Navidea Enters Exclusive License and Distribution Agreement For India with Sayre Therapeutics
JUNE 20, 2017Source: Business Wire[IST]
Tc 99m Tilmanocept Already Commercialized in Three Major European Countries
Represents Next-Generation Standard of Diagnosis For Sentinel Lymph Node Detection
DUBLIN, Ohio–(BUSINESS WIRE)–Jun. 20, 2017– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea”), a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics, today announced that it has entered into an exclusive license and distribution agreement (the “License Agreement”) with Sayre Therapeutics for the development and commercialization of Tc 99m tilmanocept in India. Sayre Therapeutics specializes in innovative treatments and medical devices commercialization in South Asia.
Under the terms of the agreement, Navidea received an upfront payment and is eligible to receive upcoming milestone payments and double-digit royalties associated with the sale of Tc 99m tilmanocept in India.
Michael Goldberg, M.D., President and Chief Executive Officer of Navidea, stated, “We view this partnership as an important milestone in the expansion of tilmanocept’s adoption globally and reiterates our commitment to patients the world over. The terms of our agreement with Sayre are favorable and the increased economics will drive further revenues to fund our other pipeline assets.”
About Tc 99m Tilmanocept
Tc 99m tilmanocept 50 microgram kit for radiopharmaceutical preparation is approved in Europefor imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device.Tc 99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumour, which have the highest probability of harbouring cancer.
About Sayre Therapeutics
Sayre Therapeutics Private Ltd. is South Asia’s only integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics, and drug-delivery devices in the super-specialty areas of Oncology and Immunology. Companies with novel Oncology and Immunology assets can work with us in South Asia, as we focus on alleviating life-threatening diseases with high unmet need.
About Navidea Biopharmaceuticals
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its ManoceptTM platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc 99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc.Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.
For more information, please visit www.navidea.com.
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Sayre Therapeutics inks Lutrate Depot License pact with GP Pharm S.A. for India, Sri Lanka, Bangladesh and Nepal
Our Bureau, Bengaluru
Wednesday, April 05, 2017, 14:30 Hrs [IST]
Sayre Therapeutics with a portfolio of oncology and immunology focussed commercial products, has entered into an exclusive license agreement with GP Pharm S.A to distribute, market and sell Lutrate Depot in 1 and 3 month formulations in India, Sri Lanka, Bangladesh and Nepal. GP Pharm will supply Lutrate to Sayre on an exclusive basis from its manufacturing facility in Barcelona, Spain.
According to Vandana Subramanian, Senior Vice-President, BD & Corporate Strategy, Sayre Therapeutics’ collaboration with GP Pharm would help bring an EMA approved best-in-class differentiated Leuprolide Acetate depot formulation to South Asia.
“This medicine provides a further fillip to our efforts to build a portfolio for oncology diseases with advanced options for patients suffering from prostate cancer. Lutrate will greatly benefit the South Asian patient community and improve their quality of life,” she added.
“We are extremely pleased that we have been able to expand the availability of Lutrate to the SouthAsian region. This collaboration represents one step further in our worldwide expansion and it will allow us to position, said Dr. Antonio Parente, Executive President, GP Pharm.
While GP Pharm S.A. is a privately owned Spanish Biopharmaceutical Company located in Barcelona, (Spain and founded in 2000, the two-year old Sayre Therapeutics is South Asia’s only integrated platform for disease management backed by a distribution and commercialization model for novel drugs, companion diagnostics and drug-delivery devices in oncology and immunology.
Nuvo PharmaceuticalsTM Enters into Pennsaid® 2% License Agreement with Sayre Therapeutics PVT Ltd. for India, Sri Lanka, Bangladesh and Nepal
NEWS PROVIDED BY
Nuvo Pharmaceuticals Inc.
28 Mar, 2017, 07:30 ET
MISSISSAUGA, ON, March 28, 2017 /PRNewswire/ – Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced that it has entered into an exclusive license agreement with Sayre Therapeutics PVT Ltd. (Sayre Therapeutics) to distribute, market and sell Pennsaid 2% in India, Sri Lanka, Bangladesh and Nepal (the Territory). Nuvo has received an upfront payment and is eligible to receive milestone payments and a double-digit royalty on net sales. Nuvo will supply Pennsaid 2% to Sayre on an exclusive basis from its manufacturing facility in Varennes, Québec.
“We are extremely pleased that our very capable and committed new partner, Sayre Therapeutics, will represent the Pennsaid 2% brand in this significant South Asian region,” said Jesse Ledger, Nuvo’s President. “We expect to complete Pennsaid 2% out-licensing agreements for other territories throughout 2017 and 2018. Our strategy is to make Pennsaid 2% a global brand which will increase and diversify our revenue streams and increase capacity utilization at our manufacturing facility.”
