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Monday, 05/03/2010 12:46:25 PM

Monday, May 03, 2010 12:46:25 PM

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PR 5-3-10: Peregrine Licenses Certain TNT rights to Stason

Peregrine and Stason Enter Into Agreement for Innovative Tumor Necrosis Therapy (TNT) Technologies
• Agreement Includes Exclusive Rights to Develop TNT Products in Certain APEC Countries; Upon Successful Commercialization, Stason Has Option to Acquire Rights to Expand Coverage to Additional Regions
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=465795

TUSTIN & IRVINE, May 3, 2010: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, and Stason Pharmaceuticals [ http://www.stasonpharma.com ], a privately-held U.S.-based pharmaceutical company commercializing products globally since 1994, today announced agreements granting Stason certain exclusive development and commercialization rights to Peregrine's tumor necrosis therapy (TNT) technologies. Peregrine's lead TNT product candidate is Cotara(R), a novel brain cancer therapy currently in Phase II clinical development. The company's TNT-based immunocytokines technology has also been licensed to Merck KGaA.

"Stason's focus on oncology products for growing Asian markets expands the development of our TNT technologies to reach patients in this region who urgently need new options for the treatment of cancer," commented Steven W. King, president and chief executive officer of Peregrine Pharmaceuticals. "As we advance our clinical-stage pipeline of innovative products for oncology and viral infections, we will continue to pursue select partnering opportunities while retaining future potential value for our products in the major pharmaceutical markets."

Under the terms of the agreements, Stason is acquiring from Peregrine exclusive rights to Peregrine's TNT technologies in certain Asia-Pacific Economic Cooperation (APEC) countries. Peregrine has retained exclusive rights to its TNT technologies in the United States, European Union countries, and other select countries internationally. The agreements also include certain non-exclusive licenses for Peregrine's proprietary radiolabeling technologies and its fully-human NHS76 TNT antibody to enable and accelerate Stason's development of TNT products.

Harry Fan, president and CEO of Stason, stated, "This agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative and promising treatments to millions of cancer patients in Asia and the Pacific Rim. We will also continue developing new applications and bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets. To advance these efforts, a new spin-off biopharmaceutical company headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."

Stason will pursue drug development, clinical trial and commercialization activities in its exclusive APEC territories and both Stason and Peregrine will have the right to initiate new research activities worldwide. Peregrine will receive from Stason upfront fees, annual fees, and milestone payments over the term of the agreements, as well as double-digit royalty payments on net sales. Upon successful commercialization of a product and payment of predetermined royalties to Peregrine within the first 7 years of this agreement, Stason will have a right to negotiate with Peregrine further expansion into other countries worldwide. If commercialization is not achieved within the first 7 years, Stason will lose exclusivity to its APEC territories.

Peregrine's wholly-owned subsidiary Avid Bioservices will initially manufacture TNT products for Stason's research and development activities. Under the terms of the companies' agreement, Avid will be available to provide fee-based services to Stason for developing new processes and manufacturing products under cGMP conditions for clinical trials.

ABOUT TNT TECHNOLOGIES
TNT technologies use monoclonal antibodies to target intracellular tumor antigens in dead or dying (necrotic) tissues. This platform has demonstrated a broad-spectrum potential in solid tumors, including brain, lung, colon, breast, liver, prostate, and pancreatic cancers. Peregrine's lead TNT product Cotara is a monoclonal antibody conjugated with a radioisotope Iodine-131. Cotara is currently being evaluated in a Phase II clinical trial in the U.S. and India for the treatment of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer. A unique approach to treating brain cancer patients, Cotara targets necrotic cells residing at the core of solid tumors. It transports and binds the radioactive iodine to the center of the tumor, allowing the radiation to destroy the tumor from the inside out. Prior data show that Cotara delivers 300-fold more radiation to the tumor than to normal tissues. Survival benefits for recurrent GBM patients were demonstrated in a prior Phase II trial, with 25% (7/28) of patients surviving over 1 year, 11% (3/28) surviving over 5 years, and 2 patients surviving over 9 years. These data compare favorably to the 5-year survival rate of 3.4% reported by the U.S. Brain Cancer Registry. Cotara has Orphan Drug status in the U.S. and EU and Fast Track designation in the U.S.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing 3 separate clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house cGMP manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .

