surf1944
16 years ago
Bristol-Myers Squibb to Acquire Kosan Biosciences
Thursday May 29, 8:39 am ET
Bristol-Myers Squibb Advances Company Strategy with Latest Acquisition
PRINCETON, N.J. and HAYWARD, Calif.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) and Kosan Biosciences Inc. (NASDAQ: KOSN - News) announced today that the companies have signed a definitive merger agreement providing for the acquisition of Kosan, a cancer therapeutics company, by Bristol-Myers Squibb, for $5.50 per share in cash. The transaction, with a net aggregate purchase price of approximately $190 million after deducting Kosan’s projected net cash balance at June 30, 2008, has been unanimously approved by the boards of directors of both companies. The acquisition of Kosan will enhance Bristol-Myers Squibb’s pipeline with compounds in two important classes of anticancer agents: novel Hsp90 (heat shock protein 90) inhibitors and epothilones.
“Helping patients prevail against serious disease is paramount at Bristol-Myers Squibb,” said Jim Cornelius, chairman and chief executive officer. “We pursue innovative science, both internally and externally, that can accelerate the discovery and development of new medicines. Kosan’s technology, coupled with our development and commercialization capabilities, will result in new treatment options for patients, and represents another important milestone in the execution of our strategy to become a next-generation BioPharma leader.”
“We believe that this combination with Bristol-Myers Squibb, a global leader in oncology, provides an excellent opportunity for the potential of Kosan’s development portfolio to be realized through a transaction which also provides our stockholders with attractive financial terms,” said Helen S. Kim, Kosan’s president and chief executive officer. “Kosan has evolved from a research platform to a development company, and we have reached a turning point in our growth as an independent company. We believe that this transaction represents a timely opportunity to place our clinical programs and technology assets in the hands of a world-class company with the experience and expertise to bring innovative cancer treatment options to patients in need.”
“Kosan has done great work advancing two classes of novel anticancer medicines: epothilones and Hsp90 inhibitors,” said Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, Bristol-Myers Squibb. “Epothilones are microtubule stabilizers with multiple therapeutic applications in various cancers and potentially in neurodegenerative diseases. The Hsp90 program includes a Phase III compound for the treatment of patients with multiple myeloma, an area of high unmet medical need.”
Under the terms of the definitive merger agreement, Bristol-Myers Squibb will commence a cash tender offer on or about May 29, 2008 to purchase all of the outstanding shares of Kosan common stock for $5.50 per share in cash. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares that constitutes at least a majority of Kosan’s outstanding shares of common stock (on a fully diluted basis) and expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvement Act. The agreement also provides for the parties to effect, subject to customary conditions, a merger to be completed following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to received $5.50 per share in cash. The directors and executive officers of Kosan have entered into agreements with Bristol-Myers Squibb pursuant to which they have agreed to tender their shares in connection with the tender offer contemplated by the merger agreement, subject to securities law limitations. The merger agreement contains a provision under which Kosan has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources. The companies expect the tender offer to close in approximately thirty (30) days.
Bristol-Myers Squibb and Kosan also announced today that they have entered into a separate license agreement under which Kosan has granted to Bristol-Myers Squibb an exclusive worldwide license to Kosan’s epothilone compounds and related intellectual property and data and will assign to Bristol-Myers Squibb its epothilone investigational new drug (IND) applications. Under the license agreement, Kosan will receive an initial payment of $25 million and is entitled to milestone payments in connection with the development of epothilone product candidates and royalty payments on net sales of such products. The license agreement will remain in effect between the parties in the event that the acquisition is not completed, unless the merger agreement is terminated due to an intentional breach by Bristol-Myers Squibb of its covenants under that agreement.
Credit Suisse Securities (USA) LLC is serving as financial advisor to Bristol-Myers Squibb in connection with the acquisition, and Bristol-Myers Squibb is represented by Cravath, Swaine & Moore LLP, New York, New York. Lazard Frères & Co. LLC is serving as financial advisor to Kosan in connection with the acquisition, and Kosan is represented by Cooley Godward Kronish LLP, Palo Alto, California.
Kosan Conference Call and Webcast Today
Kosan will hold a conference call to discuss the planned acquisition of Kosan by Bristol-Myers Squibb today at 7:00 a.m. Pacific / 10:00 a.m. Eastern. To access the live call, please dial 800.591.6942 (U.S.) or 617.614.4909 (International), access code 40535858. Interested parties may listen to the webcast live at http://www.kosan.com by clicking on the “Webcasts” tab under the heading “Investors/Press.” The webcast is also being distributed over Thomson’s Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through Thomson’s individual investor center at http://www.earnings.com or by visiting any of the investor sites in Thomson’s Individual Investor Network. Institutional investors can access the call via Thomson’s password-protected event management site, StreetEvents, at http://www.streetevents.com. A telephonic replay will be available through June 5, 2008 by dialing 888.286.8010, access code 53056563. International callers can dial 617.801.6888, access code 53056563.
surf1944
16 years ago
Kosan Announces Data Presentations at ASCO 2008 Annual Meeting
Wednesday May 14, 6:00 am ET
HAYWARD, Calif., May 14 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today announced that updated data will be presented on tanespimycin, the company's lead Hsp90 inhibitor, from a Phase 2 trial in combination with Herceptin® in patients with HER2-positive metastatic breast cancer, at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO), being held at McCormick Place, Chicago, IL, May 31 through June 3, 2008.
Abstract 1027, titled, "Phase 2 trial of the Hsp90 inhibitor tanespimycin (Tan) + trastuzumab (T) in patients (pts) with HER2-positive metastatic breast cancer (MBC)," will be presented in a poster session in room E450a on Tuesday, June 3, 2008 from 8:00 am through 12:00 noon CT. The presenter is Shanu Modi, M.D., of Memorial Sloan-Kettering Cancer Center. This abstract will be highlighted in a poster discussion session to be held from 11:00 am - 12:00 noon CT in room E450b.
