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Pharma Stock Roundup: NVS Scores with Positive Data, Shire ADHD Drug Gets FDA Nod

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This week’s highlights include positive data from Novartis (NVS - Free Report) while the FDA approved a couple of attention deficit hyperactive disorder (ADHD) drugs.

Recap of the Week’s Most Important Stories

Novartis Eye Drug Hits Endpoints; CANTOS Data Impresses: Novartis’ experimental eye drug, RTH528, was found to be non-inferior to Regeneron’s blockbuster drug Eylea (aflibercept) in a couple of late-stage studies. Adverse event rates were also comparable. The studies were conducted in patients with neovascular age-related macular degeneration (nAMD). Novartis expects to file for approval next year. If approved, RTH528 could have a competitive edge due to a less frequent dosing regimen.

Novartis also impressed with data from a late-stage study (CANTOS) on ACZ885 (canakinumab). Top-line data showed that ACZ885 plus standard of care therapy reduces cardiovascular risk in people with a prior heart attack and inflammatory atherosclerosis. Novartis intends to start discussions with regulatory authorities.

So far in 2017, Novartis has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 18.5% while the industry is up 13.2%.

Subcutaneous Rituxan Formulation Approved: A subcutaneous formulation of Roche’s RHHBY multi-billion dollar drug, Rituxan, gained FDA approval this week. Approval was largely expected considering an FDA advisory panel had voted unanimously in favor of approving the formulation for certain types of blood cancer. Formulated using rHuPH20, a technology licensed from Halozyme, Rituxan Hycela can be administered in five to seven minutes compared to an hour and a half or more for the intravenous formulation.

FDA Green Light for Shire ADHD Drug: Shire’s SHPG ADHD drug, Mydayis, has finally gained FDA approval. Mydayis or SHP465, as it was previously referred to, has had a long journey with the FDA initially giving an approvable letter way back in May 2007. At that time, the agency had asked for additional studies. Shire, a key player in the ADHD market, expects to launch the long-lasting once-daily treatment in the third quarter of 2017. The ADHD market is huge though highly genericized. About 10.5 million adults in the U.S. are estimated to have ADHD (Read more: Shire's ADHD Drug Mydayis Receives Approval in U.S.).

Neos ADHD Drug Too Gets FDA Nod: Shire was not the only company to gain FDA approval for an ADHD drug this week. The FDA also gave its nod to Neos’ NEOS Cotempla XR-ODT, making it the first and only methylphenidate extended-release orally disintegrating tablet to be approved for the treatment of ADHD in patients 6 to 17 years old.

With this approval, Neos has both a branded methylphenidate as well as a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form. Cotempla XR-ODT will be launched this Fall.

Novo Nordisk’s Victoza Label Expansion Plans Get FDA Panel Support: Novo Nordisk’s NVO Victoza (liraglutide) got a favorable vote from an FDA advisory panel regarding the inclusion of data from the cardiovascular outcomes study LEADER in the drug’s label. The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 19-0 in favor of the use of Victoza in type II diabetes patients not being associated with excess cardiovascular risk. The panel voted 17-2 in favor of the study providing enough evidence of reduction in cardiovascular risk in type II diabetes patient on Victoza. With cardiovascular disease being a leading cause of death in type II diabetes patients, the addition of a cardiovascular indication would boost Victoza’s sales potential (Read more: Novo Nordisk's Victoza Gets FDA Panel Nod for Label Expansion).

Novo Nordisk is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Performance

Large Cap Pharmaceuticals Industry 5YR % Return

The NYSE ARCA Pharmaceutical Index was up almost 4% over the last five trading sessions with the sector reacting favorably to rumors that steps taken by the Trump administration to drive down drug prices will not be as draconian as previously expected. Among major stocks, Bristol-Myers BMY was up 5.6% while Merck MRK gained 4.5%. Over the last six months, AstraZeneca was up 30.1% while Bristol-Myers was down 2.4% (See the last pharma stock roundup here: J&J, Lilly Present Data, Merck Keytruda Study Enrolment Paused).

What's Next in the Pharma World?

Watch out for the usual pipeline and regulatory updates.

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