ABOUT STASON PHARMACEUTICALS
Stason Pharmaceuticals, Inc., established in 1994 and based in Irvine, CA is a privately-held, global pharmaceutical company involved in drug development, manufacturing, importation/exportation, licensing and marketing of both generic and branded products. The company's primary area of development is in the area of oncology, and supportive products for the treatment of side effects related to cancer therapy. Additional therapeutic areas include cardiovascular, central nervous system, autoimmune and endocrine disorders. Additional information about Stason can be found at http://www.stasonpharma.com .
Safe Harbor *snip*
Peregrine Contacts:
• Investors: Amy Figueoroa, Peregrine Pharmaceuticals, 800- 987-8256, info@peregrineinc.com
• Media: Barbara Lindheim, BioCom Partners, 212-918-4650
Stason Contact:
Diana Wood, VP, Business Dev., Stason Pharmaceuticals, Inc., 760-929-0346, diana.wood@stasonpharma.com

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EUGENE MECHETNER'S BIOGRAPHY (Ph.D)
• Director of Scientific & Clinical Trials at Oncotech Inc. - 2006
• Adjunct Associate Professor at University of California - to 2007
Eugene Mechetner joined Oncotech as Senior Dir. of Scientific, Clinical, and New Product Dev. His general research interests are focused on the areas of experimental and clinical oncology, imaging, biotechnology, and immunology, with a specific emphasis on multiple drug resistance in normal and tumor cells and new methods of biomarker detection using monoclonal antibodies. Dr. Mechetner has authored over 60 peer-reviewed scientific publications and several US and intl. patents. He has over 12 years of extensive experience in a variety of industries, including biotechnology, drug development, bioreagents, and clinical laboratory testing. In addition to his responsibilities at Oncotech, Dr. Mechetner holds a position of Adjunct Associate Professor with the College of Medicine, Univ. of California - Irvine.
http://www.spoke.com/info/p7DsYM9/EugeneMechetner
PUBS: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&orig_db=pubmed&term=Mechetner%20e

11-27-07: Exiqon A/S and Oncotech Inc today announce that they have entered into a binding Letter of Intent under which Exiqon will acquire Oncotech, a California based leading supplier of extreme drug resistance diagnostic tests in cancer. The transaction will create a world leader in molecular diagnostic products based on miRNA. The consideration amounts to approximately USD 45 million (approximately DKK 225 million) and will be paid through to approx. 6.2 million newly issued shares in Exiqon A/S as of November 26, 2007.

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1-19-10: PPHM & Stason websites show non-binding agreement to dev. TNT in Asia http://tinyurl.com/ybl92b7
…”Peregrine & Stason Pharm. have entered into a non-binding agreement to pursue a collaboration for developing TNT technologies in certain Asia-Pacific countries. The proposed collaboration would allow Peregrine to establish a regional partner for its proprietary TNT technology platform with an established pharmaceutical company that possesses expertise & experience in developing & marketing cancer therapies throughout the Asia-Pacific region.”

Added to bottom of PPHM’s Homepage 1-19-10 http://www.peregrineinc.com :

PEREGRINE'S STRATEGIC PARTNER
Peregrine Pharmaceuticals and Stason Pharmaceuticals to Pursue Tumor Necrosis Therapy (TNT) Develop
Peregrine has been actively seeking regional strategic partners for its preclinical and clinical programs that either are not currently in active clinical development or for territories where the company does not plan to pursue clinical development on its own. Ideal regional partners are established pharmaceutical companies with experience in drug development and commercialization. As part of this strategy, Peregrine and Stason Pharmaceuticals, Inc., have entered into a non-binding agreement to pursue a collaboration for developing tumor necrosis therapy (TNT) technologies in certain Asia-Pacific countries. The proposed collaboration would allow Peregrine to establish a regional partner for its proprietary TNT technology platform with an established pharmaceutical company that possesses expertise and experience in developing and marketing cancer therapies throughout the Asia-Pacific region. Stason was established in 1994 as a generic drug manufacturing and marketing company with an oncology and CNS focus. In 2008, Stason launched a Brand Division to develop proprietary branded drugs. It currently has 2 novel proprietary development stage oncology compounds in its portfolio.

