A key development this week was the FDA approval of the first cancer biosimilar - Amgen AMGN and Allergan’s Mvasi, a biosimilar version of Roche’s blockbuster cancer drug, Avastin. Other updates include important data presentations from companies like Nabriva Therapeutics NBRV and AbbVie ABBV.
Recap of the Week’s Most Important Stories
First Cancer Biosimilar Gets FDA Nod: The FDA approved Amgen and Allergan’s Mvasi, a biosimilar version of Roche’s blockbuster cancer drug, Avastin (bevacizumab). Mvasi can be used for all eligible indications of the reference product. Approval was in line with expectations considering the favorable vote the biosimilar got from an FDA advisory panel recently. The approval is quite a boost for the companies as well as the effort to lower drug prices though so far biosimilars are yet to make a significant dent in referenced product sales in the United States. Mvasi is under review in the EU (Read more: Amgen/Allergan's Avastin Biosimilar Secures FDA Approval).
Nabriva up on Positive Antibiotic Data: Nabriva got a major boost with the company posting positive top-line results on oral lefamulin in patients with community-acquired bacterial pneumonia (“CABP”), the leading cause of infectious death in the United States. The LEAP 1 study, the first of two pivotal late-stage studies being conducted with lefamulin, met the FDA’s primary endpoint of non-inferiority compared to moxifloxacin with or without adjunctive linezolid for early clinical response. The European Medicines Agency’s (‘EMA”) criteria were also met. Nabriva is looking to position lefamulin as a first-line empiric monotherapy. The second pivotal study is currently enrolling with topline results expected next year in spring. Positive results would allow the company to file for FDA approval in the second half of 2018. Nabriva has gained 54.2% year to date, significantly outperforming the industry’s 15.6% rally (Read more: Nabriva's Lefamulin Positive in Pivotal Study, Stock Surges).
No FDA Advisory Panel Meeting for BioMarin Drug: BioMarin Pharmaceutical BMRN, known for its strong presence in the market for serious and life-threatening rare disorders, said that the FDA is not looking to hold an advisory panel meeting for the company’s Biologics License Application (“BLA”) for pegvaliase. BioMarin is looking to get pegvaliase approved for the reduction of blood phenylalanine (Phe) levels in adult patients with phenylketonuria (PKU) who have uncontrolled blood Phe levels on existing management. Pegvaliase is currently under priority review with a response from the FDA expected by Feb 28, 2018. However, this could well be pushed out by three months as the agency has asked BioMarin for additional Chemistry, Manufacturing, and Controls (“CMC”) information (Read more: BioMarin Says FDA Not Planning an AdCom for Pegvaliase BLA).
TESARO’s Zejula a Step Closer to EU Nod: Cancer-focused TESARO TSRO got some good news with the EMA's Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Given the positive opinion, chances of gaining EU approval look high. Approval would make Zejula the first oral, once-daily PARP 1/2 inhibitor in Europe for use in patients regardless of BRCA mutation or biomarker status. Zejula is already approved in the United States (Read more: TESARO Ovarian Cancer Drug Zejula Gets Positive CHMP Opinion).
AbbVie/Roche Cancer Drug Positive in Late-Stage Study: AbbVie and partner Roche are looking to expand the label of their cancer therapy, Venclexta/Venclyxto and results from a late-stage study (MURANO) should help in these efforts. Venclexta plus Rituxan met the primary endpoint of prolonged progression-free survival compared with Treanda (bendamustine) plus Rituxan in patients with relapsed/refractory chronic lymphocytic leukemia (“CLL”) in the MURANO study. An independent data monitoring committee has recommended the unblinding of the study based on the positive results. Label expansion for this indication will expand the patient population for Venclexta significantly and boost its commercial potential (Read more: Roche Announces Positive Data on Leukemia Drug).
Halozyme Signs Deals, Raises View: Halozyme Therapeutics’s HALO shares shot up with the company announcing deals with Roche and Bristol-Myers Squibb for its ENHANZE drug-delivery technology and raising its outlook for the year. Under the Roche agreement, Halozyme stands to receive $30 million upfront and up to $160 million on the achievement of specified development, regulatory and sales-based milestones. The company will also receive tiered, mid-single digit royalties on sales of commercialized products.
The Bristol-Myers deal will see the company getting $105 million upfront plus future milestone and royalty payments. Based on these two licensing deals, Halozyme upped its revenue guidance by $130 million and expects to exit the year with a cash balance of $380 million to $395 million, $135 million more from its previous guidance (Read more: Bristol-Myers Collaborates With Halozyme for ENHANZE).
Halozyme is a Zacks Rank #2 (Buy) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index was down 1.6% over the last five trading sessions. Among major biotech stocks, Celgene was up 0.9% while Biogen lost 3.6%. Over the last six months, Vertex VRTX was up 67.6% (See the last biotech stock roundup here: Alexion to Cut Jobs, Streamline Operations, Kura Up on Cancer Data).
What's Next in the Biotech World?
Watch out for the usual regulatory and pipeline updates.
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