Puma Biotechnology, Inc. PBYI announced that it has amended and extended the terms of its license agreement with French pharmaceutical company Pierre Fabre, giving the latter the exclusive rights to develop/commercialize Nerlynx (neratinib) in additional countries. This new amendment provides Pierre Fabre with the rights to Nerlynx in the Middle East, South Africa, Sudan and Turkey.
Notably, in April 2019, Puma Biotech
signed the license agreement with Pierre Fabre to develop/commercialize Nerlynx within Europe and across parts of Africa.
Nerlynx is approved in several countries including the United States and Europe as an extended adjuvant treatment of HER2-positive early stage breast cancer in adult patients, previously treated with Roche’s
RHHBY Herceptin-based adjuvant therapy.
Per the amended agreement, Puma Biotech is eligible to receive an upfront payment of $4 million and up to $3 million in regulatory and sales-based milestones.
The company is focused on making Nerlynx available to patients around the world seeking adjuvant treatment options for breast cancer.
Shares of Puma Biotech were up 13.1% following the aforementioned news on Monday. However, the stock has plunged 47.3% so far this year against the
industry’s rise of 5.3%.
Nerlynx is the only approved product in Puma Biotech’s portfolio right now. The drug generated sales of $152.9 million in the first nine months of 2019, reflecting a 9.7% increase year over year. The license amendment should boost the drug’s commercial potential.
Apart from Pierre Fabre, Puma Biotech has agreements with many international companies to pursue regulatory approval and commercialize Nerlynx. These include CANbridge in Mainland China, Hong Kong and Taiwan; Medison Pharma in Israel; Specialised Therapeutics Asia in South East Asia; Knight Therapeutics in Canada and Pint Pharma International in Argentina, Brazil, Chile, Colombia, Mexico and the rest of Latin America.
In a separate press release, Puma Biotech announced that its licensing partner in South East Asia, Specialised Therapeutics Asia, received the marketing approval for Nerlynx in Singapore.
Zacks Rank & Stocks to Consider
Puma Biotech currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Anika Therapeutics Inc.
ANIK and Vertex Pharmaceuticals Incorporated ( VRTX Quick Quote VRTX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 68.3% so far this year.
Vertex’s earnings estimates have been revised 5% upward for 2019 and 10.6% for 2020 over the past 60 days. The stock has surged 33.2% year to date.
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