company will be successful in
collaborating with a marketing partner or not; the company's ability
to receive regulatory approval for Cyplex(TM) on a timely basis, if at
all; and whether Cyplex will become a substitute for traditional
platelet infusions, as well as other risks detailed from time to time
in the company's SEC reports, including its report on the most recent
Form 10-K.
CONTACT: Cypress Bioscience Inc.
Jay D. Kranzler, Carl Bobkoski, and Manda Hall
619/452-2323
or
Adam Friedman Associates
Adam Friedman, 212/391-7596
or
The Oxford Group
Mark Corbae, 760/918-0593
=======================================================
The Prosorba Column
The PROSORBA(R) column
The PROSORBA column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
●Click here for more information on the PROSORBA column and Rheumatoid Arthritis (RA)
The PROSORBA column is indicated for use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containing circulating immune complexes from plasma in patients with idiopathic thrombocytopenic purpura (ITP) having platelet counts less than 100,000mm3.
●Click here for more information on the PROSORBA column and Idiopathic Thrombocytopenic Purpura (ITP)
The Cyplex Platelet Alternative
CyplexTM Infusible Platelet Membranes*
The Cyplex infusible platelet membranes is an experimental potential substitute for traditional platelet transfusions. It may offer important clinical and logistical advantages over conventional platelet transfusions such as the ability to control bleeding in patients refractory to platelets, a significant problem for cancer patients undergoing chemotherapy and irradiation. After the successful completion of a Phase II efficacy trial, Cypress is planning a Phase IIb clinical trial to determine the correct dosing of the product.
●Click here for more information on the Cyplex infusible platelet membranes
*This product is experimental and is not yet approved by the FDA for commercial distribution
Last modified: March 25, 1999
=======================================================
Rheumatoid Arthritis
The Prosorba Column
The PROSORBA(R) column
The PROSORBA column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
Information for Patients with Rheumatoid Arthritis
Information for Health Care Professionals Who Treat Rheumatoid Arthritis
Last modified: June 16, 1999
=======================================================
Patients with RA
The PROSORBA(R) Column for Patients with Rheumatoid Arthritis
The PROSORBA column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
Patient Guide - Frequently Asked Questions (FAQ)
Help finding a rheumatologist in your area
If you are currently using the PROSORBA column and wish to enroll in NEW HOPE, our patient support program, click here
If you have further questions about the PROSORBA column, please call toll free 1-800-635-HOPE, 8am-5pm PST, M-F.
Last modified: March 25, 1999
=======================================================
The PROSORBA(R) Column Patient Guide
Cypress Bioscience, Inc.
Feel free to browse through some of the most commonly asked questions we receive from patients. Please consult your physician if you have questions related specifically to your health.
●Directory of Questions:
What is the PROSORBA column?
What is involved in the PROSORBA treatment?
How often is the procedure performed?
How will I know if the procedure is working?
What about side effects?
If I am treated as an outpatient, will I be able to return home after each treatment?
How shall I care for myself after the treatment?
IMPORTANT PATIENT INFORMATION
Your physician has been supplied with full
and complete prescribing information advising him/her of the best way to use the PROSORBA(R) column. The following summary includes an abbreviated version of this information for your review.
For what conditions is the PROSORBA column used?
For what conditions should the PROSORBA column not be used?
What if I have problems after my treatment when I have returned home?
●What is the PROSORBA column?
The PROSORBA column is a plastic cylinder about the size of a coffee mug that contains a sand-like substance coated with a special material called Protein A. Protein A is unique in that it binds certain elements from your blood called antibodies. Normally, antibodies protect you from disease. However, sometimes your body produces unwanted antibodies that attack your own body tissues. These unwanted antibodies can result in disease. The PROSORBA column works to counter the effect of these harmful antibodies
●What is involved in the PROSORBA column treatment?
Normally, during therapy, blood is drawn from a vein in your arm and is then pumped into an apheresis machine, or cell separator. This machine separates the liquid part of your blood (the plasma) from the blood cells. Your plasma passes through the PROSORBA column, out through another tube and, after being reunited with your blood cells, is returned to your body through a vein in your other arm (see the diagram). The entire procedure treats 4-8 cups of plasma and takes approximately 2 hours.
●How often is the procedure performed?
How often you receive these treatments is based upon your condition. Twelve treatments, once per week for 12 weeks are recommended for patients with rheumatoid arthritis (RA). The recommended treatment for patients with idiopathic thrombocytopenic purpura (ITP) is more variable and may range from daily to weekly treatments. Your physician will advise you of the best method of treating your disease.
●How will I know if the procedure is working?
Like other therapies, the response to treatment will vary from person to person and your doctor will closely monitor your progress. Not all patients respond to PROSORBA column treatments. Patients with RA should not expect any evidence of improvement until a full course of treatments have been received. This delayed reaction is normal and you should not be concerned that the treatment isn't working. It may take this long for your body to respond. Our clinical study has demonstrated that those patients who do notice improvement may continue to experience reduced symptoms for some months after completion of the treatments. Patients with ITP may show improvement after only a few treatments, but commonly require 6 treatments to obtain the best results.
