It was another busy week for the pharma sector, marked by earnings of bigwigs like Pfizer (PFE - Free Report) , Allergan (AGN - Free Report) , Sanofi (SNY - Free Report) and Glaxo (GSK - Free Report) . Merck (MRK - Free Report) and AbbVie (ABBV - Free Report) gained regulatory approvals for label expansion of their key cancer drugs. Eli Lilly (LLY - Free Report) , Pfizer and Sanofi announced collaboration deals.
Recap of the Week’s Most Important Stories
Earnings: Pfizer beat estimates for third-quarter earnings while recording in-line sales. The company narrowed its earnings as well as sales expectations for the full year. Pfizer attributed the lowered sales guidance to weaker-than-expected revenues in the Essential Health segment as a result of continued shortages in the sterile-injections business, and currency headwinds.
Allergan delivered solid performance in the third quarter, beating estimates for both earnings and sales while also raising its full-year expectations. However, revenues declined year over year as some of its key blockbuster drugs lost exclusivity and are facing generic competition.
Sanofi and Glaxo beat estimates for earnings as well as sales in the third quarter. Both the companies raised the lower end of their full-year earnings growth guidance.
Collaboration/Divestiture Announcements: Lilly signed a deal with Dicerna Pharmaceuticals to help develop new medicines for the treatment of cardio-metabolic, neurodegeneration disorders and pain using the latter’s proprietary RNAi technology platform. RNAi is an emerging technology for drug discovery attracting the attention of big drugmakers.
Per the deal, Lilly will make an upfront payment of $100 million to Dicerna as well as invest $100 million in the latter’s stock. In addition, Dicerna is eligible to receive up to approximately $350 million for each development target and also commercialization milestones and royalties.
Two big drug giants, Pfizer and Novartis, came together to research on combination therapies of their early-stage investigational candidates for the treatment of non-alcoholic steatohepatitis (NASH), a fatty liver disease with no approved treatments at present. Pfizer has three candidates in clinical development with several others in pre-clinical stage for NASH. Per the deal, one or more of Pfizer’s three early-stage candidates will be studied in combination with Novartis’s tropifexor targeting different pathways in NASH.
Sanofi said it plans to collaborate with Denali Therapeutics to develop multiple molecules, which have the potential to treat neurologic and inflammatory diseases like multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and systemic inflammatory diseases. For the deal, Sanofi will pay $125 million upfront payment and Denali Therapeutics will also be entitled to future milestone payments that could amount to more than $1 billion.
AstraZeneca announced an agreement to divest European rights to its acid reflux medicine, Nexium and worldwide rights (excluding the US and Japan) to arthritis pain reliever, Vimovo to Grünenthal. The divestiture will allow AstraZeneca to focus on its core areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory. For the purchase, Grünenthal will make upfront payments of $700 million and $150 million for Nexium and Vimovo, respectively. AstraZeneca will also be entitled to future milestones and sales-related payments of up to $107 million. AstraZeneca will continue to market Nexium in markets outside EU.
Merck’s Keytruda Gets FDA Nod for Difficult Lung Cancer: Merck received FDA approval for the label expansion of its blockbuster PD-1 inhibitor, Keytruda (in combination with chemotherapy) for first-line treatment of metastatic squamous NSCLC — a difficult-to-treat lung cancer patient population. The supplemental biologics license application (sBLA) filing was based on data from the KEYNOTE-407 study.
We remind investors that data presented from this study stole the limelight at the annual meeting of the American Society of Clinical Oncology in June. Data from the study showed that the combination of Keytruda plus chemotherapy led to significant improvement in both overall survival (OS) and progression-free survival regardless of tumor PD-L1 expression status. The approval further strengthens Keytruda’s position in the lung cancer market.
AbbVie Gets EU Approval for Venclexta and Rituxan Combo: AbbVie received European Commission’s (EC) marketing approval for use of Venclexta in combination with Roche’s MabThera (rituximab) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (“CLL”) who have received at least one prior therapy. Regulatory applications seeking approval for the combination use in this broader patient population were approved in the United States in June.
Label expansion for this indication should expand the patient population for Venclexta significantly and boost its commercial potential. The approval was based on positive data from the phase III MURANO study, which showed that the combination led to a profound improvement in progression free survival compared to Treanda plus Rituxan.
AbbVie also announced that a phase III study evaluating a Venclexta combo met the primary endpoint. The study, CLL14, was evaluating a combination of Venclexta plus Roche’s Gazyva (obinutuzumab) as a first-line therapy with a fixed duration of treatment in patients with chronic lymphocytic leukemia versus standard of care Gazyva plus chlorambucil. Data from the study demonstrated that patients in the Venclexta arm had superior progression-free survival (PFS) compared to those in the standard of care arm. AbbVie is optimistic that the data may serve as the basis to expand into first-line setting.
District Court Invalidates J&J’s Zytiga Patent: A New Jersey district court invalidated J&J’s patent (patent ‘438) related to Zytiga, opening the doors for generic launches. However, the court prohibited commercial launches of generic products before Oct 31. J&J said it will appeal the court’s decision. Several generic companies are looking to bring generic versions of 250 mg and/or 500 mg tablets of Zytiga.
In a separate development, J&J received FDA approval for the inclusion of cardiovascular outcomes data from the CANVAS program on the label of its diabetes drug, Invokana. This means the drug can be prescribed to reduce the risk of cardiovascular events like heart attack, stroke or cardiovascular death in adults with type II diabetes and established cardiovascular disease. The filing was based on data from a large CANVAS outcomes program. However, the label will include a warning about an increased risk of amputations. A similar label update was approved in the EU in September.
Glaxo Presents New HIV Data: Glaxo’s HIV company, ViiV Healthcare announced 160-week data from the LATTE-2 phase IIb study evaluating the efficacy of a long-lasting HIV injection in ART-naïve HIV patients. Data from the study showed that the long-acting, two-drug, injectable regimen of cabotegravir and rilpivirine led to high rates of virologic response, long-term durability of virologic response and good overall tolerability. In the study, the patients were administered cabotegravir+rilpivirine either every eight weeks or every four weeks.
Glaxo also announced positive headline 48-week results from another study, FLAIR, evaluating the once monthly dose of the long-lasting HIV injection. The study met the primary endpoint, showing similar efficacy of the once-monthly regimen as a daily, oral three-drug HIV pill in virally-suppressed adults.
Glaxo is developing the long-acting injectable dosing regimen to reduce the patients’ number of annual doses from 365 to 12.
The NYSE ARCA Pharmaceutical Index rose 2.2 % in the last five trading sessions.
All stocks were in the green this week except Lilly, which declined 0.1%. Bristol-Myers rose the most (5.9%) in the last five trading sessions.
In the past six months, Lilly (LLY - Free Report) has been the biggest gainer (38.2%) while Bristol-Myers recorded the lowest gain (1.3%).
(See the last pharma stock roundup here: MRK, BMY Q3 Earnings, Cancer Data Presentations at ESMO)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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