In addition, data from a Phase 1 trial of Kosan's Hsp90 inhibitor, alvespimycin, will be presented in an oral session on Monday, June 2, 2008 at 8:00 am to 11 am CT. Abstract 2502, titled, "First use of an oral Hsp90 inhibitor in patients (Pts) with solid tumors: Alvespimycin (A) administered QOD or QD," will be presented at 8:00 to 8:15 am CT in room W375a by Keith Flaherty, M.D., of the University of Pennsylvania.
surf1944
16 years ago
Kosan Announces First Quarter 2008 Financial Results
Thursday May 1, 4:00 pm ET
HAYWARD, Calif., May 1 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today reported financial results for the quarter ended March 31, 2008.
Net loss for the quarter ended March 31, 2008 was $8.5 million, or $0.20 per share, compared to net income of $2.7 million, or $0.07 per share, in the same period last year.
Revenues were $4.6 million for the first quarter of 2008, compared to $12.9 million in the same period in 2007. Revenues for the quarter were for development activities under the Roche-Kosan global development and commercialization agreement for epothilones and included $3.3 million for the remaining amortization of the up-front fee from Roche. Revenues for the same period last year included $10.7 million for amortization of the up-front fee received from Pfizer, Inc for the Company's worldwide motilin agonist agreement.
Total operating expenses were $13.7 million, including non-cash stock-based compensation expense of $0.5 million, for the quarter ended March 31, 2008, compared to $11.1 million for the same period last year. Research and development expenses were $10.8 million for the quarter ended March 31, 2008, compared to $9.0 million in the same period in 2007. The increase for the first quarter compared to the same period in the prior year is primarily due to the continued clinical development of the Kosan's Hsp90 inhibitor and epothilone programs, including the initiation of TIME-1, Kosan's pivotal Phase 3 trial for tanespimycin as a potential treatment for multiple myeloma, and a Phase 2 trial of epothilone KOS-1584 in patients with non-small cell lung cancer, and costs associated with the Company's previously announced corporate restructuring.
General and administrative expenses were $2.9 million for the quarter ended March 31, 2008, compared to $2.2 million in the same period in 2007. The increase for the first quarter compared to the same period in the prior year was primarily due to costs associated with the Company's restructuring and the resignation of the former chief executive officer.
At March 31, 2008, cash, restricted cash and marketable securities totaled $59.0 million, compared to $71.0 million at December 31, 2007.
"In the first quarter of 2008, we advanced tanespimycin into a registration trial for multiple myeloma, initiated a Phase 2 trial in non-small cell lung cancer for our lead epothilone, KOS-1584 and transformed our company into a leaner, stronger and more strategically focused organization," said Helen S. Kim, Kosan's President and Chief Executive Officer. "Kosan today is operating as a product-focused, commercially driven enterprise. Our resources, efforts and personnel are focused on advancing tanespimycin and KOS-1584, our lead product candidates, along clearly defined clinical and regulatory paths."
http://biz.yahoo.com/prnews/080501/aqth116.html?.v=40
surf1944
16 years ago
Kosan Announces Fourth Quarter and Full Year 2007 Financial Results and 2008 Outlook
Thursday February 28, 4:05 pm ET
HAYWARD, Calif., Feb. 28 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today reported financial results for the quarter and year ended December 31, 2007.
Net losses for the quarter and year ended December 31, 2007 were $9.5 million and $28.7 million, or $0.22 and $0.69 per share, compared to $4.6 million and $29.5 million, or $0.13 and $0.88 per share, in the same periods for the prior year.
Revenues were $5.6 million and $22.7 million for the quarter and year ended December 31, 2007, compared to $5.7 million and $13.5 million in the same periods in 2006. Revenues for the quarter were for development activities under the Roche-Kosan global development and commercialization agreement for epothilones and included $4.2 million in amortization of the up-front fee from Roche.
Total operating expenses were $16.0 million and $55.4 million, including non-cash stock-based compensation expense of $0.6 million and $3.2 million, for the quarter and year ended December 31, 2007, compared to $10.9 million and $45.0 million for the same periods last year. Research and development expenses were $13.9 million for the quarter ended December 31, 2007, compared to $8.8 million in the same period in 2006. The increase for the fourth quarter is primarily due to increased clinical costs in the Hsp90 inhibitor and epothilone programs, including costs associated with the initiation of the clinical trials in the TIME registration program in multiple myeloma and preparation for the KOS-1584 Phase 2 clinical program. General and administrative expenses were $2.1 million for the quarter ended December 31, 2007, compared to $2.1 million in the same period in 2006.
At December 31, 2007, cash, cash equivalents, restricted cash and marketable securities totaled $71.0 million, compared to $64.1 million at December 31, 2006. Cash used in operating activities was $34.7 million for the year ended December 31, 2007.
"Today, Kosan announced a reprioritization of its clinical development portfolio to focus resources on product candidates with the highest near-term therapeutic potential and commercial value for the company," said Helen S. Kim, Kosan's President and Chief Business Officer. "Kosan's top priorities in 2008 are the advancement of the tanespimycin TIME program in multiple myeloma and the tanespimycin metastatic breast cancer clinical program, and the development of epothilone KOS-1584, which is entering Phase 2 in non-small cell lung cancer. We believe that focusing our resources and efforts on these promising later-stage programs now will bring the most benefit to Kosan and its shareholders in the near-term and support our ability to utilize our resources most effectively and to invest in those high-value programs that will be the key value drivers of our company. We enter 2008 with renewed focus, resolve and confidence in our ability to successfully transform these product candidates into meaningful commercial opportunities for our company."
2008 Financial Outlook
Kosan's outlook for 2008 excludes any potential collaborations, strategic alliances or financings Kosan may conclude this year. The Company anticipates that cash used in operating activities will be in the range of $40 million to $50 million.