Shukrit Chimote, CEO, Sayre Therapeutics said, “Our collaboration with Nuvo helps us bring a U.S. FDA approved best-in-class solution to South Asia. Pennsaid adds an additional first-line treatment option to our growing portfolio of rheumatology medicines. Pennsaid 2% will greatly benefit the South Asian patient community and improve their quality of life.”
License Agreement Details
The License Agreement grants Sayre the exclusive right throughout the Territory to market, sell and distribute Pennsaid 2% as a prescription drug for the human treatment of osteoarthritis of the knee and acute pain from sprains and strains. Nuvo will provide Sayre with its existing Pennsaid 2% regulatory dossier and the U.S. Food and Drug Administration (FDA) approval of Pennsaid 2% which Sayre will use to support its application for regulatory approvals in the countries within the Territory.
About Pennsaid 2%
Pennsaid 2% is topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium. It is approved by the FDA for treating the pain of osteoarthritis of the knee(s). Pennsaid 2% is a gel formulation that is supplied in a metered dose pump bottle. It is the only topical NSAID approved by the FDA for twice daily dosing. Pennsaid 2% is protected by multiple U.S. patents that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories. Pennsaid 2% has not yet received regulatory approval outside of the U.S. and Russia.
About Nuvo Pharmaceuticals Inc.
Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities. Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch. Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ: HZNP), is approved for sale, but has not yet been commercially launched, in Russia and is available for partnering in certain other territories around the world. Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA, Health Canada and E.U. approved manufacturing facility in Varennes, Québec.
For additional information, please visit www.nuvopharmaceuticals.com.
M/S Sayre Therapeutics Private Ltd. is South Asia’s only integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics and drug-delivery devices in the super-specialty areas of Oncology and Immunology/Rheumatology. Sayre Therapeutics was founded in 2015 backed by leading global venture capital firms. The Sayre team boasts 25 years of global executive experience in leading Pharmaceuticals, Medical Diagnostics & Devices companies. Sayre is creating a portfolio of differentiated global assets in emerging markets, including India, Pakistan, Sri Lanka and Nepal which are witnessing high growth for pharmaceutical products. Sayre has a geographically focused strategy, strong financial backing and established relationships with clinicians and regulatory know-how, and will be a committed partner to licensors like Nuvo Pharmaceuticals for their global assets.
Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, “forward-looking statements”) within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, the future approval, marketing and sale of Pennsaid 2% in certain jurisdictions, as well as statements with respect to management’s beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “believe”, “should” or “plans”, or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management’s current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include, but are not limited to, general business and economic uncertainties and adverse market conditions; as well as other risk factors included in the Company’s Management Information Circular dated December 31, 2015 and the Company’s Annual Information Form dated March 1, 2017 under the heading “Risks Factors”, and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on the Company’s forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. Although the forward-looking information contained in this press release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. All forward-looking statements in this press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Nuvo Pharmaceuticals Inc.
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Sayre Therapeutics announces DaunoXome named patient program in India
A Named Patient Program is a mechanism through which physicians can legally and ethically prescribe drugs which are not yet approved in a specific country, in line with local country regulations.
October 04, 2016, 12:44 IST | Source: ETHealthWorld
Bangalore: Sayre Therapeutics on Monday announced the establishment of a Named Patient Program for DaunoXome (liposomal daunorubicin) for India, Sri Lanka, Bangladesh, Nepal and Pakistan, under an exclusive distribution arrangement with Galen Limited. DaunoXome is an anti-cancer medicine (a cytotoxic agent) that belongs to a group of medicines called anthracyclines. A Named Patient Program is a mechanism through which physicians can legally and ethically prescribe drugs which are not yet approved in a specific country, in line with local country regulations.
The active substance of DaunoXome is daunorubicin. DaunoXome is a special formulation of daunorubicin (in liposome form), which is used to treat a type of cancer known as Kaposi’s sarcoma. Kaposi’s sarcoma is a form of cancer that mainly affects the skin, but which can also affect the lungs and intestines. DaunoXome reduces the growth of these tumour cells. DaunoXome is used for the treatment of a severe form of Kaposi’s sarcoma in patients with AIDS.
A Sayre Therapeutics company spokesperson stated, “We are committed to improving patient access to liposomal daunorubicin in a legal and ethical manner. Our agreement with Galen provides a valuable resource for healthcare professionals and patients who are unsatisfied with their current approved treatment options to access liposomal daunorubicin on a named-patient basis.”ompanies with novel Oncology and Immunology assets can work with us in South Asia, as we focus on alleviating life-threatening diseases with high unmet need.
David Bennett, Managing Director of Galen Limited, stated, “We are delighted to have established this partnership with Sayre Therapeutics for India and the SAARC countries. This agreement provides an important additional option for clinicians in these countries, who are treating patients with advanced HIV-related Kaposi’s sarcoma.”
