Glaxo (GSK - Free Report) made some of the biggest announcements this week. On the one hand, it announced the divestiture of Horlicks and other nutrition products business in India and Bangladesh to Unilever while on the other hand it announced a definitive deal to buy small cancer biotech, TESARO, Inc. Meanwhile, at the annual meeting of the American Society of Hematology (ASH) held in San Diego, CA, several companies presented data, mostly long term, from studies on their cancer drugs.
Recap of the Week’s Most Important Stories
Glaxo Sells Horlicks to Unilever, to Buy TESARO: Glaxo said that it is divesting its Horlicks and other nutrition products business in India and Bangladesh to Unilever for 3.3 billion euros ($3.8 billion) in a cash-and-stock deal. In addition to selling its 72.5% stake in its India-based subsidiary GSK Consumer Healthcare Limited, Glaxo will sell its 82% stake in its subsidiary in Bangladesh, GlaxoSmithKline Bangladesh Limited, and certain other assets outside India to Unilever. GSK Consumer Healthcare Limited - which sells these nutrition products —will merge with Unilever’s listed Indian counterpart Hindustan Unilever Limited (“HUL”). Emma Walmsley said that the proceeds generated from the deal will be used to invest in Glaxo’s growing pharmaceuticals business.
Alongside, Glaxo announced a definitive agreement to acquire small cancer biotech, TESARO for $5.1 billion including the latter’s debt. The acquisition will add TESARO’s orally-available PARP inhibitor, Zejula to Glaxo’s product portfolio and strengthen the latter’s position in the oncology market. However, the acquisition announcement did not go down well with investors as they found it to be a costly deal for Glaxo, considering that Zejula is at an early stage of commercialization in a fiercely competitive market.
Cancer Update from ASH: At ASH, AbbVie (ABBV - Free Report) and J&J (JNJ - Free Report) presented interim data from a phase III study, which evaluated their drug Imbruvica in combination with Roche’s (RHHBY - Free Report) Rituxan versus standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) in previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. At nearly three years of follow-up, the data showed that Imbruvica+Rituxan significantly prolonged progression-free survival (PFS) and improved overall survival (OS) compared to FCR.
Also, long-term follow up data from a phase Ib/II study on Imbruvica in CLL/SLL patients showed that with up to seven years of follow up treatment, Imbruvica led to durable responses in such patients with an overall response rate (ORR) of 89%. Moreover, the drug sustained PFS in 80% of previously untreated patients over seven years of treatment duration.
AbbVie and Roche also presented encouraging 36 month follow-up data from the phase III MURANO study of Venclexta in combination with Rituxan in previously treated chronic lymphocytic leukemia patients. The data showed continued clinical benefit of Venclexta plus Rituxan was sustained after patients completed a fixed-duration regimen. Roche also presented updated results from two studies in newly-diagnosed AML patients, which demonstrated that Venclexta combinations continued high rates of deep remission.
At ASH, Roche also presented longer-term data from the phase Ib/II GO29365 study evaluating its pipeline candidate polatuzumab vedotin for the treatment of relapsed or refractory diffuse large B-cell lymphoma in patients not eligible for a hematopoietic stem cell transplant. The data showed that polatuzumab vedotin in combination with MabThera/Rituxan (rituximab) plus bendamustine more than doubled overall survival, compared to MabThera/Rituxan plus bendamustine alone in the study.
J&J presented data from a the phase III MAIA study on Darzalex in combination with a standard-of-care treatment regimen in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The data showed that the addition of Darzalex to lenalidomide and dexamethasone (Rd) significantly reduced the risk of disease progression or death by 44% in such patients compared to treatment with Rd alone. J&J also presented updated long-term data from the phase III ALCYONE study on Darzalex, which showed that addition of Darzalex to bortezomib, melphalan and prednisone (VMP) continued to show improvement in progression-free survival and response rates in newly diagnosed patients.