ABOUT STASON PHARMACEUTICALS, INC.
Stason Pharmaceuticals, Inc., established in 1994 and based in Irvine, CA, is a privately-held, global pharmaceutical company involved in drug development, manufacturing, importation/exportation, licensing and marketing of both generic and branded products. Stason established a brand division in 2008 to acquire or license new chemical entities, and has offices throughout North America and Asia. The company's primary area of development is oncology, as well supportive products for the treatment of side effects related to cancer therapy. Due to its focus in the area of oncology, Stason specializes in the development of cytotoxic products requiring high containment operations for their production. Stason also provides contract services for non-high containment products. Additional therapeutic areas include cardiovascular, central nervous system, autoimmune and endocrine disorders. For more information on Stason Pharmaceuticals please visit their website at http://www.stasonpharma.com .
http://www.peregrineinc.com/index.php?option=com_content&task=view&id=90

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Versions of TNT (Tumor Necrosis Therapy)
TNT1 - USA, directed against DNA histone H1 complex in the nucleosome (TNT1+I131=CORATA)
TNT3 – China, targets both single & double stranded DNA

TUMOR NECROSIS THERAPY (TNT/COTARA/VEA’s) NEWS:
Highlights of Cotara/GBM Trials History 1998-2009: http://tinyurl.com/y8fyl2r
1-19-10: PPHM & Stason websites show non-binding agreement to dev. TNT in Asia http://tinyurl.com/ybl92b7
…”Peregrine & Stason Pharm. have entered into a non-binding agreement to pursue a collaboration for developing TNT technologies in certain Asia-Pacific countries. The proposed collaboration would allow Peregrine to establish a regional partner for its proprietary TNT technology platform with an established pharmaceutical company that possesses expertise & experience in developing & marketing cancer therapies throughout the Asia-Pacific region.”
7-1-09 Eur. Patent #1638989 for ‘In-Line Labeling’ (used in Cotara GBM trials) & JNM Article: http://tinyurl.com/mlgz8p

India (expanded Jan'10 to U.S.) Cotara/Brain Ph.2 Trial (40 patients, 1st relapse):
India’s DCGI protocol (init=7-2007): http://clinicaltrials.gov/ct2/show/NCT00677716
1-28-10 U.S. site (Barrow/Phoenix) added formerly India-Only Ph.2 trial: http://tinyurl.com/yk565jy
…Per 3-11-10 QtlyCC, VP/ClinAffairs J.Shan said also exp. UPenn & Univ. of S.Car. http://tinyurl.com/yl4befh
…9-2-09 Interim Ph.2 data (10 pts) presented at AANS Annual Mtg/Boston: http://tinyurl.com/mxzbzm
……P.I. Dr. A.K. Mahapatra: “Most importantly, Cotara has demonstrated promising signs of efficacy.”
...8-2-07 1st Patient Dosed in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/296mcj
...The obvious desire is to compare Cotara vs. SOC Temodar for GBM therapy: http://tinyurl.com/yttt99
USA Cotara/Brain ‘Dosimetry & Dose Confirmation Trial’ (originally funded by NABTT):