Conference Call and Webcast Today
Simultaneous with this announcement of Kosan's fourth quarter and full year 2007 financial results, Kosan also announced a reprioritization of its clinical portfolio. Kosan will hold a conference call and webcast today to discuss both of these announcements. Access information is as follows:
Kosan will hold a conference call to discuss the Company's fourth quarter and full year 2007 financial results today at 1:30 p.m. Pacific / 4:30 p.m. Eastern. To access the live call, please dial 888.713.4213 (US) or 617.213.4865 (international), access code 10071927. Interested parties may listen to the webcast live at http://www.kosan.com by clicking on the "Webcasts" tab under the heading "Investors/Press." The webcast is also being distributed over Thomson's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through Thomson's individual investor center at http://www.earnings.com or by visiting any of the investor sites in Thomson's Individual Investor Network. Institutional investors can access the call via Thomson's password-protected event management site, StreetEvents, at http://www.streetevents.com. A telephonic replay will be available through March 6, 2008 by dialing 888.286.8010, access code: 51294639. International callers can dial 617.801.6888, access code: 51294639
surf1944
16 years ago
Kosan Presents Updated Data on Hsp90 Inhibitor, Tanespimycin, in Multiple Myeloma at Ash
Saturday December 8, 9:00 am ET
HAYWARD, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) presented updated data from a dose-escalating Phase 1b clinical trial of Hsp90 inhibitor tanespimycin (KOS-953) in combination with bortezomib (Velcade®), showing durable antitumor activity and tolerability in patients with multiple myeloma who had previously progressed following treatment with multiple conventional therapies. The data presentation includes summary aggregate results from patients treated with all doses of Kosan's prior Cremophor-containing formulation and with Kosan's new injectable suspension formulation. Responses were seen across dose levels in the bortezomib-naive, pre-treated and refractory patients. Both formulations demonstrated activity, and the combination was manageable relative to safety, with no Grade 3 neurotoxicity to date. This finding supports the potential neuroprotective effect of tanespimycin. The data were presented on Saturday, December 8, 2007, by Paul Richardson, M.D., Department of Hematology, Dana Farber Cancer Center, Boston, MA, in a poster titled "Tanespimycin (T) + Bortezomib (BZ) in Multiple Myeloma (MM): Confirmation of the Recommended Dose Using a Novel Formulation," at the 2007 Annual Meeting of the American Society of Hematology (ASH).
"Tanespimycin continues to be of interest as a potential treatment for patients with multiple myeloma who have failed prior regimens due to its tolerability and potential for additive or synergistic activity with bortezomib," said Kenneth C. Anderson, M.D., Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, senior author on the poster. "The new injectable suspension formulation appears to be well-tolerated and may represent a benefit for patients in terms of convenience and ease of administration. Tanespimycin is clearly an active and manageable agent and is deserving of further clinical study."
"We continue to see meaningful antitumor activity and tolerability with the tanespimycin plus bortezomib combination in multiple myeloma across patient populations. In addition, we are observing intriguing evidence supporting the hypothesis that in the tanespimycin/bortezomib combination, tanespimycin may be exerting a neuroprotective effect based on the observation of reduced neuropathy, a side effect associated with bortezomib," said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "The data from this ongoing trial are still being evaluated, and multiple patients remain on study. At this time, the overall response rate appears to be lower than previously reported. We are investigating whether there were patient characteristics that may have contributed to this lower response rate, including the possibility that patients added to the study since the data were last reported represented a more advanced and heavily pretreated population. We will complete the study and further evaluate the data in consultation with multiple myeloma experts to confirm the most expeditious course forward. Taken as a whole, the currently available data from this trial suggest that there may be utility in adjusting the TIME program to optimize the therapeutic potential of the tanespimycin and bortezomib combination. We have not, however, made any definitive decisions concerning a potential adjustme
http://biz.yahoo.com/prnews/071208/aqsa004.html?.v=1
surf1944
16 years ago
Kosan Announces Third Quarter 2007 Financial Results
HAYWARD, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today reported financial results for the quarter and nine months ended September 30, 2007.
Net loss for the quarter and nine months ended September 30, 2007 were $11.1 million and $19.2 million, or $0.26 per share and $0.46 per share, compared to a net loss of $7.5 million and $24.9 million, or $0.22 and $0.76 per share, in the same periods last year.
Revenues were $1.9 million and $17.1 million for the quarter and nine months ended September 30, 2007, compared to $2.2 million and $7.8 million in the same periods in 2006. Revenues for the quarter were for development activities under the Roche-Kosan global development and commercialization agreement for epothilones.
Total operating expenses were $14.2 million and $39.4 million for the quarter and nine months ended September 30, 2007, including non-cash stock- based compensation expense of $0.7 million and $2.5 million, respectively, compared to $10.3 million and $34.1 million for the same periods last year. Research and development expenses were $12.3 million and $33.4 million for the quarter and nine months ended September 30, 2007, compared to $8.7 million and $28.4 million in the same periods in 2006. The increase for the quarter compared to the same period in the prior year was primarily due to costs associated with initiating the TIME registration program in multiple myeloma and investment in Kosan's epothilone program, including KOS-1584 process development which was funded by Roche, and development of the next generation epothilone, KOS-1803. General and administrative expenses were $1.9 million and $6.1 million for the quarter and nine months ended September 30, 2007, compared to $1.6 million and $5.7 million in the same periods in 2006. The increase for the quarter compared to the same period in the prior year was primarily due to increased personnel costs to support Kosan's increasing development activities.
In the fourth quarter of 2007, Kosan announced that Roche and Kosan are concluding their epothilone development and commercialization collaboration. The collaborative research, development and commercialization agreement entered into in September 2002 will terminate in February 2008, following which Kosan will reacquire worldwide rights to its epothilone program and have full control of clinical development of KOS-1584 and its other epothilone product candidates going forward.
At September 30, 2007, cash, restricted cash and marketable securities totaled $81.7 million, compared to $64.1 million at December 31, 2006. Cash used in operating activities was $24.3 million for the nine months ended September 30, 2007.
'Kosan delivered a strong third quarter performance, led by key achievements: the initiation of our TIME-2 clinical trial of our Hsp90 inhibitor tanespimycin in a relapsed-refractory multiple myeloma population; completion of a Special Protocol Assessment with the FDA for our TIME-1 pivotal Phase 3 clinical trial of tanespimycin; the presentation of updated positive Phase 1 data on alvespimycin in HER2-positive metastatic breast cancer; Phase 1 data on the antitumor activity of KOS-1584; our partner Pfizer's initiation of a Phase 1 trial for KOS-2187, being developed as a potential treatment for gastroesophageal reflux disease and other gastrointestinal disorders; and, after the close of the quarter, completion of preparations for initiating a Phase 2 monotherapy trial of our Hsp90 inhibitor alvespimycin in newly-diagnosed patients with HER2-positive metastatic breast cancer, which we anticipate opening for enrollment shortly,' said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. 'We believe that the growing body of positive clinical data that we have generated in our clinical trials to date, combined with development and regulatory strategies that are being successfully implemented in all of our clinical programs and the commercial potential of our Hsp90 and epothilone programs, position Kosan as an attractive investment opportunity.'