In addition, J&J also presented data from the phase II LYRA and GRIFFIN studies on Darzalex. The data supports efficacy and safety of Darzalex in newly diagnosed patients, including those who are eligible for high-dose therapy/ASCT and in relapsed patients.
Pfizer (PFE - Free Report) presented positive 26-week data from ongoing 52-week REFLECTIONS B328-06 study on PF-05280586, its biosimilar version of Roche’s Rituxan. Pfizer announced that the study met its primary endpoint of overall response rate (ORR) at week 26. PF-05280586 is under review in the United States with the FDA decision expected in the second quarter of 2019.
Novartis (NVS - Free Report) presented longer-term analyses from pivotal studies on Kymriah that showed durable responses are maintained in patients with advanced blood cancers. AstraZeneca (AZN - Free Report) also presented new, long-term follow-up results from leukemia/lymphoma studies on its new cancer drug, Calquence.
AbbVie’s Key Lung Cancer Study on Rova-T Halted: AbbVie said it is stopping enrollment in a late-stage study, TAHOE, evaluating its cancer candidate rovalpituzumab tesirine or Rova-T in second-line small cell lung cancer (SCLC). The Independent Data Monitoring Committee (IDMC) responsible for ongoing review of data recommended stoppage of enrollment. Rova-T was added to AbbVie’s portfolio following the $5.8 billion acquisition of Stemcentrx in June 2016.
In March this year, Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later SCLC. The failure of TRINITY and now the clinical hold on TAHOE raised skepticism about Rova-T’s potential and has brought into question the viability of the Stemcentrx deal.
AbbVie also signed another licensing deal to protect revenues from its blockbuster arthritis drug, Humira. This time the settlement is with Pfizer, per which the latter will have anon-exclusive license to launch Humira in the United States on Nov 20, 2023. In the EU, Pfizer can launch Humira biosimilar when it gets approval from the European Medicines Agency.
Roche’s Breast Cancer Drugs Cut Death Risk in Study: Roche’s breast cancer drug, Kadcyla significantly reduced the risk of disease recurrence by 50% in the phase III KATHERINE study, which compared it to Herceptin for the treatment of HER2-positive early breast cancer patients with residual disease following a neoadjuvant (before surgery) therapy. The company is planning to submit regulatory applications for label expansion of Kadcyla in early breast cancer patients based on the study data.
J&J Buys Rights to Oncology Candidate: J&J entered into a global collaboration and license agreement with Netherlands based argenx BVBA and argenx SE to jointly develop and globally commercialize the latter’s promising antibody, cusatuzumab. Cusatuzumab is currently being evaluated in phase I/II studies in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). Additionally, J&J will buy a stake in argenx SE. For the deal, J&J will make an upfront payment of $300 million and will also be entitled to pay future milestone payments based on achievement of certain milestones.
FDA Grants Priority Review to Novartis’ SMA Candidate: Novartis announced that the FDA has accepted its regulatory filing looking for approval of its pipeline candidate, AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1, a progressive neuromuscular disease.
With the FDA granting priority review to the biologics license application (BLA), a decision on AVXS-101, now known as ZOLGENSMA, is expected in May next year. Please note that AVXS-101 was added to Novartis’ portfolio with the April acquisition of clinical-stage gene therapy company, AveXis, Inc.
Novartis also announced the initiation of phase III studies on pipeline candidate, ligelizumab (QGE031), a monoclonal antibody, in chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines.
The NYSE ARCA Pharmaceutical Index declined 1.3% in the last four trading sessions.
Here is how the seven major stocks performed in the last four trading sessions:
While Bristol-Myers recorded the highest gain (2.8%), Glaxo declined the most (9.4%) in the last four trading sessions.
In the past six months, Lilly has been the biggest gainer (34.5%) while Glaxo recorded the lowest gain (8.8%).
(See the last pharma stock roundup here: Cancer Approvals for PFE & ABBV, CHMP Nod for Several Drugs)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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