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Cancer Genetics, Inc. and Sayre Therapeutics Announce Distribution Agreement to Commercialize CGI’s Proprietary FDA-cleared Tissue of Origin (TOO®) Test Throughout India and South Asia
June 23, 2016 08:25 ET | Source: Cancer Genetics, Inc.
TOO® is the ONLY FDA-cleared test of its type, used to aid in identifying challenging tumors, including metastatic, poorly differentiated, and undifferentiated cancers
The partnership will leverage Sayre’s distribution and sales personnel that engages over 500 key opinion and healthcare business leaders vital in the Indian oncology landscape
RUTHERFORD, N.J. and HYDERABAD, India, June 23, 2016 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX); (“CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announces an exclusive distribution agreement that provides Sayre Therapeutics sales and marketing rights of Cancer Genetics’ Tissue of Origin® (TOO®) test in India and South Asia. TOO® data generated by the use of the test in India will contribute to the expansion of CGI’s knowledge base to further validate the clinical utility of the test on a global basis.
“We view this partnership with Sayre as an important milestone in making precision medicine increasingly available outside the US, especially in high-growth, high-demand markets like India,” said Panna Sharma, CEO and President of Cancer Genetics. “We plan to continue broadening the access to our unique, proprietary portfolio of genomic and biomarker driven tests, which help in the management of cancer care, and Sayre has demonstrated reach and influence in the oncology sector throughout India.”
According to Dr. Palanki Satya Dattatreya, Senior Consultant and Medical Oncologist at Omega Hospitals, in Hyderabad, India, “Cancer of Unknown Primary (CUP) is not an uncommon condition in India. CUP continues to be an enigma to the physicians and an aggressive disease with unfavorable prognosis to the patients. Generally, CUP patients are subjected to a battery of repeated tests and go through agonizing uncertainty about their disease condition. The Tissue Of Origin (TOO®) test, which is based on the principle of gene expression profiling, can be very useful in such cases. TOO® test with its high specificity and sensitivity takes away the element of ambiguity, and enables the patient to get a more specific guideline-based therapy which translates into potentially better survival rates.”
CGI’s TOO® is a microarray-based gene expression test that aids in identifying challenging tumors, including metastatic, poorly differentiated, and undifferentiated cancers. It is able to report the tissue of origin of 15 of the most common tumor types (thyroid, breast, non-small cell lung, pancreatic, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate tumors), representing 58 cancer morphologies and covering 90% of all solid tumors. TOO® leads to a change in treatment 65% of the time.
Sayre has begun active marketing efforts in major metro markets of India and South Asia and has held seminars and workshops with key opinion leaders and clinicians. “It is heartening to note that many physicians are very positive about the test and feel that this is the way forward in making guided decisions or modifications of the treatment plan of patients with Cancer of Unknown Primary (CUP),” said Ravindranath Kunjithai, Head Medical and Regulatory Affairs at Sayre Therapeutics.
For more information about TOO® please visit www.cancergenetics.com
About Cancer Genetics
Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.
The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.
Sayre Therapeutics Private Ltd. is South Asia’s only integrated platform for disease management backed by a unique distribution and commercialization model for novel and/or differentiated drugs, companion diagnostics, and drug-delivery devices in the super-specialty areas of Oncology and Immunology. Companies with novel Oncology and Immunology assets can work with us in South Asia, as we focus on alleviating life-threatening diseases with high unmet need.
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CROSSJECT enters into partnering agreement with Sayre Therapeutics to commercialize ZENEO® Methotrexate in India
Chenôve (France) and Bangalore (India), September 14 2015 –
CROSSJECT (ISIN : FR0011716265 ; Mnémo : ALCJ) , the creator of ZENEO®, a needle-free injection system developed to be used with a portfolio of well-known drugs announces today a partnering agreement with Sayre Therapeutics to commercialise ZENEO® Methotrexate in India. The filing of the marketing authorisation files of this innovative product for the treatment of rheumatoid arthritis in the region, is anticipated early 2017.
The agreement provides Sayre Therapeutics with exclusive distribution and marketing rights in India, Bangladesh, Sri Lanka and Nepal. In return, CROSSJECT will receive a share from 20% to 40% of the revenues generated from the product. Sayre Therapeutics has committed to minimum levels of volumes and marketing investment.
Patrick Alexandre, CROSSJECT’s founder and CEO said: “The Indian market has been chosen due to the pricing environment which will allow us to generate attractive returns. This is a high margin niche market thanks to the free pricing mechanisms in this area. This deal will allow us to capture value from ZENEO® without any further investments. It also allows us to continue to focus our commercial strategy on North America and Europe. We are convinced that Sayre Therapeutics with its entrepreneurial spirit, experienced team, including its sales force, has all the attributes needed to successfully commercialise ZENEO® Methotrexate.”