U.S.A. Cotara Brain Cancer trial protocol (added 8-14-07): http://clinicaltrials.gov/show/NCT00509301
...2-11-10: “Current Cancer Therapy Reviews” article on Cotara/GMB http://tinyurl.com/yg2on8f
......the cases of “2 patients who have survived more than 9 years” are also reviewed.
...12-2-09: U.S. Trial Enrollment Complete http://tinyurl.com/yez7lzd
...6-16-09: Cotara/Brain Oral-Pres. at SNM Annual Meeting http://tinyurl.com/lmhkw2
......Dr. Sui Shen (U-Alabama), “With a mean dose ratio showing 300-fold greater delivery of radiation to the tumor as compared to other organs, Cotara represents a potentially valuable new therapy for GBM patients."
…9-23-08: Article in Cleveland paper – comments by P.I. Dr. Andrew Sloan (Case Western/CLEV) http://tinyurl.com/3mkmas
...5-31-08: Cotara USA Ph.1B data presented at ASCO/2008: http://tinyurl.com/68apro
...8-29-05: NABTT Initiates Cotara/Brain Trial (28 patients/4 sites): http://tinyurl.com/9w3cr
...Orig. NABTT protocol, “6-2007, completed”: http://www.clinicaltrials.gov/ct/show/NCT00128635
...The Phil (Marfuta) Bannister Story (NABTT Cotara/GBM patient #1, diag. 2-4-06) - articles & updates: http://tinyurl.com/24gkml
.....Update 12-29-08: Phil posts on iHub that he's doing OK (34 mos. since diag.): http://tinyurl.com/8r5fnz
.....Update 10-14-09: Phil posts on YASG.com that he’s doing well, 44 mos. after diagnosis: http://tinyurl.com/yfbpk57

Previous USA Cotara/Brain Ph.1-2 Trials, completed in 2003:
...Slides showing correlation between Cotara dosage levels and MST vs. Temodar(curr.SOC): http://tinyurl.com/26s265
...4-27-08 update: The Jerod Swan Cotara/Brain Success Story (10 years after diag.): http://tinyurl.com/68ofsv
...5-22-07 update: The Freddie Sanford Cotara/Brain Success Story (7 years after diag.): http://tinyurl.com/2du2e5
...6-1-05: Cotara w/CED Brain Delivery pub. in Neurosurgery Jrnl: http://tinyurl.com/anmaa
...”Cotara Holds Promise for Treating Brain Cancer - P1/P2 Data Suggests Extended Survival in a Number of Patients"
TNT3 (Vivatuxin) Lung Cancer Approval/Launch in China:
...Shanghai MediPharm Biotech’s TNT/China website: http://www.vivatuxin.com
...1-16-07: Medipharm Launches TNT in China for Lung Cancer http://tinyurl.com/ttlne
...6-19-02: TNT Interim Lung Data from China: http://tinyurl.com/ggcba & http://tinyurl.com/em6da

Peregrine v. CTL Lawsuit – Settled 6-19-09:
...6-19-09: Form 8-K, Peregrine & CTL Settle: http://tinyurl.com/mhgcg7
...3-29-07 CTL countersues PPHM over TNT/China licensing dispute: http://tinyurl.com/39k8sx
...3-30-07 PPHM comments on CTL's 3-29-07 countersuit: http://tinyurl.com/33xzzq
...1-12-07: New China Subsidiary; Suit Filed Against Cancer Therapeutics Labs (CTL) http://tinyurl.com/y4vzbj

Eur. Licensee Merck-KGaA’s TNT/Cytokine Fusion Protein Ph.1 Trial:
...4-2009: 2nd SELECTIKINE Ph.1 trial added: SELECTIKINE+RAD/NSCLC: http://tinyurl.com/pzl9j8
...5-2007: 2nd SELECTIKINE Ph.1 site added, Univ. of Lausanne, Switz: http://tinyurl.com/2l933s
...Ph.1 Trial Protocol (Merck KGaA/Germany, PI=Dr. R.Stupp): http://tinyurl.com/2f4u2t
...2-22-07: TNT-based European Cancer Trial initiated by ‘Licensee’: http://tinyurl.com/2zcjqr
...Clearly, it's Merck-KGaA's 'SELECTIKINE' (NHS-IL2-LT/EMD521873): http://tinyurl.com/yud7pw

VEAs:
...5-1-08 Dr. Missag Parseghian (Dir/R&D) presents VEAs at PEGS/2008: http://tinyurl.com/66onj2
...NOTE: Drs. Parseghian (Dir.R&D) & Luhrs, key PPHM TNT/VEA researchers: http://tinyurl.com/2ahhdp
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