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Tuesday, September 29, 2009 10:29:42 PM
09/15/2009 (16:15 ET) CRTX: Filed New Form 8-K, Material Event Disclosure - Edgar
http://www.knobias.com/individual/public/quote.htm?ticker=CRTX
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6515053
8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): September 9, 2009
Cornerstone Therapeutics Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware 000-50767 04-3523569
_____________________
(State or other jurisdiction _____________
(Commission ______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
1255 Crescent Green Drive, Suite 250, Cary, North Carolina 27518
_________________________________
(Address of principal executive offices) ___________
(Zip Code)
Registrant’s telephone number, including area code: 919-678-6611
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Top of the Form
Item 1.01 Entry into a Material Definitive Agreement.
On September 9, 2009, Cornerstone BioPharma, Inc. (the "Company"), a wholly owned subsidiary of Cornerstone Therapeutics, Inc. ("Cornerstone"), completed the previously announced acquisition from Oscient Pharmaceuticals Corporation ("Oscient") of the commercial rights to the antibiotic Factive® (gemifloxacin mesylate) in North America and certain countries in Europe, certain inventory and related assets. The United States Bankruptcy Court for the District of Massachusetts had approved the transaction on September 4, 2009.
In connection with the closing of the transaction, Oscient assigned to the Company the License and Option Agreement with LG Life Sciences, Ltd. related to Factive (as amended, the "Agreement"). The Agreement provides the Company with rights to commercialize gemifloxacin in North America, France, Germany, the United Kingdom, Luxembourg, Ireland, Italy, Spain, Portugal, Belgium, the Netherlands, Austria, Greece, Sweden, Denmark, Finland, Norway, Iceland, Switzerland, Andorra, Monaco, San Marino, Vatican City, Poland, Czech Republic, Slovakia, Slovenia, Hungary, Estonia, Latvia, Lithuania, Liechtenstein, Malta, Cyprus, Romania, Bulgaria, Croatia, Serbia and Montenegro, Bosnia and Herzegovina, Albania and the Former Yugoslav Republic of Macedonia.
The term of the Agreement will expire upon the termination or expiration in all of the countries covered by the license of the Company’s obligation to pay royalties on sales of Factive. The Company has the unilateral right at any time with 30 days’ prior notice to abandon its rights and obligations with respect to any country covered by the Agreement, or to terminate the Agreement in its entirety. In addition, either party may terminate the Agreement if the other party challenges the validity and/or enforceability of any of the party’s patent rights granted to the other party under the Agreement. The Agreement also provides certain termination rights to a party in connection with a material breach of the Agreement by the other party.
Under the terms of the Agreement, LG Life Sciences has agreed to supply and the Company is obligated to purchase from LG Life Sciences all of the Company’s anticipated commercial requirements for the Factive active pharmaceutical ingredient ("API"). LG Life Sciences currently supplies the Factive API from its manufacturing facility in South Korea.
Under the Agreement, the Company is responsible, at its expense and through consultation with LG Life Sciences, for the clinical and commercial development of gemifloxacin in the countries covered by the license, including the conduct of clinical trials, the filing of drug approval applications with applicable regulatory authorities in the Company’s territory and the marketing, distribution and sale of gemifloxacin in the Company’s territory.
The Company is obligated to pay a royalty on sales of Factive in North America and the territories covered by the license in Europe. These royalty obligations expire with respect to each country covered by the Agreement on the later of (i) the expiration of the patents covering Factive in such country or (ii) the expiration of data exclusivity in Mexico, Canada or the European Union respectively, or 2014 in the U.S.
Top of the Form
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Cornerstone Therapeutics Inc.
September 15, 2009 By: /s/ David Price
Name: David Price
Title: Executive Vice President, Finance and Chief Financial Officer
http://www.knobias.com/individual/public/quote.htm?ticker=CRTX
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6515053
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6515053
News for OSCIQ News -- Lupin Expands Branded Play --Announces Acquisition of US Rights to ANTARA
Tuesday, September 29, 2009 4:45 PM
Scottrade.com
This email is compliments of Scottrade.com
News for 'OSCIQ' - (Lupin Expands Branded Play --Announces Acquisition of US Rights to ANTARA)
MUMBAI, India, Sept 29, 2009 /PRNewswire-FirstCall via COMTEX/ --
Pharmaceutical Major, Lupin Ltd. announced today the acquisition of US rights
for Antara(R) (Fenofibrate Capsules 43 mg and 130 mg). Lupin acquired the
product from Oscient Pharmaceuticals on September 25, 2009, under the procedures
of the U.S. Bankruptcy Court. Antara recorded net sales of US $ 70 million for
2008 (Source: IMS Dec 2008). Lupin paid $ 38.61 million for the product and
related assets inclusive of inventory.
