Positive Phase III sets stage for levomilnacipran NDA

Posted under Blog, Companies, Diagnostics, Forest Laboratories, Funding, levomilnacipran, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Investigators at Forest Laboratories ($FRX) and Pierre Fabre Medicament say they're on track to file an NDA for the anti-depression drug levomilnacipran after racking up a fresh set of positive Phase III data. The study was the second of three late-stage clinical trials of the drug. "We have successfully completed two positive Phase III studies for the treatment of MDD in adults and plan to file a new drug application for levomilnacipran with the FDA later this year," said Dr. Marco Taglietti, the head of R&D at the Forest Research Institute. The application is slated for later this year with another Phase III readout expected soon. Release
 

Forest Labs notches victory en route to FDA ruling on COPD drug

Posted under Advair, Almirall, Blog, Companies, COPD, Diagnostics, FDA, Forest Laboratories, Funding, Medical Devices, Medical Supply, Pearl Therapeutics, Pharmaceuticals, QVA149, Relovair, Startups, Universities, Videos by Ryan McBride

Eyeing the major market for a chronic lung condition, Forest Laboratories ($FRX) picked up the backing of an FDA panel for its experimental COPD drug known as aclidinium. It's a key endorsement for the New York-based drugmaker, which would be competing in the COPD arena with a crowd of Big Pharma outfits that includes GlaxoSmithKline ($GSK), Pfizer ($PFE) and AstraZeneca ($AZN) if the FDA approves its treatment.   

Impressed with the clinical evidence on the inhaled drug, the non-agency experts on the FDA panel voted 12-2 that the treatment should be approved, Bloomberg reported. Yet there were concerns raised about the potential cardiovascular side effects linked to the drug, and at least one panelist called for a post-marketing study to dig deeper into the question about the risk. Still, clinical studies showed the drug's cardiovascular risks were lower than those of other COPD treatments, The Wall Street Journal reported.

Forest, which has rights to market aclidinium in the U.S. from Spanish developer Almirall, is in a crowded race to grab a piece of the blockbuster COPD market with a new product. GSK, which already markets Advair for the lung ailment, has a Phase III program under way with partner Theravance ($THRX) for the experimental drug Relovair. Swiss drug giant Novartis ($NVS) has a horse in this race as well with its potential blockbuster QVA149. And up-and-coming developer Pearl Therapeutics, a 2011 Fierce 15 company, is making headway with its mid-stage trials for its own contender.

With a number of existing products already on the market for COPD, which affects 12 million Americans, expect U.S. regulators to have a high safety standard for any candidate that would be used to treat the chronic illness. No doubt they'll likely see plenty of new drugs for the condition over the next few years, allowing regulators to be choosy.  

- check out the WSJ's article
- see the Reuters report
- and Bloomberg's piece

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FDA raises cardio concerns on Forest’s new COPD drug

Posted under aclidinium bromide, Almirall, Blog, Companies, COPD, Diagnostics, Forest Laboratories, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Forest Laboratories ($FRX) and Almirall got a thumbs up from the FDA for their efficacy data on a COPD drug candidate. But regulators want an upcoming panel review to closely explore cardio risks linked with the entire drug class it belongs to. One big issue is whether the companies designed large enough trials to accurately gauge the cardio risk. Story

Gedeon Richter, Forest tout promising results from antipsychotic Ph3

Posted under Bipolar disorder, Blog, Cariprazine, Companies, depression, Diagnostics, Forest Laboratories, Funding, Gedeon Richter, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Investigators are reporting promising preliminary top-line results from a late-stage study of an experimental antipsychotic being studied by Hungary's Gedeon Richter and Forest Laboratories ($FRX). Shares of Gedeon Richter climbed a bit on the news.

Bipolar patients suffering from acute mania reported progress as early as 5 days after beginning treatment with cariprazine (RGH-188). Cariprazine is also being investigated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment for major depression.

"As we continue to move forward with the development of this important compound, these positive phase III results further demonstrate the opportunity for cariprazine as a potential new treatment option for patients suffering from bipolar mania" said Marco Taglietti, senior VP of R&D at the Forest Research Institute.

"In the three consecutive positive trials, statistically significant results demonstrated improvement in symptoms compared to placebo, importantly including the low dose range arm," noted Gedeon's Zsolt Szombathelyi.

- here's the press release
- get the story from Bloomberg

Related Article:
Promising PhIII antipsychotic data sets stage for Forest app