Third Quarter 2007 Highlights
-- Kosan reached a binding agreement with the U.S. Food and Drug
Administration (FDA) on the design of Kosan's TIME-1 clinical trial, a
pivotal Phase 3 trial of Kosan's Hsp90 inhibitor tanespimycin as a
treatment for patients with multiple myeloma, through a Special
Protocol Assessment (SPA) process with the FDA. Kosan also completed
the 'Scientific Advice' process with the centralized European Medicines
Agency (EMEA) for TIME-1.
-- At the 2007 Breast Cancer Symposium of the American Society of Clinical
Oncology (ASCO), Kosan presented updated data from a Phase 1 clinical
trial showing that Kosan's Hsp90 inhibitor alvespimycin demonstrated
antitumor activity and tolerability in combination with trastuzumab
(Herceptin(R)), with clinical benefit observed in 42% of evaluable
patients (8 of 19 evaluable) with HER2-positive metastatic breast
cancer.
-- Pfizer Inc. initiated a Phase 1 clinical trial designed to test the
safety, tolerability and pharmacokinetics of motilin receptor agonist
KOS-2187, a selective and potent motilin receptor agonist being
developed for the treatment of gastroesophageal reflux disease (GERD)
and potentially other gastrointestinal disorders.
-- Kosan completed preparations and is planning to initiate later this
quarter a Phase 2 clinical trial of alvespimycin in patients with
newly-diagnosed HER2-positive metastatic breast cancer to
evaluate the safety and anticancer activity of alvespimycin as a single
agent.
-- Kosan presented updated Phase 1 data on KOS-1584 at the 2007 Annual
Meeting of the American Association for Cancer Research/National Cancer
Institute/European Organization for Research and Treatment of Cancer
(AACR/NCI/EORTC) showing that KOS-1584 was well-tolerated and
demonstrated antitumor activity in ovarian, non-small cell lung,
breast, pancreatic and prostate cancers.
-- Kosan hosted its first Kosan Research and Development Day in New York,
highlighting Kosan's leadership in Hsp90 inhibitor therapeutics,
clinical progress, regulatory strategies and future pipeline
opportunities.
Conference Call and Webcast Today
Kosan will hold a conference call to discuss its financial results for the quarter and nine months ended September 30, 2007 and provide an update on its business today at 1:30 p.m. Pacific / 4:30 p.m. Eastern. To access the live call, please dial 866.510.0707 (US) or 617.597.5376 (international), access code 93636825. Interested parties may listen to the webcast live at http://www.kosan.com by clicking on the 'Webcasts' tab under the heading 'Investors/Press.' The webcast is also being distributed over Thomson's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through Thomson's individual investor center at http://www.earnings.com or by visiting any of the investor sites in Thomson's Individual Investor Network. Institutional investors can access the call via Thomson's password-protected event management site, StreetEvents, at http://www.streetevents.com. A telephonic replay will be available through November 15, 2007 by dialing 888.286.8010, access code: 98027185. International callers can dial 617.801.6888, access code: 98027185.
About Kosan
Kosan Biosciences is a biotechnology company advancing two new classes of anticancer agents through clinical development -- Hsp90 (heat shock protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary discovery platform to generate a pipeline of potentially significant product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer cell growth and survival. Tanespimycin (KOS-953) is being tested in combination with bortezomib in patients with multiple myeloma in a registration program called TIME. Tanespimycin is also being studied in HER2-positive metastatic breast cancer in combination with Herceptin, and as monotherapy in metastatic melanoma. Intravenous and oral formulations of Kosan's second-generation Hsp90 inhibitor, alvespimycin (KOS- 1022), are being evaluated in Phase 1 clinical trials in hematological cancers and in HER2-positive metastatic breast cancer.
Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents. KOS-1584 is in Phase 1 clinical trials in patients with solid tumors.
Kosan's motilin agonist compound, KOS-2187, licensed to Pfizer, is in a Phase 1 trial in gastroesophageal reflux disease (GERD).
For additional information on Kosan Biosciences, please visit Kosan's website at http://www.kosan.com.
This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995 (the 'Act'). Such forward-looking statements include, but are not limited to, statements regarding the further development (including the planned commencement of one or more Phase 2 clinical trials and the timing thereof) and potential safety, efficacy, commercialization and other characteristics of Kosan's product candidates, including tanespimycin, alvespimycin and KOS-1584. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward- looking statements, including, among others, risks related to Kosan's expectation that additional financing will be required, Kosan's past dependence on its collaboration with Roche for development of its epothilone product candidates and current dependence on Pfizer for development of KOS- 2187, Kosan's ability to enter into new partnering arrangements and the highly uncertain nature of the progress and results of Kosan's testing of its product candidates, including the risk that studies may not demonstrate safety and efficacy sufficient to initiate additional clinical trials, continue clinical development, obtain the requisite regulatory approvals or result in a marketable product, competition and other risks detailed from time to time in Kosan's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.
Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
Selected Financial Information
Condensed Statements of Operations
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Total revenues $1,947 $2,169 $17,071 $7,796
Operating expenses:
Research and development $12,299 8,712 $33,381 28,362
General and administrative $1,851 1,632 $6,054 5,733
Total operating expenses 14,150 10,344 39,435 34,095
Loss from operations (12,203) (8,175) (22,364) (26,299)
Other income, net 1,070 635 3,187 1,389
Net loss $(11,133) $(7,540) $(19,177) $(24,910)
Basic and diluted net loss per
common share $(0.26) $(0.22) $(0.46) $(0.76)
Shares used in computing basic and
diluted net loss per common share 42,528 34,573 41,384 32,778
Condensed Balance Sheets
(in thousands)
September 30, December 31,
2007 2006
(unaudited)
Cash, cash equivalents, restricted
cash $81,650 $64,087
and marketable securities
Total assets $89,095 $71,187
Deferred revenue $7,497 $19,591
Total liabilities $20,718 $29,433
Total liabilities and stockholders'
equity $89,095 $71,187
Shares issued and outstanding 42,584 35,390
SOURCE Kosan Biosciences Incorporated
Source: PR Newswire (November 8, 2007 - 4:00 PM EST)
News by QuoteMedia
www.quotemedia.com
surf1944
17 years ago
Kosan to Reacquire Epothilone Program From Roche
Kosan to Commence Phase 2 Clinical Program for KOS-1584
HAYWARD, Calif., Oct. 25 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that Roche and Kosan are concluding their epothilone development and commercialization collaboration. The collaborative research, development and commercialization agreement entered into in September 2002 will terminate after a transition period, following which Kosan will reacquire worldwide rights to its epothilone program and have full control of clinical development of KOS-1584 and its other epothilone product candidates going forward.
'Based on our discussions with Roche, we believe that the ending of our epothilone collaboration has been driven by a re-prioritization within Roche's research and development group rather than the value of our epothilone program,' said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. 'Our control of the program permits us to determine the optimal strategy for advancing KOS-1584 into larger-scale clinical trials, potentially with a new collaborative partner, which we plan to actively seek. In the meantime, we intend to commence a Phase 2 clinical program. We continue to believe that KOS-1584 has best-in-class potential in the emerging epothilone market.'
Roche believes that KOS-1584 is worthy to proceed into Phase 2 clinical trials, and that the Roche-Kosan collaboration has been highly productive,' said Dan Zabrowski, Global Head of Roche Pharma Partnering. 'We believe that Kosan is in the best position to exploit the therapeutic and commercial potential of KOS-1584. Kosan has been an excellent development partner, and we have appreciated the opportunity to be supportive of their progress.'
Kosan does not expect the termination of its collaborative research, development and commercialization agreement with Roche to impact its financial guidance for 2007 due to transition period funding.
KOS-1584 Plans and Clinical Data
Kosan plans to commence a Phase 2 clinical program for KOS-1584. Kosan anticipates providing more information about the Phase 2 program at its upcoming Research & Development Day on October 31, 2007.
Recently, at the 2007 Annual Meeting of the American Association for Cancer Research/National Cancer Institute/European Organization for Research and Treatment of Cancer (AACR/NCI/EORTC) in San Francisco, Kosan presented updated data from an ongoing Phase 1 clinical trial of KOS-1584 demonstrating encouraging antitumor activity and tolerability in patients with solid tumors. KOS-1584 showed signs of activity in patients with non-small cell lung, ovarian, breast, prostate, pancreatic, head and neck and colon cancer.
Conference Call
Kosan will hold a conference call to discuss the termination of the collaborative research, development and commercialization agreement with Roche and related matters tomorrow at 5:30 a.m. Pacific / 8:30 a.m. Eastern. To access the live call, please dial 800.901.5231 (US) or 617.786.2961 (international), access code 41951713. Interested parties may listen to the webcast live at http://www.kosan.com by clicking on the 'Webcasts' tab under the heading 'Investors/Press.' The webcast is also being distributed over Thomson's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through Thomson's individual investor center at http://www.earnings.com or by visiting any of the investor sites in Thomson's Individual Investor Network. Institutional investors can access the call via Thomson's password-protected event management site, StreetEvents, at http://www.streetevents.com. A telephonic replay will be available through November 2, 2007 by dialing 888.286.8010, access code: 61167995. International callers can dial 617.801.6888, access code: 61167995.
About Kosan
Kosan Biosciences is a biotechnology company advancing two new classes of anticancer agents through clinical development -- Hsp90 (heat shock protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary discovery platform to generate a pipeline of potentially significant product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer cell growth and survival. Tanespimycin (KOS-953) is being tested in combination with bortezomib (Velcade(R)) in patients with multiple myeloma in a registration program called TIME. Tanespimycin is also being studied in HER2-positive metastatic breast cancer in combination with trastuzumab (Herceptin(R)), and as monotherapy in metastatic melanoma. Intravenous and oral formulations of Kosan's second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being evaluated in Phase 1 clinical trials in hematological cancers and in HER2-positive metastatic breast cancer.
Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents. KOS-1584 is in Phase 1 clinical trials in patients with solid tumors.
Kosan's motilin agonist compound, KOS-2187, licensed to Pfizer, is in a Phase 1 safety trial, with plans to pursue development in gastroesophageal reflux disease (GERD).
For additional information on Kosan Biosciences, please visit the company's website at http://www.kosan.com.
This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding the further development (including the planned commencement of one or more Phase 2 clinical trials and the timing thereof) and potential safety, efficacy, commercialization and other characteristics of KOS-1584, Kosan's plans to seek a new collaborative partner for its epothilone program and the anticipated financial impact of the termination of its collaborative research, development and commercialization agreement with Roche. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks related to Kosan's expectation that additional financing will be required, Kosan's past dependence on its collaboration with Roche for development of its epothilone product candidates, Kosan's ability to enter in to new partnering arrangements and the highly uncertain nature of the progress and results of Kosan's testing of KOS-1584, including the risk that studies may not demonstrate safety and efficacy sufficient to initiate additional clinical trials, continue clinical development, obtain the requisite regulatory approvals or result in a marketable product, competition and other risks detailed from time to time in Kosan's SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.
Velcade(R) (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc. Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
SOURCE Kosan Biosciences Incorporated
Source: PR Newswire (October 25, 2007 - 8:45 PM EDT)
surf1944
17 years ago
Kosan Presents Phase 1 Data Showing Antitumor Activity and Safety Profile of Epothilone KOS-1584 at AACR/NCI/EORTC Meeting
HAYWARD, Calif., Oct. 23 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) presented updated data today from a Phase 1 clinical trial showing that KOS-1584/R1645, an epothilone under co-development with Roche, demonstrated antitumor activity and tolerability in patients with solid tumors. KOS-1584/R1645 showed signs of activity in patients with non-small cell lung, ovarian, breast, prostate, pancreatic, head and neck and colon cancer. The Phase 1 trial explored two different schedules of KOS-1584/R1645 using escalating doses. Data reported today were from a trial investigating weekly dosing schedules (weekly 2 weeks out of 3 weeks and weekly 3 weeks out of 4 weeks). Common toxicities were generally low-grade and manageable.
