2019 News Releases
Puma Biotechnology and Pierre Fabre Enter into Exclusive License Agreement to Develop and Commercialize NERLYNXÂ® (neratinib) in Europe
LOS ANGELES, Calif. and CASTRES, France, April 1, 2019 - Puma Biotechnology, Inc. (Nasdaq: PBYI) and Pierre Fabre have entered into an exclusive license agreement under which Pierre Fabre will develop and commercialize NERLYNXÂ® (neratinib) within Europe and part of Africa. In September 2018 the European Commission granted marketing authorization for NERLYNXÂ® (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy.
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates â€” PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNXÂ® (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in September 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
About Oncology at Pierre Fabre
Pierre Fabreâ€™s expertise in oncology is based on almost four decades of experience in the discovery, development and global marketing of innovative cancer drugs, including monoclonal antibodies and ADCs. NavelbineÂ® has been one of the companyâ€™s major successes and is valuable in the treatment of breast cancer patients. The company conducts its R&D in two oncology centers, based in Saint-Julien-en-Genevois (near Geneva) and at the Oncopole campus in Toulouse. The Oncopole is officially recognized by the French government as a National Center of Excellence for cancer research. In 2015, Pierre Fabre entered into an agreement with the American biotech company, Array BioPharma, to codevelop two small molecules (kinase inhibitors), BraftoviÂ® & MektoviÂ®. The primary indication (melanoma) was approved in September 2018 by EMA and marketing is already underway in Germany, the UK, the Netherlands, Austria, Norway and Denmark.
About Pierre Fabre
With a portfolio representing a continuum of activities spanning from prescription drugs and consumer healthcare products to dermo-cosmetics, Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several global brands and franchises among which Eau Thermale AvÃ¨ne, Klorane, Ducray, RenÃ© Furterer, A-Derma, GalÃ©nic, Elancyl, Naturactive, Pierre Fabre Health Care, Pierre Fabre Oral Care, Pierre Fabre Dermatologie and Pierre Fabre Oncologie.
In 2018, Pierre Fabre generated 2.3 billion euros in revenues, of which 63% came from its international business and 61% from its dermo-cosmetics division. Pierre Fabre, which has always been headquartered in the South-West of France, counts about 11,000 employees worldwide, owns subsidiaries and offices in 47 countries and enjoys distribution agreements in over 130 countries. In 2018, Pierre Fabre dedicated 187 million euros to R&D efforts, split between oncology, consumer healthcare, dermatology and dermo-cosmetics.
Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.
The independent French certification group AFNOR audited in 2015 Pierre Fabre for its corporate social responsibility policy at the "exemplary" level, according to the ISO 26000 standard for CSR.
To find out more about Pierre Fabre, please go to www.pierre-fabre.com.
This press release contains forward-looking statements, including statements regarding the commercialization and commercial availability of NERLYNXÂ® in European countries excluding Russia and Ukraine, along with countries in North Africa and francophone countries of West Africa; the registration and regulatory approval of NERLYNX in the region; and potential payments and royalties payable under the license agreement.. All forward-looking statements involve risks and uncertainties that could cause Pumaâ€™s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumaâ€™s Annual Report on Form 10-K for the year ended December 31, 2018. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.
Puma Biotechnology, Inc.
Alan H. Auerbach or Mariann Ohanesian, +1 424-248-6500
David Schull or Alex Fudukidis, Russo Partners, +1 212-845-4200
ValÃ©rie Roucoules, Pierre Fabre + 33 1 49 10 83 84 / + 33 6 20 88 61 65 email@example.com
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Puma Biotechnology, Inc.