A spokesperson for Sayre Therapeutics comments: “This collaboration with CROSSJECT will further reinforce our product portfolio, particularly for the home care market. Sayre Therapeutics is now well established through the Indian subcontinent and South Asia, and we are now ready to focus on chronic diseases such as rheumatoid arthritis by providing patients with a needle-free injection system that is easy and safe to use.”
About Crossject • www.crossject.com
Crossject is using its world-leading needle-free injection system, ZENEO™ to develop an attractive pipeline of high-value SUPERGENERICS or New Therapeutics Entities. These needle-free products, which are based on well-known injectable drugs (chemicals & biologics), are designed to enhance patient safety, compliance and comfort. Crossject’s needle-free, pre-filled, single-use ZENEO ™ injection systems are unique in that they can be tailored to deliver drugs intradermally, subcutaneously and intramuscularly. This means that ZENEO™ can allow a wide range of drugs and vaccines for a broad range of indications to be developed and approved in a very short period. Outside its own portfolio of SUPERGENERICS, Crossject anticipates partnering ZENEO with other pharma/biotech looking to improve the life cycle management of their key drugs or biologics.
CROSSJECT is listed on Alternext Paris (Mnemo : ALCJ, ISIN : FR0011716265)
About Sayre Therapeutics
Sayre Therapeutics is specialized in innovative treatments and medical devices commercialization in South Asia. The founders experience and its dynamic team have allowed Sayre to rapidly develop its product portfolio
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BMG PHARMA S.r.l. Announces the Signature of a Distribution Agreement for its Cancer Supportive Care Line Including its Iron in Liposomal Technology Based Product With Sayre Therapeutics for India and Other Asian Area Countries
MILAN, Italy, July 31, 2015 /PRNewswire/ —
BMG Pharma S.r.l. is pleased to announce the signature of a Distribution
Agreement with Sayre Therapeutics Ltd,Bangalore, India, for its cancer supportive products under the brand name GelX® and for its liposomal iron based food supplement IronOne.
Thanks to its innovative formulas, the GelX® range alleviates pain in oncological patients, offering different solutions for chemotherapy & radiation induced oral mucositis, xerostomia, dry mouth and radiation dermatitis.
IronOne is a new iron concept, available in softgel capsules, utilizing a unique coating technology in liposomes to create a product, which allows the molecule to pass through the stomach, avoiding gastrointestinal irritation. This means that the iron is absorbed directly through the lining of the gastrointestinal tract, proving it extremely effective,
“We are proud to cooperate with Sayre who we have signed up with as our preferred and exclusive partner in achieving registration & distribution of the products in their territory” – said Marco Mastrodonato, CEO of BMG Pharma S.r.l. – “We are pleased to offer our products to allow patients to receive the best care possible by using innovative formulations to provide fast pain relief for oncologic and anemic patients “This partnership is a major milestone for BMG as it allows our company to enter the Indian and south Asian market and we are sure that Sayre will implement strong strategies in order to support the distribution of our products in all these markets”.
A Sayre spokesperson said “Our collaboration with BMG Pharma S.r.l. provides a tremendous boost to our efforts to bring cutting-edge cancer supportive care products to the Indian subcontinent. Sayre is committed to making available life-saving medicines in South Asia, to benefit the patient community and improve their quality of life.” “We are thrilled to partner with BMG Pharma S.r.l. to fulfill a high unmet need segment and explore newer therapies in cancer in the future.
M/S Sayre Therapeutics Private Ltd. is South Asia’s only integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics and drug-delivery devices in the super-specialty areas of Oncology and Immunology. Companies with novel Oncology and Immunology assets can work with us in South Asia, as we focus on alleviating life-threatening diseases with high unmet need.
For press releases and other company information, visit: http://www.sayretherapeutics.com
About BMG Pharma S.r.l.
BMG Pharma S.r.l. is a specialty pharmaceutical company with head office in Milan, Italy, leveraging its proprietary technology to develop products that address unmet needs of patients. The Company is currently focused on cancer supportive care, dermatology gynecology, ENT and oral health. BMG Pharma S.r.l. is dedicated to helping patients, pharmacists and physicians by providing valuable and innovative products to the market.
The Company’s key features are:
- Full involvement in business and partnering
- Presence in different therapeutic areas
- Specific regulatory strategies for each product as Prescription and OTC Medical Devices in EC and US to allow rapid market introduction. BMG focuses on bringing products to market quickly with supportive clinical data.
- IP protection for most of the products and technologies.
For press releases and other company information, visit: http://www.bmgpharma.com
Contact: Mrs. Loredana Galli, email@example.com, +39-3385706413
SOURCE BMG Pharma
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