First-quarter results of pharma bigwigs like Pfizer PFE , Merck MRK and Allergan AGN stole the limelight this week. Other than that, Novartis NVS gained FDA approval for the second indication of its CAR-T therapy, Kymriah. While AbbVie ABBV submitted a regulatory application in the EU for its psoriasis candidate, risankizumab, Merck's PD-L1 inhibitor, Keytruda gained FDA's Priority Review status for yet another label expansion application.
Recap of the Week's Most Important Stories
Mixed Q1 Results for Merck & Pfizer: Both the pharma giants beat estimates for earnings but missed the same for sales. While Pfizer re-affirmed its previously issued guidance for 2018, Merck raised its outlook for both earnings and sales. Both the companies witnessed a relatively weaker top-line performance in the quarter.
For Merck, strong sales of Keytruda, Gardasil and Bridion were partially offset by lower sales of other key therapies - RotaTeq, Zepatier and Zostavax. Meanwhile, loss of market exclusivity for several drugs also hurt the top line.
While for Pfizer, the top-line was hurt by decline in sales of key drugs like Lyrica, Prevnar 13/Prevenar 13, and Enbrel, loss of exclusivity for some products like Viagra and Pristiq and continued supply shortages in legacy Hospira products.
Allergan beat estimates for both earnings and revenues in the first quarter of 2018 and raised its 2018 guidance for both earnings and sales.
Novartis' Kymriah Gets FDA Approval for Second Indication: Novartis' supplemental Biologics License Application (sBLA) looking to get its CAR-T therapy Kymriah approved for the second indication was granted approval by the FDA. With the latest approval, Kymriah suspension has been approved for intravenous infusion for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Kymriah was the first CAR-T therapy to obtain FDA approval in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.
Separately, Novartis announced that the FDA has given a complete response letter to its BLA for its proposed biosimilar version of Roche's cancer drug, Rituxan.
Merck's Keytruda in News: Merck's supplemental Biologics License Application (sBLA) looking to get overall survival data from the phase III KEYNOTE-189 study included on the label of the PD-L1 inhibitor, Keytruda was granted priority review by the FDA. The FDA will give its decision on Sep 23, 2018.
The study evaluated Keytruda, in combination with Lilly's Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic non-squamous NSCLC regardless of PD-L1 expression. The combination treatment improved overall survival regardless of PD-L1 expression including in patients whose tumors tested negative for PD-L1.
Notably, in May 2017, this combination therapy was granted an accelerated approval by the FDA for the aforementioned indication. The approval was based on tumor response rate and PFS data from the KEYNOTE-021 study. Hence, the positive readouts from the KEYNOTE-189 confirmatory study will help the company gain continued approval for the combo therapy, which should support uptake and sales.
Merck also announced interim data from another pivotal lung cancer study on Keytruda, which met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants. The phase 3 KEYNOTE-407 study evaluated Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel for the first-line treatment of metastatic squamous NSCLC.
AbbVie Submits Application for Psoriasis Candidate in EU : AbbVie submitted a marketing application to the European regulatory authorities for investigational interleukin-23 (IL-23) inhibitor, risankizumab for the treatment of moderate-to-severe plaque psoriasis. The Marketing Authorization Application (MAA) is supported by data from four pivotal phase III studies. Data from these studies have shown that more than half of the patients receiving risankizumab achieved complete skin clearance at one year.
Meanwhile, AbbVie also announced commencement of a self-tender offer for up to $7.5 billion of its common stock at a price not less than $99.00 per share and not more than $114.00 per share.
United Therapeutics to Acquire SteadyMed: United Therapeutics Corporation UTHR announced a definitive merger agreement with SteadyMed Ltd. per which United Therapeutics will acquire the latter for $216 million including contingent payments. With the deal, United Therapeutics will add SteadyMed's drug device pipeline product, Trevyent for pulmonary arterial hypertension (PAH) patients to its portfolio. The product could have posed competition to United Therapeutics' RemoSynch implantable pump, which is under review in the United States.
Trevyent is a single-use, pre-filled pump that has been developed by SteadyMed to deliver a two-day supply of treprostinil subcutaneously using SteadyMed's PatchPump technology to treat PAH. Though SteadyMed received a refuse-to-file letter from the FDA for want of further information, SteadyMed intends to resubmit its NDA by the end of 2018.
Allergan's Ubrogepant Succeeds in 2nd Phase III Study: Allergan announced that the second of two pivotal phase III studies evaluating its oral anti-CGRP acute migraine treatment ubrogepant met its co-primary endpoints. The phase III data showed ubrogepant displaying strong efficacy and a clean side effect profile.
The ACHIEVE II study evaluated the efficacy and safety of orally administered ubrogepant (25 mg and 50 mg) for treating a single migraine attack of moderate-to-severe headache intensity.
The study data demonstrated that a "significant greater percentage of patients" treated with ubrogepant, at both the doses, were free from pain at two hours after the initial dose as compared to those treated with placebo. Also, a statistically significant greater percentage of ubrogepant patients taking the 50 mg dose experienced absence of the "most bothersome migraine-associated symptom" -- either photophobia, phonophobia or nausea -- at two hours after the initial dose compared to those treated with placebo. However, the 25 mg dose failed to demonstrate statistical significance in this endpoint.
J&J Seeks Label Expansion of PAH Drug: J&J's JNJ Actelion submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval for a label expansion of its PAH drug, Opsumit (macitentan) to include treatment of patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Also, J&J announced a definitive agreement to acquire private biotech, BeneVir Biopharm. BeneVir, which makes oncolytic immunotherapies utilizing its proprietary, T-Stealth Oncolytic Virus Platform and has potential in the treatment of solid tumors
The NYSE ARCA Pharmaceutical Index declined 2.5% 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:
All stocks declined last week except AstraZeneca, which rose 1.4%. Pfizer declined the most (5.7%).
In the last six months, Glaxo was the biggest gainer (9.6%), while Bristol Myers declined the most (16.6%).
(See the last pharma stock roundup here: Pharma Stock Roundup: NVS, JNJ Q1 Sales & Earnings Top, MRK & BMY Active at AACR )
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates.
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