Data from the Phase 1 trial of KOS-1584/R1645 were presented in a poster titled, 'Optimization of the Phase 2 Dose of KOS-1584 (a Novel, Synthetic Epothilone) via Weekly Administration,' by Howard Burris, M.D., Sarah Cannon Research Institute, Nashville, TN, at the 2007 Annual Meeting of the American Association for Cancer Research/National Cancer Institute/European Organization for Research and Treatment of Cancer (AACR/NCI/EORTC).
'We believe that KOS-1584 has the potential to achieve best-in-class status in the emerging epothilone market as well as to compete in the established taxane market,' said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. 'We look forward to our planned commencement of a Phase 2 clinical program for KOS-1584 toward the end of 2007.'
Phase 1 Trial Results of KOS-1584
The Phase 1 trial was designed to define the maximum tolerated dose, dose-limiting toxicity and recommended Phase 2 dose and to assess early activity of KOS-1584/R1645 when administered to patients with advanced solid tumors (who have no standard therapy options) on two dosing schedules. The Phase 1 trial enrolled 60 patients investigating a wide range of doses from 0.8 mg/m2 to 25 mg/m2 on the 3 of 4 week schedule and 16 to 30 mg/m2 on the 2 of 3 week schedule; the 1-hour and 3-hour durations of infusion were included on both schedules. Indications of antitumor activity included:
-- 1 confirmed partial response (PR) in a patient with advanced non-small
cell lung cancer (3 prior chemotherapy regimens); this patient had 44%
tumor shrinkage by RECIST withdrew after 10 months (10 cycles) and
remains in PR over one year later;
-- 1 patient with breast cancer (3 prior regimens, active on study at
Cycle 5) experienced a 40% reduction in tumor marker CA-15.3, 42.5%
reduction in CA27,29 and 30% reduction in CEA;
-- 1 patient with advanced ovarian cancer (4 prior regimens) had 40% tumor
marker CA125 decrease and 20% shrinkage of nodal disease (on study for
6 cycles);
-- 1 patient with advanced prostate cancer had 94% reduction in PSA and
improved nodal disease after cycle 2 and was on study for 6 months (6
cycles);
-- 1 patient with pancreatic cancer had a 39% decrease in CA19-9
after 4 cycles; and
-- 6 patients had stable disease (3 or more months), including those with
head and neck, pancreatic, colon, breast and non-small cell lung
cancers.
Common drug related toxicities varied depending on dose and dose schedule, and were predominantly gastrointestinal symptoms, primarily diarrhea, that were generally manageable with supportive care. Grade 3 neuropathy was limited to one patient at the recommended dose on the 4-week schedule and two patients at the highest doses tested on the 3-week schedule. The recommended Phase 2 dose will be based on clinical activity, dose intensity, side effect profile and schedule compatibility with established chemotherapy regimens: 36 mg/m2 every 3 weeks; or 25 mg/m2 twice every 3 weeks depending on data from expanded dose cohorts.
surf1944
17 years ago
Kosan's Second-Generation Hsp90 Inhibitor, Alvespimycin, Shows 42% Clinical Benefit in Phase 1 HER2-Positive Metastatic Breast Cancer Trial
Monday September 10, 6:00 am ET
Data Presented at ASCO Breast Cancer Symposium; Additional Positive Results Seen Since Presentation at ASCO Annual Meeting in June
Phase I Trial Expanding to Include Alvespimycin Plus Trastuzumab Plus Paclitaxel Regimen
HAYWARD, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) presented updated data from a Phase 1 clinical trial showing that alvespimycin, its second-generation Hsp90 inhibitor, demonstrated antitumor activity and tolerability in combination with trastuzumab (Herceptin®) in patients with refractory HER2-positive metastatic breast cancer, and in patients with refractory ovarian cancer who were progressing on standard chemotherapy. Data from the ongoing trial in patients with solid tumors were presented on Friday, September 7, 2007 by Shanu Modi, M.D., Memorial Sloan Kettering Cancer Center, in a poster, titled, "Alvespimycin (KOS-1022) and Trastuzumab (T): Activity in HER2+ Metastatic Breast Cancer (MBC)" at the 2007 Breast Cancer Symposium of the American Society of Clinical Oncology (ASCO), San Francisco, CA.
"Alvespimycin continues to demonstrate meaningful antitumor activity in patients with highly refractory HER2-positive metastatic breast cancer and ovarian cancer, with additional positive Phase 1 data showing sustained responses and clinical benefit," said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "Our strategy is to pursue potentially a broad and fast-to-market development pathway for alvespimycin in HER2-positive metastatic breast cancer. We are expanding the Phase 1 trial to include an alvespimycin plus trastuzumab plus paclitaxel regimen to establish a safety profile of this triplet regimen and to lay the groundwork for a potential larger Phase 2/3 trial. We expect to start our Phase 2 monotherapy trial in newly-diagnosed HER2-positive patients later this year. We believe that the clinical activity of alvespimycin seen in our breast cancer Phase 1 trials to date validates the compound's therapeutic potential as a novel anticancer agent and strengthens Kosan's leadership in the Hsp90 inhibitor area."
Phase 1 Updated Results
Alvespimycin is a second-generation Hsp90 inhibitor that has demonstrated the potential to disrupt the activity of multiple oncogenes and cell signaling pathways implicated in tumor growth, including HER2, a key signaling pathway in breast cancer.
