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Biotech Stock Roundup: Actelion Remains In M&A Spotlight, ASH Data In Focus

Published 12/06/2016, 08:49 PM
Updated 07/09/2023, 06:31 AM

Several companies like Celgene (Read more: Acceleron, Celgene Present Myelodysplastic Syndromes Data), Alexion (Read more: Alexion Presents Data from Ultra-Rare Blood Disorder Study), Juno and Kite (NASDAQ:KITE) were present at the annual meeting of the American Society of Hematology (ASH) with data on approved and pipeline products.

Meanwhile, Switzerland-based Actelion (OTC:ALIOF) continued to be a part of acquisition chatter with Sanofi (PA:SASY) now rumored to be interested in the company.

Recap of the Week’s Most Important Stories

Is Sanofi Planning to Come Up with an Offer for Actelion? Actelion, which had confirmed that it is in discussions with Johnson & Johnson (NYSE:JNJ), could well receive an offer from French pharma giant, Sanofi, according to a Bloomberg article. Per sources, Sanofi is apparently considering a counterbid for Actelion and is weighing its options. The company is yet to decide whether it will approach Actelion with a formal offer.

Meanwhile, according to sources, J&J has hiked its offer though Actelion is reportedly not interested in a complete takeover. We note that Actelion has often been considered an attractive takeover target mainly due to its rare disease portfolio. In addition to holding a strong position in the pulmonary arterial hypertension (PAH) market, Actelion’s portfolio also has treatments approved in certain countries for specialist diseases like type I Gaucher disease, Niemann-Pick type C disease, digital ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma. Actelion has consistently outperformed the Zacks categorized Medical-Biomedical/Genetics industry year-to-date (YTD) with Actelion gaining 50.3% while the Zacks categorized Medical-Biomedical/Genetics industry declined 25.4%.

AbbVie at ASH, Gets Orphan Drug Status for Immunology Drug: AbbVie (NYSE:ABBV) was present at ASH with data on its cancer drug, Imbruvica. The company presented positive mid-stage data from a study in chronic graft-versus-host-disease (cGVHD) patients showing that Imbruvica has the potential to be evaluated for non-cancer ailments. Imbruvica has orphan drug status as well as breakthrough therapy designation in the U.S. for this indication.

AbbVie also announced safety and efficacy findings on Imbruvica from a phase II study in patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) with a 48% overall response rate being observed. AbbVie is currently seeking FDA approval for this slow-growing form of non-Hodgkin's lymphoma for which no specifically indicated treatments or standards of care are available in the U.S.

AbbVie also presented data supporting the use of Imbruvica combination therapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and first-line follicular lymphoma (FL) -- two of the most common types of non-Hodgkin's lymphoma. Moreover, a 5-year analysis of Imbruvica data for chronic lymphocytic leukemia/small lymphocytic lymphoma showed that 89% of patients achieved complete or partial response while long-term RESONATE-2 follow-up data showed lasting efficacy (Read more: AbbVie Presents Impressive Imbruvica Data at ASH).

Meanwhile, AbbVie continues to work on strengthening its presence in cancer and entered into 5-year collaborations with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University as well as the Johns Hopkins University School of Medicine to work in several areas of oncology research including lung, colorectal, breast, prostate and hematological cancer.

Among non-cancer updates, AbbVie’s investigational immunology treatment, risankizumab, got orphan drug status in the U.S. for Crohn's disease in pediatric patients (Read more: AbbVie Crohn's Disease Drug Gets Orphan Drug Status in U.S.).

Amgen Files for Avastin Biosimilar: Amgen (NASDAQ:AMGN) and partner Allergan (NYSE:AGN) have submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for ABP 215, a biosimilar version of Roche’s multi-billion dollar cancer drug, Avastin (bevacizumab). According to the companies, this may be the first bevacizumab biosimilar application to be submitted to the EMA (Read more: Amgen/Allergan File for EU Approval of Avastin Biosimilar). Amgen has performed better than the Zacks categorized Medical-Biomedical/Genetics industry YTD with its shares declining 10.6% compared to the Zacks categorized Medical-Biomedical/Genetics industry decline of 25.4%.

Agios Stumbles on Data: Agios (NASDAQ:AGIO) presented new data on a couple of pipeline candidates, AG-348 and AG-519, at ASH. Although data looked positive at first glance, the AG-348 results fell short of investor expectations while the drug-related cholestatic hepatitis serious adverse event for the 300 mg dose of AG-519 left investors jittery. Shares were down 12.4%. Both molecules are being evaluated for PK deficiency, a rare, potentially debilitating, congenital anemia. Agios has been underperforming the Zacks categorized Medical Products industry -- while the Zacks categorized Medical Products industry declined 1.4% YTD, Agios declined 25.1% during this period.

Kite Starts Rolling BLA Submission for CAR-T Therapy: Kite has started the rolling submission of its BLA for its CAR-T therapy KTE-C19 (axicabtagene ciloleucel) in the U.S. The company said that it expects to complete the submission by Mar 2017. Timely approval would allow the company to launch the product as early as 2017. Kite is looking to get the CAR-T treatment approved for use in patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). The company has breakthrough designation for the candidate. Kite was also present at ASH with data on KTE-C19 (Read more: Kite Pharma Begins Filing for KTE-C19, Presents Data at ASH). Kite has outperformed the Zacks categorized Medical-Biomedical/Genetics industry with shares declining 17.1% compared to the industry decline of 25.4%.

Performance

Medical - Biomedical and Genetics Industry Price Index

The NASDAQ Biotechnology Index declined 2.1% over the last five trading days. All major biotech stocks were down with Vertex (NASDAQ:VRTX) losing 8.8%. Vertex has been underperforming the Zacks categorized Medical-Biomedical/Genetics industry YTD with the stock being affected for a major part of the year by political rhetoric regarding rising drug prices. Over the last six months, Celgene (NASDAQ:CELG) was up 9.1% while Alexion lost 19.9% (See the last biotech stock roundup here: Actelion Soars on Acquisition Talks, Another Clinical Hold for Juno). Celgene is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates from biotech companies.

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VERTEX PHARM (VRTX): Free Stock Analysis Report

CELGENE CORP (CELG): Free Stock Analysis Report

AMGEN INC (AMGN): Free Stock Analysis Report

ACTELION LTD (ALIOF): Free Stock Analysis Report

KITE PHARMA INC (KITE): Free Stock Analysis Report

ABBVIE INC (ABBV): Free Stock Analysis Report

AGIOS PHARMACT (AGIO): Free Stock Analysis Report

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