●What about the side effects?
When they occur, the side effects of the PROSORBA column are usually temporary and manageable. The most common side effect is a "flu-like" condition with chills, mild fever, nausea and joint/muscle pain. Your physician may prescribe medications to make you more comfortable. In our clinical study, patients with rheumatoid arthritis often experienced some fatigue and a temporary increase in joint pain and swelling for a day or two after treatment. The process of removing your blood for treatment may cause a temporary drop in your blood pressure. In such cases, the doctor administering the apheresis treatment may decide to slow down the blood flow or give you additional fluids by vein.
As with any medical therapy, you should always report any rash or other unusual symptoms to your doctor as soon as possible. Please read the IMPORTANT PATIENT INFORMATION below.
●If I am treated as an outpatient, will I be able to return home after each treatment?
Yes, if you are not already staying overnight in the hospital because of your underlying condition, you will normally return home after each treatment.
●How shall I care for myself after the treatment?
It is not unusual to feel tired after this type of treatment. Your physician may recommend rest for some time after the treatment.
Additional Patient Information About the PROSORBA column
●IMPORTANT PATIENT INFORMATION
Your physician has been supplied with full and complete prescribing information advising him/her of the best way to use the PROSORBA column. The summary below includes an abbreviated version of this information for your review.
●For what conditions is the PROSORBA column used?
The PROSORBA column is approved for use in the treatment of some patients with idiopathic thrombocytopenic purpura (ITP) and for some patients with rheumatoid arthritis (RA) who are not responsive or are intolerant of DMARD therapy. Both diseases are conditions brought about by an abnormal situation in the body's antibody system. Your doctor has made a determination that you may benefit from a course of PROSORBA column treatments.
●For what conditions should the PROSORBA column not be used?
Heart conditions or high blood pressure: You should never
participate in a PROSORBA column treatment program if you are currently taking or have recently (within a week or so) taken angiotensin-converting-enzyme medications. These medications are often referred to as "ACE inhibitors" and would normally be prescribed to you if you have been experiencing heart problems or high blood pressure. If you have either of these conditions or related conditions, talk to your doctor before starting the PROSORBA column treatments.
Blood Clotting Problems: Tell your physician if you have experienced strokes or blood clotting.
Pregnancy: The use of the PROSORBA column has not been studied in pregnant women.
●What if I have problems after my treatment when I have returned home?
Although rare, unusual reactions to the PROSORBA column do occur. You should always report unusual symptoms to your doctor. Any rash should be reported since it may (rarely) signal a reaction called vasculitis which requires discontinuation of the PROSORBA column treatments.
Distributed Exclusively by: Fresenius Technology, Inc.
110 Mason Circle Suite A Concord, CA 94520-1238; Phone 925:688-0990 Fax 925:688-0999
Customer Service: 800:909-3872, 7am-5pm PST, M-F
www.freseniusht.com
This patient guide is provided as an educational service of: Cypress Bioscience, Inc. , 4350 Executive Drive, Suite 325, San Diego, California 92121
Phone/619:452-2323, Fax/619:452-1222, Email/prosorba@cypressbio.com
Last modified: March 25, 1999
=======================================================
Information on the PROSORBA(R) Column for Health Care Professionals Who Treat Patients Who Suffer with Rheumatoid Arthritis
The PROSORBA column is indicated for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
Prescribing information
HTML version - view in your internet browser
PDF file - If you wish to print out the PROSORBA column Prescribing Information, please download the PDF file. (Click icon below, if you need to download a free version of the Adobe Acrobat Reader)
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Get Acrobat Reader
Frequently asked questions/patient guide
HTML version - view in your internet browser
PDF file - If you wish to print out the PROSORBA column Patient Guide, please download the PDF file. (Click icon below, if you need to download a free version of the Adobe Acrobat Reader)
Presentation of the clinical data. Click here to download a PowerPoint presentation file (1.7 MB).
Bibliography
Professional programs (coming soon)
About NEW HOPE, our patient support program
How to order the PROSORBA column
For questions about reimbursement and insurance coverage, call the PROSORBA Column Reimbursement Hotline
at 800.255.7277 9am-5pm EST, M-F. For more information click here.
Request a visit from a Cypress Bioscience, Inc Representative
Last modified: March 30, 1999
=======================================================
Idiopathic Thrombocytopenic Purpura
The
PROSORBA(R) column
Clinical Data
Bibliography (Hematology)
Prescribing Information
In addition to Rheumatoid Arthritis, the PROSORBA column is a medical
device used for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a potentially life-threatening bleeding disorder. It is indicated for use in the therapeutic removal of immunoglobulin G (IgG) and
IgG-containing circulating immune complexes from plasma in patients with idiopathic
thrombocytopenic purpura (ITP) having platelet counts less than 100,000mm3.
The PROSORBA column employs approximately 200 mg of protein A covalently
bound to an inert silica matrix that is contained within a 300 ml polycarbonate housing.
