The pharma M&A saga continued this week with two drug giants, Merck MRK and Sanofi SNY offering hefty premiums to buy small cancer drugmakers to strengthen their oncology pipelines. Meanwhile, Lilly LLY began the first-ever randomized late-stage study in treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC).
Recap of the Week’s Most Important Stories:
Merck to Buy ArQule for $2.7B: Merck offered to pay $20 per share in cash for an approximate total equity value of $2.7 billion to buy Massachusetts-based ArQule. The acquisition of ArQule, if successfully closed, is expected to strengthen Merck’s oncology pipeline with the addition of some strategic assets, most notably, ARQ 531, ArQule’s novel, oral Bruton’s tyrosine kinase inhibitor. ARQ 531 is currently being evaluated in a phase II dose expansion study for the treatment of B-cell malignancies.
Sanofi to Buy Synthorx for $2.5B: Sanofi announced a definitive deal to buy small cancer biotech Synthorx for $68 per share in cash, representing an aggregate equity value of approximately $2.5 billion. The deal will add Synthorx’s lead pipeline asset, THOR-707 to Sanofi’s immuno-oncology portfolio. THOR-707 is being evaluated across multiple solid tumor types alone and in combination with immune checkpoint inhibitors.
Sanofi and Regeneron announced their intent to restructure their antibody collaboration for Kevzara and Praluent into a royalty-based agreement while collaboration relating to Dupixent remains unchanged. Under the restructured deal, Sanofi is expected to gain sole global rights to Kevzara and sole ex-U.S. rights to Praluent while Regeneron is expected to gain sole U.S. rights to Praluent.
Meanwhile at its Capital Markets Day, Sanofi said that it is discontinuing all its research activities in diabetes and cardiovascular area. It said it does not plan to launch late-stage type II diabetes candidate, efpeglenatide to help it focus on high growth franchises. Meanwhile, the company said it will prioritize key growth drivers — Dupixent and vaccines — and accelerate R&D focus on six potentially transformative medicines.
Lilly Initiates Lung Cancer Study on Selpercatinib: Lilly began a phase III study to evaluate its oral RET inhibitor, selpercatinib/LOXO-292in previously untreated patients with RET fusion-positive non-small cell lung cancer. The LIBRETTO-431 study, which aims to enrol 400 patients, will evaluate selpercatinib against standard-of-care medicines in the above patient population. Selpercatinib was added to Lilly’s portfolio with the February 2019 acquisition of Loxo Oncology.
Bristol-Myers’ Lymphoma Candidate Meets Goal in Pivotal Study: Bristol-Myers’ BMY pivotal study evaluating its investigational CAR-T therapy lisocabtagene maraleucel (liso-cel) for the treatment of patients with relapsed/refractory large B-cell lymphoma, met the primary and secondary endpoints. Data from the pivotal TRANSCEND NHL 001 study demonstrated that patients treated with liso-cel experienced a high rate of durable responses with low incidence of severe cytokine release syndrome and neurologic events. Based on the positive results from the study, Bristol-Myers plans to submit a biologics license application to the FDA by the end of the year.
Roche Meets Goal in Study on Tecentriq in BRAF-mutant Melanoma: Roche’s RHHBY phase III study evaluating its PD-L1 inhibitor, Tecentriq plus Exelixis’ Cotellic and Roche’s Zelboraf in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, met the primary endpoint. The study demonstrated a significant and clinically meaningful improvement in progression-free-survival, which was the primary endpoint. The data from the study showed that when Tecentriq was added to Cotellic and Zelboraf, it helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf.
AstraZeneca’s Imfinzi Gets China Approval for Lung Cancer: AstraZeneca’s AZN Imfinzi was granted marketing approval in China by National Medical Products Administration (NMPA) for an early-stage lung cancer indication based on positive survival data from the phase III PACIFICstudy. The approval is for the treatment of unresectable, stage III NSCLC patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi is already approved for this indication in many countries including the United States and EU
Pfizer’s Xeljanz XR Gets FDA Nod for Ulcerative Colitis: The FDA granted approval to Pfizer’s PFE Xeljanz extended release tablets (11 mg and 22 mg) as a convenient once-daily dosing option for the treatment of ulcerative colitis. Xeljanz was approved by the FDA in May last year for UC as 10 mg twice-daily (BID) dose for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID
The NYSE ARCA Pharmaceutical Index was up 1.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, all the stocks were in the green with Bristol-Myers rising the most (7.5%).
In the past six months, Bristol-Myers has risen the most (22.7%) while Pfizer (PFE) lost the maximum (12%).
(See the last pharma stock roundup here: FDA Updates for RHHBY, AZN, MRK, JNJ Says No Asbestos in Talc)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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