Preliminary results from the Phase 1 trial of alvespimycin in combination with trastuzumab were presented at the 2007 ASCO annual meeting in June, and were updated in this presentation. The Phase 1 trial was designed to identify the recommended Phase 2 dose through the evaluation of toxicity and activity in patients with solid tumors. Patients were enrolled in three dose cohorts. The dosing schedule for alvespimycin was a one-hour weekly intravenous infusion of 60, 80 or 100 mg/m2 administered along with the standard dose of trastuzumab. Patients were assessed every 4 weeks for toxicity and every 8 weeks for response. Disease response was assessed by RECIST and by tumor markers, if available.
Of the 27 heavily-pretreated patients enrolled in the trial, 24 patients had HER2-positive breast cancer (with the majority of patients having had multiple trastuzumab-containing regimens prior to this study) and 3 patients had ovarian cancer (HER2 status unknown).
Clinical benefit was observed in 42% of evaluable patients (8 of 19 evaluable) with HER2-positive metastatic breast cancer:
-- 1 patient (13 prior regimens, including progression on single-agent
lapatinib and 3 prior trastuzumab-containing regimens) showed complete
resolution of lung metastases by CT/PET with significant improvement in
dypsnea (shortness of breath);
-- 1 patient (11 prior regimens, 5 with trastuzumab, 2 with lapatinib)
showed 10% reduction in tumor mass with change consistent with tumor
necrosis and a decrease in 2 tumor markers (64% CEA, 63% CA27.29);
-- 1 patient (5 prior regimens) showed a partial response after 2 cycles,
confirmed after 4 cycles, with 52% decrease hepatic lesions);
-- 5 patients had extended stable disease (4, 6+, 6+, 8 and 10 months).
Of the 3 patients with ovarian cancer,
-- 1 patient (13 prior regimens) who was on study for more than 19 months
with evaluable disease had a near complete resolution of ascites and
left pleural effusion at the end of cycle 2, and an 83%
decrease in CA125.
Toxicities were mainly Grade 1 and 2 (diarrhea, fatigue, headache, arthralgia, nausea). One patient with multiple prior trastuzumab and doxorubicin containing regimens experienced a dose-limiting toxicity of shortness of breath and left ventricular ejection fraction reduction at 100 mg/m2. Two patients treated at 80 mg/m2 experienced reversible Grade 3 ocular keratitis; following a treatment holiday both patients continued therapy with reduced doses (one patient remains on study). Kosan plans to continue to enroll patients at the 80 mg/m2 for further safety and efficacy evaluation.
Expanded Phase 1 Trial Includes Paclitaxel
Kosan has expanded the Phase 1 trial to add weekly dosing with paclitaxel (Taxol ®). In this triplet combination regimen, patients will continue to receive trastuzumab at full dose on a continuous weekly schedule. Alvespimycin will be dosed weekly for 3 weeks out of 4, and paclitaxel will be given on the same schedule.
Alvespimycin Development Plan
In the fourth quarter of 2007, Kosan plans to initiate a Phase 2 trial of alvespimycin as monotherapy in patients with HER2-positive metastatic breast cancer who have not previously been treated with trastuzumab. This trial will be conducted in Eastern Europe. Kosan also plans to initiate a larger, international Phase 2/3 trial of alvespimycin in combination with trastuzumab in patients with HER2-positive metastatic breast cancer in 2008.
surf1944
17 years ago
Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Tanespimycin is the First Hsp90 Inhibitor to Enter Registration Trials
HAYWARD, Calif., Sept. 6 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that it has successfully reached a binding agreement with the U.S. Food and Drug Administration (FDA) on the design of its TIME-1 clinical trial, a pivotal Phase 3 trial of its Hsp90 inhibitor tanespimycin as a treatment for patients with multiple myeloma. Through the FDA's Special Protocol Assessment (SPA) process, Kosan and the FDA have reached agreement on overall protocol design, primary efficacy endpoints and data analysis as well as aspects of expected labeling if the data from the pivotal trial are supportive and tanespimycin is approved by the FDA. This pivotal Phase 3 protocol, as well as the overall development program, have also completed the 'Scientific Advice' process with the centralized European Medicines Agency (EMEA).
Kosan's registration program for tanespimycin, called Tanespimycin in Myeloma Evaluation or TIME, has been initiated and includes two clinical trials: TIME-1 and TIME-2. TIME-1 is a pivotal Phase 3 trial to be conducted in a first-relapse patient population. TIME-1 will evaluate the clinical benefit of adding tanespimycin to bortezomib and compare these results to those seen with single-agent bortezomib. The Special Protocol Assessment Kosan has completed applies to the TIME-1 trial. TIME-2, which is designed to be supportive of the TIME-1 trial, is a Phase 2/3 trial in patients with relapsed-refractory disease. The TIME-2 trial also has the potential to support registration in the relapsed-refractory setting. Kosan has initiated the TIME-2 trial, which is enrolling patients, and expects to initiate the TIME-1 trial at the end of 2007 or early 2008.
'Kosan's successful completion of both the Special Protocol Assessment process with the FDA and Scientific Advice from the EMEA for our TIME-1 trial provides us with a clear roadmap to registration in major countries around the world for this potentially important new treatment for patients with multiple myeloma,' said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. 'We believe that Kosan's TIME program is the most advanced Hsp90 inhibitor clinical program in the industry, underscoring Kosan's leadership in this promising new class of anticancer therapies. We appreciate the widespread support we have received from the US and international myeloma clinician and patient communities.'
About TIME
The TIME clinical program utilizes Kosan's improved, proprietary injectable suspension formulation of tanespimycin. The injectable suspension formulation is designed to provide important benefits, including improved patient safety, due to the elimination of Cremophor(R) and the associated need for steroid premedication to prevent hypersensitivity reactions. Tanespimycin injectable suspension also has a potentially enhanced intellectual property position and permits easier drug preparation and administration compared to the prior formulation.
The TIME-1 trial will be an open-label, randomized, multi-center trial conducted in the US and in Europe that is designed to enroll over 450 patients with relapse of multiple myeloma following a single prior course of treatment (first-relapse). The trial is designed to compare two groups: patients treated with bortezomib plus tanespimycin and patients treated with bortezomib alone. Tanespimycin will be administered at a dose of 340 mg/m2 and all patients will receive standard doses of bortezomib (1.3 mg/m2). TIME-1 is designed with a primary endpoint of progression-free survival. TIME-1 is designed to include an interim analysis of safety and efficacy to be conducted based on predefined criteria. Kosan anticipates providing more information on the TIME-1 trial design upon initiation.
