Replies to post #116181 on Biotech Values

[DewDiligence]

This might reflect on GSK/THRX relovair as it also has a qd LABA component (vilanterol trifenatate).

Do you consider the high dose of QAB149 DoA? The five positive panel votes and the lack of an actual safety signal makes me unsure what the FDA will do.

[DewDiligence]

FDA Orders Large Phase-4 Studies of LABA Drugs

[Inasmuch as drugs in this class have very large sales (e.g. Advair is GSK’s biggest drug with sales of about $5B), this is a meaningful decision by the FDA; however, the results of the studies in question won’t be known until 2017. The FDA’s announcement is at: http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm .]

http://www.reuters.com/article/2011/04/15/fda-asthma-idUSN1526503920110415

›Fri Apr 15, 2011 3:25pm EDT
By Esha Dey and Bill Berkrot

WASHINGTON/NEW YORK, April 15 (Reuters) - U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients [!] to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.

LABAs to be studied are AstraZeneca's (AZN) Symbicort, GlaxoSmithKline's (GSK) Advair Diskus, Merck & Co's (MRK) Dulera, and Novartis AG's (NVS) Foradil [i.e. all drugs of any consequence in this class].

LABAs have long been under FDA scrutiny as they can increase the risk of severely worsening asthma symptoms that can lead to hospitalizations and death.

The drugs work by relaxing the muscles of the airways to help people breathe easier and are also used to treat the serious lung condition, chronic obstructive pulmonary disease (COPD).

The FDA expects to receive results in 2017 for the studies that will begin later this year.

In four of the trials sought by the FDA, each of the LABAs plus a corticosteroid will be compared with the steroid alone in patients 12 years of age and older. Those studies are expected to include a total of 46,800 patients.

Some of these drugs. such as Advair and Symbicort, are combination drugs that include a LABA with a corticosteroid.

The agency has also asked for a trial of 6,200 younger patients, aged 4 to 11, using Glaxo's Advair Diskus.

The huge size of the studies signals that FDA wants to be completely sure about the safety profile of these drugs as they are used so widely, Morningstar analyst Damien Conover said.

Such a large study population might pose some financial challenges for the drugmakers, he said.

"Glaxo is complying with the FDA request to implement the Phase 4 study," Glaxo spokeswoman Lisa Behrens said of the post-marketing trial.

AstraZeneca said it was finalizing study protocol with the agency and supports efforts to address any questions regarding use of its drug.

Novartis said it was reviewing the post-marketing requirements issued by the FDA, while Merck said it would have a comment shortly.

The FDA last June issued warnings on LABAs, saying they should never be used on their own to treat asthma and called on drugmakers to conduct further studies to better understand the safety of LABAs when used with inhaled steroids.‹

[DewDiligence]

NVA237 Succeeds in ‘GLOW1’ Phase-3 Study in COPD

[NVA237 is a long-acting muscarinic antagonist (LAMA) that NVS is developing as a monotherapy for COPD and as a combination therapy with QAB149 for asthma and COPD. Please see #msg-60523825 and #msg-60733567 for background.]

http://finance.yahoo.com/news/Phase-III-Data-Show-NVA237-prnews-3721282702.html?x=0&.v=1

›Source: Sosei Group
Tuesday April 19, 2011, 2:00 am EDT

TOKYO, April 19, 2011 /PRNewswire-FirstCall/ --

- Data From the Novartis Pivotal GLOW1 Study Show Once-Daily NVA237 met its Primary Endpoint, Demonstrating Superior Bronchodilation (Trough FEV1) Relative to Placebo (p<0.001) at 12 Weeks

- NVA237 Significantly Improved Lung Function While Demonstrating a Good Safety Profile in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

- Detailed Results to be Presented at a Scientific Congress in H2 2011

Sosei Group Corporation announces that NVA237, a long-acting muscarinic antagonist (LAMA) being investigated as a once daily treatment for chronic obstructive pulmonary disease (COPD), achieved its primary endpoint in a Phase III study. As part of its first quarter earnings release today, Novartis confirmed results from the first Phase III clinical trial with once-daily NVA237 (glycopyrronium bromide) show that it significantly improved lung function while demonstrating a good safety profile in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

The pivotal double-blind 26-week GLOW1 study met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function (p<0.001).

The incidence of adverse events was similar in the NVA237 treated patients and in those receiving placebo. Detailed data will be presented at a scientific congress in H2 2011.

Mr Shinichi Tamura, CEO of Sosei, said:

"We are very encouraged that results from the initial pivotal GLOW1 trial, showing significantly increased lung function with a positive safety profile, have provided further confirmation of the clinical potential of NVA237 as a novel once-daily LAMA therapy for COPD patients."

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Novartis intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD. The first launch for QVA149; the combination of NVA237 with Novartis' once-daily, long-acting beta2-agonist (LABA), indacaterol, is planned for 2013. Indacaterol is now approved in more than 50 countries and available in more than 20, with US approval dependent on an FDA decision expected in July 2011.

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.‹