Lupin had previously filed an ANDA for Fenofibrate Capsules 43 mg and 130 mg. On
September 21, 2009, prior to the acquisition of Antara(R), Lupin sold its ANDA
to Dr. Reddy's Laboratories. Lupin also settled and resolved the pending
litigation regarding the ANDA product.
Prior to the acquisition, Antara(R) was marketed by Oscient Pharmaceuticals.
Antara(R) has a strong brand equity with primary care physicians treating
patients for high LDL-C, Total-C, triglycerides, Apo-B and low HDL-C. The
Fenofibrate products market is $ 1.9 Billion for the last 12 months. Antara(R)
has 4.5% share of this market and grew 20 % in revenue this past year. Antara(R)
is prescribed for adjunct treatment of hypercholesterolemia (high blood
cholesterol) and hyper-triglyceridemia (high triglycerides) in combination with
diet.
The Antara acquisition enables Lupin to enter the primary care market with a
three product portfolio. Lupin's Suprax Tabs and Allernaze have strong potential
in primary care. Lupin will be more than doubling its sales force size in the
next 12 months to reach the key targets for the three products.
"We are very excited with our 2nd NDA acquisition within a span of 4 months. The
Antara(R) acquisition demonstrates Lupin's success in, and commitment to
building its brand franchise and equity in the US. It underlines Lupin's
differentiated strategy for the US market. Antara(R) is a step forward that will
help us strengthen and grow our brand business. Since Antara(R) is a previously
approved, commercial product, our sales and marketing efforts will commence
immediately and we are optimistic of it contributing positively to our topline
and bottomline in the coming quarters and years," said Vinita Gupta, Group
President & CEO, Lupin Pharmaceuticals Inc
About Lupin
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational
pharmaceutical company producing a wide range of quality, affordable generic and
branded formulations and APIs for the developed and developing markets of the
world. The Company today has significant market share in key markets in the
Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI,
Anti-Infectives and NSAIDs therapy segments, not to mention global leadership
positions in the Anti-TB and Cephalosporins. The Company's R&D endeavors have
resulted in significant progress in its NCE program. The Company's foray into
Advanced Drug Delivery Systems has resulted in the development of platform
technologies that are being used to develop value-added generic pharmaceuticals.
Our Drugs and products reach over 70 countries in the world. Today, Lupin has
the unique distinction of being the fastest growing top 10 Generics player in
the two largest pharmaceutical markets of the world -- The U.S. (ranked 9th by
prescriptions & growing at 92 %) and Japan (ranked 7th and growing at 23%). The
company is also the fastest growing, top 5 pharmaceutical player in India (ORG
IMS - March 2009) and the fastest growing Generic player in South Africa (ranked
6th and growing at over 30 % YoY - IMS)
For the financial year ended March 2009, Lupin's Consolidated Revenues and
Profit after Tax were Rs. 39,145 million and Rs. 5015 million respectively.
BSE: 500257 NSE: Lupin REUTERS: LUPN.BO BLOOMBERG: LPC IN
For further information contact:
Shamsher Gorawara
Head - Corporate Communications
Lupin Limited
shamshergorawara@lupinpharma.com
Mobile: +91 9820338555
OR
Sonia Mansata
Text 100
sonia.mansata@text100.co.in
Mobile: +91 9820112481
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act
of 1995:
This release contains forward-looking statements that involve known and unknown
risks, uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or achievements
expressed or implied by such statements. Many of these risks, uncertainties and
other factors include failure of clinical trials, delays in development,
registration and product approvals, changes in the competitive environment,
increased government control over pricing, fluctuations in the capital and
foreign exchange markets and the ability to maintain patent and other
intellectual property protection. The information presented in this release
represents management's expectations and intentions as of this date. Lupin
expressly disavows any obligation to update the information presented in this
release.
