The major pipeline and regulatory updates in the biotech sector over the past week included Amgen (AMGN - Free Report) ’s Blincyto getting EC approval for a label expansion and Puma Biotechnology (PBYI - Free Report) winning EC approval for Nerlynx. Meanwhile, MannKind (MNKD - Free Report) shares surged on a deal with United Therapeutics Corporation.
Recap of the Week’s Most Important Stories:
Amgen Gets EC Nod For Label Expansion of Blincyto: Amgen announced that the European Commission (EC) has approved a label expansion of leukemia drug Blincyto. The drug is now approved as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL), which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. The approval was based on positive data from the phase I/II 205 study. Blincyto, a BiTE immunotherapy, is already approved for the treatment of this indication in adults in EU. In the United States, it is approved to treat r/r B-cell precursor ALL in adults as well as children. Meanwhile, in April, Blincyto was approved in the United States for a new indication — minimal residual disease (MRD)-positive B-cell precursor ALL.
Amgen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Puma’s Breast Cancer Drug Approved in Europe: The EC has granted marketing authorization to Puma Biotechnology, Inc.’s (PBYI - Free Report) Nerlynx (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. We note that an approval was in the cards as the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on the same in June 2018. The approval was based on positive data form phase III trial, ExteNET. Per the company, the drug becomes the first anti-HER2 treatment to be EC-approved as extended adjuvant therapy for early-stage hormone receptor positive HER2-positive breast cancer following adjuvant trastuzumab-based therapy. We note that Nerlynx was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
MannKind Surges on Deal With United Therapeutics Corporation: Shares of MannKind soared after the company announced a worldwide exclusive licensing and collaboration agreement with United Therapeutics Corporation (UTHR - Free Report) for the development and commercialization of a dry powder formulation of treprostinil, an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension. Per the terms of the agreement, United Therapeutics will be responsible for global development, regulatory and commercial activities while MannKind will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Danbury, Connecticut. MannKind Corporation will receive an upfront payment of $45 million along with potential milestone payments of up to $50 million. The company is also entitled to receive low double-digit royalties on net sales of the product. United Therapeutics has an option to expand the license to include other active ingredients for the treatment of pulmonary hypertension. Each optioned product would be subject to the payment of up to $40 million to MannKind in additional option exercise and development milestone payments as well as a low double-digit royalty on net sales of any such product.
Vertex Collaborates With Genomics: Vertex Pharmaceuticals, Inc. (VRTX - Free Report) inked a three-year collaboration deal with Genomics Plc to use human genetics and machine learning to identify novel targets, which can be developed into precision medicines for serious diseases. Vertex has also made a £10.5 million (around $13.7 million) equity investment in Genomics. Moreover, Vertex will make milestone and royalty payments to Genomics per the terms of the collaboration contract. Dr. David Altshuler, chief scientific officer, Vertex will join the board of Genomics. Separately, Vertex announced finalization of an agreement with the Australian Government that allows for the reimbursement of Orkambi (lumacaftor/ivacaftor) to patients ages six and over with cystic fibrosis (CF), who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The NASDAQ Biotechnology Index inched up 0.79% over the last four trading sessions. Among the major biotech stocks, Regeneron has gained 3.56%. Over the past six months, Gilead has lost 3.2% while Regeneron has rallied 20.9%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Gets EC Nod for Yescarta, AMGN Submits Kyprolis sNDA)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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