The TIME-2 clinical trial is being conducted at clinical sites primarily in the US and in Europe and is designed to enroll approximately 130 patients with relapsed-refractory multiple myeloma. The trial is designed to test three different doses of tanespimycin in combination with the approved dose and schedule of bortezomib (Velcade(R)) (1.3 mg/m2). The tanespimycin dose groups are 50 mg/m2, 175 mg/m2 and 340 mg/m2. Tanespimycin will be administered twice weekly as a one-hour intravenous infusion on a cycle of two weeks of treatment every three weeks (the same schedule as bortezomib). Patients eligible to participate in the TIME-2 trial must have been treated with and progressed following at least three prior treatments for multiple myeloma. Prior regimens must include bortezomib and lenalidomide (Revlimid(R)). The primary endpoint of the trial is the dose response based on objective response rate after 4 cycles of treatment. Secondary endpoints include a comparison of response rate between the three dose groups, progression-free survival, time to treatment failure and overall survival. Objective response rate in multiple myeloma is measured primarily by the patient's level of M protein.
About the Special Protocol Assessment
As stated in the Prescription Drug User Fee Act (PDUFA) and FDA's Guidance for Industry Special Protocol Assessment, '...having agreed to the design, execution, and analyses proposed in protocols reviewed under this process ... the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident. Thus, documented special protocol assessments should be considered binding on the review division and should not be changed at any time...' assuming that the sponsor follows the protocol agreed-upon with the Agency, the sponsor has provided appropriate information to the Agency to support the protocol, the sponsor and the Agency agree to modify the protocol or a substantial scientific issue is identified after clinical testing has begun. In the absence of these developments, 'completion of a SPA with FDA provides binding agreement relative to design and analysis of key Phase 3 trial(s) such that positive final results can lead to full NDA/ BLA approval.' For more information about the Agency's Special Protocol Assessment process, see, http://www.fda.gov/cder/guidance/3764fnl.htm.
About Tanespimycin
Tanespimycin has been shown to induce apoptosis of drug-sensitive and drug-resistant multiple myeloma cell lines. Tanespimycin also inhibits expression of various cell surface cytokines, such as IGF-1R and IL-6R, that are involved in growth, survival and drug resistance of multiple myeloma cells. When used in combination with bortezomib, the destabilization of client proteins with tanespimycin while blocking their degradation with bortezomib promotes the accumulation of cytotoxic proteins, leading to cell death.
Kosan reported data from a Phase 1b trial of tanespimycin in combination with bortezomib at the 2007 annual meeting of the American Society for Clinical Oncology (ASCO) on 56 patients enrolled in 7 dose cohorts (100-340 mg/m2 of tanespimycin; 0.7-1.3 mg/m2 of bortezomib; tanespimycin administered via 1-hour infusion following the bortezomib dose 2 times per week every 2 weeks out of 3 weeks). Of these 56 patients, all had received multiple prior chemotherapy regimens (median of 4) and 67% had received bone marrow transplants.
In those patients who received tanespimycin across the range of doses tested and a dose of 1.0 or 1.3 mg/m2 of bortezomib, the overall response rate including complete, partial and minimal responses was, as previously reported, 44% (18 out of 41 patients evaluable for response). Of the 18 responding patients (44%), 8 out of 14 patients were bortezomib-naïve (57%); 7 out of 16 patients were bortezomib-pretreated patients (44%); and 3 out of 11 patients were bortezomib-refractory (27%). Responses in the bortezomib-refractory patients continue to show prolonged duration (at least 10 months at the time of data presentation at ASCO in June 2007) and meaningful reduction of serum/urinary M-protein (greater than 89%). The combination of tanespimycin and bortezomib was well-tolerated.
Kosan has been granted orphan drug designation for tanespimycin in multiple myeloma in both the US and European Union.
surf1944
17 years ago
Kosan's Motilin Receptor Agonist, Licensed to Pfizer, Enters Phase 1 Clinical Trial in Gastroesophageal Reflux Disease
HAYWARD, Calif., Aug. 6 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that Pfizer Inc. has initiated a Phase 1 clinical trial of motilin receptor agonist PF-04548043, formerly KOS-2187, a selective and potent motilin receptor agonist being developed for the treatment of gastroesophageal reflux disease (GERD) and potentially other gastrointestinal (GI) disorders. The Phase 1 clinical trial is designed to test the safety, tolerability and pharmacokinetics of PF-04548043 in healthy subjects. In December 2006, Kosan and Pfizer established a worldwide license agreement for Kosan's motilin agonist program, including KOS-2187 and related compounds, in a transaction potentially valued at $250 million for the successful development and commercialization of PF-04548043 for one indication as well as royalties on worldwide sales.
'Kosan today has four advancing clinical programs, underscoring the increasing value of our development pipeline,' said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. 'Consistent with Kosan's focus on oncology, we successfully out-licensed KOS-2187 and our motilin receptor agonist program to Pfizer, a company with a strong gastrointestinal capability that could best exploit its therapeutic and commercial potential. We appreciate Pfizer's commitment to the development and potential commercialization of this promising prokinetic compound and look forward to its rapid advancement through the clinic.'
About PF-04548043 and Motilin Receptor Agonists
Motilin, a hormone secreted by the small intestine, stimulates gastrointestinal motility (movement). The activity of motilin is mediated through the G-protein coupled motilin receptor found on smooth muscle cells of the GI tract and elements of the enteric nervous system. The clinical observation that the macrolide antibiotic erythromycin, a motilin receptor agonist, accelerates gastric emptying in patients with diabetic gastroparesis (impaired gastric emptying) has resulted in efforts to develop non-antibiotic macrolides (motilides) as prokinetic agents. PF-04548043 is a potent, selective motilin receptor agonist that is chemically stable and orally bioavailable and lacks antibiotic activity. In preclinical studies, PF-04548043 showed an improved safety profile relative to erythromycin and accelerated gastric emptying, suggesting that it may provide symptom relief in several GI diseases.
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