SOURCE Lupin Limited
www.prnewswire.com
Copyright (C) 2009 PR Newswire. All rights reserved
-0-
KEYWORD: India
INDUSTRY KEYWORD: PHA
MTC
HEA
SUBJECT CODE: TNM
Source: Comtext Market News
http://www.knobias.com/individual/public/quote.htm?ticker=CRTX
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6515053
8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): September 9, 2009
Cornerstone Therapeutics Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware 000-50767 04-3523569
_____________________
(State or other jurisdiction _____________
(Commission ______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
1255 Crescent Green Drive, Suite 250, Cary, North Carolina 27518
_________________________________
(Address of principal executive offices) ___________
(Zip Code)
Registrant’s telephone number, including area code: 919-678-6611
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Top of the Form
Item 1.01 Entry into a Material Definitive Agreement.
On September 9, 2009, Cornerstone BioPharma, Inc. (the "Company"), a wholly owned subsidiary of Cornerstone Therapeutics, Inc. ("Cornerstone"), completed the previously announced acquisition from Oscient Pharmaceuticals Corporation ("Oscient") of the commercial rights to the antibiotic Factive® (gemifloxacin mesylate) in North America and certain countries in Europe, certain inventory and related assets. The United States Bankruptcy Court for the District of Massachusetts had approved the transaction on September 4, 2009.
In connection with the closing of the transaction, Oscient assigned to the Company the License and Option Agreement with LG Life Sciences, Ltd. related to Factive (as amended, the "Agreement"). The Agreement provides the Company with rights to commercialize gemifloxacin in North America, France, Germany, the United Kingdom, Luxembourg, Ireland, Italy, Spain, Portugal, Belgium, the Netherlands, Austria, Greece, Sweden, Denmark, Finland, Norway, Iceland, Switzerland, Andorra, Monaco, San Marino, Vatican City, Poland, Czech Republic, Slovakia, Slovenia, Hungary, Estonia, Latvia, Lithuania, Liechtenstein, Malta, Cyprus, Romania, Bulgaria, Croatia, Serbia and Montenegro, Bosnia and Herzegovina, Albania and the Former Yugoslav Republic of Macedonia.
The term of the Agreement will expire upon the termination or expiration in all of the countries covered by the license of the Company’s obligation to pay royalties on sales of Factive. The Company has the unilateral right at any time with 30 days’ prior notice to abandon its rights and obligations with respect to any country covered by the Agreement, or to terminate the Agreement in its entirety. In addition, either party may terminate the Agreement if the other party challenges the validity and/or enforceability of any of the party’s patent rights granted to the other party under the Agreement. The Agreement also provides certain termination rights to a party in connection with a material breach of the Agreement by the other party.
Under the terms of the Agreement, LG Life Sciences has agreed to supply and the Company is obligated to purchase from LG Life Sciences all of the Company’s anticipated commercial requirements for the Factive active pharmaceutical ingredient ("API"). LG Life Sciences currently supplies the Factive API from its manufacturing facility in South Korea.
Under the Agreement, the Company is responsible, at its expense and through consultation with LG Life Sciences, for the clinical and commercial development of gemifloxacin in the countries covered by the license, including the conduct of clinical trials, the filing of drug approval applications with applicable regulatory authorities in the Company’s territory and the marketing, distribution and sale of gemifloxacin in the Company’s territory.
The Company is obligated to pay a royalty on sales of Factive in North America and the territories covered by the license in Europe. These royalty obligations expire with respect to each country covered by the Agreement on the later of (i) the expiration of the patents covering Factive in such country or (ii) the expiration of data exclusivity in Mexico, Canada or the European Union respectively, or 2014 in the U.S.
Top of the Form
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Cornerstone Therapeutics Inc.
September 15, 2009 By: /s/ David Price
Name: David Price
Title: Executive Vice President, Finance and Chief Financial Officer
http://www.knobias.com/individual/public/quote.htm?ticker=CRTX
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6515053
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6515053
News for OSCIQ News -- Lupin Expands Branded Play --Announces Acquisition of US Rights to ANTARA
Tuesday, September 29, 2009 4:45 PM
Scottrade.com
This email is compliments of Scottrade.com
News for 'OSCIQ' - (Lupin Expands Branded Play --Announces Acquisition of US Rights to ANTARA)
MUMBAI, India, Sept 29, 2009 /PRNewswire-FirstCall via COMTEX/ --
Pharmaceutical Major, Lupin Ltd. announced today the acquisition of US rights
for Antara(R) (Fenofibrate Capsules 43 mg and 130 mg). Lupin acquired the
product from Oscient Pharmaceuticals on September 25, 2009, under the procedures
of the U.S. Bankruptcy Court. Antara recorded net sales of US $ 70 million for
2008 (Source: IMS Dec 2008). Lupin paid $ 38.61 million for the product and
related assets inclusive of inventory.
