Companies like Amgen AMGN and Regeneron REGN were in the news with Amgen providing pipeline and regulatory updates while Regeneron and partner Sanofi got some good news with an appeals court ruling in their favor in the PCSK9 inhibitor lawsuit against Amgen.
Recap of the Week’s Most Important Stories
Phase II Combination Data on Amgen’s Imlygic Published: Positive data on Amgen’s oncolytic viral therapy, Imlygic, when used in combination with Bristol-Myers Squibb’s Yervoy were published in the Journal of Clinical Oncology. Results from the mid-stage study showed that the objective response rate ("ORR") more than doubled when Imlygic was used in combination with Yervoy compared to Yervoy alone in patients with unresectable stage IIIB-IV melanoma (39% versus 18%). Moreover, the complete response rate was almost double in the combination arm compared to Yervoy alone (13% versus 7%). Responses were observed in both injected and uninjected lesions, including visceral lesions.
Advanced melanoma is highly aggressive and one of the most dangerous types of skin cancer with there being need for multiple treatment approaches over the course of the disease. The data is encouraging and could open up new avenues of revenues for Imlygic if it eventually gains approval for use in combination with a checkpoint inhibitor. Sales of Imlygic, approved in October 2015, are yet to pick up.
Meanwhile, Amgen said that the FDA has accepted its regulatory application seeking label expansion for the use of Prolia in glucocorticoid-induced osteoporosis, the most common form of secondary osteoporosis. A response from the agency should be out on May 28, 2018. Prolia, which brought in sales of $505 million in the second quarter of 2017, is an important growth driver for Amgen with the company working on improving diagnosis, treatment rates and duration in order to drive access to a greater number of patients (Read more: Amgen Label Expansion Application for Prolia Accepted by FDA).
Amgen is a Zacks Rank #2 (Buy) stock. Shares of Amgen have gained 27.1% year to date, significantly outperforming the industry’s 13.9% rally. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breather for Amgen with Neulasta Biosimilar Approval Delay: Amgen got a bit of a breather with the FDA issuing a Complete Response Letter (“CRL”) for Mylan and Biocon’s biosimilar version of Amgen’s blockbuster drug, Neulasta (pegfilgrastim). While the agency did not raise any queries regarding biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity of MYL-1401H, the CRL relates to the pending update of the regulatory application with certain CMC data from facility requalification activities post recent plant modifications.
We note that Mylan and Biocon are not the only companies to get a CRL from the FDA for a biosimilar version of Neulasta. While Novartis’s Sandoz had received a CRL last year, Coherus was issued a CRL this year in June.
Regeneron/Sanofi Score a Win in PCSK9 Inhibitor Litigation: Regeneron and partner Sanofi got a major boost with the U.S. Court of Appeals for the Federal Circuit ordering a new trial related to Amgen’s claims regarding patents for PCSK9 inhibitors. The court also vacated the permanent injunction in the lawsuit which means Sanofi and Regeneron can continue selling their PCSK9 inhibitor, Praluent, in the United States (Read more: Regeneron and Sanofi Get Favorable Ruling Against Amgen).
AbbVie in Immuno-Oncology Deal: AbbVie ABBV has entered into a research, option and license agreement with clinical-stage immuno-oncology company Turnstone Biologics. The deal provides AbbVie with an exclusive option to license up to three of Turnstone's next-generation oncolytic viral immunotherapies.
Turnstone’s Ad-MG1-MAGEA3 therapy is in a couple of phase I/II studies for different solid tumor indications alone as well as in combination with an approved anti-PD-1 checkpoint inhibitor.
Promising New Data on Biogen’s Spinraza: New phase III data presented by Biogen BIIB on Spinraza showed that earlier initiation of treatment with the therapy may improve motor function outcomes in infants and children with spinal muscular atrophy (“SMA”). Biogen and Ionis’s Spinraza is the first approved medicine for the treatment of SMA. Spinraza is off to a promising start in the United States bringing in sales of $203 million in the second quarter of 2017.
Clovis Seeks Label Expansion for PARP Inhibitor: Clovis Oncology CLVS has filed for label expansion of its PARP inhibitor, Rubraca, in the United States. The company is looking to get the drug approved for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The company had presented impressive late-stage data earlier this year in June on Rubraca showing that the treatment significantly improved progression-free survival in all ovarian cancer patient populations evaluated in the ARIEL3 study.
Rubraca had gained accelerated FDA approval in December 2016 for use in advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations. A broader label would boost Rubraca’s sales potential (Read more: Clovis Submits sNDA for Ovarian Cancer Drug Rubraca).
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index was up 0.6% over the last five trading sessions. Among major biotech stocks, Biogen gained 4.9% while Celgene CELG lost 4.4%. Over the last six months, Vertex VRTX was up 35.5% (See the last biotech stock roundup here: Endocyte Shoots up on Deal, Amgen-AbbVie Settle Humira Litigation).
What's Next in the Biotech World?
As the sector gears up for third quarter earnings, watch out for the usual regulatory and pipeline updates. Sparks Therapeutics’s voretigene neparvovec will be reviewed by the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) on October 12. Sparks is seeking FDA approval for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
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