This week, industry bellwether J&J (JNJ - Free Report) provided an update on its pharmaceutical products pipeline at a meeting and said it expects to launch or file for approval for more than 10 new blockbuster products by 2021. Meanwhile, Shire’s (SHPG - Free Report) shares were up 4.3% on pipeline data.
Recap of the Week’s Most Important Stories
J&J Unveils Pharma Pipeline: J&J showcased its pharmaceutical products pipeline at a meeting with industry analysts. The company expects to launch or file for approval for more than 10 new blockbuster products by 2021. More than 50 line-extension regulatory filings are also expected by 2021.
The company’s key areas of focus include immunology, infectious diseases & vaccines, neuroscience, cardiovascular & metabolism, and oncology while a sixth therapeutic area -- pulmonary arterial hypertension -- will be added once the Actelion acquisition goes through later this quarter.
Some of the potential blockbusters in the company’s pipeline include guselkumab (psoriasis), sirukumab (rheumatoid arthritis), apalutamide (pre-metastatic prostate cancer), esketamine (treatment-resistant depression), talacotuzumab (acute myeloid leukemia), erdafitinib (solid tumors), niraparib (prostate cancer) and imetelstat (myelofibrosis) among others. Guselkumab and sirukumab could gain approval and be launched later this year (Read more: J&J Plans to Seek Approval for 10 New Drugs by 2021).
Merck’s Keytruda Gets FDA Nod for Bladder Cancer Settings: Merck (MRK - Free Report) added two more indications to the label of its anti-PD-1 therapy, Keytruda with the FDA giving its nod for the use of Keytruda for the first- as well as second-line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
Lilly to File for Migraine Drug in 2H17: Lilly’s (LLY - Free Report) experimental migraine treatment, galcanezumab, met its primary endpoint in three late-stage studies showing statistically significant reductions in the number of monthly migraine headache days compared to placebo at both studied doses. Lilly plans to file for FDA approval in the second half of the year. Galcanezumab is also being studied for the treatment of cluster headache with phase III results expected next year (Read more: Lilly's Migraine Drug Phase III Trials Meet Primary Endpoint).
Shire Gains on HAE Data: Shire’s shares were up on impressive data from a late-stage study evaluating lanadelumab in patients with hereditary angioedema (HAE), a rare genetic disease estimated to affect about 1 in 10,000 to 1 in 50,000 people across the world. Treatment with lanadelumab cut HAE monthly attack rates by 87% compared to placebo.
Lanadelumab, which has blockbuster potential, could provide patients with a favorable dosing option as it has the potential to be administered as infrequently as every four weeks. Currently available treatments include injections for acute attacks or short-acting intravenous infusions administered twice a week. Shire itself has a strong presence in the HAE market with products like Cinryze, Firazyr and Kalbitor in its portfolio.
Shire intends to seek FDA approval later this year or early next year. Lanadelumab has orphan drug as well as breakthrough therapy designation in the U.S. and orphan drug status from the European Medicines Agency (EMA).
Year-to-date, Shire has outperformed the Zacks-categorized Medical-Drugs industry with shares gaining 11.5% compared to the industry gain of 4.9%.
Priority Review for Bayer Cancer Drug: Bayer’s (BAYRY - Free Report) PI3K inhibitor, copanlisib, has been granted priority review by the FDA for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. Priority review means the FDA will complete its review within 6 months instead of the usual 10 months.
Bayer is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. So far in 2017, Bayer has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 24.6% while the industry is up 8.2%.
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up slightly (0.3%) over the last five trading sessions. AstraZeneca was up 9.3% while both Pfizer and Bristol-Myers (BMY - Free Report) slipped 2.5%. Over the last six months, AstraZeneca was up 25.4% while Bristol-Myers was down 5.3% (See the last pharma stock roundup here: Mylan, Teva Q1 Earnings, Roche Drug Misses in Pivotal Study).
What's Next in the Pharma World?
Sanofi (SNY - Free Report) and partner, Regeneron, expect a decision from the FDA for their experimental rheumatoid arthritis (RA) drug Kevzara (sarilumab) on May 22, 2017. Kevzara’s approval would be a major positive for the companies with the drug representing blockbuster potential.
Meanwhile, AstraZeneca will be presenting new data from its respiratory portfolio and pipeline at the 113th annual conference of the American Thoracic Society (ATS).
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