Lupin had previously filed an ANDA for Fenofibrate Capsules 43 mg and 130 mg. On
September 21, 2009, prior to the acquisition of Antara(R), Lupin sold its ANDA
to Dr. Reddy's Laboratories. Lupin also settled and resolved the pending
litigation regarding the ANDA product.
Prior to the acquisition, Antara(R) was marketed by Oscient Pharmaceuticals.
Antara(R) has a strong brand equity with primary care physicians treating
patients for high LDL-C, Total-C, triglycerides, Apo-B and low HDL-C. The
Fenofibrate products market is $ 1.9 Billion for the last 12 months. Antara(R)
has 4.5% share of this market and grew 20 % in revenue this past year. Antara(R)
is prescribed for adjunct treatment of hypercholesterolemia (high blood
cholesterol) and hyper-triglyceridemia (high triglycerides) in combination with
diet.
The Antara acquisition enables Lupin to enter the primary care market with a
three product portfolio. Lupin's Suprax Tabs and Allernaze have strong potential
in primary care. Lupin will be more than doubling its sales force size in the
next 12 months to reach the key targets for the three products.
"We are very excited with our 2nd NDA acquisition within a span of 4 months. The
Antara(R) acquisition demonstrates Lupin's success in, and commitment to
building its brand franchise and equity in the US. It underlines Lupin's
differentiated strategy for the US market. Antara(R) is a step forward that will
help us strengthen and grow our brand business. Since Antara(R) is a previously
approved, commercial product, our sales and marketing efforts will commence
immediately and we are optimistic of it contributing positively to our topline
and bottomline in the coming quarters and years," said Vinita Gupta, Group
President & CEO, Lupin Pharmaceuticals Inc
About Lupin
Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational
pharmaceutical company producing a wide range of quality, affordable generic and
branded formulations and APIs for the developed and developing markets of the
world. The Company today has significant market share in key markets in the
Cardiovasculars (prils and statins), Diabetology, Asthma, Pediatrics, CNS, GI,
Anti-Infectives and NSAIDs therapy segments, not to mention global leadership
positions in the Anti-TB and Cephalosporins. The Company's R&D endeavors have
resulted in significant progress in its NCE program. The Company's foray into
Advanced Drug Delivery Systems has resulted in the development of platform
technologies that are being used to develop value-added generic pharmaceuticals.
Our Drugs and products reach over 70 countries in the world. Today, Lupin has
the unique distinction of being the fastest growing top 10 Generics player in
the two largest pharmaceutical markets of the world -- The U.S. (ranked 9th by
prescriptions & growing at 92 %) and Japan (ranked 7th and growing at 23%). The
company is also the fastest growing, top 5 pharmaceutical player in India (ORG
IMS - March 2009) and the fastest growing Generic player in South Africa (ranked
6th and growing at over 30 % YoY - IMS)
For the financial year ended March 2009, Lupin's Consolidated Revenues and
Profit after Tax were Rs. 39,145 million and Rs. 5015 million respectively.
BSE: 500257 NSE: Lupin REUTERS: LUPN.BO BLOOMBERG: LPC IN
For further information contact:
Shamsher Gorawara
Head - Corporate Communications
Lupin Limited
shamshergorawara@lupinpharma.com
Mobile: +91 9820338555
OR
Sonia Mansata
Text 100
sonia.mansata@text100.co.in
Mobile: +91 9820112481
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act
of 1995:
This release contains forward-looking statements that involve known and unknown
risks, uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or achievements
expressed or implied by such statements. Many of these risks, uncertainties and
other factors include failure of clinical trials, delays in development,
registration and product approvals, changes in the competitive environment,
increased government control over pricing, fluctuations in the capital and
foreign exchange markets and the ability to maintain patent and other
intellectual property protection. The information presented in this release
represents management's expectations and intentions as of this date. Lupin
expressly disavows any obligation to update the information presented in this
release.
SOURCE Lupin Limited
www.prnewswire.com
Copyright (C) 2009 PR Newswire. All rights reserved
-0-
KEYWORD: India
INDUSTRY KEYWORD: PHA
MTC
HEA
SUBJECT CODE: TNM
Source: Comtext Market News
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