Each column contains 123 ｱ 2 grams of this matrix. Protein A is a component of certain
strains of the Staphylococcus bacterium and it binds immunoglobulin G (IgG) and IgG bound to an antigen, i.e., circulating immune complex.
Last modified: March 25, 1999
=======================================================
米国RA患者は250万人、うち70%が女性で最多年齢帯は10-60才。 Prosorbaの対象となるのは25万人。
The Company has embarked on a three-part business strategy:
●Strategy 1
Winning approval for the PROSORBA(R) column in rheumatoid arthritis (RA)
In March 1999, Cypress Bioscience, Inc received FDA approval for the PROSORBA column for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
In January 1998, Cypress successfully completed--a year in
advance--a pivotal Phase III trial studying the use of the PROSORBA column for treating
Rheumatoid Arthritis patients who have not responded to traditional therapies.
Rheumatoid Arthritis is a chronic, often debilitating auto-immune disease in which the body's immune system attacks its own tissue, which can lead to painful inflammation and deformity of the joints. The disease affects more than 2 1/2 million Americans, 70% of them women, most between the ages of 25 and 60. The PROSORBA is targeted toward the over 250,000 patients with the most serious form of the disease.
●Strategy 2
Substantiating the clinical effectiveness of Cyplex™ Infusible Platelet Membranes in controlling bleeding
Cypress Bioscience, Inc. completed a small, open label Phase II trial in 1997, which suggested that the Cyplex infusible platelet membranes were safe and effective when given intravenously to patients with low levels of circulating platelets (thrombocytopenia) to control bleeding. In addition, the trial suggested efficacy of Cyplex infusible platelet membranes even in patients who were resistant to platelet transfusions. Successful demonstration of the ability of Cyplex infusible platelet membranes to control bleeding could position the product as an alternative when platelet infusions fail or cannot be used.
●Strategy 3
Maintaining a presence with the PROSORBA column in hematology
In 1987, the FDA approved the PROSORBA column for the treatment of idiopathic thrombocytopenic purpura (ITP), an immune disorder in which the body produces antibodies that destroy its own healthy platelets, leading to potentially serious bleeding.
While treating patients with ITP has been an important goal for Cypress Bioscience, Inc., the Company will shift its sales focus to the new market opportunity in rheumatology. For those patients in hematology who need PROSORBA column therapy, the Company will be able to continue to supply the product.
Last modified: March 25, 1999
=======================================================
1981
Company established.
1983
Initial Public Offering completed.
1987
PROSORBA(R) column approved for idiopathic thrombocytopenic purpura (ITP) by the U.S. Food and Drug Administration (FDA).
1994
Distribution agreement with Baxter Healthcare established.
1995
Achieved positive results with the PROSORBA column in pilot trial for rheumatoid arthritis (RA).
1996
January: New senior management hired. Company reorganized.
February: Raised $14 million in private placement.
April: Company's name changed from IMRE Corp. to Cypress Bioscience, Inc. Patent dispute settled.
May: Marketing rights to PROSORBA column reacquired from Baxter
June: PROSORBA column RA Phase III trial began. Established Scientific Advisory Boards.
July: Corporate headquarters relocated to San Diego.
August: Post-marketing trial with PROSORBA column in ITP begun
October: Raised net proceeds of $7.3 million in private placement.
November: Acquired PRP, Inc. and the Cyplex™ infusible platelet membranes (IPM).
1997
January: Achieved positive results in Phase II trial with Cyplex infusible platelet membranes.
April: Redmond manufacturing facility received Good Manufacturing Practices (GMP) approval by the FDA.
July: Data Safety and Monitoring Board (DSMB) recommended continuation of PROSORBA column Phase III RA trial. Cyplex patent allowance granted.
October: Raised net proceeds of $5.7 million in private placement.
1998
January: DSMB recommended early cessation of the Phase III RA trial due to favorable safety and statistically significant efficacy results.
February: PROSORBA column awarded patents for RA and ITP indications. Signed collaboration agreement with the Dutch Sanquin Blood Supply Foundation for the scale-up and development of Cyplex infusible platelet membranes.
July: Filed PMA supplement for the PROSORBA column in RA.
October: Positive recommendation by the FDA Gastroenterology and Medical Device Panel for the use of the PROSORBA column in moderate to severe rheumatoid arthritis.
Neo Retro 1999.jpg (2916 bytes)
January: Signed letter of intent for collaboration with Fresenius AG in distribution of the PROSORBA column.
March: Received FDA approval for the PROSORBA column for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis in adult patients with long standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
Signed definitive licensing and distribution agreements for U.S, Europe and Latin America markets with Fresenius AG for the PROSORBA column; agreement includes equity investment and profit sharing.
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Fukumi Corporation MedicalMedia
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- 関連●MLリソース:NSAIDS
- ■1999 -----------------------------------------
★1058★15/16★99.07.30★069★慢性関節リウマチに対するProsorbaカラム/2p●1058追加メモ[83KB]
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- 作成：1999.8.12 最終更新:99.8.12 小菅博之
The Medical Letter日本語版
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On Drugs and Therapeutics
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